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Tag: Food and Drug Administration

FDA approves Moderna COVID vaccine for kids under 12 at higher risk

Vaccine maker Moderna announced today that the US Food and Drug Administration (FDA) has granted full approval of its Spikevax (mRNA-1273) COVID vaccine for children 6 months to 11 years old. But, because federal officials in May restricted its recommendations for COVID-19 vaccines to adults 65 and older and to people of all ages who are at increased risk for severe disease, Spikevax will be available only to kids in that age range who are at higher risk.

“COVID-19 continues to pose a significant potential threat to children, especially those with underlying medical conditions. Vaccination can be an important tool for protecting our youngest against severe disease and hospitalization,” said Moderna CEO Stéphane Bancel, MBA, MEng. “We appreciate the FDA’s diligent scientific review and approval of Spikevax for pediatric populations at increased risk for COVID-19 disease.”

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Inside the Collapse of the F.D.A.

The reckoning that Robert Califf spent years warning about began, as so many things seem to these days, on social media. It was October 2024. His tenure as commissioner of the Food and Drug Administration was winding down, and he was starting to imagine a happy retirement surrounded by grandchildren when he noticed Robert F. Kennedy Jr. taking aim at his agency, and the 19,000 or so people who worked there, on X.

“FDA’s war on public health is about to end,” Kennedy wrote. “This includes its aggressive suppression of psychedelics, peptides, stem cells, raw milk, hyperbaric therapies, chelating compounds, ivermectin, hydroxychloroquine, vitamins, clean foods, sunshine, exercise, nutraceuticals and anything else that advances human health and can’t be patented by Pharma. If you work for the FDA and are part of this corrupt system, I have two messages for you. 1. Preserve your records, and 2. Pack your bags.”

It was a confused, almost comically pompous declaration, Califf recalls thinking, and it ought to have been the least of his concerns. Kennedy had not yet been tapped to serve as anything, let alone the highest health official in the land. Still, it struck a nerve. More and more, people seemed to clamor for things that were unproven, to question things that were and to express not only mistrust but outright hostility toward the doctors, scientists and civil servants trying to separate one from the other. That hostility was being nourished by exactly the kind of mis- and disinformation Kennedy was espousing. It was easy to paint the F.D.A. as a supervillain (an aggressive suppressor of sunlight, vitamins and exercise, to borrow Kennedy’s language), in part because the truth was so much more complex.

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Trump indicates he would consider a ban on vaccines if elected

Donald Trump has suggested vaccines could be banned if he becomes president, in the clearest sign yet of a radical shake-up in public health policy should he put his ally Robert F Kennedy Jr in charge of it.

Trump on Sunday told NBC that Kennedy, the anti-vaccine conspiracy theorist and former independent candidate who dropped out and endorsed Trump, would have a “big role in the administration” if wins Tuesday’s presidential election. Trump said he would talk to Kennedy about vaccinations.

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FDA may greenlight updated Covid-19 vaccines as soon as next week, sources say

The US Food and Drug Administration is poised to sign off as soon as next week on updated Covid-19 vaccines targeting more recently circulating strains of the virus, according to two sources familiar with the matter, as the country experiences its largest summer wave in two years.

The agency is expected to greenlight updated mRNA vaccines from Moderna and Pfizer/BioNTech that target a strain of the virus called KP.2, said the sources, who declined to be named because the timing information isn’t public. It was unclear whether the agency simultaneously would authorize Novavax’s updated shot, which targets the JN.1 strain.

The move would be several weeks ahead of last year’s version of the vaccine, which got FDA signoff on September 11.

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San Diego COVID-19 testmaker Cue Health is shutting down

Cue Health, the once high-flying San [Diego] biotech supplying rapid COVID-19 test kits to the NBA and others, is shutting down this week.

Cue’s closure comes a week after the U.S. Food and Drug Administration warned consumers to throw out any of its COVID-19 test kits because they could give false results. The San Diego firm said it has stopped selling the COVID-19 tests, which was its only fully FDA-approved commercial product.

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H5N1 bird flu virus particles found in pasteurized milk but FDA says commercial milk supply appears safe

Testing conducted by the Food and Drug Administration on pasteurized commercially purchased milk has found genetic evidence of the H5N1 bird flu virus, the agency confirmed Tuesday. But the testing, done by polymerase chain reaction, or PCR, cannot distinguish between live virus or fragments of viruses that could have been killed by the pasteurization process.

The agency said it has been trying to see if it could grow virus from milk found to contain evidence of H5N1, which is the gold standard test to see if there is viable virus in a product. The lengthy statement the agency released does not explicitly say FDA laboratories were unable to find live virus in the milk samples, but it does state that its belief that commercial, pasteurized milk is safe to consume has not been altered by these findings.

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FDA authorizes Novavax’s updated COVID vaccine for fall 2023

The Food and Drug Administration announced Tuesday it had authorized Novavax’s updated COVID-19 vaccine, adding a third option for Americans ages 12 and older looking for a new shot this fall and winter.

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