CDC PANEL TO WEIGH WHICH KIDS SHOULD BE VACCINE-ELIGIBLE — Today marks the last major regulatory hurdle for Pfizer and BioNTech to clear to get their pediatric Covid vaccine doses into younger kids’ arms. CDC Director Rochelle Walensky is expected to quickly endorse the shots’ administration; the main question is whether her agency’s external advisory panel will try to recommend limiting the vaccines to high-risk children as opposed to everyone in the 5-11 age group. Some members of FDA’s independent vaccine advisory committee last week suggested they would have been more comfortable supporting emergency use authorization if the shot would be recommended only for kids of color or those with certain underlying health conditions, given the higher risk for those groups and the paucity of safety data so far. Ultimately, the panel backed an EUA without that caveat, punting to the CDC group. But if the CDC panel does take that approach, Walensky could always override it and recommend the shots for all kids 5 and up. A former FDA official’s take: Joshua Sharfstein, vice dean for public health practice and community engagement at Johns Hopkins’ Bloomberg School of Public Health and FDA’s former principal deputy commissioner, said “the benefit-risk [balance] looks pretty, pretty good” in the favor of authorizing pediatric doses. “I don't know that they really have justification to limit it to a smaller group of kids,” he told our Katherine Ellen Foley, though he declined to predict the meeting’s outcome. The CDC can help prepare parents for making vaccine decisions for their kids by making it clear the agency will track safety data closely and will “continually communicate with the public as it receives more data,” Sharfstein said. “What we hope is that, as we get more data, it will be reassuring and encouragement for people to move off the fence” and get their children immunized, he added. The CDC meeting comes days after FDA authorized Pfizer-BioNtech’s Covid-19 vaccine for children 5-11 years old. "Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy,” acting FDA Commissioner Janet Woodcock said. The White House Covid-19 Task Force said Monday 15 million pediatric Pfizer doses, which are one-third the amount of an adult dose, are being sent to distribution centers in preparation for the CDC’s recommendation. “Over the next couple of days, several million doses will start arriving at local pediatricians and family doctors offices, pharmacies, children's hospitals, community health centers, rural health clinics and other locations,” White House Covid-19 Coordinator Jeff Zients told reporters. “More doses will be packed and shipped and delivered each and every day over the next week or so.” Zients said the federal government has enough Pfizer vaccine to vaccinate for every child 5-11 years old. “We're in great shape on supply, and the whole plan is based on Pfizer vaccines,” Zients said. MODERNA PUTS KID COVID SHOTS ON HOLD — Another issue for CDC advisers to chew on is that Pfizer’s vaccine is the only offering young kids will have for the foreseeable future. Moderna announced Sunday that it will delay applying to FDA for authorization of its own messenger RNA shot for kids ages 6 to 11 while the agency continues to assess its myocarditis risk in adolescents, Lauren reports. That review may not wrap up until January, the company said, noting FDA notified Moderna of the timeline on Friday. While both Pfizer’s and Moderna’s vaccines have been linked to an elevated risk of myocarditis in adolescent and young adult males, some countries’ side effect surveillance systems — including one in the U.S. — has noted a stronger correlation between the condition and the Moderna product. BIDEN ADMIN LAYS OUT VAX REQUIREMENT FOR FEDERAL CONTRACTORS — Federal contractors subject to President Joe Biden’s vaccine mandate will largely be in charge of policing noncompliant employees, according to guidance the White House released Monday. If a worker refuses to get vaccinated and hasn't requested an accommodation, federal contractors “should determine the appropriate means of enforcement,” according to the guidance from the Safer Federal Workforce Task Force. Federal contractors have until Dec. 8 to ensure their workforces received the Covid-19 vaccine, except where an employee needs a religious or disability accommodation, POLITICO’s Rebecca Rainey reports. DC HEALTH LAUNCHES PORTAL FOR AT-HOME COVID TEST RESULTS — Local readers who use at-home Covid-19 tests can report results to DC Health via an online portal launched Monday. FDA EXPANDS ORASURE AUTHORIZATION — OraSure Technologies’ emergency use authorization for its InteliSwab Covid-19 test was expanded Monday to include labeling as a non-prescription single test for those with symptoms of Covid-19. |