Hahn pledges no politics in COVID vaccine decisions

Regulatory NewsRegulatory News
| 23 September 2020 | By Michael Mezher 

Testifying before the Senate Health, Education, Labor and Pensions Committee on Wednesday, US Food and Drug Administration (FDA) Commissioner Stephen Hahn said that politics will not play a part in the decision to approve or authorize a vaccine for coronavirus disease (COVID-19).
Hahn stressed that he supports science and has “100% confidence” in his staff, and said that, “FDA will not authorize or approve any COVID-19 vaccine before it has met the agency’s rigorous expectations for safety and effectiveness.”
“There won’t be politics that play any part in that decision,” Hahn added.
Hahn’s reassurances come amid reports from the Washington Post, Financial Times and New York Times that the agency is preparing to issue guidance on its expectations for a COVID-19 vaccine EUA that will ask for a median two months of monitoring after Phase 3 trial participants receive their last dose, making an EUA for a vaccine before the election unlikely.
Hahn and Center for Biologics Evaluation and Research (CBER) Director Peter Marks have both previously said that such guidance is coming but have not expressly disclosed what it would entail. (RELATED: Marks, Hahn confirm COVID vaccine EUA guidance coming, Regulatory Focus 11 September 2020).
The news of more stringent EUA guidance for vaccines follows criticism of the agency’s handling of previous EUAs for COVID-19 therapeutics, including the recent one issued for convalescent plasma and the now-revoked authorization for hydroxychloroquine and chloroquine. (RELATED: Lawmakers, experts raise questions after convalescent plasma EUA, Regulatory Focus 25 August 2020; FDA revokes EUA for hydroxychloroquine, chloroquine, Regulatory Focus 15 June 2020).
During the hearing, Hahn said that vaccine makers will be the ones to decide when to submit data to FDA and whether to seek full approval or an EUA for their vaccine. “This will be based upon the trial meeting prespecified success criteria that were established by that sponsor … they should also be consistent with FDA recommendations regarding those criteria,” he said.
While Hahn did not touch on any specifics raised in the recent news reports, he said that companies will have to demonstrate that they have met the statutory standards for an EUA.
“We expect that this would be demonstrated based on adequate manufacturing data to ensure a vaccine’s quality and consistency and data from at least one well-designed Phase 3 clinical trial that demonstrates its safety and efficacy in a clear and compelling manner,” Hahn said, adding that the agency will expect EUA requests to include a plan for long-term safety monitoring for individuals who receive the vaccine.


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