Overnight Health Care — Pfizer seeks green light for young kids' vax

View in your browser OVERNIGHT POLICY: Health Care Pfizer seeks green light for young kids' vax © Associated Press/Carolyn Kaster, file Welcome to Tuesday’s Overnight Health Care, where we’re following the latest moves on policy and news affecting your health. Subscribe here: thehill.com/newsletter-signup. In sports news: the Washington Football Team will unveil its new nickname tomorrow—while most of the sports world is focused on an entirely different scandal unfolding. Pfizer started the application for the FDA to authorize its COVID-19 vaccine for kids under age 5. But it’s a bit of a complicated process. For The Hill, we’re Peter Sullivan (psullivan@thehill.com) and Nathaniel Weixel (nweixel@thehill.com). Write to us with tips and feedback, and follow us on Twitter: @PeterSullivan4 and @NateWeixel. Let’s get started. Pfizer begins FDA vax filing for kids under 5 © Pfizer Media Relations via AP Pfizer said Tuesday that it has begun applying for authorization for its COVID-19 vaccine for children ages 6 months to 4 years from the Food and Drug Administration (FDA).   The announcement marks a step forward in the process for the only age group for whom COVID-19 vaccines are not yet authorized.    The wrinkle: The application is for two doses, though the company said it realized three doses will eventually be needed. Pfizer said it is applying now at the request of the FDA, so the agency can start the process on authorizing two doses. The theory is authorization could later be expanded to three doses once the data becomes available.  “As hospitalizations of children under 5 due to COVID-19 have soared, our mutual goal with the FDA is to prepare for future variant surges and provide parents with an option to help protect their children from this virus,” Pfizer CEO Albert Bourla said.  “Ultimately, we believe that three doses of the vaccine will be needed for children 6 months through 4 years of age to achieve high levels of protection against current and potential future variants. If two doses are authorized, parents will have the opportunity to begin a COVID-19 vaccination series for their children while awaiting potential authorization of a third dose.”  Timeline: Pfizer said in December that the vaccine application for children under 5 could take as long as the middle of 2022, given that the immune response from two doses was not sufficient and a third dose needed to be tested. It said there were no safety concerns.   The latest move could significantly move up the timeline to begin the process with the first two shots, with a third following later.  The FDA announced Tuesday that its vaccine advisory committee would meet on Feb. 15, indicating that a final decision could come fairly soon after that.  Read more here. HOSPITALIZATIONS 23 TIMES HIGHER FOR UNVACCINATED: CDC Unvaccinated adults were 23 times more likely to be hospitalized with COVID-19 during the omicron wave than adults who were vaccinated and boosted, according to a new study that further highlights the importance of coronavirus vaccination and booster shots.     The study, released Tuesday, from the Centers for Disease Control and Prevention (CDC) found by far the highest rates of cases and hospitalizations among unvaccinated people, followed by vaccinated but not boosted people, with vaccinated and boosted people having the most protection.    The study used data from Los Angeles County as of Jan. 8, during the omicron wave.    Hospitalizations were 5.3 times higher among the unvaccinated than vaccinated but not boosted.    “Efforts to promote COVID-19 vaccination and boosters are critical to preventing COVID-19–associated hospitalizations and severe outcomes,” the study states.    While the largest effects were in reducing hospitalizations, the study also shows that vaccines and boosters lowered the chance of getting infected at all. The protection is not total, meaning there are still frequent breakthrough cases, but the severity is far lower among people who are vaccinated and boosted than among the unvaccinated.    Read more here.  White House says it's confident in Bacerra © Getty White House press secretary Jen Psaki said President Biden remains confident in Health and Human Services Secretary Xavier Becerra amid reports White House officials are frustrated with the job the secretary has done during the COVID-19 pandemic. “I would just reiterate that the president remains confident in the role of Secretary Becerra, he is somebody who is an important partner, he has been leading a range of efforts from the …Department of Health and Human Services,” Psaki said when asked if the president still has confidence in Becerra.  Becerra has been under fire for what critics say is a lack of leadership in the COVID-19 response and outside health experts and former officials have accused him of taking a back seat during the crisis.  The Washington Post on Monday night reported that officials have openly discussed who might be better suited for Becerra’s role and that they have a poor relationship with Becerra.  Psaki called such reporting “palace intrigue.”  Read more here. NATIVE TRIBES REACH $665M SETTLEMENT Native American tribes have reached a $665 million settlement with three of the nation’s biggest opioid distributors as well as drugmaker Johnson & Johnson, a filing with the U.S. District Court in Cleveland on Tuesday showed.   More than 400 tribes and intertribal organizations sued  Johnson & Johnson, McKesson, AmerisourceBergen and Cardinal Health for allegedly producing and shipping opioids to Native American tribes despite warnings of health issues and overdoses that were affecting the community.   All federally recognized tribes will be able to participate in the settlements, even if they did not sue.  The companies say they did not do anything wrong and followed federal laws.   Breakdown: McKesson, Cardinal Health and AmerisourceBergen have agreed to pay almost $440 million over a seven-year time frame, according to the court document. The companies also previously agreed to pay around $75 million to the Cherokee Nation.   Johnson & Johnson said it would pay $150 million over a two-year time frame.   The same four companies are nearing the final stages of approval of settlements worth $26 billion with state and local governments across the U.S.  Read more here. No signs BA.2 subvariant more severe: WHO © Getty Images The World Health Organization (WHO) said Tuesday that the new BA.2 subvariant of the omicron strain of COVID-19 is no more severe than omicron’s original strain.  "There's no indication that there's a change in severity," Maria Van Kerkhove, the WHO’s technical lead for COVID-19, said at Tuesday’s press briefing.  She added that BA.2 has a “slight increase in growth rate” over BA.1, meaning the subvariant is slightly more transmissible than the omicron variant’s original strain.  “Beyond that, the data is really quite limited,” she said, noting that “most of the research that is available is on the subvariant BA.1.”   “BA.2 is one of the sublineages of omicron, so BA.2 is omicron, and it is a variant of concern,” Van Kerkhove explained. “It’s in the family of the variants of concern around omicron.”  “We need people to be aware that this virus is continuing to circulate and it’s continuing to evolve,” she added. “That’s why it’s really important that we take measures to reduce our exposure to this virus, whatever variant is circulating.”  Read more here.   WHAT WE'RE READING How the falsehood of athletes dying from coronavirus vaccines spread (Washington Post)  Denmark Covid restrictions lifted despite increase in cases (BBC)    How a decades-old database became a hugely profitable dossier on the health of 270 million Americans (Stat)  Faxes and snail mail: will pandemic-era flaws unleash improved health technology? (Kaiser Health News)  STATE BY STATE ‘Epidemic among the unvaccinated’ in a California COVID ICU (San Francisco Chronicle)  In pandemic’s isolation, an alarming number of teenage girls are attempting suicide (Texas Tribune)  Missouri Senate rejects governor's pick for health director over support for COVID vaccines (KCUR)  Senate committee scraps legislation aimed at controlling prescription drug costs (Virginia Mercury)  That's it for today, thanks for reading. Check out The Hill's health care page for the latest news and coverage. See you tomorrow. Sign Up for Health Care Forward Health Care Privacy Policy  |   Manage Subscriptions  |   Unsubscribe Email to a friend  |   Sign Up for Other Newsletters The Hill 1625 K Street, NW 9th Floor, Washington DC 20006 © 1998 - 2022 Nexstar Media Inc. | All Rights Reserved.

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