Welcome to Tuesday’s Overnight Health Care.
FDA scientists published promising details about Pfizer’s vaccine ahead of Thursday’s advisory panel. New data is out on AstraZeneca’s COVID-19 vaccine but questions remain while the President-elect on Tuesday announced his three goals for the first 100 days of his pandemic response.
But meanwhile, the virus is still spreading wildly:
First signs of Thanksgiving COVID-19 wave emerge
The first signs of a post-Thanksgiving surge in coronavirus cases are beginning to show up in data released by states across the country in a troubling prelude of what may become the deadliest month of the pandemic so far.
Those hints of an uptick in case counts come as the country faces an already substantial wave of infections that began in the Upper Midwest and spread to every corner of the map as summer turned to fall and the weather cooled.
The United States has averaged nearly 200,000 new confirmed cases a day over the last week, according to The Covid Tracking Project, run by a group of independent researchers. More than 2,200 people a day have died on an average during that period. The number of patients being treated in hospitals has crested 102,000, the highest levels of the pandemic.
The country still lacks a national testing strategy that public health experts say is essential to bringing the pandemic under control. President Trump‘s remarks about the virus have become few and far between, even as he continues to hold in-person events where attendees are mostly maskless. The White House held a vaccine summit on Tuesday, though representatives from the two companies that have produced the earliest vaccines were not present.
One sort of bright spot: There are some hopeful signs that the third wave is ebbing in parts of the Midwest. The number of newly confirmed cases has declined for two straight weeks in 10 states, including hard-hit Wisconsin, Iowa, Michigan and New Mexico.
FDA says Pfizer COVID vaccine is highly effective, even after first dose
The coronavirus vaccine manufactured by Pfizer and BioNTech is highly effective and poses no significant safety risks, according to documents published by a Food and Drug Administration (FDA) advisory panel Tuesday.
The endorsement of the trial results means that FDA clearance for the two-dose vaccine could come shortly after the Vaccines and Related Biological Products Advisory Committee meets on Thursday to publicly review the evidence, and likely recommend authorization.
Agency staff conducted their own analysis of the research presented by the companies and found the vaccine was 95 percent effective at preventing COVID-19 infection a week after the second dose was administered.
The results also show some protection begins even after the first dose, but the report cautioned that two doses are still needed. COVID cases tapered off in the vaccinated group shortly after the first dose was administered; 50 cases of COVID-19, compared with 275 cases in the placebo group.
Biggest unknown: The report gives a deep dive into the evidence, but because the virus, and the vaccines, are so new, it’s unclear how long protection lasts. The report showed protection at least through the two month monitoring period required by the FDA, but it has not been possible to monitor for longer.
Trump officials passed on ‘multiple’ offers to buy more Pfizer vaccine, Gottlieb says
Former Food and Drug Administration Commissioner Scott Gottlieb, now a member of the Pfizer board of directors, said Tuesday that the pharmaceutical giant offered the Trump administration the chance to buy additional doses of its coronavirus vaccine multiple times, but that officials turned down the offers.
The comments from Gottlieb confirm a report in The New York Times, which on Monday revealed that additional doses of the Pfizer vaccine, beyond the 100 million already purchased, may not be available in the U.S. until June because they were committed to other countries after the Trump administration passed on them.
“Pfizer did offer an additional allotment coming out of that [Michigan] plant, basically the second quarter allotment, to the United States government multiple times, and as recently as after the interim data came out and we knew this vaccine looked to be effective,” Gottlieb said on CNBC.
While Trump administration officials denied the Times report during a background call with reporters on Monday, they have stressed that their strategy has always been to spread their bets across six different companies working on vaccines, not just Pfizer.
Moncef Slaoui, the chief science adviser for the administration’s Operation Warp Speed, did not deny the Times report on Tuesday and instead emphasized that the administration is relying on six different companies, not just Pfizer.
Video: HHS expects 40M doses of vaccine by December 31 (USA TODAY)
Bipartisan fix for ‘surprise’ medical bills hits roadblock with powerful chairman
It’s not looking good for a surprise billing fix in Congress.
A broad bipartisan effort to pass legislation protecting patients from massive “surprise” medical bills is now on life support as House Ways and Means Committee Chairman Richard Neal (D-Mass.) digs in on a separate proposal.
Democratic and Republican leaders of three committees in the House and Senate have been pushing for months to pass their measure, which would prevent Americans from unexpectedly getting hit with medical bills for thousands of dollars for common scenarios like treatment from a doctor outside their insurance network when they require emergency care.
Neal has been holding out for his own rival proposal and has not shown any willingness to budge despite concessions offered by top lawmakers on the three committees.
Speaker Nancy Pelosi (D-Calif.) even stepped in over the weekend to speak to Neal in an effort to get him to compromise, sources said.
Biden aims for 100 million vaccinations in first hundred days
President-elect Joe Biden on Tuesday laid out three goals for the first hundred days of his administration’s COVID-19 response: getting 100 million people vaccinated against the virus, requiring masks where he has authority to and getting kids back in school.
Biden laid out his plan while introducing nominees and appointees who will play a key role in his administration’s response to the pandemic.
“I’m absolutely convinced that in 100 days we can change the course of this disease and change life in America for the better,” Biden said from Wilmington, Del., where he was joined by some of his appointees.
Biden discussed the path ahead in terms of distributing a COVID-19 vaccine, urging Congress to provide more resources to help vaccinate 100 million people by late April.
State and local governments have warned they do not have enough funding needed to run mass vaccination campaigns once a vaccine is widely available.
“Developing a vaccine is only one herculean task. Distributing a vaccine is another herculean task,” he said. “We need Congress to finish the bipartisan work underway now or else millions of Americans will wait months longer for the vaccine.”
AstraZeneca COVID-19 vaccine safe and effective, studies suggest
Studies on the COVID-19 vaccine candidate from AstraZeneca and Oxford University suggest that it is safe and about 70 percent effective on average, though some questions remain.
The partial results published in The Lancet on Tuesday confirmed that the two full doses given at least one month apart appeared to be 62 percent effective, while a half dose followed by a full dose was about 90 percent effective.
AstraZeneca and Oxford first announced the efficacy results of their vaccine late last month. The findings later came under scrutiny after the company acknowledged that members of a sub-group of trial participants were originally mistakenly given a half dose followed by a full dose.
The admission, along with a relatively small test group compared to other studies, drew questions among experts on the accuracy of the findings.
The Lancet’s interim analysis published Tuesday focused on studies of the vaccine in the U.K., Brazil and South Africa, with efficacy data on 11,636 participants reported.
Virtual Event Announcement: 1:00 ET Wednesday 12/9 — From Platform to Policy: 2021 Health Care Agenda
With the election behind us we turn our attention to the future of health care in a new political climate. As a new Congress convenes, how can we ensure our health system is ready for the challenges of the present and future? Join The Hill for a discussion with policymakers and health care stakeholders about health policy in the 117th Congress. Sen. Bill Cassidy, Rep. Lauren Underwood and more. RSVP for event reminders.
What we’re reading:
Here’s why vaccinated people still need to wear a mask (The New York Times)
On COVID-19 vaccine, ‘get as many shots in arms as possible, right away’: ex-FDA chief Q&A (USA Today)
Tracking COVID’s spread inside a tight-knit Latino community (Kaiser Health News)
As U.K. begins vaccinations, a glimpse of life after Covid (New York Times)
State by state
Texas launches COVID-19 rapid testing pilot program for small business workers in 5 cities (Dallas Morning News)
Massachusetts reimposes coronavirus restrictions (NPR)
Michigan cancels Ohio State showdown, citing COVID-19 cases (Associated Press)