FDA AUTHORIZES COVID BOOSTERS FOR TEENS 12–15 — FDA made some major updates Monday to its emergency use authorization for Pfizer and BioNTech’s Covid-19 vaccine in children, Lauren reports, green-lighting boosters for teens ages 12 to 15 and additional doses for kids ages 5 to 11 with certain immunocompromising conditions. The agency also shortened the minimum timeframe for people who received the primary Pfizer vaccine series to seek a booster to five months from six. FDA made the changes without convening its independent vaccine advisory group, a decision that’s always discretionary, as Center for Biologics Evaluation and Research Director Peter Marks said in response to Lauren’s question during a news conference. Given the sharp uptick in Covid cases in the last several days, he said, “it made sense to try to move as quickly as we possibly could.” The CDC’s own external advisers are scheduled to meet Wednesday afternoon, a confab that’s all but certain to center on the latest EUA amendments. Benefits and risks: The teen booster call is the latest example of federal health regulators responding to the rapid rise of the Omicron variant — and grappling with the competing needs for speed and adequate data to assess benefits and risks. The EUA amendment says a booster dose “may be effective” for 12- to 15-year-olds and that real-world safety data from Israel showed no myocarditis cases among the 6,300 kids boosted in that age group so far — though they only recently became eligible for booster shots there. Independent FDA vaccine advisers who spoke to Lauren emphasized the obvious: Boosting adolescents won’t get us out of the pandemic. “This is a disease of the unvaccinated, and I just think that boosting is largely a detour that is not going to have a big impact on this pandemic,” said Paul Offit of the Children’s Hospital of Philadelphia. COVID PILLS MAKE THEIR DEBUT — In case you missed it, FDA authorized before Christmas two antiviral pill regimens to treat Covid-19. The drugs, Paxlovid by Pfizer and molnupiravir by Merck and Ridgeback Biotherapeutics, could prove to be game-changers in keeping Covid patients at high risk for developing severe illness out of the hospital — if they can confirm their infections early enough to qualify for the treatments. Both drugs should be taken within five days of symptom onset. Still, the pills are no substitute for vaccines, and they come with their own sets of risks. The Pfizer drug can interact with several other medications and supplements, and the Merck pill can’t be prescribed to children and is not recommended for pregnant people, based on results seen in animal testing. The Wall Street Journal has a handy rundown of the pros and cons of the drugs, but the quick takeaway: Molnupiravir is a drug of last resort because of its safety profile and much lower efficacy compared to Paxlovid. To put a finer point on it: The National Institutes of Health updated their Covid treatment guidelines on Dec. 30 for nonhospitalized high-risk patients, ranking available therapies in order of preference: Paxlovid, monoclonal antibodies (specifically the GlaxoSmithKline-Vir cocktail if the Omicron variant is suspected), remdesivir, molnupiravir. “Molnupiravir should only be administered when the other 3 options are either not available or cannot be used,” NIH says. Pharmacists fire back: A coalition of national pharmacy groups sounded off on FDA’s EUAs for blocking pharmacists from writing prescriptions for the drugs, despite authority the government has already granted them to order and dispense oral treatments under the PREP Act. The organizations — the American Pharmacists Association, the American Society of Consultant Pharmacists, the American Society of Health-System Pharmacists, the National Alliance of State Pharmacy Associations and the National Community Pharmacists Association — argue the restrictions will hinder their ability to help patients quickly access the pills, which are authorized to be taken early in infection. “Time is of the essence,” they said in a statement. “Requiring patients to make an appointment with another prescriber just to get a prescription that their pharmacist will fill adds time, cost, and inconvenience but most concerning of all, it could cause hospitalizations and even deaths.” FDA AUTHORIZES MORE HOME TESTS — SD Biosensor and Siemens Healthineers are the latest firms to receive EUAs for serial at-home Covid-19 tests. Combined, the two firms will be able to manufacture “tens of millions of tests per month,” according to HHS. The National Institutes of Health helped facilitate the new authorizations through its Rapid Acceleration of Diagnostics Technology initiative’s Independent Test Assessment Program, which conducted studies that allowed FDA to evaluate the tests. “This program is incredibly beneficial to increasing access to rapid tests by quickly and consistently gathering the critical data companies need to request EUA and subsequently enter the U.S. market once authorized,” CDRH Director Jeff Shuren said in a statement. The Department of Defense also last week awarded a $137 million contract to establish domestic manufacturing of nitrocellulose membrane, a material used to make over-the-counter tests. The investment into MilliporeSigma will help it make enough of the product to support production of 83.3 million tests a month, according to DoD. | 
