Pressure on the U.S. drug regulatory body rose Wednesday after the U.K. approved the Pfizer (PFE) and BioNTech (BNTX) COVID-19 vaccine, with Britons expected to get the first doses next week.
That puts the U.S. approximately one week behind, at best, with the U.S. Food and Drug Administration’s (FDA) vaccine advisory committee set to meet and review the companies’ emergency use authorization (EUA) filing on December 10.
Pfizer and BioNTech are already shipping out doses of its vaccine in anticipation of a quick turnaround.
Gen. Gustave Perna, chief operating officer of Operation Warp Speed (OWS), said Wednesday the government has marked December 15 as the deadline for the FDA to grant an EUA.
Perna said for planning purposes only, OWS anticipates 6.4 million doses of the Pfizer vaccine and 12.5 million doses of the Moderna (MRNA) vaccine to be available for the 64 health jurisdictions including states and territories, as well as for the five federal agencies that will receive doses following an EUA.
Only half of the doses will be sent out in the first round, followed by a second when needed for the different vaccines at 21 or 28 days, depending on the company, Perna said.
The five federal agencies include the Department of Defense, State Department, Department of Veterans Affairs, Indian Health Services and Bureau of Federal Prisons.
Perna noted that at earliest, a decision for the EUA for Pfizer could arrive on December 11, and at latest December 15.
He emphasized that the regulatory agency is following its own process — and not a political agenda.
There is “100% no interference with the FDA,” Perna said.
OWS chief scientific advisor Moncef Slaoui said the vaccine companies expect to deliver enough doses for 20 million people by December, 30 million people in January and 50 million people by March. Each vaccine requires two doses, so in total, 200 million doses will be shipped by March. If AstraZeneca (AZN) or Johnson & Johnson (JNJ) file for emergency use by then, the number of available doses will increase.
Questions still remain, however, about who can and should be vaccinated with each type of vaccine, including for individuals who have recovered from the virus.
Among health personnel, who are likely to be first in line to receive a vaccine based on the CDC’s guidelines Tuesday, some health systems plan to administer the vaccine to everyone.
New Jersey’s University Hospital, which is receiving its first doses as part of OWS’s initial tests of the delivery process, has no plans to differentiate between recipients, according to CEO Dr. Shereef Elnahal.
Elnahal, who previously served as the state’s health commissioner, told Yahoo Finance Wednesday the delivery process is very complex.
“I think its a very wise idea that the HHS wants to stress test this to see if there are any hangups, issues and human error risks,” Elnahal said, noting that in addition to vaccinating his staff, many will need to be quickly trained on how to administer each of the new vaccines based on new technologies.
But OWS’s Slaoui noted that no trial results have determined the efficacy of the vaccine for recovered patients — even though the antibody levels of recovered patients was the benchmark for antibody production in the vaccines.
Slaoui said up to 10% of the trial population turned out to have antibodies present, and the data is currently being analyzed.
Meanwhile, concerns about unfair distribution of the vaccine remain. Despite the CDC’s vote to give health workers and nursing home residents first dibs, politicians and wealthy individuals are likely to find ways to jump the line.
Emergency physician and former Baltimore health commissioner Dr. Leana Wen told Yahoo Finance that the various states are likely going to follow the CDC guidelines, but local level decisions are likely to vary in some ways.
“Local variation is a good thing, as local jurisdictions know their populations the best and are best positioned to make decisions about who is most vulnerable and how to quickly reach these groups. Given the high stakes involved, it will take a lot for any jurisdiction to completely go against the CDC guidelines, and I don't expect that to happen, especially with the initial prioritization,” Wen said.
Dr. Arthur Caplan, leading bioethicist and professor at NYU Langone, told Yahoo Finance that precedent set by President Donald Trump and former N.J. Gov. Chris Christie in receiving monoclonal antibody treatment before emergency use authorizations were granted — and the lack of outrage by that— will likely spillover into vaccines as well.
In addition, Caplan said he worries an illegal market will emerge initially in which wealthy individuals are likely to pay for access to the highly-coveted doses.
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