Science will guide COVID-19 vaccine decisions, timeline, agency leaders say

After much confusion on the timeline for approving or authorizing a novel coronavirus (COVID-19) vaccination, the U.S. Senate Committee on Health. Education, Labor, and Pensions held a hearing last Wednesday addressing concerns on whether the focus would be politics or producing a safe and effective vaccine.

The U.S. Food and Drug Administration (FDA) Commissioner Stephen Hahn, MD, said any of the agency’s decisions surrounding a COVID-19 vaccine have not been, and will not be, politically motivated, and every decision reached thus far have been made by career scientists of the FDA based on science and data, not politics.

"[The] FDA will not authorize or approve any COVID-19 vaccine before it has met the agency's rigorous expectations for safety and effectiveness,” said Hahn during the committee hearing. “Decisions to authorize or approve any such vaccine or therapeutic will be made by the dedicated career staff at FDA through our thorough review processes, and science will guide our decisions.”

When pressed by senators for a vaccine timeline, Hahn said the agency recognizes the urgency, but will not cut corners in their processes. Additionally, he said the FDA will not “permit pressure from anyone to change that,” noting he will “put the interests of the American people before anything else."

Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, echoed Hahn’s statement and said in the hearing it is unlikely political interference will play a role in the approval of a COVID-19 vaccine. Additionally, COVID-19 vaccinations could be made available as early as November or December 2020, noting several companies are manufacturing in advance. However, an approved or authorized vaccine will not be widely available at first, but will follow a priority-based implementation timeline where healthcare providers and vulnerable populations get the first doses before it is rolled out to the larger population.

The U.S. Centers for Disease Control and Prevention (CDC) director Robert Redfield, MD, said in the hearing that he has total confidence in the importance of vaccines, but mask wearing will still be very important moving forward. He added that the agency has projected about 700 million doses by late March or April 2021, which should be enough to vaccinate 350 million people based on the anticipated two dose requirement. He said it would likely be late second quarter or early third quarter next year before the entire public was vaccinated.

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