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Churches dealing with new Oregon masks rules

Biden health team hatches new vaccine strategy as variant threat builds

Biden health team hatches new vaccine strategy as variant threat builds POLITICO 2/5/2021 © Michael Ciaglo/Getty Images Pharmacy technicians prepare doses of the Covid-19 vaccine. The Food and Drug Administration is preparing to release new standards for Covid-19 vaccine booster shots, tests and drugs in the coming weeks all aimed at preparing the country to beat back fast-spreading virus variants that are less susceptible to existing shots. The agency confirmed Thursday that it plans to release draft guidance. It could come in two to three weeks, according to four people familiar with the discussion. In the meantime, federal and state officials are scrambling to track how widely the coronavirus variants first found in South Africa, Brazil and the United Kingdom are spreading in the United States.

Writing the variant playbook

POLITICO Get the Prescription Pulse newsletter Email Sign Up By signing up you agree to receive email newsletters or updates from POLITICO and you agree to our privacy policy and terms of service. You can unsubscribe at any time and you can contact us here. This sign-up form is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply. Presented by CVS Health On Tap J&J files for emergency use setting the stage for a third option. FDA limits plasma to early use after new data. It’s Friday, welcome back to Prescription Pulse. Let s hear it for beer-reviewed research, up there with vaccine sh s and pubic health. As always, send tips (and, I guess, typos) to Sarah Owermohle at [email protected] or @owermohle. Loop in David Lim ([email protected] or @davidalim) and Brianna Ehley ([email protected] or @briannaehley)

Woodcock steps in as acting FDA chief with crucial vaccine decisions ahead

Dive Brief: Janet Woodcock, head of the Food and Drug Administration s drug review division, will serve as acting commissioner of the agency while President Joseph Biden decides on a permanent chief. She is one of several current and former high-ranking FDA officials believed to be under consideration for the permanent job. Detailed last year to the former Trump administration s coronavirus response team, Operation Warp Speed, Woodcock will recuse herself from FDA decisions involving certain COVID-19 drugs that she assisted in development. That recusal will not apply to vaccines or diagnostics. Woodcock will have a full plate, with as many as three coronavirus vaccines potentially needing review in coming months and two others that may convert to full agency approval after already gaining emergency authorization. Meanwhile, the FDA will need to work on a backlog of non-COVID drug approval decisions that have been put on hold because inspectors can t travel to some manufacturing f

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