Welcome to Monday’s Overnight Health Care. If you missed it over the weekend, the FDA — and Mississippi— really don't want you taking ivermectin. It's not a COVID-19 treatment and it could kill you. If you have any tips, email us at nweixel@thehill.com, psullivan@thehill.com and jcoleman@thehill.com. Follow us on Twitter at @NateWeixel, @PeterSullivan4, and @JustineColeman8. Today: FDA gave full approval to Pfizer's coronavirus vaccine. As a result, we're likely to see more vaccine mandates from private businesses – something the White House enthusiastically endorses. We'll start with the vaccine news: FDA grants full approval to Pfizer's COVID-19 vaccine The Food and Drug Administration (FDA) on Monday granted the Pfizer-BioNTech COVID-19 vaccine full approval in a highly anticipated move that’s expected to boost vaccinations and spark more mandates nationwide. The federal agency reached the milestone of issuing the first complete authorization for a COVID-19 vaccine after an approximately three-month review of Pfizer and its German partner BioNTech’s application to the FDA for full approval. The vaccine will be marketed as Comirnaty, with the full authorization applying to vaccine recipients age 16 and older. Acting FDA Commissioner Janet Woodcock praised the authorization in a press briefing, saying it "holds the promise of altering the course of the pandemic in the United States." "This is an unprecedented timeline given the volume of review and the meticulous manner in which it was done," she said. "But we want to underscore that our efforts to move as quickly as possible have in no way sacrifice scientific standards for the integrity of our process." Why it matters: With slightly more than half of the total U.S. population fully vaccinated, experts and Biden administration officials are hopeful the agency’s full approval will serve as a catalyst for vaccinations in the country. Read more here. Biden used the announcement to urge the unvaccinated to stop waiting and get the shots The full FDA approval is a chance to step up the messaging, and President Biden quickly gave remarks after the move on Monday, calling on unvaccinated Americans who have been waiting to get the shots to get vaccinated "today.” Biden called the FDA's full approval for the vaccine from Pfizer and its German partner BioNTech earlier on Monday a "key milestone" in the fight against the virus, and said it takes away any final excuse for not getting vaccinated. "After a strict process the FDA has reaffirmed its findings that the Pfizer COVID-19 vaccine is safe and effective and the FDA has given its full and final approval," Biden said. "So let me say this loudly and clearly: If you're one of the millions of Americans who said that they will not get the shot until it has full and final approval of the FDA, it has now happened." Read more here. And more people could now be mandated to get the shots through their employers The full federal approval of the Pfizer-BioNTech vaccine on Monday immediately, as expected, led to new vaccination mandates by government entities, a development that suggests more could be coming. Immediately after the Food and Drug Administration (FDA) gave full approval to the vaccine Monday, New York City announced that all public school teachers and staff will be required to get the shot. The Pentagon later confirmed that it would move forward with a vaccine mandate for military service members. Biden administration officials believe that the private sector will follow suit. “For businesses and universities that have been thinking about putting vaccine requirements in place in order to create safer spaces for people to work and learn, I think that this move from the FDA, when it comes, will actually help them to move forward with those kinds of plans,” Surgeon General Vivek Murthy told CNN on Sunday, prior to the FDA announcement. A few dozen corporations, including Microsoft, Tyson Foods, Walt Disney and Netflix, announced vaccine requirements after the Biden administration mandated vaccinations for federal employees late last month. More companies will implement their own vaccine requirements following the FDA decision, said Michelle Strowhiro, a lawyer at McDermott Will & Emery who advises businesses on COVID-19 employment issues. Read more here. Biden threw his support behind company vaccine requirements Biden called on companies to mandate COVID-19 vaccines on Monday, voicing strong support for such requirements following the FDA’s full approval for Pfizer’s vaccine. “Today I’m calling on more companies in the private sector to step up the vaccine requirements that’ll reach millions more people,” Biden said during an address. “If you’re a business leader, a nonprofit leader, a state or local leader, who has been waiting for full FDA approval to require vaccinations, I call on you now to do that.” The president requested that business and government leaders follow in his footsteps after he previously ordered federal employees and onsite contractors to get vaccinated or endure regular COVID-19 testing. The administration has also directed troops, nursing home staff and workers at federal medical centers to get vaccinated. “Do what I did last month: Require your employees to get vaccinated or face strict requirements,” he said in his plea to leaders. “It only makes sense to require a vaccine to stop the spread of COVID-19,” he added. Read more here. NYC mandates COVID-19 vaccinations for all public school teachers, staff All New York City public school teachers and staff will need to be vaccinated against COVID-19, the city announced Monday, shortly after the Food and Drug Administration gave final approval to the Pfizer vaccine. Students in the country's largest school district return to classes next month, and teachers and staff will need to have their first dose by Sept. 27. There is no alternative option for regular testing as some other districts have allowed. Schools Chancellor Meisha Ross Porter called the policy “another layer of protection for our kids." Previously, teachers were subject to the same requirements as other city employees, which meant they would need to be vaccinated or face weekly testing. Currently, about 63 percent of school employees have already been vaccinated. Labor reaction: Vaccine requirements have been a thorny issue among some labor unions and it's unclear how the unions representing teachers and other staff will respond. Mayor Bill de Blasio (D) said during a news conference that he will start bargaining with unions immediately over the specifics to make sure it is implemented fairly and equitably. United Federation of Teachers President Michael Mulgrew in a statement said those details, like medical exemptions, may need to be worked out through arbitration if necessary. Read more here. What we’re reading States gripped by Delta variant face case surge with fewer health workers (Politico) Pandemic unveils growing suicide crisis for communities of color (Kaiser Health News) ‘I haven’t even told my wife’: Inside the frantic and secretive sprint to name the Covid-19 vaccines (Stat) How to calculate delta-variant risks for children this fall (The Wall Street Journal) State by state Breakthrough COVID infections add even more chaos to school's start in 2021 (KQED) Oklahoma leaders say COVID vaccine mandate for nursing home staff could mean ‘catastrophe’ (The Oklahoman) Tougher Hawaii travel restrictions possible as COVID-19 surge continues (Honolulu Star Advertiser) Op-eds in The Hill Biden administration's unshakable focus on vaccinations is working The perpetual pandemic: Politicians won't let COVID end Masks and vaccines: What price freedom? |
No comments:
Post a Comment