Top officials in charge of making sure that a safe and effective Covid-19 vaccine is swiftly delivered to the American people waved caution flags on Tuesday, all but assuring that a shot won’t be widely available by Election Day.
The Food and Drug Administration has been working for months to hammer out clear standards for vaccines seeking to be fast-tracked to market. The process has placed the agency at odds with the White House, which has wanted to get a shot approved by the time Americans head to the polls on Nov. 3.
On Tuesday, the FDA said it would demand two months of safety data before it would review any application for a vaccine emergency-use authorization. Additionally, any shot submitted will need to be considered by an independent panel. Those measures will likely add several weeks or months to a review.
The release of the guidelines was followed by remarks from the head of the White House’s Operation Warp Speed program, Moncef Slaoui, who said that no vaccine manufacturer should apply for use of the shots until it has millions of them ready for use, in order to avoid a photo-op vaccine approval that leaves Americans demanding a shot few could actually get.
Further, the head of the FDA department that will review any submitted vaccine, Peter Marks, warned drugmakers that the agency could call upon rarely used powers to force the companies to disclose potential safety issues, after being asked about an investigation into AstraZeneca Plc’s vaccine candidate. The U.S. trial of that shot has been halted since at least Sept. 8.
The day’s developments amounted to a display of muscle by the scientific and pharmaceutical establishment that has been racing to find a viable vaccine while attempting to resist political pressure to go even faster. Any vaccine cleared by the FDA will be taken by millions of healthy Americans. Missteps could have lasting consequences for people’s health and their willingness to take vaccines in the longer run.
“We did face the threat of a vaccine emergency approval before the election and I think the chances of that as of today have been reduced substantially,” said Eric Topol, director of Scripps Research Translational Institute.
President Donald Trump has always been the biggest backer of making a vaccine available before the election. He has repeatedly announced the goal in contradiction of the top science officials in his administration, who have suggested that it’s much more likely that Americans will have broad access to an inoculation some time next year.
At the same time, Trump, who tested positive for Covid-19 last week and spent the weekend in the hospital, has been losing ground in the polls to Democratic challenger Joe Biden.
Slaoui, FDA Commissioner Stephen Hahn and other health officials in the administration have also made clear they won’t be rushed by Trump, pushing the message that the public’s trust that a vaccine is safe and works is far more important than any artificial deadline. Drugmakers have also pledged not to cut corners in the testing and approval process.
Trump, in a Tuesday-evening tweet, accused the FDA of a “political hit job,” tagging Hahn in the post. “New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day,” Trump said.
New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job! @SteveFDA— Donald J. Trump (@realDonaldTrump) October 7, 2020
A spokesman for the FDA declined to comment.
The guidance’s publication ends a protracted battle between the White House and the FDA. Trump had said last month he could overrule any standards he thought were too onerous, while agency officials have repeatedly said that they had already communicated the guidance to companies.
“There are few moments I can think of where so much political dust was created by political officials for so little actual, practical effect,” said Trump’s first FDA Commissioner, Scott Gottlieb, at the John Hopkins University and University of Washington Vaccine Symposium.
Pfizer Inc., Moderna Inc., AstraZeneca and Johnson & Johnson all have vaccine candidates in late-stage clinical trials. Pfizer has said it could have the data to support an application for an emergency authorization as soon as this month. Moderna doesn’t expect to have such data until late November. J&J began its large phase 3 trial only recently.
Like U.S. regulators, drugmakers have also been eager to avoid the perception that they are bending to political interference. In a series of tweets, Pfizer Chief Executive Officer Albert Bourla said the drugmaker has “never discussed” the FDA’s vaccine guidelines with the White House and “will never do so as it could undermine the agency’s independence.”
Bourla said Pfizer has full faith in FDA’s “ability to set appropriate standards for the approval of a Covid vaccine or treatment.”
The regulator could reach deeper into its tool box, if needed. FDA officials indicated they will look carefully when concerns arise about a vaccine candidate and could compel drugmakers to make more information public.
Marks, the agency’s top vaccines official, said that the FDA could force a company to disclose information when there are serious concerns about safety. Typically, companies under the FDA’s regulatory powers disclose such information voluntarily, though often with the agency’s encouragement.
Vaccine data will be reviewed both by the FDA and in public in front of an advisory committee, so the public can have confidence in the process, said Marks.
“We are going to vet them in a public venue,” he said.
Even as vaccine makers study their compounds and prepare to seek the nod from regulators, they also have been preparing to make billions of doses in the coming months and years to supply populations around the world.
U.S. officials underlined that the ability to produce and distribute a vaccine will be as important as the capacity to develop one. Slaoui said Tuesday that Operation Warp Speed has asked vaccine makers to hold off filing for an emergency authorization of a Covid-19 vaccine, even if they get positive efficacy results from triala, until they can make several million doses.
The program has told the companies it supports to refrain from filing “if they achieve efficacy demonstration while there are no vaccine doses available at industrial scale at several million doses,” Slaoui said in an online presentation at the Johns Hopkins event on Tuesday.
Slaoui suggested that authorizing a vaccine without being able to make it might be a “major disappointment” to the public.