COVID Vaccine May Be Available in November, Fauci Says

In a Senate hearing yesterday, Anthony Fauci, director of the NIH’s National Institute of Allergy and Infectious Diseases, said that “some time by November or December we will know” which of the three COVID-19 vaccine candidates now in late-stage trials — soon to be joined by a fourth — are safe and effective.

Fauci’s comments support the view among the nation’s top healthcare policy officials that a vaccine is unlikely to receive FDA approval before the Nov. 3 presidential election, despite President Trump’s repeated statements to the contrary.

“If a vaccine is approved on Nov. 1, how many Americans could get a vaccine by the end of the year?” Sen. Mitt Romney (R-Utah) asked Fauci, who was testifying before the Senate Health, Education, Labor and Pensions Committee.

In such a scenario, Fauci said, 50 million doses could be available in November, more than 100 million doses in December and 700 million doses by April. Assuming a two-dose regimen, 700 million would be enough to vaccinate the entire U.S. population, he said.

The needed doses “will be rolling in” over those months, Fauci said. The question of how to prioritize delivery of the smaller number of vaccine doses that will be available initially among healthcare workers and vulnerable populations was raised in the hearing, but nothing definitive was said about how the prioritization would work.

FDA Commissioner Stephen Hahn noted that if the vaccine or vaccines that are approved must be stored at very low temperatures the agency “will provide technical assistance and work with the [Centers for Disease Control and Prevention]” (CDC) to help make widespread distribution possible. Robert Redfield, director of the CDC, said funding for the states would be critical in such a case.

Hahn fought back hard at the lawmakers’ strongly worded questions over whether the FDA’s independence is at risk of political pressure from the Trump administration. “Every one of the decisions we have reached has been by career FDA scientists based on science and data, not politics,” he asserted.

In reviewing the vaccines now in development, Hahn said, sponsors will decide whether to ask for vaccine approval or an Emergency Use Authorization from the FDA, and “career scientists will review safety, efficacy, quality and consistency data. … In the end, FDA will not approve or authorize a vaccine that we would not give our families,” he said. That statement was echoed by Fauci, Redfield and Assistant Secretary for Health Administration Brett Giroir. — Martin Berman-Gorvine