Trump’s management suspected Wednesday that the timing of the approval and publication of a COVID-19 vaccine would be political, as it has published detailed plans for the distribution of a COVID-19 vaccine across the country in the coming months.
Operation Warp Speed officials made a press call Wednesday morning to announce the plans, but they also made some revealing confessions about where and when the vaccine can be targeted.
Paul Mango, a former fitness services representative who now works as deputy director of policy at the Department of Health and Human Services, said the Trump administration is targeting the last 3 months of 2020 for vaccine distribution.
The schedule begins next month, as Trump’s leadership faces an effort to distribute vaccines whose effectiveness and protection parameters are unknown.
“The message we need to leave is that we are ready for all those uncertainties,” Mango said, adding that the application would first exceed the source in what he described as the “restricted phase of vaccine distribution. “
“Think of it as the fourth quarter of 2020,” Mango said. “Because the source is equivalent to asking and exceeds the call until 2021, our distribution principles will change. “
Health workers, staff and vulnerable populations are most likely the first to be vaccinated.
But no COVID-19 vaccine can be distributed with some form of approval from the Food and Drug Administration.
This will most likely take the form of an emergency use authorization, a tool that regulators will need to take into account early approvals of remedies that may be useful but have not yet been fully tested for efficacy and safety.
For COVID-19 vaccines, 3 applicants are in massive Phase III trials. Big questions about a COVID vaccine are reduced to the point of evidence that the FDA will want to factor emergency approval and whether the FDA will pay attention to the independent clinical recommendation that weighs on vaccine approvals.
Meanwhile, President Trump has publicly pressured the FDA to pass a vaccine before the November election, and some Trump crusades described early approval as a “holy grail” for the president’s re-election.
It has been an unprecedented political tension on the FDA to pass a vaccine on a political and non-medical calendar.
Operation Warp Speed’s call Wednesday morning reflected that thought. An administrative officer admitted that the efficacy of the vaccine would be known “before the end of Phase III trials”.
Two of the trials have not yet completed registration, while one has completed registration this morning. In the two maximum remote candidate vaccines, Moderna and Pfizer, patients get two injections, one month apart, extending the time needed to know if they are safe and effective, or even how effective they can be.
But the schedule proposed in government documents also shows that the Trump administration is planning a distribution in the vanquished fall.
An appendix to the CDC’s “game book” on vaccines presents 3 prospective vaccine distribution scenarios, provided that scenarios are “considered hypothetical” and subject to FDA approval.
Scenarios indicate the amount of vaccine to be given this fall if the FDA issues emergency approval, indicating that up to 3 million doses can be obtained by the end of October 2020 if Pfizer and Moderna applicants obtain approval, and that the same can lead to the availability of 30 million vaccines approved through the end of November.
CDC is transparent that they are developing plan documents, which should reflect what would happen if FDA approval was given until the end of October. As things stand, the key clinical advisory organization advising the FDA on whether to approve or reject vaccines – VRBPAC – has an assembly scheduled for the end of October, but has made it clear in the agfinisha that “no express requests will be discussed at this assembly. “
In general, the concept of having a “time limit” to comply with vaccine approval has been criticized by experts.
“We don’t need to run until a safe date, because we need this approval done very well and correctly,” Claire Hannan, executive director of the Immunization Officers Association, told TPM this month.
Or, as the president said after this morning’s call:
– Donald J. Trump (@realDonaldTrump) September 16, 2020