A: Nope, but they did make some requests to state public health officials that have a lot of folks reading the vaccine tea leaves. So what actually went down?
On August 27, Dr. Robert Redfield, Director of the CDC, sent a letter to state governors asking that they expedite requests from McKesson Corporation for permits and licenses to open new vaccine distribution centers. (It had been previously announced that the CDC was contracting with McKesson to distribute the vaccine.)
Redfield’s letter to the governors included this sentence: “CDC urgently requests your assistance in expediting applications for these facilities, and, if necessary, asks that you consider waiving requirements that would prevent these facilities from becoming fully operational by November 1, 2020.” Aha! Clue #1.
Clue #2 was found in three documents sent, also on August 27, to state and territorial public health officials (plus a handful of cities) with guidance on preparing for a COVID-19 vaccine roll out. One of the documents presented 3 scenarios for “Vaccine A” and “Vaccine B” (not otherwise named or identified). Scenario 1 has about 2 million doses of Vaccine A available for distribution by “end of October 2020”, Scenario 2 has about 1 million doses of Vaccine B available by the end of October, and Scenario 3 has doses of both vaccines available then. (By the way, there is strong speculation that Vaccine A is the Pfizer vaccine and Vaccine B is the Moderna vaccine.)
The document also notes “the planning scenarios described below should be used by state and local jurisdictions to develop operation plans for early COVID-19 vaccination when vaccine supply may be constrained.”
So how should we interpret this?
One way to interpret this is that the CDC is being proactive in making sure that states and other entities responsible for vaccine delivery are not caught unprepared if one or more vaccines currently in Phase 3 trials are indeed approved in October.
Is that even possible? In theory, yes. Pfizer, for example, has said that it will look at preliminary data in an interim analysis once 32 people in their Phase 3 trial have developed COVID-19. That could happen soon. Then what? If the interim analysis shows that at least twice as many people in the trial who came down with COVID-19 did *not* receive the vaccine as *did* receive the vaccine, that would be a strong (although preliminary) signal that the vaccine was effective. At that point, the FDA would review efficacy and safety data and determine if an approval or an emergency use authorization is warranted. If that were to actually happen in October, then it would be a good thing if state public health authorities were prepared to begin delivering any available vaccine doses to high-priority populations.
Of course, some people are suspicious that the Redfield letter and CDC scenario documents are more political ploy than public health planning exercise. The November 1 date (immediately before the US presidential election) plus recent concerns about the independence of both the CDC and the FDA have led some to a very different reading of the same tea leaves.
More on this story:
NYT story: https://www.nytimes.com/2020/09/02/health/covid-19-vaccine-cdc-plans.html
STAT News on how vaccine approval could work: https://www.nytimes.com/2020/09/02/health/covid-19-vaccine-cdc-plans.html
Vaccine A and Vaccine B scenarios from CDC:
https://int.nyt.com/data/documenttools/phase-1-vaccination-planning-scenarios-8-27/e0b519d686f4dda5/full.pdf
