Welcome to Wednesday's Overnight Health Care. It looks like President-elect Joe Biden’s pick to lead HHS is in for a rocky confirmation process, with Senate Republicans vowing to oppose him. Trump administration officials are confident there will not be a shortage of any COVID-19 vaccines and the future of a coronavirus relief bill is up in the air. We'll start in Congress: Momentum stalls for COVID-19 relief bill Momentum appeared to stall Wednesday on a COVID-19 relief bill amid differences not only between the parties, but between Senate Republicans and the White House over what should be included in the legislation. Senate Majority Leader Mitch McConnell (R-Ky.) accused Democratic leaders of blocking progress, casting doubt on reaching a deal this week. “At every turn they’ve delayed, deflected, moved the goalpost and made the huge number of places where Congress agrees into a hostage ... for the few places where we do not agree,” he said on the Senate floor. Moderate plan details MIA: A bipartisan group of moderates released more details of their $908 billion proposal, which has played a key role in the negotiations in recent days. However, they didn’t provide specifics about how they’d address state and local aid and liability protection. Instead, their document states that they have agreements in principle on these topics “as the basis for good faith negotiations.” The moderates had set themselves an informal deadline of Monday for reaching an agreement and releasing legislative text, but as of Wednesday afternoon the text had yet to emerge as lawmakers remained stymied on the contentious issue of giving liability protection to businesses and other organizations. Read more here. Canada authorizes Pfizer coronavirus vaccine Canada became the third country after the U.K. and Bahrain to authorize the Pfizer coronavirus vaccine. The U.S., where an FDA advisory committee meets tomorrow, likely won’t be far behind. “Health Canada received Pfizer's submission on October 9, 2020, and after a thorough, independent review of the evidence, Health Canada has determined that the Pfizer-BioNTech vaccine meets the Department's stringent safety, efficacy and quality requirements for use in Canada,” the agency said in a statement. Clinical trials have shown Pfizer’s vaccine, which it developed with German firm BioNTech, is 95 percent effective, an extremely high level of efficacy. Another vaccine, from Moderna and with a similar level of efficacy, is expected to soon follow on its heels and be authorized. “Canadians can feel confident that the review process was rigorous and that we have strong monitoring systems in place,” Health Canada said, adding it “will closely monitor the safety of the vaccine once it is on the market and will not hesitate to take action if any safety concerns are identified.” Read more here. White House task force: Vaccine may not reduce virus spread until late spring The White House coronavirus task force this week warned governors that coronavirus vaccinations will not drive down the spread of COVID-19 until late spring, calling for states to emphasize the need for other mitigation measures. "The current vaccine implementation will not substantially reduce viral spread, hospitalizations, or fatalities until the 100 million Americans with comorbidities can be fully immunized, which will take until the late spring," the task force wrote in its weekly report to states, issued Tuesday and obtained by The Hill. "Behavioral change and aggressive mitigation policies are the only widespread prevention tools that we have to address this winter surge," the report adds. The report underscores the degree to which a vaccine will not be an instant cure-all as the pandemic rages across the United States. "Despite the severity of this surge and the threat to the hospital systems, many state and local governments are not implementing the same mitigation policies that stemmed the tide of the summer surge; that must happen now," the task force wrote. Read more here. It probably won’t be smooth sailing for Becerra: Biden's top health nominee attracts early opposition from Senate GOP President-elect Joe Biden’s choice of California Attorney General Xavier Becerra (D) to head the Department of Health and Human Services (HHS) is running into early opposition from Senate Republicans. GOP lawmakers are raising concerns about Becerra’s lack of professional experience in the health care sector, although he did sit on the House Ways and Means Committee, which has oversight of health issues, when he served in the House. Another red flag for Republicans is Becerra’s aggressive resistance to Trump administration policies as the attorney general of California. Becerra participated in nearly 100 lawsuits challenging the Trump administration and was recently dubbed “California’s anti-Trump attack dog” by The New York Times. Sen. John Cornyn (R-Texas), an adviser to the Senate GOP leadership, questioned his lack of direct professional experience in the healthcare field. “I think it would be controversial,” he said of Becerra’s nomination. “I think most of us feel like there should be some deference in the president-elect’s choice for his Cabinet, but some of these folks are pretty radical.” Read more here. Azar dismisses concerns of COVID-19 vaccine supply shortages We’ll see how the vaccine supply issues work out, but Secretary Azar is dismissing the concerns at the moment. Health and Human Services Secretary Alex Azar said the administration is confident that it has enough contracts with other companies to make sure there are enough doses of a vaccine for all Americans. "We are very confident that during the second quarter of next year we'll have enough vaccines for every American who wants to be vaccinated," Azar said during the Milken Institute's health summit. "So, I don't see where this math is coming from." The problem? We don't know if those other vaccines are safe and effective. And when/if the evidence shows they are, scaling up manufacturing takes time. The administration's goal is to vaccinate 20 million by the end of the year. Azar said the goal for the end of January is to inject at least 50 million people with the first of two doses. Two other key vaccines that would help add more doses: - Warp Speed officials said they expect interim data from Johnson & Johnson's trial in early January, though company executives have said that because of how quickly the virus is spreading they could have data before the end of the year. Emergency authorization could come by early 2021.
- AstraZeneca released partial data this week, but missteps during the trial process have made regulators skeptical. The company won't have a complete readout of results until January or early February, and it's unclear when they might ask for emergency authorization.
Read more here. FDA authorization of Pfizer vaccine will come 'days to a week' after panel meeting Food and Drug Administration (FDA) regulators may not make a decision about authorizing Pfizer's COVID-19 vaccine until next week, according to an agency official. Peter Marks, the director of the FDA division overseeing vaccines, said Wednesday that a decision would come in "days to a week" after an agency advisory panel meeting Thursday. Members of the agency's Vaccines and Related Biological Products Advisory Committee will meet Dec. 10 to publicly evaluate the evidence from Pfizer and its partner BioNTech. The independent panel of experts is likely to recommend the full agency grant emergency authorization to the Pfizer/BioNTech COVID-19 vaccine. Read more here. |
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