WASHINGTON — A group of nine leading pharmaceutical and biotechnology companies pledged on Tuesday to only seek approval for Covid-19 vaccines demonstrated to be safe and effective, an apparent attempt to provide public reassurance despite the widely held view that the Covid-19 vaccine development process is politically tainted.
In a statement, the companies pledged to “make the safety and well-being of vaccinated individuals our top priority.” The vaccine developers said they would continue to impose high ethical and scientific standards on the vaccine-testing process, and apply for government authorizations only “after demonstrating safety and efficacy through a Phase 3 clinical study.”
The group of nine companies includes Moderna, AstraZeneca, and the ongoing collaboration between Pfizer and BioNTech — three of the Covid-19 vaccine efforts that have advanced into late-stage clinical trials, and whose vaccine candidates are likely to be considered for emergency approvals in the coming months. Top executives at Merck, GlaxoSmithKline, Johnson & Johnson, Sanofi, and Novavax also signed the pledge.
Their statement comes as President Trump continues to push for a rapid vaccine approval, repeatedly pointing to late October as a potential approval date. At a press conference on Monday, he said a vaccine authorization could come “before a very special date” — a clear allusion to the Nov. 3 general election.
In recent weeks, top U.S. health officials have further damaged the Food and Drug Administration’s reputation for making independent, science-driven decisions. Last month, FDA commissioner Stephen Hahn misrepresented data about the ability of blood plasma from recovered Covid-19 patients to treat the disease after Trump falsely touted the treatment as a breakthrough. Though he issued a partial apology in the ensuing days, he has not fully corrected his misleading remarks. Health secretary Alex Azar, who made a nearly identical false claim that blood plasma could reduce Covid-19 deaths by 35%, has not recanted his remarks.
Hahn also generated alarm when he told the Financial Times in late August that the FDA would consider an emergency authorization for a vaccine candidate that has not completed a Phase III clinical trial, the final stage of testing for safety and efficacy typically required for an approval.
Already, the Trump administration’s rhetoric, and scientists’ criticisms, have led to dramatic shifts in how Americans view the FDA and vaccine safety. In a recent STAT-Harris survey, 82% of Democrats and 72% of Republicans expressed concern that the Covid-19 vaccine approval process would be driven more by politics than by science.
More than 80% of independents, Republicans, and Democrats said they would worry about the safety of a vaccine that was approved quickly.
Sen. Kamala Harris of California, the Democratic vice presidential nominee, hinted that she would not take a Covid-19 vaccine if one were approved and distributed before the election.
“I would not trust Donald Trump,” she said in a CNN interview. “I will not take his word for it.”
Tim Murtaugh, the communications director for Trump’s reelection campaign, tweeted in response that Harris was an “anti-vaxxer,” accusing her and Joe Biden, Trump’s challenger, of “using dangerous rhetoric to scare people away from a vaccine when it’s ready.”
In the Tuesday statement, titled “Biopharma leaders unite to stand with science,” the drug companies said they believed the pledge would “help ensure public confidence in the rigorous scientific and regulatory process by which COVID-19 vaccines are evaluated and may ultimately be approved.”
The drug and biotech companies’ pledge comes on the heels of a separate, similar open letter from the biotech trade group, the Biotechnology Innovation Organization, which warned that the “FDA should maintain its historic independence as the gold-standard international regulatory body, free from external influence.”