In the final weeks of the Trump administration, the great news of multiple successes in developing safe and extremely effective vaccines for COVID-19 got tempered with bad news on logistical bottlenecks and slower-than-expected production. The opening two weeks of the Biden administration didn’t produce any immediate improvement on either issue, despite promises during the campaign and transition that Biden had a plan to unlock mass access to vaccines. Governors have complained for weeks about slow supplies and overwhelming demand.
Today, however, they got some good news from the White House. Pfizer will accelerate its deliveries of vaccines in the first quarter. Washington Post reporter initially reported it as an increase of 50 million doses, but the increase is in the dosage-per-bottle change from a previous commitment on increases:
Deleted a previous tweet about increased Pfizer allocations this quarter, which I regret. Misunderstanding on call with governors about already announced increase of 20m this quarter + effects of counting the sixth dose.
— Isaac Stanley-Becker (@isaacstanbecker) February 9, 2021
If the bottles normally hold five doses but the FDA has authorized six doses instead, that’s four million vials with an extra dose in the increased deliveries. That gives us 24 million extra doses rather than 2o million. The 20 million dose increase in deliveries was announced almost two weeks ago, and it’s not quite clear when that got arranged. And even at that time, the extra dose was already being discussed as a boost to deliveries.
That’s good news, but it comes with a couple of caveats. The Pfizer vaccines requires such specialized storage that its delivery has been mainly limited to state-run vaccination centers, and access seriously limited by age or “essential job” designations. It’s not going to unlock a path to vaccination on demand.
The FDA may have an opportunity to work on that with the new Johnson & Johnson vaccine and their request for an emergency-use authorization. Unfortunately, the Biden administration has a fight on its hands over FDA leadership, as Politico reports that factions are already forming over the agency:
FACTIONS BREAK OUT IN FDA SEARCH — President Joe Biden has not yet picked a permanent Food and Drug Administration commissioner, and advocates are mounting their own campaigns. On one side are supporters of longtime FDA drug director Janet Woodcock, who is currently serving as acting commissioner; on the other are those backing Joshua Sharfstein, an Obama administration principal deputy commissioner. …
In Woodcock’s camp: More than 80 major health organizations penned a letter to President Joe Biden and his Health and Human Services nominee Xavier Becerra on Sunday advocating for Woodcock, arguing her 37 years with the agency serve “as both a touchstone for how to get things done and a master class in understanding the intricacies of the agency’s work.”
… But those decades of experience also bring detractors. Critics argue there has been inadequate opioid oversight under her tenure and point to controversial decisions such as the approval of Sarepta’s Duchenne muscular dystrophy medicine on limited evidence, and Woodcock’s earlier hesitation to make Plan B readily available over-the-counter.
In Sharfstein’s camp: Eighteen prominent scientists issued a similar letter supporting Sharfstein on Friday. Those researchers and doctors — who noted that none of them have ever endorsed an FDA candidate — said the current director of the Bloomberg American Health Initiative at the Johns Hopkins Bloomberg School of Public Health can balance needs between public health and the industries that FDA regulates.
This really should be a simple choice: Which one can take the EUA process from two weeks to 48 hours, as it should be in an emergency? The adherence to bureaucratic review of data based on final delivery rather than simply monitoring the Operation Warp Speed trials up front is a great example of institutional thinking rather than creative nimbleness. Johnson & Johnson should already have an answer on its candidate by now and be in the process of shipping doses around the country. After all, we’ve already bought those doses and sponsored the trials that proved them out. That is what will unlock mass vaccination on demand.
This FDA food fight is also a bit inexplicable for another reason. The Biden campaign and transition repeatedly emphasized its focus and prioritization on COVID-19 and vaccinations. And yet, Biden and his team still haven’t gotten around to a decision on the lead agency handling vaccines and vaccinations? They have had three full months since the election, and almost three weeks since the inauguration. Biden should have already had his FDA Commissioner hired before January 20th, let alone wait three weeks to allow the “factions” to sort it out.
So yes, the Pfizer boost is good news. Everything else, however, points to a lot more bottlenecking in our immediate future, thanks to a lack of focus.
