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May 27, 2023

Zika Virus Infection Fast Facts | CNN

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CNN
—

Here’s a look at Zika virus, an illness spread through mosquito bites that can cause birth defects and other neurological defects.

Sources: Centers for Disease Control and Prevention (CDC), World Health Organization (WHO) and CNN

Zika virus is a flavivirus, part of the same family as yellow fever, West Nile, chikungunya and dengue fever.

Zika is primarily transmitted through the bite of an infected female Aedes aegypti mosquito. It becomes infected from biting an infected human and then transmits the virus to another person. The Aedes aegypti mosquito is an aggressive species, active day and night and usually bites when it is light out. The virus can be transmitted from a pregnant woman to her fetus, through sexual contact, blood transfusion or by needle.

The FDA approved the first human trial of a Zika vaccine in June 2016. As of May 2022, there is still no available vaccine or medication.

Cases including confirmed, probable or suspected cases of Zika in US states and territories updated by the CDC.

Most people infected with Zika virus won’t have symptoms. If there are symptoms, they will last for a few days to a week.

Fever, rash, joint pain and conjunctivitis (red eyes) are the most common symptoms. Some patients may also experience muscle pain or headaches.

Zika virus infection during pregnancy can cause microcephaly, a neurological disorder that results in babies being born with abnormally small heads. Microcephaly can cause severe developmental issues and sometimes death. A Zika infection may cause other birth defects, including eye problems, hearing loss and impaired growth. Miscarriage can also occur.

An August 2018 report published by the CDC estimates that nearly one in seven babies born to women infected with the Zika virus while pregnant had one or more health problems possibly caused by the virus, including microcephaly.

According to the CDC, there is no evidence that previous infection will affect future pregnancies.

(Sources: WHO, CDC and CNN)

1947 – The Zika virus is first discovered in a monkey by scientists studying yellow fever in Uganda’s Zika forest.

1948 – The virus is isolated from Aedes africanus mosquito samples in the Zika forest.

1964 – First active case of Zika virus found in humans. While researchers had found antibodies in the blood of people in both Uganda and in Tanzania as far back as 1952, this is the first known case of the active virus in humans. The infected man developed a pinkish rash over most of his body but reported the illness as “mild,” with none of the pain associated with dengue and chikungunya.

1960s-1980s – A small number of countries in West Africa and Asia find Zika in mosquitoes, and isolated, rare cases are reported in humans.

April-July 2007 – The first major outbreak in humans occurs on Yap Island, Federated States of Micronesia. Of the suspected 185 cases reported, 49 are confirmed, and 59 are considered probable. There are an additional 77 suspected cases. No deaths are reported.

2008 – Two American researchers studying in Senegal become ill with the Zika virus after returning to the United States. Subsequently, one of the researchers transmits the virus to his wife.

2013-2014 – A large outbreak of Zika occurs in French Polynesia, with about 32,000 suspected cases. There are also outbreaks in the Pacific Islands during this time. An uptick in cases of Guillain-Barré Syndrome during the same period suggests a possible link between the Zika virus and the rare neurological syndrome. However, it was not proven because the islands were also experiencing an outbreak of dengue fever at the time.

March 2015 – Brazil alerts the WHO to an illness with skin rash that is present in the northeastern region of the country. From February 2015 to April 29, 2015, nearly 7,000 cases of illness with a skin rash are reported. Later in the month, Brazil provides additional information to WHO on the illnesses.

April 29, 2015 – A state laboratory in Brazil informs the WHO that preliminary samples have tested positive for the Zika virus.

May 7, 2015 – The outbreak of the Zika virus in Brazil prompts the WHO and the Pan American Health Organization (PAHO) to issue an epidemiological alert.

October 30, 2015 – Brazil reports an increase in the cases of microcephaly, babies born with abnormally small heads: 54 cases between August and October 30.

November 11, 2015 – Brazil declares a national public health emergency as the number of newborns with microcephaly continues to rise.

November 27, 2015 – Brazil reports it is examining 739 cases of microcephaly.

November 28, 2015 – Brazil reports three deaths from Zika infection: two adults and one newborn.

January 15 and 22, 2016 – The CDC advises all pregnant women or those trying to become pregnant to postpone travel or consult their physicians prior to traveling to any of the countries where Zika is active.

February 2016 – The CDC reports Zika virus in brain tissue samples from two Brazilian babies who died within a day of birth, as well as in fetal tissue from two miscarriages providing the first proof of a potential connection between Zika and the rising number of birth defects, stillbirths and miscarriages in mothers infected with the virus.

February 1, 2016 – The WHO declares Zika a Public Health Emergency of International Concern due to the increase of neurological disorders, such as microcephaly, in areas of French Polynesia and Brazil.

February 8, 2016 – The CDC elevates its Emergency Operations Center for Zika to Level 1, the highest level of response at the CDC.

February 26, 2016 – Amid indications that the mosquito-borne Zika virus is causing microcephaly in newborns, the CDC advises pregnant women to “consider not going” to the Olympics in Rio de Janeiro. The CDC later strengthens the advisory, telling pregnant women, “Do not go to the Olympics.”

March 4, 2016 – The US Olympic Committee announces the formation of an infectious disease advisory group to help the USOC establish “best practices regarding the mitigation, assessment and management of infectious disease, paying particular attention to how issues may affect athletes and staff participating in the upcoming Olympic and Paralympic Games.”

April 13, 2016 – During a press briefing, CDC Director Thomas Frieden said, “It is now clear the CDC has concluded that Zika does cause microcephaly. This confirmation is based on a thorough review of the best scientific evidence conducted by CDC and other experts in maternal and fetal health and mosquito-borne diseases.”

May 27, 2016 – More than 100 prominent doctors and scientists sign an open letter to WHO Director General Margaret Chan, calling for the summer Olympic Games in Rio de Janeiro to be postponed or moved “in the name of public health” due to the widening Zika outbreak in Brazil.

July 8, 2016 – Health officials in Utah report the first Zika-related death in the continental United States.

August 1, 2016 – Pregnant women and their partners are advised by the CDC not to visit the Miami neighborhood of Wynwood as four cases of the disease have been reported in the small community and local mosquitoes are believed to be spreading the infection.

September 19, 2016 – The CDC announces that it has successfully reduced the population of Zika-carrying mosquitoes in Wynwood and lifts its advisory against travel to the community.

November 18, 2016 – The WHO declares that the Zika virus outbreak is no longer a public health emergency, shifting the focus to long-term plans to research the disease and birth defects linked to the virus.

November 28, 2016 – Health officials announce Texas has become the second state in the continental United States to confirm a locally transmitted case of Zika virus.

September 29, 2017 – The CDC deactivates its emergency response for Zika virus, which was activated in January 2016.

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May 26, 2023

Autism Fast Facts | CNN

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CNN
—

Here is a look at autism.

Autism or autism spectrum disorder (ASD) incorporates a group of neurodevelopmental disorders causing impaired communication skills and social skills. ASD generally starts before three years of age and lasts a lifetime, but early intervention plays a role in treatment and progress.

ASD is about four times more common among boys than girls, according to the Centers for Disease Control and Prevention (CDC).

ASD can be found among all races, ethnicities and socioeconomic groups.

The prevalence of ASD in the United States is about one in 36 8-year-olds, according to a 2023 CDC report.

Health care costs for children with autism are four to six times greater than medical costs for children without autism, according to research published in the Journal of Autism and Developmental Disorders.

April 2 is World Autism Day.

There is no definitive medical test to diagnose autism. Instead, the disorder is diagnosed by observing a child’s development.

According to the CDC, signs of autism may include deficits in social communication and interaction in a variety of contexts, difficulty engaging in back-and-forth conversation and an absence of interest in forming friendships with peers.

The debate over whether autism spectrum disorders are caused by vaccines started in 1998 when the medical journal The Lancet published a now-retracted study by researcher Andrew Wakefield linking the MMR vaccine to autism.

Most of Wakefield’s co-authors withdrew their names from the study when they learned he had been compensated by a law firm intending to sue manufacturers of the vaccine in question. In 2010, Wakefield lost his medical license. In 2011, the Lancet retracted the study after an investigation found Wakefield altered or misrepresented information on the 12 children who were the basis for the conclusion of the study.

Other researchers have not been able to replicate Wakefield’s findings. Several subsequent studies trying to reproduce the results have found no link between vaccines and autism, including several reviews by the Institute of Medicine.

Early 1900s – Autistic characteristics are studied as symptoms of schizophrenia.

1938 – Donald Gray Triplett of Mississippi is first examined by child psychiatrist Leo Kanner of Johns Hopkins Hospital and later becomes the first person diagnosed with autism symptoms.

1943 – Triplett is identified as “Donald T.” in the paper “Autistic Disturbances of Affective Contact” by Kanner. The paper elaborates on the idea that autism is related to lack of parental warmth; this is later dubbed the “refrigerator mother” theory.

1944 – Hans Asperger, an Austrian physician, publishes a paper about autistic syndrome. The paper gains wider recognition when it is translated into English in the early 1990s.

1964 – Bernard Rimland, a research psychologist, publishes “Infantile Autism: The Syndrome and Its Implications for a Neural Theory of Behavior,” which contradicts the “refrigerator mother” hypothesis. Kanner is the author of the foreword.

1965 – Rimland founds the National Society for Autistic Children (now the Autism Society). He later establishes the Autism Research Institute.

1980 – Autism is classified separately from schizophrenia in the third edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-III).

December 18, 2007 – The United Nations adopts a resolution declaring April 2 World Autism Awareness Day.

October 29, 2014 – The medical journal Nature reports that scientists have identified 60 genes with a greater than 90% chance of increasing a child’s autism risk.

December 17, 2015 – Scientists at Harvard and MIT announce they have found, for the first time, a link between autistic behavior and reduced activity of a key neurotransmitter, a type of brain chemical that enables the transmission of signals across neurons, allowing the brain to communicate with other organs.

April 21, 2016 – The Simons Foundation announces that it is launching an autism research project called SPARK. The study, which involves scientists at 21 hospitals and university clinics, will focus on the possible connection between genetics and autism. Parents of children with autism are invited to sign up online and participate in the study. The group also works with Autism Speaks and the Autism Science Foundation to run the Autism BrainNet network, which is an autism brain bank that collects postmortem donations.

February 2017 – Researchers find that monitoring MRI brain scans of infants may help predict whether they will develop autism, according to a study published in the journal, Nature. The researchers found a possible link between brain enlargement during the first year of life and an autism diagnosis at age 2. This builds on previous similar research.

March 19, 2017 – CBS News’ “60 Minutes” profiles “Sesame Street’s” newest Muppet character, a girl named Julia who has autism.

April 11, 2017 – A study published in the American Journal of Public Health finds that people with autism are three times more likely than the general population to die because of preventable injuries, and children and young teens with autism are 40 times more likely to die from preventable injury than the general child population. Suffocation, asphyxiation and drowning are the leading causes of fatal injuries among people with autism.

March 26, 2018 – According to a study published in JAMA Pediatrics, children with autism spectrum disorder and their younger siblings are less likely to be fully vaccinated than children unaffected by autism.

March 4, 2019 – A study of over 650,000 children published in the journal Annals of Internal Medicine shows that the measles, mumps, and rubella vaccine does not increase the risk of autism and does not trigger autism in children who are at risk.

April 29, 2019 – A study published in JAMA Pediatrics suggests that children can be screened for autism spectrum disorder at 14 months of age with high accuracy (instead of 18 to 24 months of age, as is currently recommended).

January 23, 2020 – A study in the journal Cell identifies 102 genes that are associated with an autism risk. Previously, researchers were only aware of 65.

May 10, 2020 – In a report published in the Journal of Autism and Developmental Disorders, the CDC estimates that 2.2% of Americans adults have autism spectrum disorder. The report, which is the first US study of autism in adults, indicates that up to 5.4 million people age 18 and older, or about 1 in 45 people, have an autism spectrum condition.

February 14, 2022 – A meta-analysis published in JAMA Pediatrics finds that early mortality, due to natural or unnatural causes, is more than two times more likely for people with autism spectrum disorder than the general population.

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May 13, 2023

Mpox in the United States Fast Facts | CNN

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Editor’s Note: This story has been updated to include the WHO’s updated recommendation for what the virus should be called.

CNN
—

Here’s a look at mpox, formerly known as monkeypox, in the United States. In 2022, an outbreak was declared a public health emergency of international concern by the World Health Organization (WHO). The virus originated in Africa and is the cousin of the smallpox virus.

In November 2022, WHO renames the monkeypox virus as mpox after working with International Committee on the Taxonomy of Viruses (ICTV) to rename the the virus using non-stigmatizing, non-offensive social and cultural nomenclature.

(Source: Centers for Disease Control and Prevention)

Mpox is a poxvirus. It generally causes pimple- or blister-like lesions and flu-like symptoms such as fever. The disease is rarely fatal.

Mpox spreads through close contact. This includes direct physical contact with lesions as well as “respiratory secretions” shared through face-to-face interaction and touching objects that have been contaminated by mpox lesions or fluids. The virus may also pass to a fetus through the placenta.

Anyone can become ill from mpox, but the US Centers for Disease Control and Prevention (CDC) says that more than 99% of mpox cases in the United States in the 2022 outbreak have been among men who have sex with men. However, mpox is not generally considered a sexually transmitted disease.

Mpox is usually found in West and Central Africa, but additional cases have been seen in Europe, including the United Kingdom, and other parts of the world in recent years. Those cases are typically linked to international travel or imported animals infected with the poxvirus.

CDC Mpox Map and Case Count

WHO Situation Reports

1958 – Mpox is discovered when monkeys kept for research cause two outbreaks in Copenhagen, Denmark.

1970 – The first human case is recorded in Zaire (now the Democratic Republic of Congo).

2003 – An outbreak in the United States is linked to infected pet prairie dogs imported from Ghana and results in more than 80 cases.

July 16, 2021 – The CDC and local health officials in Dallas announce they are investigating a case of mpox in a traveler from Nigeria. “The individual is a City of Dallas resident who traveled from Nigeria to Dallas, arriving at Love Field airport on July 9, 2021. The person is hospitalized in Dallas and is in stable condition,” the Dallas County Department of Health and Human Services says in a statement.

May 17, 2022 – The first confirmed US case of mpox in the 2022 outbreak is reported to the CDC in a traveler who returned to Massachusetts from Canada.

May 19, 2022 – WHO reports that death rates of the outbreak have been between 3% and 6%.

May 23, 2022 – The CDC announces the release of mpox vaccine doses from the nation’s Strategic National Stockpile for “high-risk people.” In the United States, the two-dose Jynneos vaccine is licensed to prevent smallpox and specifically to prevent mpox.

May 26, 2022 – CDC Director Dr. Rochelle Walensky announces that the United States is distributing the vaccine to states with reported cases and recommends vaccination for people at highest risk of infection due to direct contact with someone who has mpox.

June 22, 2022 – The CDC announces a partnership with five commercial laboratories to ramp up testing capacity in the United States.

June 23, 2022 – New York City launches the first mpox vaccination clinic in the United States.

June 28, 2022 – The US Department of Health and Human Services (HHS) and the Biden administration announce an enhanced vaccination strategy and report that more than 9,000 doses of vaccine have been distributed to date.

July 22, 2022 – Two American children contract mpox – a first in the United States. According to the CDC, the two cases are unrelated.

July 23, 2022 – WHO declares mpox a public health emergency of international concern, “an extraordinary event that may constitute a public health risk to other countries through international spread of disease and may require an international coordinated response.”

July 27, 2022 – After weeks of mpox vaccines being in limited supply, more than 786,000 additional doses are made available in the United States, according to HHS.

July 29, 2022 – New York declares a state disaster emergency in response to the mpox outbreak.

August 1, 2022 – California and Illinois declare states of emergency. California has reported more than 800 cases, while Illinois has had more than 500, according to data from the CDC.

August 2, 2022 – An mpox response team is created by the Biden administration. President Joe Biden names Robert Fenton from the Federal Emergency Management Agency (FEMA) as the White House national mpox response coordinator.

August 2, 2022 – A report from Spain’s National Institute for Microbiology indicates two men, ages 31 and 44, who died from mpox in unrelated cases had both developed encephalitis, or swelling of the brain, which can be triggered by viral infections. Encephalitis is a very rare condition known to be associated with mpox. It has been reported in people with mpox in West Africa and in a patient in the United States in 2003 during the small outbreak linked to imported prairie dogs.

August 4, 2022 – The Biden administration declares the mpox outbreak a national public health emergency.

August 5, 2022 – A report published by the CDC finds that 94% of cases were among men who had recent sexual or close intimate contact with another man. Further, 54% of cases were among Black Americans and Latinos.

August 9, 2022 – In an effort to stretch the limited supply of the Jynneos mpox vaccine, federal health officials authorize administering smaller doses using a different method of injection. The new injection strategy allows health-care providers to give shallow injections intradermally, in between layers of the skin, with one-fifth the standard dose size instead of subcutaneously, into the fatty layer below the skin, with the larger dose.

August 18, 2022 – The White House announces the acceleration of the HHS vaccine distribution timeline, with an additional 1.8 million doses of the Jynneos vaccine being made available. Additional vaccines will be distributed to communities hosting large LGBTQI+ events.

August 19, 2022 – Washington’s King County, which includes Seattle, declares mpox a public health emergency, with more than 270 recorded cases.

September 12, 2022 – The first US death due to mpox is confirmed in Los Angeles County, California.

May 11, 2023 – WHO declares the mpox outbreak is no longer a global health emergency.

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May 13, 2023

FDA advisers narrowly vote in favor of experimental gene therapy for rare muscle disease | CNN

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CNN
—

Most parents wouldn’t be thrilled with the idea of their kids getting hooked up to an IV bag filled with trillions of viruses.

But for Melanie Hennick, whose son, Connor, has Duchenne muscular dystrophy, it was an opportunity she hoped would change his life.

“We knew this wasn’t a cure,” Hennick said. “But it was a chance.”

Connor is one of just dozens of kids to have received SRP-9001, an experimental gene therapy that aims to slow or stop the progression of Duchenne muscular dystrophy, or DMD. Current treatments for the disease – which primarily affects boys because of the way it’s inherited – include steroids and, later, heart drugs. But none stop it.

SRP-9001 uses viruses to ferry a copy of a gene to muscles to help make up for one that’s causing the disease. Hennick and many other parents like her advocated for the treatment’s accelerated approval Friday in a meeting of outside advisers to the US Food and Drug Administration.

The advisers voted 8-6 in favor of approving the treatment, and the FDA will now decide whether to follow their advice.

“The decision the FDA has to make doesn’t just affect the patients in study 301 [an ongoing confirmatory trial that Sarepta is running]; it affects the entire field of drug development for Duchenne,” said Dr. Caleb Alexander, a professor of epidemiology and medicine in the Bloomberg School of Public Health at Johns Hopkins University, who voted against recommending approval. “The totality of evidence … simply doesn’t rise to the threshold that’s required for accelerated approval.”

Dr. Raymond Roos, a neurology professor at the University of Chicago Medical Center, voted in favor. “The downside of the gene therapy here is relatively small compared to whether it really helps the patient, and for this reason, I voted yes,” he said.

Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said his agency will take the recommendation and “do something that we have to do every day at FDA. … We have to manage through the uncertainty here.”

The FDA’s decision, expected by the end of the month, will have implications not just for families like Connor’s but for how the agency regulateths treatments like this one more broadly: It would be the first of its kind of medicine – one-time treatments delivering a gene to try to fix a disease – to get accelerated approval, a faster track through the regulatory process. Its approval would set a precedent for other drugs like this based on so-called surrogate endpoints, a measure of what the drug does in the body, before further clinical evidence is available.

“Approval of a gene therapy for Duchenne muscular dystrophy will be huge,” said Jeffrey Chamberlain, a professor at the University of Washington School of Medicine who helped pioneer gene therapy approaches for the disease. “This, I think, will spur further research and further development of gene therapies for other diseases.”

DMD patients don’t have a lot of time to wait. Kids with Duchenne typically lose the ability to walk before they’re teenagers and often don’t live well into their 30s, Chamberlain said. He’s not directly involved with SRP-9001, which is being developed by Sarepta Therapeutics, and is on the scientific advisory board for another company working on DMD gene therapies, Solid Biosciences.

“Gene therapy appears to be a really good approach to try to treat this disease, because it’s a genetic disease,” Chamberlain said. “The cause of the disease is a mutation in a single gene.”

That gene is responsible for the production of dystrophin, a protein key to the structure of muscle cells.

“It’s kind of like the two-by-fours that make up your house,” Chamberlain said. “It’s really important for just holding everything together.”

SRP-9001, invented at Nationwide Children’s Hospital in Columbus, Ohio, before being licensed for development by Sarepta, delivers a miniaturized version of the dystrophin gene to cells, aiming to help them make a version of the muscle-preserving protein.

In a key clinical trial, the therapy appeared to do that. But it didn’t meet another main goal: showing a benefit on a measure of muscle function, complicating SRP-9001’s path through the FDA.

Sarepta blamed the outcome on an imbalance in how the trial separated patients into the placebo and treatment groups. But key FDA reviewers appear unconvinced.

“The clinical studies conducted to date do not provide unambiguous evidence that SRP-9001 is likely beneficial for ambulatory patients with DMD,” agency reviewers wrote in briefing documents released ahead of Friday’s meeting, referring to patients who can still walk – the group who will initially be eligible for the treatment if it gets approved.

Family after family who participated in Sarepta’s trials, like the Hennicks, disagree with the reviewers. They say they believe that the treatment has helped keep their kids walking and running in ways they never would have without it.

“It’s really miraculous,” said Nate Plasman, whose son Andrew got SRP-9001 as part of the trial in January 2019, at age 4.

Sara, left, Andrew and Nate Plasman on the day he was dosed in the trial in January 2019.

Andrew was away from school for more than two months when he got the experimental therapy, Plasman said, and when he returned, “his teachers at the preschool were blown away,” he recalled. “They’re like, ‘Who is this kid?’ He’s running. He’s jumping. He’s pedaling the tricycle. He’s getting up and down off the ground” – all things he couldn’t do as well before the therapy.

Marit Sivertson, mom to 9-year-old Brecken, agrees.

“We’ve seen the incredible changes with our son,” she said. “He’s not just walking around. He’s running; he’s swimming; he’s diving. He’s truly living the life that every 9-year-old boy ought to be living.”

Dr. Jerry Mendell of Nationwide Children's Hospital in Ohio, who developed the gene therapy, left, with Brecken Kinney.

Sivertson and Plasman also spoke at Friday’s meeting. Their goal isn’t to secure the therapy for their own kids; because it’s designed as a one-time treatment, they wouldn’t take it again. They say they’re speaking up on behalf of children who are still waiting.

That wait is especially painful for Daniel and Lindsey Flessner, who have two sons with DMD. Their 5-year-old son, Mason, is in the SRP-9001 clinical trial. Their 2-year-old, Dawson, is still too young.

“With every trip, every fall, every time he stands up by walking up his legs using his hands to help stabilize him, it just keeps chipping away at us,” Flessner said. “It’s very painful as the parents watching your children struggling knowing all you can do is wait, when waiting is what you don’t have time for.”

Lindsey and Daniel Flessner's sons, Mason and Dawson, both have DMD.

In addition to questions about how well the treatment works, the FDA reviewers raised concerns about safety, particularly “related to the possibility of administering an ineffective gene therapy.”

The reviewers focused on opportunity cost: Because of the viruses used to deliver the gene, patients can develop an immune response that could render future doses ineffective.

Chamberlain said work is underway to find ways to be able to administer more doses, if needed, but it’s currently a one-and-done treatment.

For now, he thinks this approach is the best hope for DMD patients.

“It’s not perfect,” he acknowledged. “It’s not a complete cure, but from what I can gauge from the clinical results that have been released by Sarepta and some of the other companies, I think the micro-dystrophin gene therapy is working better than any other drug that’s been tried for Duchenne muscular dystrophy.”

It’s unclear how long the effects will last; Sarepta is continuing trials, and a confirmatory study would be required as part of accelerated approval. Sarepta has proposed a trial that it’s already running to satisfy that requirement, with results expected later this year.

For families facing DMD, there’s an opportunity cost to waiting, too. In its briefing documents for the FDA meeting, Sarepta estimated that accelerated approval would speed up broad access to SRP-9001 by at least a year, a time in which about 400 boys could lose the ability to walk and another 400, whose disease is more advanced, would die.

Melanie Hennick said Connor was admitted to the trial just weeks before he’d have aged out, at 8 years old. She said she believes the therapy is the reason Connor’s doing so well.

“We had the opportunity to see Connor grow as an 8-, 9-, 10-, 11- and 12-year-old with more capacity than we ever dreamed,” she said. “He climbs stairs unaided; he runs around; he plays football; he plays hockey; he plays on a baseball team. … Those are things that we never thought we would be able to see him do, especially at 12.”

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May 12, 2023

‘We never want to have this happen again,’ FDA official testifies about formula shortage | CNN

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CNN
—

In a rare moment of bipartisan agreement, lawmakers were highly critical of the US Food and Drug Administration’s handling of the infant formula shortage Thursday.

The hearing of the US House Oversight and Accountability Subcommittee on Health Care and Financial Services was one of several Congress has held to better understand what contributed to the recent formula shortage and to understand how to prevent more problems down the road.

Rep. Lisa McClain, R-Michigan, said that the FDA has not been fully forthcoming with Congress and the public.

“Why was the FDA unprepared for the crisis?” she asked in her opening statement.

She said that the agency failed to prioritize food safety. “The FDA has not taken the action needed to prevent a similar crisis from happening again.”

Rep. Katie Porter, D-California, said she agreed with McClain that another shortage could happen, “and that is a deadly serious problem.”

“There is a lot of blame to go around,” Porter added. “It’s clear with today’s witness selection that Republicans want to blame the FDA, and I’ll level with you, I think some of that blame is well-placed. We’ve had two subsequent infant formula recalls in 2023 already, and we’re still seeing that the FDA can make further improvements on internal processes, intervene in issues sooner and follow through with more inspections to prevent further contamination.”

Three major manufacturers in the US control over 90% of the formula market, and that consolidation is a “serious concern” that “contributed significantly to shortages,” according to Dr. Susan Mayne, director of the FDA’s Center for Food Safety and Applied Nutrition, who testified Thursday.

A shortage that started in 2021 was exacerbated when the country’s largest infant formula maker, Abbott Nutrition, recalled multiple products in mid-February 2022 and had to pause production at its plant in Sturgis, Michigan, after FDA inspectors found potentially dangerous bacteria.

The plant inspection was tied to an outbreak of Cronobacter sakazakii that had sickened at least four infants and killed two, although investigations did not find a genetic link between bacteria samples from the facility and bacteria found in the water and powder used to mix the formula that the infants had consumed.

Mayne testified that it was difficult to trace the cases and determine how big of a concern the outbreak was. The bacteria is a common pathogen in the environment “but one about which we have limited information.”

The FDA has urged the US Centers for Disease Control and Prevention to make Cronobacter infection a notifiable disease – meaning providers would be required to report cases to local or state public health officials – so public health experts would be able to more quickly determine the source of any contamination.

In addition to the bacteria, an FDA inspection of the Sturgis plant found unsanitary conditions and several violations of food safety rules.

A whistleblower had alerted the FDA to alleged safety lapses at the plant in February 2021, months before Abbott’s formula was recalled. The complaint suggested that the plant lacked proper cleaning practices and that workers falsified records and hid information from inspectors.

Like other FDA leaders who have been called before Congress, Mayne testified that she was not made aware of the complaint right away. She called it “a failure of escalation.”

“I do wish I had been made aware of this particular whistleblower complaint, but just to reiterate, the complaint was acted upon,” Mayne said. However, she noted, it was “less than ideal” how quickly there was an FDA inspection of the plant and how quickly the agency was able to act.

When the whistleblower made the complaint, there was no process within the FDA to escalate it. The process has since changed so that if a complaint meets certain criteria involving vulnerable populations, hospitalizations or deaths, leadership would be immediately informed. If a consumer complaint involves an infant death or hospitalization, it also immediately gets escalated to leadership.

To prevent future shortages, Mayne testified, it won’t just be the FDA that needs to change. The industry should do more to adopt enhanced food safety measures to “deliver the safest possible” infant formula, she said.

The agency would also like better regulations. There have been been two infant formula recalls already in 2023, and in neither case was the manufacturer required to notify the FDA that it had found contamination before the formula left the plant.

The FDA has asked formula makers to inform the agency about positive tests, but such reporting is only voluntary. If it were mandatory, the FDA could know about problems in real time and could take action.

“Our food safety experts, our compliance experts can work with the manufacturers,” Mayne said. In such a collaboration, they could quickly identify what product to focus on to prevent a shortage.

The FDA has taken recent steps to improve. In February, it announced that it is restructuring its food division to be more responsive and that it is creating an office of critical foods. The FDA is also hiring specialized infant formula inspection staff, Mayne said.

The infant formula supply is generally in good shape, she said, but there are still some distribution issues.

The in-stock rate is near 90%, even higher than pre-recall levels. But some rural areas are having a hard time getting all the formula they need.

Formula manufacturers have been producing more than is being purchased week after week to build up supply, Mayne said. The Biden administration has also worked to bring in formula from manufacturers overseas.

But another shortage is not out of the question, particularly if one of the country’s main manufacturers is taken offline for any significant amount of time.

“We never want to have this happen again,” Mayne said.

Lawmakers have proposed significant cuts, about 22%, to the FDA’s budget for 2023. Mayne said that consumers and the industry would be “adversely affected” if the cuts go through.

“Broadly, across the FDA, I can say it would be devastating,” she said, resulting in a loss of 32% of domestic inspections and 22% of foreign inspections. The cuts would also disproportionately affect its food programs, which get much of their funding from the budget, unlike divisions involving drugs that get money from user fees.

“We would be unable to do what I think American consumers expect us to do,” Mayne said.

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May 12, 2023

FDA advisers vote unanimously in support of over-the-counter birth-control pill | CNN

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CNN
—

Advisers for the US Food and Drug Administration voted unanimously on Wednesday in support of making the birth-control pill Opill available over-the-counter, saying the benefits outweigh the risks.

Two FDA advisory panels agreed that people would use Opill safely and effectively and said groups such as adolescents and those with limited literacy would be able to take the pill at the same time every day without help from a health care worker.

The advisers were asked to vote on whether people were likely to use the tablet properly so that the benefits would exceed the risks. Seventeen voted yes. Zero voted no or abstained.

Opill manufacturer Perrigo hailed the vote as a “groundbreaking” move for women’s health.

“Perrigo is proud to lead the way in making contraception more accessible to women in the U.S.,” Murray Kessler, Perrigo’s president and CEO, said in a statement. “We are motivated by the millions of people who need easy access to safe and effective contraception.”

The FDA doesn’t have to follow its advisers’ advice, but it often does. It is expected to decide whether to approve the over-the-counter pill this summer.

If it’s approved, this will be the first birth-control pill available over the counter in the United States. Opill is a “mini-pill” that uses only the hormone progestin.

At Wednesday’s meeting, Dr. Margery Gass of the University of Cincinnati College of Medicine thanked the FDA for its consideration of switching Opill to an over-the-counter product.

“I think this represents a landmark in our history of women’s health. Unwanted pregnancies can really derail a woman’s life, and especially an adolescent’s life,” she said.

The FDA has faced pressure to allow Opill to go over-the-counter from lawmakers as well as health care providers.

Unwanted pregnancies are a public health issue in the US, where almost half of all pregnancies are unintended, and rates are especially high among lower-income women, Black women and those who haven’t completed high school.

In March 2022, 59 members of Congress wrote a letter to FDA Commissioner Dr. Robert Califf about OTC contraception.

“This is a critical issue for reproductive health, rights, and justice. Despite decades of proven safety and effectiveness, people still face immense barriers to getting birth control due to systemic inequities in our healthcare system,” the lawmakers wrote.

A recent study showed that it’s become harder for women to access reproductive health care services more broadly – such as routine screenings and birth control – in recent years.

About 45% of women experienced at least one barrier to reproductive health care services in 2021, up 10% from 2017. Nearly 19% reported at least three barriers in 2021, up from 16% in 2017.

Increasing reproductive access for women and adolescents was a resounding theme among the FDA advisers.

“We can take this opportunity to increase access, reduce disparities and, most importantly, increase the reproductive autonomy of the women of our nation,” said Dr. Jolie Haun of the James A. Haley Veterans’ Hospital and the University of Utah.

Dr. Karen Murray, deputy director of the FDA’s Office of Nonprescription Drugs, said the agency understands the importance of “increased access to effective contraception” but hinted that the FDA would need more data from the manufacturer.

Some of the advisers and FDA scientists expressed concern that some of Perrigo’s data was unreliable due to overreporting of “improbable dosing.”

Murray said the lack of sufficient information from the study poses challenges for approval.

“It would have been a much easier time for the agency if the applicant had submitted a development program and an actual use study that was very easy to interpret and did not have so many challenges. But that was not what happened for us. And so the FDA has been put in a very difficult position of trying to determine whether it is likely that women will use this product safely and effectively in the nonprescription setting,” she said. “But I wanted to again emphasize that FDA does realize how very important women’s health is and how important it is to try to increase access to effective contraception for US women.”

Ultimately, the advisers said, they don’t want further studies of Opill to delay the availability of the product in an over-the-counter setting.

“I just wanted to say that the improbable dosing issue is important, and I don’t think it’s been adequately addressed and certainly leads to some uncertainty in the findings. But despite this, I would not recommend another actual use study this time, and I think we can make a decision on the totality of the evidence,” said Kate Curtis of the US Centers for Disease Control and Prevention.

Curtis said she voted yes because “Opill has the potential to have a huge positive public health impact.”

Earlier in the discussion, Dr. Leslie Walker-Harding of the University of Washington and Seattle Children’s Hospital said the pill is just as safe as many other medications available on store shelves.

“The safety profile is so good that we would need to take every other medicine off the market like Benadryl, ibuprofen, Tylenol, which causes deaths and people can get any amount of that without any oversight. And this is extremely safe, much safer than all three of those medications, and incorrect use still doesn’t appear to have problematic issues,” she said.

Dr. Katalin Roth of the George Washington University School of Medicine and Health Sciences also emphasized the safety of the pill over the 50 years it has been approved as a prescription drug in the US.

“The risks to women of an unintended pregnancy are much greater than any of the things we were discussing as risks of putting this pill out out over-the-counter,” she said. “The history of women’s contraception is a struggle for women’s control over their reproduction, and we need to trust women.”

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May 10, 2023

Bacterial infection linked to recent baby formula shortage may join federal disease watchlist | CNN

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CNN
—

US health officials may soon ask states to notify them of any cases of infants with serious infections caused by Cronobacter sakazakii, bacteria that can contaminate infant formula.

Cronobacter infections typically strike infants who are less than 2 months old, and they can be fatal or permanently disabling.

In an outbreak that the US Centers for Disease Control and Prevention investigated last year, four babies were sickened, including two who died. All the infants had been fed baby formula manufactured at the same factory in Sturgis, Michigan, triggering an extensive investigation by the US Food and Drug Administration and ultimately stopping production at the facility for months. The shutdown worsened ongoing supply chain issues and threw the country into a nationwide shortage.

Ultimately, the FDA and the CDC could find no genetic links between Cronobacter samples from the facility and the bacteria found in the water and powder used to mix the formula that the infants had consumed.

These infections are thought to be infrequent, but the true burden in the US is unknown because Cronobacter is not currently part of the National Notifiable Diseases Surveillance System, a list of about 120 illnesses given special priority by the CDC because they’ve been deemed to be important to public health.

The Council of State and Territorial Epidemiologists, a nonprofit organization that advocates for effective disease surveillance, identified Cronobacter as a priority area for investigation this year.

A work group was formed in the winter to assess conditions, risks and surveillance processes related to the bacterial infection, and it will present recommendations to advance Cronobacter surveillance in June.

Adding Cronobacter infections to the national watchlist is among the strategies being considered.

“When we look back at large-scale outbreaks over the course of the last year, many of those outbreaks were associated with diseases and conditions that were nationally notifiable, but not all of them,” said Janet Hamilton, executive director of the council – and Cronobacter was one of the exceptions.

“So whenever we have something like that, that prompts the council to determine and assess whether we need to potentially be doing more.”

Adding an illness to the national list can have a sizable impact. After E. coli O157 was added to the notifiable disease list in 1994 and most states required doctors to report cases by 2000, the number of reported outbreaks tripled.

However, it would take quite some time for any changes to take effect.

If the Council of State and Territorial Epidemiologists votes in favor of adding Cronobacter infections to the national list of notifiable diseases, the recommendation will go to the CDC for approval. If the CDC deems an illness to be notifiable, it’s up to state and local governments to adjust their reporting laws and develop processes for doctors to report cases to health departments, which then forward those reports to the CDC.

The soonest that data collection could start is the beginning of 2024, and it would most likely be well into the year, depending on state legislative sessions.

Currently, only two states, Minnesota and Michigan, require doctors to report Cronobacter cases, which may be diagnosed more generically as sepsis or meningitis, conditions that can result from an infection.

“Unless detailed studies are done, the diagnosis as a Cronobacter illness may be missed,” FDA Commissioner Dr. Robert Califf wrote in a blog post last week. “The lack of mandatory reporting significantly hampers the ability to fully understand Cronobacter’s public health impact.”

Dr. Peter Lurie, executive director of the Center for Science in the Public Interest, applauded the potential move.

“I think it’s a necessary step. It is difficult to prevent diseases that you can’t count,” Lurie said.

In addition, Lurie says, manufacturers should be required to notify the FDA when a batch of baby formula tests positive for Cronobacter before it leaves the plant. The FDA has asked manufacturers to tell it about positive tests, but such reporting is voluntary.

Lurie says the FDA should also be doing more sampling and testing for Cronobacter in the environment to get a better understanding of where the bacteria can turn up.

“I think we have a lot to learn there,” he said.

Mitzi Baum, CEO of the group Stop Foodborne Illness, which has been advocating for the change, said she was grateful the Council of State and Territorial Epidemiologists was moving toward a vote on it.

She said greater awareness of the infection was long overdue.

“It’s always prefaced by ‘this is rare,’ but we don’t know how rare it is because it’s not reportable. And there needs to be a lot more education about this pathogen and a lot more research,” Baum said.

Baum said her group is working with the council to create an education campaign to raise awareness of the infection among doctors. The next step, she says, is getting funding.

The council’s Hamilton points out that “simply making something nationally notifiable doesn’t necessarily translate into awareness and recognition on the prevention side. If people don’t have the right set of information and education, by the time we’re doing public health surveillance for it, the disease or infection has already occurred.”

According to the FDA, Cronobacter sakazakii is a common natural pathogen that can enter homes and other spaces on hands, shoes and other contaminated surfaces. It is “especially good at surviving in dry foods,” such as powdered baby formula.

Infections are harmless for most people, but it can be life-threatening for infants, especially those who are born prematurely or with weakened immune systems. It’s particularly important to be sure that parents of high-risk infants know how to keep them safe, Hamilton said.

“Providing good education around how to stop infections is really what leads to the level of change that we would love to see,” she said.

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May 9, 2023

Covid-19 Pandemic Timeline Fast Facts | CNN

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CNN
—

Here’s a look at the coronavirus outbreak, declared a worldwide pandemic by the World Health Organization. The coronavirus, called Covid-19 by WHO, originated in China and is the cousin of the SARS virus.

Coronaviruses are a large group of viruses that are common among animals. The viruses can make people sick, usually with a mild to moderate upper respiratory tract illness, similar to a common cold. Coronavirus symptoms include a runny nose, cough, sore throat, possibly a headache and maybe a fever, which can last for a couple of days.

WHO Situation Reports

Coronavirus Map

CNN’s early reporting on the coronavirus

December 31, 2019 – Cases of pneumonia detected in Wuhan, China, are first reported to WHO. During this reported period, the virus is unknown. The cases occur between December 12 and December 29, according to Wuhan Municipal Health.

January 1, 2020 – Chinese health authorities close the Huanan Seafood Wholesale Market after it is discovered that wild animals sold there may be the source of the virus.

January 5, 2020 – China announces that the unknown pneumonia cases in Wuhan are not SARS or MERS. In a statement, the Wuhan Municipal Health Commission says a retrospective probe into the outbreak has been initiated.

January 7, 2020 – Chinese authorities confirm that they have identified the virus as a novel coronavirus, initially named 2019-nCoV by WHO.

January 11, 2020 – The Wuhan Municipal Health Commission announces the first death caused by the coronavirus. A 61-year-old man, exposed to the virus at the seafood market, died on January 9 after respiratory failure caused by severe pneumonia.

January 17, 2020 – Chinese health officials confirm that a second person has died in China. The United States responds to the outbreak by implementing screenings for symptoms at airports in San Francisco, New York and Los Angeles.

January 20, 2020 – China reports 139 new cases of the sickness, including a third death. On the same day, WHO’s first situation report confirms cases in Japan, South Korea and Thailand.

January 20, 2020 – The National Institutes of Health announces that it is working on a vaccine against the coronavirus. “The NIH is in the process of taking the first steps towards the development of a vaccine,” says Dr. Anthony Fauci, director of the National Institutes of Allergy and Infectious Diseases.

January 21, 2020 – Officials in Washington state confirm the first case on US soil.

January 23, 2020 – At an emergency committee, WHO says that the coronavirus does not yet constitute a public health emergency of international concern.

January 23, 2020 – The Beijing Culture and Tourism Bureau cancels all large-scale Lunar New Year celebrations in an effort to contain the growing spread of coronavirus. On the same day, Chinese authorities enforce a partial lockdown of transport in and out of Wuhan. Authorities in the nearby cities of Huanggang and Ezhou Huanggang announce a series of similar measures.

January 28, 2020 – Chinese President Xi Jinping meets with WHO Director General Tedros Adhanom in Beijing. At the meeting, Xi and WHO agree to send a team of international experts, including US Centers for Disease Control and Prevention staff, to China to investigate the coronavirus outbreak.

January 29, 2020 – The White House announces the formation of a new task force that will help monitor and contain the spread of the virus, and ensure Americans have accurate and up-to-date health and travel information, it says.

January 30, 2020 – The United States reports its first confirmed case of person-to-person transmission of the coronavirus. On the same day, WHO determines that the outbreak constitutes a Public Health Emergency of International Concern (PHEIC).

January 31, 2020 – The Donald Trump administration announces it will deny entry to foreign nationals who have traveled in China in the last 14 days.

February 2, 2020 – A man in the Philippines dies from the coronavirus – the first time a death has been reported outside mainland China since the outbreak began.

February 3, 2020 – China’s Foreign Ministry accuses the US government of inappropriately reacting to the outbreak and spreading fear by enforcing travel restrictions.

February 4, 2020 – The Japanese Health Ministry announces that ten people aboard the Diamond Princess cruise ship moored in Yokohama Bay are confirmed to have the coronavirus. The ship, which is carrying more than 3,700 people, is placed under quarantine scheduled to end on February 19.

February 6, 2020 – First Covid-19 death in the United States: A person in California’s Santa Clara County dies of coronavirus, but the link is not confirmed until April 21.

February 7, 2020 – Li Wenliang, a Wuhan doctor who was targeted by police for trying to sound the alarm on a “SARS-like” virus in December, dies of the coronavirus. Following news of Li’s death, the topics “Wuhan government owes Dr. Li Wenliang an apology,” and “We want freedom of speech,” trend on China’s Twitter-like platform, Weibo, before disappearing from the heavily censored platform.

February 8, 2020 – The US Embassy in Beijing confirms that a 60-year-old US national died in Wuhan on February 6, marking the first confirmed death of a foreigner.

February 10, 2020 – Xi inspects efforts to contain the coronavirus in Beijing, the first time he has appeared on the front lines of the fight against the outbreak. On the same day, a team of international experts from WHO arrive in China to assist with containing the coronavirus outbreak.

February 10, 2020 – The Anthem of the Seas, a Royal Caribbean cruise ship, sets sail from Bayonne, New Jersey, after a coronavirus scare had kept it docked and its passengers waiting for days.

February 11, 2020 – WHO names the coronavirus Covid-19.

February 13, 2020 – China’s state-run Xinhua News Agency announces that Shanghai mayor Ying Yong will be replacing Jiang Chaoliang amid the outbreak. Wuhan Communist Party chief Ma Guoqiang has also been replaced by Wang Zhonglin, party chief of Jinan city in Shandong province, according to Xinhua.

February 14, 2020 – A Chinese tourist who tested positive for the virus dies in France, becoming the first person to die in the outbreak in Europe. On the same day, Egypt announces its first case of coronavirus, marking the first case in Africa.

February 15, 2020 – The official Communist Party journal Qiushi publishes the transcript of a speech made on February 3 by Xi in which he “issued requirements for the prevention and control of the new coronavirus” on January 7, revealing Xi knew about and was directing the response to the virus on almost two weeks before he commented on it publicly.

February 17, 2020 – A second person in California’s Santa Clara County dies of coronavirus, but the link is not confirmed until April 21.

February 18, 2020 – Xi says in a phone call with British Prime Minister Boris Johnson that China’s measures to prevent and control the epidemic “are achieving visible progress,” according to state news Xinhua.

February 21, 2020 – The CDC changes criteria for counting confirmed cases of novel coronavirus in the United States and begins tracking two separate and distinct groups: those repatriated by the US Department of State and those identified by the US public health network.

February 25, 2020 – The NIH announces that a clinical trial to evaluate the safety and effectiveness of the antiviral drug remdesivir in adults diagnosed with coronavirus has started at the University of Nebraska Medical Center in Omaha. The first participant is an American who was evacuated from the Diamond Princess cruise ship docked in Japan.

February 25, 2020 – In an effort to contain the largest outbreak in Europe, Italy’s Lombardy region press office issues a list of towns and villages that are in complete lockdown. Around 100,000 people are affected by the travel restrictions.

February 26, 2020 – CDC officials say that a California patient being treated for novel coronavirus is the first US case of unknown origin. The patient, who didn’t have any relevant travel history nor exposure to another known patient, is the first possible US case of “community spread.”

February 26, 2020 – Trump places Vice President Mike Pence in charge of the US government response to the novel coronavirus, amid growing criticism of the White House’s handling of the outbreak.

February 29, 2020 – A patient dies of coronavirus in Washington state. For almost two months, this is considered the first death due to the virus in the United States, until autopsy results announced April 21 reveal two earlier deaths in California.

March 3, 2020 – The Federal Reserve slashes interest rates by half a percentage point in an attempt to give the US economy a jolt in the face of concerns about the coronavirus outbreak. It is the first unscheduled, emergency rate cut since 2008, and it also marks the biggest one-time cut since then.

March 3, 2020 – Officials announce that Iran will temporarily release 54,000 people from prisons and deploy hundreds of thousands of health workers as officials announced a slew of measures to contain the world’s deadliest coronavirus outbreak outside China. It is also announced that 23 members of Iran’s parliament tested positive for the virus.

March 4, 2020 – The CDC formally removes earlier restrictions that limited coronavirus testing of the general public to people in the hospital, unless they had close contact with confirmed coronavirus cases. According to the CDC, clinicians should now “use their judgment to determine if a patient has signs and symptoms compatible with COVID-19 and whether the patient should be tested.”

March 8, 2020 – Italian Prime Minister Giuseppe Conte signs a decree placing travel restrictions on the entire Lombardy region and 14 other provinces, restricting the movements of more than 10 million people in the northern part of the country.

March 9, 2020 – Conte announces that the whole country of Italy is on lockdown.

March 11, 2020 – WHO declares the novel coronavirus outbreak to be a pandemic. WHO says the outbreak is the first pandemic caused by a coronavirus. In an Oval Office address, Trump announces that he is restricting travel from Europe to the United States for 30 days in an attempt to slow the spread of coronavirus. The ban, which applies to the 26 countries in the Schengen Area, applies only to foreign nationals and not American citizens and permanent residents who’d be screened before entering the country.

March 13, 2020 – Trump declares a national emergency to free up $50 billion in federal resources to combat coronavirus.

March 18, 2020 – Trump signs into law a coronavirus relief package that includes provisions for free testing for Covid-19 and paid emergency leave.

March 19, 2020 – At a news conference, officials from China’s National Health Commission report no new locally transmitted coronavirus cases for the first time since the pandemic began.

March 23, 2020 – United Nations Secretary-General António Guterres calls for an immediate global ceasefire amid the pandemic to fight “the common enemy.”

March 24, 2020 – Japan’s Prime Minister Shinzo Abe and International Olympic Committee (IOC) president Thomas Bach agree to postpone the Olympics until 2021 amid the outbreak.

March 25, 2020 – The White House and Senate leaders reach an agreement on a $2 trillion stimulus deal to offset the economic damage of coronavirus, producing one of the most expensive and far-reaching measures in the history of Congress.

March 27, 2020 – Trump signs the stimulus package into law.

April 2, 2020 – According to the Department of Labor, 6.6 million US workers file for their first week of unemployment benefits in the week ending March 28, the highest number of initial claims in history. Globally, the total number of coronavirus cases surpasses 1 million, according to Johns Hopkins University’s tally.

April 3, 2020 – Trump says his administration is now recommending Americans wear “non-medical cloth” face coverings, a reversal of previous guidance that suggested masks were unnecessary for people who weren’t sick.

April 8, 2020 – China reopens Wuhan after a 76-day lockdown.

April 14, 2020 – Trump announces he is halting funding to WHO while a review is conducted, saying the review will cover WHO’s “role in severely mismanaging and covering up the spread of coronavirus.”

April 20, 2020 – Chilean health officials announce that Chile will begin issuing the world’s first digital immunity cards to people who have recovered from coronavirus, saying the cards will help identify individuals who no longer pose a health risk to others.

April 21, 2020 – California’s Santa Clara County announces autopsy results that show two Californians died of novel coronavirus in early and mid-February – up to three weeks before the previously known first US death from the virus.

April 28, 2020 – The United States passes one million confirmed cases of the virus, according to Johns Hopkins.

May 1, 2020 – The US Food and Drug Administration issues an emergency-use authorization for remdesivir in hospitalized patients with severe Covid-19. FDA Commissioner Stephen Hahn says remdesivir is the first authorized therapy drug for Covid-19.

May 4, 2020 – During a virtual pledging conference co-hosted by the European Union, world leaders pledge a total of $8 billion for the development and deployment of diagnostics, treatments and vaccines against the novel coronavirus.

May 11, 2020 – Trump and his administration announce that the federal government is sending $11 billion to states to expand coronavirus testing capabilities. The relief package signed on April 24 includes $25 billion for testing, with $11 billion for states, localities, territories and tribes.

May 13, 2020 – Dr. Mike Ryan, executive director of WHO’s health emergencies program, warns that the coronavirus may never go away and may just join the mix of viruses that kill people around the world every year.

May 19, 2020 – WHO agrees to hold an inquiry into the global response to the coronavirus pandemic. WHO member states adopt the proposal with no objections during the World Health Assembly meeting, after the European Union and Australia led calls for an investigation.

May 23, 2020 – China reports no new symptomatic coronavirus cases, the first time since the beginning of the outbreak in December.

May 27, 2020 – Data collected by Johns Hopkins University reports that the coronavirus has killed more than 100,000 people across the US, meaning that an average of almost 900 Americans died each day since the first known coronavirus-related death was reported nearly four months earlier.

June 2, 2020 – Wuhan’s Health Commission announces that it has completed coronavirus tests on 9.9 million of its residents with no new confirmed cases found.

June 8, 2020 – New Zealand Prime Minister Jacinda Ardern announces that almost all coronavirus restrictions in New Zealand will be lifted after the country reported no active cases.

June 11, 2020 – The United States passes 2 million confirmed cases of the virus, according to Johns Hopkins.

June 16, 2020 – University of Oxford scientists leading the Recovery Trial, a large UK-based trial investigating potential Covid-19 treatments, announce that a low-dose regimen of dexamethasone for 10 days was found to reduce the risk of death by a third among hospitalized patients requiring ventilation in the trial.

June 20, 2020 – The NIH announces that it has halted a clinical trial evaluating the safety and effectiveness of drug hydroxychloroquine as a treatment for the coronavirus. “A data and safety monitoring board met late Friday and determined that while there was no harm, the study drug was very unlikely to be beneficial to hospitalized patients with Covid-19,” the NIH says in a statement.

June 26, 2020 – During a virtual media briefing, WHO announces that it plans to deliver about 2 billion doses of a coronavirus vaccine to people across the globe. One billion of those doses will be purchased for low- and middle-income countries, according to WHO.

July 1, 2020 – The European Union announces it will allow travelers from 14 countries outside the bloc to visit EU countries, months after it shut its external borders in response to the pandemic. The list does not include the US, which doesn’t meet the criteria set by the EU for it to be considered a “safe country.”

July 6, 2020 – In an open letter published in the journal Clinical Infectious Diseases, 239 scientists from around the world urge WHO and other health agencies to be more forthright in explaining the potential airborne transmission of coronavirus. In the letter, scientists write that studies “have demonstrated beyond any reasonable doubt that viruses are released during exhalation, talking, and coughing in microdroplets small enough to remain aloft in air and pose a risk of exposure at distances beyond 1 to 2 meters (yards) from an infected individual.”

July 7, 2020 – The Trump administration notifies Congress and the United Nations that the United States is formally withdrawing from WHO. The withdrawal goes into effect on July 6, 2021.

July 21, 2020 – European leaders agree to create a €750 billion ($858 billion) recovery fund to rebuild EU economies ravaged by the coronavirus.

July 27, 2020 – A vaccine being developed by the Vaccine Research Center at the National Institutes of Health’s National Institute of Allergy and Infectious Diseases, in partnership with the biotechnology company Moderna, enters Phase 3 testing. The trial is expected to enroll about 30,000 adult volunteers and evaluates the safety of the vaccine and whether it can prevent symptomatic Covid-19 after two doses, among other outcomes.

August 11, 2020 – In a live teleconference, Russian President Vladimir Putin announces that Russia has approved a coronavirus vaccine for public use before completion of Phase 3 trials, which usually precedes approval. The vaccine, which is named Sputnik-V, is developed by the Moscow-based Gamaleya Institute with funding from the Russian Direct Investment Fund (RDIF).

August 15, 2020 – Russia begins production on Sputnik-V, according to Russian state news agency TASS.

August 23, 2020 – The FDA issues an emergency use authorization for the use of convalescent plasma to treat Covid-19. It is made using the blood of people who have recovered from coronavirus infections.

August 27, 2020 – The CDC notifies public health officials around the United States to prepare to distribute a potential coronavirus vaccine as soon as late October. In the documents, posted by The New York Times, the CDC provides planning scenarios to help states prepare and advises on who should get vaccinated first – healthcare professionals, essential workers, national security “populations” and long-term care facility residents and staff.

September 4, 2020 – The first peer-reviewed results of Phase 1 and Phase 2 clinical trials of Russia’s Covid-19 vaccine are published in the medical journal The Lancet. The results “have a good safety profile” and the vaccine induced antibody responses in all participants, The Lancet says.

October 2, 2020 – Trump announces that he and first lady Melania Trump have tested positive for Covid-19. He spends three nights at Walter Reed National Military Medical Center receiving treatment before returning to the White House.

October 12, 2020 – Drugmaker Johnson & Johnson announces it has paused the advanced clinical trial of its experimental coronavirus vaccine because of an unexplained illness in one of the volunteers.”Following our guidelines, the participant’s illness is being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board (DSMB) as well as our internal clinical and safety physicians,” the company said in a statement. ENSEMBLE is the name of the study. The trial resumes later in the month.

December 10, 2020 – Vaccine advisers to the FDA vote to recommend the agency grant emergency use authorization to Pfizer and BioNTech’s coronavirus vaccine.

December 14, 2020 – US officials announce the first doses of the FDA authorized Pfizer vaccine have been delivered to all 50 states, the District of Columbia and Puerto Rico.

December 18, 2020 – The FDA authorizes a second coronavirus vaccine made by Moderna for emergency use. “The emergency use authorization allows the vaccine to be distributed in the U.S. for use in individuals 18 years and older,” the FDA said in a tweet.

January 14, 2021 – The WHO team tasked with investigating the origins of the outbreak in Wuhan arrive in China.

January 20, 2021 – Newly elected US President Joe Biden halts the United States’ withdrawal from WHO.

February 22, 2021 – The death toll from Covid-19 exceeds 500,000 in the United States.

February 27, 2021 – The FDA grants emergency use authorization to Johnson & Johnson’s Covid-19 vaccine, the first single dose Covid-19 vaccine available in the US.

March 30, 2021 – According to a 120-page report from WHO, the novel coronavirus that causes Covid-19 probably spread to people through an animal, and probably started spreading among humans no more than a month or two before it was noticed in December of 2019. The report says a scenario where it spread via an intermediate animal host, possibly a wild animal captured and then raised on a farm, is “very likely.”

April 17, 2021 – The global tally of deaths from Covid-19 surpasses 3 million, according to data compiled by Johns Hopkins.

August 3, 2021 – According to figures published by the CDC, the more contagious Delta variant accounts for an estimated 93.4% of coronavirus circulating in the United States during the last two weeks of July. The figures show a rapid increase over the past two months, up from around 3% in the two weeks ending May 22.

August 12, 2021 – The FDA authorizes an additional Covid-19 vaccine dose for certain immunocompromised people.

August 23, 2021 – The FDA grants full approval to the Pfizer/BioNTech Covid-19 vaccine for people age 16 and older, making it the first coronavirus vaccine approved by the FDA.

September 24, 2021 – CDC Director Dr. Rochelle Walensky diverges from the agency’s independent vaccine advisers to recommend boosters for a broader group of people – those ages 18 to 64 who are at increased risk of Covid-19 because of their workplaces or institutional settings – in addition to older adults, long-term care facility residents and some people with underlying health conditions.

November 2, 2021 – Walensky says she is endorsing a recommendation to vaccinate children ages 5-11 against Covid-19, clearing the way for immediate vaccination of the youngest age group yet in the US.

November 19, 2021 – The FDA authorizes boosters of the Pfizer/BioNTech and Moderna Covid-19 vaccines for all adults. The same day, the CDC also endorses boosters for all adults.

December 16, 2021 – The CDC changes its recommendations for Covid-19 vaccines to make clear that shots made by Moderna and Pfizer/BioNTech are preferred over Johnson & Johnson’s vaccine.

December 22, 2021 – The FDA authorizes Pfizer’s antiviral pill, Paxlovid, to treat Covid-19, the first antiviral Covid-19 pill authorized in the United States for ill people to take at home, before they get sick enough to be hospitalized. The following day, the FDA authorizes Merck’s antiviral pill, molnupiravir.

December 27, 2021 – The CDC shortens the recommended times that people should isolate when they’ve tested positive for Covid-19 from 10 days to five days if they don’t have symptoms – and if they wear a mask around others for at least five more days. The CDC also shortens the recommended time for people to quarantine if they are exposed to the virus to a similar five days if they are vaccinated.

January 31, 2022 – The FDA grants full approval to Moderna’s Covid-19 vaccine for those ages 18 and older. This is the second coronavirus vaccine given full approval by the FDA.

March 29, 2022 – The FDA authorizes a second booster of the Pfizer/BioNTech and Moderna Covid-19 vaccines for adults 50 and older. That same day, the CDC also endorses a second booster for the same age group.

April 25, 2022 – The FDA expands approval of the drug remdesivir to treat patients as young as 28 days and weighing about seven pounds.

May 17, 2022 – The FDA authorizes a booster dose of Pfizer/BioNTech’s Covid-19 vaccine for children ages 5 to 11 at least five months after completion of the primary vaccine series. On May 19, the CDC also endorses a booster dose for the same age group.

June 18, 2022 – The CDC recommends Covid-19 vaccines for children as young as 6 months.

August 31, 2022 – The FDA authorizes updated Covid-19 vaccine booster shots from Moderna and Pfizer. Both are bivalent vaccines that combine the companies’ original vaccine with one that targets the BA.4 and BA.5 Omicron sublineages. The CDC signs off on the updated booster shots the following day.

May 5, 2023 – The WHO says Covid-19 is no longer a global health emergency.

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May 6, 2023

The way the US government tracks Covid-19 is about to change | CNN

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CNN
—

When the US public health emergency ends May 11, the US Centers for Disease Control and Prevention will have to change some of the ways it tracks Covid-19 in the United States, but the agency says it won’t lose its sightlines on the infection as it continues to be part of American life.

On Thursday, for the first time in three years, the CDC will stop posting a national count of Covid-19 cases. The agency’s color-coded maps of county-level transmission and disease burden will be retired, the CDC will no longer track variants down to the state level, and it will update its genomic surveillance estimates every two weeks instead of weekly.

“Though our data going forward will be different, they will continue to provide timely insights for CDC, for local health officials, as well as for the public to understand Covid-19 dynamics,” CDC Principal Deputy Director Dr. Nirav Shah said.

“In short, we will still be able to tell that it’s snowing, even though we’re no longer counting every snowflake.”

Instead of following Covid-19 cases, the agency will track the burden and spread of disease primarily through hospitalizations and deaths.

The move to stop posting a national case count is largely symbolic. The number of Covid-19 cases known to public health officials has long been undercounted. The percent of detected cases has only fallen further as people have turned to rapid home testing for a diagnosis. At some points in the pandemic, experts estimated that the true number of cases was more than 14 times higher than official counts.

Other metrics that people are used to seeing on the CDC’s Covid Data Tracker are also going to go away. As CNN previously reported, the CDC will stop publishing detailed, color-coded Covid-19 Transmission Levels and Covid-19 Community Level maps that have been tied to recommendations about when to wear masks, when it’s a good idea for people to test to prevent the spread of disease and when to avoid large indoor public gatherings.

When the public health emergency ends, more states are expected to stop reporting Covid-19 cases to CDC. Iowa, for example, has already stopped. So the CDC says it won’t be feasible to maintain a national count or update its maps.

Future recommendations for precautions like masking will instead be tied to hospitalization levels.

Covid-19 will retain its designation as a nationally notifiable disease, but that’s just a recommendation, says Dr. Brendan Jackson, who leads the CDC’s Covid-19 response. It doesn’t carry any authority for required reporting. When the public health emergency ends, it will be a state-by-state decision whether to share those numbers, Jackson said Thursday.

The CDC says it will still publish the case counts it gets from states, but that will be in a different section of its website, and the numbers won’t be totaled.

Some experts say they’re disappointed to see that the CDC will have to go back to an older, fragmented system of having to ask states to share data.

“We’re kind of reverting back to a system where the CDC kind of independently negotiates all these data sharing agreements with the states and they make it more voluntary,” said Beth Blauer, associate vice provost for public sector innovation at Johns Hopkins University.

“I think having the states do this all independently doesn’t make a ton of sense because it doesn’t help us understand, in the aggregate, the impact that disease is having on our communities,” Blauer said.

She also said it will be very difficult to scale this system back up should another large, immediate public health threat emerge.

Starting next week, vaccination counts will become discretionary. Jackson said that most, but not all, of the 64 jurisdictions that report to the CDC have signed data use agreements to share their vaccine administration numbers. They may not share as much as they have in the past about who is getting vaccinated or do it as frequently, which may limit the nation’s ability to spot widespread racial, ethnic or socioeconomic disparities for future vaccination campaigns. Starting in June, the CDC says, it will update its vaccination data on a monthly basis.

Laboratories will no longer be required to send testing data to the CDC, which will hamper the ability to understand test positivity rates, a metric that, early in the pandemic, helped public health officials know whether they were doing enough testing or if transmission in a community was going up or down. Positivity rates were used in the transmission maps but also for the CDC’s tracking of variants.

The CDC will still get some lab testing data from another system called the National Respiratory and Enteric Virus Surveillance System, a network of about 450 labs that help it track illnesses like influenza and respiratory syncytial virus, or RSV.

Variant tracking will continue, but the CDC will have to adjust some of the metrics it uses to model variant proportions. State-level estimates of variant proportions with go away, but regional levels will remain. Those will be updated twice a month going forward instead of weekly, as they are now.

The way the CDC will collect data on deaths will change, too. Instead of scraping numbers from state website and getting direct reports from states, which counted deaths based on the date they were reported, the CDC will switch to a national system that counts deaths based on death certificate data. The agency says this system has become much more timely and will be a more stable way to count Covid-19 deaths going forward. It will also add a new metric to its death reporting: the percentage of all deaths reported that week that are caused by Covid-19.

Hospitals will still have to report Covid-19 data through April 2024, but they won’t track as many metrics or submit that information as frequently. Hospitals have shared information daily through most of the pandemic, but now that reporting will be weekly.

Hospitalizations and deaths are known as lagging indicators because they increase only after people have gotten sick. Studies released Friday from CDC epidemiologists show that hospitalizations may not lag behind cases as much as we once thought they did.

The new studies, published in the CDC’s Morbidity and Mortality Weekly Report, show that Covid-19 hospitalizations lagged one day behind increases in reported cases and four days behind increases in emergency room visits.

The research also shows that the new system the CDC will be using to track deaths will show trends 13 days earlier than data collected from states, the system that’s being discontinued.

With case levels low across most of the country, the need for these kinds of insights has gone away, or scientists have found other ways to get the information, such as testing of wastewater, which begins to increase about a week before testing data reflects an uptick in spread. Wastewater testing is available in some places, but not all areas have this capability.

The CDC will also maintain traveler surveillance, testing wastewater on airplanes in an effort to spot new incoming threats.

The CDC will also maintain what it calls sentinel systems: smaller, but nationally representative networks of hospitals and laboratories that will feed in more detailed data. This is much the same way the agency tracks patterns in other respiratory diseases, such as the flu and RSV. The CDC says recent investments in these sentinel systems will help it maintain eyes on Covid-19.

Instead, it will be using hospitalizations and emergency room visits as the primary ways it tracks Covid-19 and as the basis for its recommendations. When hospitalization rates in an area are high, for example, it will be recommending that people wear masks, said Jackson.

CDC Director Dr. Rochelle Walensky acknowledged some of these data changes in a Senate committee hearing this week, although she emphasized that the CDC was not “changing the steam” of its work on Covid-19.

“As the public health emergency is set to end next week, I do want to just reiterate that we at CDC are not changing the steam at which we are working through resolving this public health emergency,” Walensky said at a hearing of the Senate Committee on Health Education, Labor and Pensions.

“It is the case at the end of the public health emergency, we will have less window as to the data,” she said. “We won’t get laboratory reporting. We won’t get case reporting. So we’ll lose some of that.”

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April 30, 2023

New approach gets newborns with opioid withdrawal out of the hospital sooner and with less medication | CNN

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CNN
—

Rates of neonatal abstinence syndrome surged in recent years, but a newer approach to caring for newborn babies exposed to opioids during pregnancy gets them out of the hospital sooner and with less medication, according to a study published on Sunday in the New England Journal of Medicine.

Newborns in opioid withdrawal may experience upset stomach, inconsolable crying, seizures and extreme discomfort. The study looked at the impacts of the Eat, Sleep, Console care approach on 1,300 infants at 26 US hospitals, and compared them with the current standard for caring for infants exposed to opioids.

Eat, Sleep, Console encourages involvement from parents, and prioritizes care that doesn’t involve medication, such as swaddling, skin-to-skin contact and breastfeeding. The usual approach involves a nurse measuring a baby’s withdrawal symptoms – such as their level of irritability, pitch of crying, fever or tremors – before providing treatment such as methadone or morphine.

“Compared to usual care, use of the Eat, Sleep, Console care approach substantially decreased time until infants with neonatal opioid withdrawal syndrome were medically ready for discharge, without increasing specified adverse outcomes,” the researchers wrote in the study.

The infants assessed with the Eat, Sleep, Console care method were discharged after eight days on average, compared with almost 15 days for the infants who were cared for by the standard approach, the researchers said. Additionally, infants in the Eat, Sleep, Console care group were 63% less likely to receive opioid medication – 19.5% received medication compared with 52% in the group receiving usual care.

The current approach to usual care “is a very comprehensive and nurse-led way of assessing the infant, whereas the Eat, Sleep, Console approach involves the mom in the way that you assess the infant, and allows the mom to take part in trying to soothe the infants and see if the infant is able to be soothed or is able to eat or is able to sleep,” according to Rebecca Baker, the director of the NIH HEAL Initiative, which provides grants to researchers studying ways to alleviate the country’s opioid health crisis.

“So, in that way, it’s a little bit more functional, like looking at the abilities of the infants versus how severely the infant is affected.”

Assessment results determine whether a baby should receive medication to control withdrawal symptoms, Baker said.

“So even with Eat, Sleep, Console, some infants that were exposed to a lot of opioids during a mother’s pregnancy, they’ll still need medication-based treatment for withdrawal. It’s just fewer of them need it and when they need it, they need less medication to manage the withdrawal symptoms,” she said.

The Eat, Sleep, Console method was developed about eight years ago, and some hospitals have already implemented it. But Baker said the study’s findings could change how more hospitals practice caring for infants with neonatal abstinence syndrome, which primarily occurs in infants who were exposed to opioids while in utero.

“The rise of really powerful fentanyl, the synthetic opioid, means that if a mother has used drugs during pregnancy, the baby will be exposed to more powerful drugs, which likely has an effect. We haven’t had a chance to study it in detail yet, but it will affect how they feel when they’re born and separated from the mom,” Baker said.

Findings from the study, which were presented at the PAS 2023 Meeting on Sunday, could have a big impact on hospitals by freeing up bed space in the neonatal intensive care unit and boosting morale among nurses at risk of burnout.

“We trained over 5,000 nurses as part of the study. They felt really empowered to help the mom care for the infant to help the infant recover, and so I think from a morale perspective, that’s incredibly important and valuable,” Baker said. “And as you know, nurses are facing really severe staffing shortages and morale challenges so having this tool available to them where they are kind of able to do something positive in the life of the infant and the connection with the mom is really important.”

The researchers are currently following up with a subgroup of the infants from the study for up to two years to see how they grow and develop.

“One of the things that we want to be really sure of is that there are no negative consequences associated with taking less medication, so we’ll be looking for that,” Baker said.

The United States has seen an explosion in the number of infants born with neonatal abstinence syndrome in recent years, swelling by about 82% between 2010 and 2017, according to the US Centers for Disease Control and Prevention. The number of maternal opioid-related diagnoses is also on the rise, increasing by 131% during that same time frame.

Nearly 60 infants are diagnosed with NAS each day, based on data from the U.S. Agency for Healthcare Research and Quality in 2020.

The United States’ opioid epidemic has been expanding in recent years and opioid deaths are the leading cause of accidental death in the US.

More than a million people have died of drug overdoses – mostly opioids – in the two decades since the US Centers for Disease Control and Prevention began collecting that data. Deaths from opioid overdoses rose more than 17% in just one year, from about 69,000 in 2020 to about 81,020 in 2021, the CDC found.

Most are among adults, but children are also dying, largely after ingesting synthetic opioids such as fentanyl. Between 1999 and 2016, nearly 9,000 children and adolescents died of opioid poisoning, with the highest annual rates among adolescents 15 to 19, the CDC found.

Opioid use during pregnancy has been linked to maternal mortality and risk of overdose for the mother, according to the CDC, while infants risk preterm birth, low birthweight, breathing problems and feeding problems.

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