A group of pharmaceutical companies competing with each other to be among the first to develop coronavirus vaccines plan to promise early next week not to release vaccines that do not meet strict standards of effectiveness and safety, according to representatives from three companies.
The pending statement is intended to reassure the public that under political pressure from the Trump administration, the companies will not seek early approval of vaccines. President Trump has been pushing for a vaccine to be available by October – just before the presidential election – and a growing number of scientists, regulators and public health experts have raised concerns about what the Trump administration sees as a pattern of political arm twisting his efforts to fight the virus.
The drug companies aren’t the only ones pushing back. Senior Food and Drug Administration regulators have discussed making their own joint public statement about the need to rely on proven science, which would go against their usual reluctance as officials, according to two senior administrators.
Scientists have been developing a vaccine at record speed that could end the pandemic that killed nearly 190,000 people and infected more than six million people in the United States. Three companies – Moderna, Pfizer, and AstraZeneca – are testing their candidates in late-stage clinical trials.
Pfizer’s CEO said this week the company could see results as early as October, but the others just said they plan to release a vaccine by the end of the year.
Public health experts have welcomed the company’s rapid development of a vaccine and the initial results are encouraging. But for the past few weeks, they have been concerned as Mr. Trump and his allies started talking about a vaccine that could be ready before the November 3rd election.
Even when companies compete to be the first to market a coronavirus vaccine, they have to navigate dangerous political terrain. If they are among the first to bring a successful vaccine to market, they could generate significant profits and help restore the image of an industry hit by soaring drug prices.
However, if a vaccine turns out to have dangerous side effects for some people, the consequences can be catastrophic, damaging the company’s reputation, jeopardizing its broader product portfolio, and putting trust in vaccines, one of the great advances in human public health, largely undermine history.
In tweets and public comments, Mr Trump has explicitly tied his re-election power to a vaccine, an idea that was unveiled at the Republican National Convention last week. Promotional videos featured the government’s efforts to fund and develop such a vaccine in their crash program called Operation Warp Speed.
Trump campaign advisors privately called a vaccine “the holy grail” ahead of the election.
Also last week, the Centers for Disease Control and Prevention sent letters to public health authorities across the country asking them to prepare for the possibility that a vaccine could be ready in late October or early November.
And on Friday, despite federal health officials lowering expectations about when a vaccine would be ready, Trump said one would be “likely” to be ready by October. Even companies can’t see the results while the trials are in progress, but he promised, “You will see results that are shockingly good.”
The day before, Dr. Moncef Slaoui, the top scientist for Operation Warp Speed, in an interview with National Public Radio that the chance of successful vaccination results by October is “very, very small”.
Scientists inside and outside the federal government are dismayed by what they see as the Trump administration’s meddling in the federal pandemic response, the president’s misguided promotion of hydroxychloroquine as a treatment, and his exaggeration of the benefits of convalescent plasma for the federal government’s CDC is changing his Instructions on who should be tested.
Several high-ranking health officials have made it clear in the past few weeks that they would rather stop than be co-opted by the White House in approving a vaccine.
Dr. Slaoui told science magazine on Thursday that if this process is unduly disrupted, he would “resign immediately,” although he said there had been none to date.
In a conference call last month, Dr. Peter Marks, director of the FDA that approves new vaccines and treatments, made the same promise to members of a vaccine working group at the National Institutes of Health.
“If something isn’t safe and effective enough for my family, there is absolutely no way I can watch it be handed over to the rest of the country,” said Dr. Marks in an interview on Thursday. “It won’t happen under my watch.”
Dr. Stephen M. Hahn, the FDA commissioner, has stated repeatedly that his decisions are based solely on scientific data. He has made a public commitment to review every vaccine approval by an advisory panel of external experts, who usually review clinical trial data before a new vaccine is approved.
Senior FDA officials, including political figures, have been frustrated with comments Mr. Trump has made in recent weeks about his efforts to speed up approvals, which gives the impression that the White House has a regulatory role.
Speaking at his news conference on Friday, Mr. Trump said he had just spoken to the head of Pfizer and described him as a “great guy” whose company is a leader in the race to develop a vaccine.
In a separate appearance on Friday, the president said drug companies had told him that “if this were a more typical type of president, it would take two or three years to get these approvals.”
With vaccines, Mr Trump’s ability to influence the approval process has its limits. While a government agency like the CDC can apply for vaccine approval, inquiries usually come from drug manufacturers.
Companies have separately tried to underscore their commitment to rigorous scientific review.
On Monday, Pascal Soriot, CEO of AstraZeneca, released a statement that took into account recent questions about the speed of vaccine development. “I want to reaffirm my commitment to putting science and the interests of society at the center of our work,” he said. “We move fast, but without compromising.”
And on Friday, Moderna’s executive director Stéphane Bancel told CNBC that the company is slowing down participation in its studies to include more people from groups at high risk for Covid-19. “I would prefer if we have more different participants and need an extra week,” said Bancel in the interview.
Michael D. Shear contributed to the coverage.