Hahn says COVID-19 vaccines will be reviewed in ‘real time’
Regulatory News | 28 July 2020 |
At an event marking the launch of Moderna’s Phase 3 clinical trial for its mRNA coronavirus vaccine in Miami on Monday, US Food and Drug Administration (FDA) Commissioner Stephen Hahn repeated assurances that his agency would not cut corners in approving a COVID-19 vaccine.
Pfizer also announced on Monday that it would begin a Phase 2/3 study of its COVID-19 vaccine developed in partnership with BioNTech. Both companies say they plan to enroll 30,000 participants and expect a readout from their studies as early as this fall. (RELATED: Drugmakers to Congress: Trust an FDA-approved COVID-19 vaccine, Regulatory Focus 21 July 2020).
Hahn’s remarks come as some observers have raised concerns that FDA might be pressured to approve a vaccine before the November election without adequate evidence of safety and efficacy. Officials have also sought to reassure the public that an eventual vaccine will be held to rigorous standards as recent polls have found a significant number of Americans are hesitant about getting a coronavirus vaccine.
“FDA scientists in our Center for Biologics Evaluation and Research will not cut corners. Let me just stress that: Will not cut corners in order to evaluate a vaccine,” Hahn said, adding that the agency will only approve a vaccine, “Based upon the data and upon the gold standard that we have at FDA regarding the safety and efficacy of a vaccine.”
Hahn also explained that FDA is doing what it can to enable the rapid pace of development for COVID-19 vaccines by reviewing data from clinical trials in real time and by providing scientific, regulatory and technical advice to sponsors.
“In this situation, these trials have been compressed, so Phase 1 and Phase 2 could be done together. You generate the appropriate information, and FDA is doing what’s called a real-time review. We’re not just waiting for the end of the trial; we’re reviewing in real time so that we can look at the data in real time and then come to a quicker decision at the end of the trial,” Hahn said.
Pfizer also announced on Monday that it would begin a Phase 2/3 study of its COVID-19 vaccine developed in partnership with BioNTech. Both companies say they plan to enroll 30,000 participants and expect a readout from their studies as early as this fall. (RELATED: Drugmakers to Congress: Trust an FDA-approved COVID-19 vaccine, Regulatory Focus 21 July 2020).
Hahn’s remarks come as some observers have raised concerns that FDA might be pressured to approve a vaccine before the November election without adequate evidence of safety and efficacy. Officials have also sought to reassure the public that an eventual vaccine will be held to rigorous standards as recent polls have found a significant number of Americans are hesitant about getting a coronavirus vaccine.
“FDA scientists in our Center for Biologics Evaluation and Research will not cut corners. Let me just stress that: Will not cut corners in order to evaluate a vaccine,” Hahn said, adding that the agency will only approve a vaccine, “Based upon the data and upon the gold standard that we have at FDA regarding the safety and efficacy of a vaccine.”
Hahn also explained that FDA is doing what it can to enable the rapid pace of development for COVID-19 vaccines by reviewing data from clinical trials in real time and by providing scientific, regulatory and technical advice to sponsors.
“In this situation, these trials have been compressed, so Phase 1 and Phase 2 could be done together. You generate the appropriate information, and FDA is doing what’s called a real-time review. We’re not just waiting for the end of the trial; we’re reviewing in real time so that we can look at the data in real time and then come to a quicker decision at the end of the trial,” Hahn said.
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