Overnight Health Care — FDA endorses first pill to treat COVID-19

View in your browser OVERNIGHT POLICY: Health Care FDA endorses first pill to treat COVID-19 © iStock Welcome to Wednesday’s Overnight Health Care, where we’re following the latest moves on policy and news affecting your health. Subscribe here: thehill.com/newsletter-signup. Johns Hopkins University is known for its health care expertise, but apparently they are also pretty good at making Home Alone-themed videos about vaccinations! Check out the clip here. The U.S. took a step forward in the fight against the coronavirus Wednesday, as the FDA authorized the first pill to fight COVID-19, one that has been shown to be highly effective. Supply will be an issue, though.  For The Hill, we’re Peter Sullivan (psullivan@thehill.com), Nathaniel Weixel (nweixel@thehill.com) and Justine Coleman (jcoleman@thehill.com). Write to us with tips and feedback, and follow us on Twitter: @PeterSullivan4, @NateWeixel and @JustineColeman8. Let’s get started. FDA authorizes Pfizer pill to treat COVID-19 in major advance © Associated Press/Mark Lennihan The Food and Drug Administration (FDA) on Wednesday authorized a new COVID-19 treatment from Pfizer, the first pill to treat the virus to become available. The pill, known as Paxlovid, is seen as a major step forward in the fight against the virus. The fact it is a pill should make it more accessible and easier to take than previous treatments, which required injections. It has also shown very promising results in trials in reducing the worst outcomes from the virus, putting the country on the path to defanging COVID-19. Trials have shown it reduced the risk of hospitalization or death by 89 percent in high-risk patients. The drawback: Experts are warning that supply will be constrained in the short term, and they have called on the Biden administration to take actions like enlisting other manufacturers to help make it. The company has said about 180,000 courses will be available this year. That is not a sufficient amount given there are more than 100,000 cases of COVID-19 every day just in the U.S. Another challenge: The treatment is intended to be started within five days of the onset of symptoms. Plentiful testing will be needed to ensure that people know that they have COVID-19, and can get results in time to be able to seek the treatment. Read more here.  South African study finds omicron may be significantly less severe © Getty Images A new South African study found the omicron variant could be significantly less severe than previous strains of the novel coronavirus.  The study found people with omicron infections had an 80 percent lower chance of being hospitalized, compared to other COVID-19 cases.  The researchers cautioned, though, that it is unclear to what extent omicron is intrinsically less severe than earlier strains, and to what extent the drop is due to more immunity in the population, from both prior infection and vaccination, than there was in earlier waves.  “It is difficult to disentangle the relative contribution of high levels of previous population immunity versus intrinsic lower virulence to the observed lower disease severity,” the study, which has not yet been peer-reviewed, states.  Still, the findings could provide some good news.  “New pre-print from South Africa suggests that, at least among those vaccinated and/or previously infected, Omicron is much less severe than Delta,” tweeted Tom Frieden, former director of the Centers for Disease Control and Prevention. “Will that hold true in the US with an older population? We'll find out in the coming weeks.” The South African study adds to earlier indications that omicron could be less severe, though researchers are still gathering data.  Read more here.  OBAMACARE OPEN ENROLLMENT HITS RECORD NUMBERS A record 13.6 million people have enrolled in health insurance coverage through the Affordable Care Act to date, with another month left before open enrollment ends, Biden administration officials said Wednesday. According to the Centers for Medicare and Medicaid Services (CMS), more than 9.7 million Americans enrolled in coverage in the 33 states using HealthCare.gov for 2022 from the start of open enrollment through Dec. 15.  Health and Human Services Secretary Xavier Becerra said much of the progress was due to increased outreach, as well as the premium assistance from the American Rescue Plan which helped make coverage more affordable.  According to CMS, 92 percent of people in the 33 states with a federally-run exchange who signed up for plans through December 15 will receive premium tax credits. Becerra said nine out of 10 consumers have plans for less than $10 a month. The Biden administration and congressional Democrats are trying to extend that premium assistance through the $1.7 trillion Build Back Better plan, though its prospects were dealt a major blow by Sen. Joe Manchin (D-W.Va.) and are uncertain, at best.  Read more here. DC to require COVID-19 vaccination for indoor public spaces © Bonnie Cash Washington, D.C., will soon require proof of coronavirus vaccination to enter a number of indoor public spaces, Mayor Muriel Bowser (D) announced Wednesday. Beginning Jan. 15, patrons over the age of 12 will need to show proof of at least one dose of a COVID-19 vaccine to enter places including restaurants, bars, nightclubs, theaters or gyms. Negative coronavirus tests will not be accepted. Beginning Feb. 15, patrons must be fully vaccinated with two doses of an mRNA vaccine or a single dose of Johnson & Johnson's shot. D.C. officials emphasized the requirement is for patrons only, not for staff. The new rules will not require booster shots. Houses of worship, retail and grocery stores will be exempt. The vaccine requirement will also not apply to museums. How it works: The vaccine requirement aligns D.C. with other cities that have already implemented or recently announced a vaccine requirement, such as New York City, Chicago, Philadelphia and Boston.  Businesses will be required to check for a copy of a vaccine record, like a photo or a printout, or a verification app such as VaxYes or CLEAR. A negative test will not count.  "If you are a resident who is not yet vaccinated but wants to continue to enjoy these activities, now's the time to get vaccinated," Bowser said during a press briefing. Record-breaking week: The moves come as D.C. has broken its own daily coronavirus case count record multiple times over the past week. Read more here.  NEXT STEP IN THE MANDATES: CALIFORNIA TO REQUIRE BOOSTERS FOR HEALTH CARE WORKERS The state of California will require that all health care workers receive their COVID-19 booster.  In a tweet posted Tuesday, California Gov. Gavin Newsom (D) announced: "California will require healthcare workers to get their booster. With Omicron on the rise, we’re taking immediate actions to protect Californians and ensure our hospitals are prepared." The governor's office said that Newsom would officially announce "new state actions to protect Californians" including the booster mandate during a visit to a COVID-19 vaccine and testing site in Alameda County on Wednesday.  News of the additional measures for the Golden State come amid increasing concern from public health and government officials over the spread of the omicron variant. The variant, first discovered in South Africa, has become the dominant strain in the United States amid a surge of COVID-19 infections.  California has reverted to some previous pandemic-related policies to combat a recent rise in infections like reviving the statewide indoor mask mandate until at least Jan. 15. However, officials in Los Angeles said that things were not as dire as they were at times last year.  Read more here.  WHAT WE’RE READING The flu makes an unwelcome comeback as omicron surges (The New York Times)  Hospitals grapple with Omicron — and legal brawl over vaccinating staff (Politico) Biden tries COVID cajoling, avoids new decrees that divide (The Associated Press) STATE BY STATE Virus cases spike in New York City jails, where less than half of detainees are vaccinated. (The New York Times) Massachusetts reports record-breaking number of daily coronavirus cases (Boston Herald) Minnesota dials back COVID-19 antibody strategy as omicron rises to 50% of new cases (Star Tribune) 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. 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