Drugmakers, FDA try to build public confidence in COVID vaccine decisions

  • November 17, 2020

The CEOs, who head vaccine front-runners AstraZeneca, Moderna and partners Pfizer and BioNTech, as well as GlaxoSmithKline, Johnson & Johnson (J&J), Merck, Novavax and Sanofi, also say they will put patient safety first and will “adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of manufacturing processes,” according to a joint statement.

The pledge comes amid concerns that the US Food and Drug Administration (FDA), under pressure from President Donald Trump, could prematurely greenlight a vaccine for COVID-19.  Such concerns have been heightened amid Trump’s repeated claims that a vaccine could be available before the November election and FDA’s controversial issuance of EUAs for hydroxychloroquine and chloroquine and convalescent plasma to treat COVID-19.

However, the vaccine makers’ pledge still leaves the door open for the companies to seek approval or authorization before Phase 3 trials are completed.  Both Pfizer and BioNTech have suggested they will have results backing their vaccine as early as October 2020, well before their estimated primary completion date of April 2021.  “I’m quite concerned about any premature announcements from ongoing trials.  To me … there is a lack of regard for the importance of fully completing the trial,” Eric Topol, MD, Founder and Director of the Scripps Research and Translational Medicine Institute, told RAPS Regulatory Focus.

Topol also said the pledge fails to provide adequate reassurance that drug makers will not prematurely seek approval or authorization for a vaccine.  “They haven’t done that; it’s really quite a serious disappointment.  They should say that they won’t apply for emergency use authorization (EUA), or any authorization, before the phase 3 trials are completed as planned,” he said.

Aaron Kesselheim, Professor of Medicine at Harvard Medical School, told RAPS Regulatory Focus he thinks “the pledge reflects the industry’s awareness that the credibility of the vaccine development process and FDA have taken a substantial hit over the last few months … so it’s good to see the pharmaceutical industry stepping up to support science in absence of support for that from this government.”

But, Kesselhiem added, “the pledge is relatively limited; for example, it doesn’t describe the sort of Phase 3 study that would qualify for the pledge, how well it would be organized, what its endpoints would be, etc.”

In the pledge, the CEOs also lean on FDA and other global regulators for setting safety and efficacy criteria for COVID-19 vaccines and ultimately determining whether they will be approved or authorized.

The pledge follows an open letter from the Biotechnology Innovation Organization (BIO) released in early September that calls on drug makers to ensure the “integrity, transparency, and objective assessment,” of COVID-19 clinical data and urges FDA to “maintain its historic independence as the gold-standard international regulatory body, free from external influence.”

FDA Commissioner Stephen Hahn also took to Twitter on 08 SEP 2020 to reaffirm the Agency’s commitment to upholding its regulatory standards for COVID-19 vaccines, including those laid out in guidance in late-June.  “FDA’s professional staff will only authorize or approve a #COVID19 vaccine if it meets the high standards that Americans expect for safety and effectiveness,” Hahn tweeted.  Hahn, who is set to testify before the Senate Health, Education, Labor and Pensions committee later in September, is facing pressure from Senate Democrats Patty Murray (D-WA) and Chuck Schumer (D-NY) to explain how FDA will resist political interference in its decision-making.

REFERENCE:  RAPS Regulatory Focus (News Articles 2020 9); 08 SEP 2020; Michael Mezher

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