Hahn insists FDA will stick to guidelines for COVID-19 vaccine decisions

Regulatory NewsRegulatory News
| 29 September 2020 | By Michael Mezher 

Hahn testifying before the Senate HELP Committee

Speaking at the Financial Times’ US Pharma and Biotech Summit on Tuesday, US Food and Drug Administration (FDA) Commissioner Stephen Hahn said the agency will stick to the standards and criteria it has laid out to approve or authorize applications for vaccines to prevent coronavirus disease (COVID-19).
In recent weeks, Hahn has made numerous statements asserting that the agency will not approve or authorize a vaccine that does not meet the agency’s “rigorous expectations,” despite repeated claims by President Donald Trump that a vaccine could be greenlighted before the November election. (Hahn pledges no politics in COVID vaccine decisions, Regulatory Focus 23 September 2020).
Hahn’s statements also follow news that FDA has developed guidance on its expectations for emergency use authorizations (EUAs) for COVID-19 vaccines that are reportedly under review by the White House. (RELATED: Marks, Hahn confirm COVID vaccine EUA guidance coming, Regulatory Focus 11 September 2020).
“The criteria that we’ve established for a vaccine, are the criteria we are going to use. We’ve been very clear about that with sponsors, very clear about that with the public,” Hahn said. While Hahn specifically addressed FDA’s 30 June guidance on vaccine development and licensure, he did not make mention of the EUA-specific guidance. (RELATED: FDA issues COVID-19 vaccine guidance, setting 50% effectiveness threshold, Regulatory Focus 30 June 2020).
Nonetheless, Hahn said the 30 June guidance lays out the criteria FDA will be looking at to make a decision about safety and efficacy and that the agency continues to have conversations with sponsors about the data it wants to see. Hahn added that it is up to vaccine makers to determine the timing of an application, but that when one is submitted, “We will apply the standards that we’ve stated to look at those data and we’ll make a decision.”
Hahn also said he could not predict when a vaccine would be available. “I don’t have a crystal ball here,” he said and affirmed that, “We won’t cut corners, we will use our rigorous criteria.”
In remarks made Monday at the Vaccine World Congress, Philip Krause, deputy director of the Office of Vaccines Research and Review within the Center for Biologics Evaluation and Research (CBER) addressed reports about the agency’s EUA guidance.
“Of course, as you’ve read in the paper, there is FDA guidance which exists but hasn’t yet been released,” Krause said during a panel discussion with Paul Stoffels, chief science officer at Johnson & Johnson, and Julie Gerberding, executive vice president and chief patient officer at Merck.
Krause asked whether the two pharmaceutical executives feel it is important for the EUA guidance to be released to the public, referencing a pledge by the CEOs of nine vaccine makers to not seek approval or authorization for a vaccine before demonstrating safety and efficacy through Phase 3 trials. (RELATED: Drugmakers, FDA try to build public confidence in COVID vaccine decisions, Regulatory Focus 8 September 2020).
“In the context of your CEOs’ pledge to follow FDA guidance, how important do you think it is that this guidance be made publicly available so that the public can judge whether or not your CEOs are doing what they said you would do,” he asked.
“I think it is important that the guidance against which we will be judged will be available,” said Paul Stoffels. Gerberding concurred, saying that, “Transparency really matters right now, even if there is no shocking perspective that is part of this new guidance, just getting it out there so that people can see it, I think we really have to err on the side of transparency.”


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