Top Drug Companies “Stand With Science” & Promise COVID-19 Vaccine Won’t Be Rushed
The nine companies racing to develop a vaccine pledged not to rush for a vaccine to gain FDA approval before there is enough data backing the vaccination’s efficiency.
Nine top pharmaceutical companies have pledged not to rush a COVID-19 vaccine for government approval and to follow “sound scientific principles.” The pledge came after President Trump has repeatedly said a vaccine could be ready by Election Day, drawing accusations that he’d politicize the scientific work and undermine public trust in a vaccine’s efficacy.
The companies’ CEOs released a joint letter on Tuesday, pledging to “always make the safety and well-being of vaccinated individuals our top priority” in developing a COVID-19 vaccine. The corporations include AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer, and Sanofi.
The companies also pledged to only submit a vaccine “for approval or emergency use authorization” from a government agency after “demonstrating safety and efficacy through a Phase 3 clinical study.” The companies also pledged to provide a “sufficient supply” of vaccinations “suitable for global access.”
“We, the undersigned biopharmaceutical companies, want to make clear our on-going commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles,” the pledge reads. “We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which COVID-19 vaccines are evaluated and may ultimately be approved.”
The pledge also states that the companies will follow the U.S. Food and Drug Administration’s requirement for “scientific evidence for regulatory approval” that comes from “large, high quality clinical trials.”
The pledge comes as the race for a vaccine continues from several researchers and labs around the world. In July, the University of Oxford announced its vaccine developed in collaboration with AstraZeneca was showing promising immune responses in its early trials. The vaccine, called ChAdOx1 nCoV-19, is currently in Phase III testing.
Last month, the commissioner of the FDA, Dr. Stephen Hahn, told the Financial Times that the agency might approve a vaccine for emergency use authorization (EUA) before Phase III trials are finished. EUA is not the same as FDA approval, according to the agency’s website. EUA is granted for medical products during emergency situations “when there are no adequate, approved, and available alternatives,” and has been applied to drugs and therapies such as remdesivir and convalescent plasma during the pandemic.
President Trump accused the FDA last month of “making it very difficult for drug companies” to get volunteers in clinical trials, adding that the agency is hoping to “delay” the vaccination development until after the election.
While the nine companies have pledged to ensure a safe vaccine isn’t pushed too soon, Trump is promising a vaccine sooner than initially expected. The president said during a Friday press conference that he spoke with the head of Pfizer who said its vaccine results would be available as soon as next month.
“We remain on track to deliver a vaccine before the end of the year and maybe even before November 1st,” Trump said during the briefing. “Through Operation Warp Speed, we have three vaccines in the final stage of clinical trials.”
But some leaders are concerned with the rush to get early approval on a COVID-19 vaccine, including Senate Minority Leader Chuck Schumer (D-NY), who said in a statement last week that the administration’s race for a vaccine is part of Trump’s re-election effort.
“Too much of the evidence points to the Trump administration pressuring the FDA to approve a vaccine by Election Day to boost the President’s re-election campaign,” Schumer wrote. “This raises serious safety concerns about politics, not science and public health, driving the decision making process.”
Last week, the head of the National Institute of Allergy and Infectious Diseases Dr. Anthony Fauci told Kaiser Health News that he’s “not concerned about political pressure” and that scientists would have a “moral obligation” to stop clinical trials early if the results are “overwhelmingly positive.”
“If you are making a decision about the vaccine, you'd better be sure you have very good evidence that it is both safe and effective,” Fauci said. “The only time you get concerned is if there is any pressure to terminate the trial before you have enough data on safety and efficacy.”