By Ciara Linnane, MarketWatch
• Global case tally is edging toward 70 million
• FDA advisory committee votes in favor of authorizing Pfizer–BioNTech vaccine candidate, and FDA says it will do so
• U.S. suffers worst week for cases, deaths and hospitalizations since start of the pandemic
• Germany may be headed for a national lockdown
The U.S. suffered its worst week for cases, deaths and hospitalizations with the coronavirus illness COVID-19, as the Food and Drug Administration said it would grant emergency-use authorization to the vaccine developed by Pfizer Inc. and Germany partner BioNTech SE.
The announcement comes a day after a federal advisory committee made up of independent medical experts voted 17-4-1 that the benefits of the Pfizer–BioNTech vaccine outweigh the risks. The FDA is not required to follow the recommendation of the committee but often does.
The FDA said it has been in touch with the Centers for Disease Control and Prevention and “Operation Warp Speed,” the program set up to expedite development of therapeutics and vaccines during the pandemic (Pfizer–BioNTech vaccine development took place outside that program), “so they can execute their plans for timely vaccine distribution.” Once the vaccine is authorized, it will be the first COVID-19 vaccine to be made available to Americans outside of clinical trials.
FDA head Dr. Stephen Hahn said the regulator is now finalizing the documents needed to ensure that patients and providers have the information they need to safely administer the vaccine. “This is a critical part of what the agency does to promote and protect the public health,” he said.
The same vaccine has already received emergency authorizations from the governments of the U.K., Canada and Bahrain, and the U.K. has launched a vaccine-distribution program. The FDA’s advisory committee will meet again on Dec. 17 to review a second vaccine candidate developed by biotech company Moderna Inc. /zigman2/quotes/205619834/composite MRNA +2.48% .
The U.S. recorded another 223,570 new cases on Thursday, and at least 2,923 people died, according to a New York Times tracker. The U.S. has averaged 211,127 cases a day for the past week.
The number of COVID-19 patients in hospitals climbed to a record of 107,248, according to the COVID Tracking Project, breaking a one-day-old record. Hospitalizations held below 60,000 during the spring pandemic peak.
“By nearly all measures it has been a horrible week, a horrible month (nine days in), and a horrible year,” stated the COVID Tracking Project’s weekly coronavirus update. “The United States set pandemic records in all three metrics that measure the pandemic’s severity this week, recording a total of 1.4 million new cases and 15,966 deaths.”
Worse news is that the worst is still to come: “Given the rapid increase in the number of new cases, we expect the metrics for hospitalizations and deaths to continue to rise in the coming weeks — especially if in-person gatherings over Thanksgiving led to increased spread of the novel coronavirus, as public health experts warned,” said the update.
Dr. Robert Redfield, head of the Centers for Disease Control and Prevention, said Thursday that the U.S. will suffer more deaths every day for the next two to three months than died in the attacks on Sept. 11, 2001, or at Pearl Harbor. The U.S. leads the world by case numbers at 15.6 million, and deaths at 292,190, according to data aggregated by Johns Hopkins University. With 4% of the world’s population, the U.S. accounts for about 20% of both cases and fatalities.
In a typical year, between 12,000 and 61,000 people in the U.S. die from influenza, according to the CDC.
Redfield appeared exhausted and even downcast as he detailed the latest virus metrics.
With a vaccine now so close — health-care workers and nursing-home residents could start receiving inoculations as early as Monday — it’s crucial that Americans comply with public safety measures, washing hands frequently, socially distancing and wearing face masks in public, experts say.