From my blog on Thursday evening:
So the FDA panel voted 17 to 4 with one abstention to approve the Pfizer vaccine. But that still isn’t official FDA approval, which is expected to come “within days.” (Why not tonight? Does the FDA brass have something more important on their schedules?)
From the New York Times Friday morning:
The accelerated timeline comes after President Trump’s chief of staff threatened the F.D.A. head’s job if he didn’t get it done on Friday. The Trump Administration will buy another 100 million doses of Moderna vaccine.
The Food and Drug Administration accelerated its timeline for issuing an emergency authorization for Pfizer’s Covid-19 vaccine after President Trump’s chief of staff, Mark Meadows, told Dr. Stephen M. Hahn, the agency’s leader, to consider looking for another job if the vaccine was not approved Friday, according to a senior administration official.
Regulators had been planning to authorize the vaccine for emergency use early Saturday. But on Friday morning, Dr. Hahn told officials at the agency’s Center for Biologics Evaluation and Research to act by the end of the day, according to one person familiar with his directive.
It is unclear whether shaving a half-day off the timetable for authorization would speed up the delivery of vaccine shipments to sites around the country or simply placate the White House’s desire for action. Several officials said that the delivery timetable was already set.
The pressure also did not alter the outcome of the process. F.D.A. had already determined it would approve Pfizer’s vaccine for emergency authorization after an advisory panel of experts on Thursday recommended that it do so, according to multiple administration officials.
But it nonetheless showed that even at the 11th hour, the White House was unwilling to allow regulators the independence to work according to their own plan as they processed key documents, including instructions to physicians for use of the vaccine and a fact sheet on the product.
Can you imagine how bad the anti-vax propaganda in the New York Times would be if Pfizer had announced its vaccine worked on November 2 and that had flipped 1 out of every 300 votes, giving Trump a 269-269 Electoral College tie and likely victory with House delegations voting by state? The mainstream media would be screaming right now about how nobody can trust the vaccine.
You can understand why Pfizer shut down lab work on the World’s Most Important Trial from late October until the day after the election, when it discovered belatedly that it had more cases on hand than it had specified for the first, second, and even third interim analyses.
From the New York Times Friday evening:
F.D.A. Clears Pfizer Vaccine, and Millions of Doses Will Be Shipped Right Away
An initial shipment of about 2.9 million doses of the vaccine will be sent around the United States over the next week.
By Katie Thomas, Sharon LaFraniere, Noah Weiland, Abby Goodnough and Maggie Haberman
Dec. 11, 2020, 9:10 p.m. ET
The Food and Drug Administration authorized Pfizer’s Covid-19 vaccine for emergency use on Friday, according to three people with knowledge of the decision who spoke on condition of anonymity because they were not authorized to discuss it. The action means millions of highly vulnerable people will begin receiving the vaccine within days.
These vaccinations should start lowering the death rate around Biden’s inauguration day, if it takes 14 days for the first dose to start working at reducing infections, and then there’s a 22 day lag on average between infections and subsequent deaths, that sounds like the good effect will kick in about January 20. Expect coverage of how President Biden is already saving lives around January 21.
In other vaccine news, Britain’s AstraZeneca will be teaming up with Russia’s Sputnik V in a clinical trial. The highly touted Oxford-designed vaccine reported mediocre results for most of the sample (62% efficacy) but serendipitously botched its way to 90% efficacy among a subsample who had incompetently been given a first dose only half as strong as planned. The Russians claim 92% efficacy in a small clinical trial. The Russians use two different vectors for their two doses, which sounds in theory like it might work better than the Brits’ original plan of using the same vector twice. The Anglo-Russian alliance is now considering making one dose the Russian vaccine and one the British vaccine, so some other combinations.
And from StatNews, bad news on the French Sanofi vaccine trial that is reminiscent of the AstraZeneca screw-up:
Sanofi suffers major setback in development of a Covid-19 vaccine
By HELEN BRANSWELL @HelenBranswellDECEMBER 11, 2020
… The problem relates to inadequate results in older adults in Sanofi’s Phase 1/2 trial, which the company traced back to an inadequate formulation of their vaccine, Su-Peing Ng, global medical head for Sanofi Vaccines, told STAT in an interview.
Ng said both Sanofi and GSK are committed to continuing work on the vaccine, and plan to begin a Phase 2b trial in February.
“We’re disappointed that there is a delay,” she said. “I think, though, that we’re encouraged that we have enough information, enough of the results from preclinical and clinical [studies] to tell us that we have a path forward. We need to optimize this formulation.”
In effect, participants in the trial received too little vaccine. While the too-small dose generated adequate levels of neutralizing antibodies in adults aged 18 to 49 in the trial, adults 60 and older generated lower levels of neutralizing antibodies than are seen in the blood of people who have recovered from Covid-19 infection, Ng said.
Perplexed by the findings, the company set out to figure out why the vaccine underperformed. It discovered two commercial reagents used to measure how much antigen — active vaccine — was included in each dose were giving false readings. In fact, Ng said, the concentration of the antigen “was insufficient.”
Much the same thing happened to AstraZeneca’s vaccine, except their botch turned out to work better.
Because it will be harder to get volunteers in 2021 for trials with a 50% chance of getting a placebo, Sanofi is inquiring if it can do a clinical trial versus one of the mRNA vaccines that are 95% efficacious.]