FDA SUGGESTS KIDS BENEFIT FROM COVID SHOTS — You’d be forgiven for thinking FDA’s late-night Friday release of its first analysis of Covid-19 vaccines for children was an attempt to hide bad news. But the document on Pfizer and BioNTech's vaccine data for kids 5 to 11 largely found that the benefits of immunizing outweigh the risks, POLITICO's Lauren Gardner writes. Still, the agency suggested that, if case numbers dropped to levels seen in June, the case for vaccination could be harder to make if myocarditis is seen as an adverse reaction among children that age. There were no cases of heart inflammation reported in Pfizer’s pediatric trial, but the company acknowledged something our Prescription Pulse colleagues have noted for months — the trial size, which was doubled at FDA’s request, wasn’t large enough to identify myocarditis as a safety concern. BIDEN NEARS FDA PICK — The president on Friday met privately with Robert Califf, in the clearest sign yet that he’s preparing to nominate the former Food and Drug Administration commissioner to a return to the agency's top job, two people with knowledge of the matter told Adam and David Lim. The meeting comes after Califf emerged in recent weeks as a leading candidate to run the FDA, and amid a drawn-out search for Biden's first permanent commissioner. The White House also spent the last several weeks vetting Califf, who led the FDA for a year under President Barack Obama. Neither the White House nor Califf responded to requests for comment. Califf won broad bipartisan support during his first stint as commissioner in 2016, winning Senate confirmation by an 89-4 margin. Yet among his skeptics were Manchin, instrumental earlier this year in marshaling opposition to the potential nomination of acting Commissioner Janet Woodcock as the permanent chief. Sanders also questioned Califf’s work with the industry when he was nominated by Obama — such as consulting for different drug and device makers — but ultimately voted for the nominee. CDC CHIEF: ‘ENJOY YOUR TRICK OR TREATING’ — CDC Director Rochelle Walensky on Sunday said families can still celebrate Halloween and other holidays amid the pandemic but urged “prevention strategies.” “I would say put on those costumes, stay outside and enjoy your trick-or-treating,” she said to “Fox News Sunday” host Chris Wallace. But she added caveats: “I wouldn't gather in large settings outside and do screaming like you are seeing in those football games, if you are unvaccinated, those kids that are unvaccinated,“ Walensky said, “but if you are spread out doing your doing or trick-or-treating, that should be very safe for your children.” The CDC director made another plea for people to get vaccinated so they could spend the upcoming holidays — beyond Halloween — safely. ROCKEFELLER FUNDS PANDEMIC PREP GROUP — The Rockefeller Foundation will put up to $150 million toward the Pandemic Prevention Institute, a new effort led by former Biomedical Advanced Research and Development Authority Director Rick Bright, who will take over as PPI’s CEO when it launches. Rockefeller is investing the funds through RF Catalytic Capital, which is incubating the initiative until its launch, but the group also has backing from the World Health Organization and United Kingdom’s Global Pandemic Radar, among others . Rockefeller originally put $20 million toward the effort this summer. Bright said in a panel with global officials this weekend that the group is creating a new headquarters in D.C. and has hired 18 people so far. |