Vaccine developers pledge to separate politics from science amid COVID-19 rush
In a “historic pledge,” nine biopharmaceutical companies vowed to ensure that the coronavirus vaccines they develop are safe and effective before submitting them for approval to federal health officials, according to a joint statement released Tuesday.
The companies’ CEOs said they hope their pledge will “help ensure public confidence” in the future COVID-19 vaccine as the Trump administration continues to push for a Nov. 1 deadline — just two days before Election Day.
“We, the undersigned biopharmaceutical companies, want to make clear our ongoing commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles,” the statement said. “We pledge to only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as [the U.S. Food and Drug Administration].”
The signatories include Moderna, AstraZeneca, BioNTech, Pfizer, GlaxoSmithKline, Johnson & Johnson, Merck, Novavax and Sanofi, the first four of which have potential vaccines in late-stage clinical trials.
Together, the nine companies have developed more than 70 vaccines that have “helped eradicate some of the world’s most complex and deadly public health threats,” the statement said.
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An infectious diseases and immunization expert at Vanderbilt University in Nashville told USA Today the joint pledge is “unprecedented.”
“I’ve only been doing vaccines for 40 years and I’ve never heard of anything like this before,” Dr. William Schaffner told the outlet. “Having the companies themselves issue this statement I think will offer some reassurance. Not completely, but some reassurance to the medical profession.”
A July Yahoo News/YouGov poll revealed that 42% of Americans said they plan on getting the coronavirus vaccination when it’s available to the public — that’s 13 percentage points lower than a similar survey conducted in mid-May, the Miami Herald reported.
Other surveys and polls have found that much of the doubt stems from the politicization of science that could put the public at risk.
President Donald Trump said, without evidence, the “deep state, or whoever, over at the FDA” is impeding the vaccination approval process, “hoping to delay the answer until after November 3rd,” in an Aug. 22 tweet.
The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics. Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives! @SteveFDA
— Donald J. Trump (@realDonaldTrump) August 22, 2020
Five days after Trump’s tweet, the Centers for Disease Control and Prevention sent a letter to state governors asking them to be prepared to distribute a vaccine by Nov. 1., McClatchyDC previously reported.
Shortly after, FDA commissioner Dr. Stephen Hahn told the Financial Times that a COVID-19 vaccine could be considered for emergency use authorization before Phase 3 trials are complete.
“It is up to the sponsor [vaccine developer] to apply for authorisation or approval, and we make an adjudication of their application,” Hahn told the outlet. “If they do that before the end of Phase Three, we may find that appropriate. We may find that inappropriate, we will make a determination.”
He made it clear that an emergency use authorization is different from a “full approval,” and that the former means that the “benefit outweighs the risk in a public health emergency.”
“We have a convergence of the COVID-19 pandemic with the political season, and we’re just going to have to get through that and stick to our core principles. This is going to be a science, medicine, data decision. This is not going to be a political decision,” Hahn said.
