Drug companies making vaccines have been under increasing pressure from independent scientists and public health experts to be more transparent about how they are running their clinical trials. |
But none of the nine companies that are testing vaccines in late-stage clinical trials had released detailed blueprints — until today. |
Moderna became the first to release detailed protocols for its vaccine trials, and hours later Pfizer followed suit. The disclosures are aimed at addressing growing suspicion among Americans that President Trump’s drive to produce a vaccine before the election on Nov. 3 could result in a product that was unsafe. |
Moderna and Prizer revealed how trial participants were selected and monitored, what kinds of problems would prompt the trials to be stopped early, and the evidence researchers would use to determine whether people who got the vaccine were protected from the coronavirus. |
AstraZeneca, another leader in the race for a vaccine, did not respond to inquiries about whether it would now disclose its study protocol. |
Our reporters are still reviewing Pfizer’s disclosures. Here are a few highlights from Moderna’s: |
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Despite the president’s repeated claims that a vaccine will be available in October, scientists, companies and federal officials all say that most people won’t get one until well into next year.
Katie Thomas and Jesse Drucker
Sept. 17, 2020 Updated 8:03 p.m. ET
Americans are desperate to know when a coronavirus vaccine will be available to finally curb the pandemic that has already taken nearly 200,000 lives in the United States, and allow schools and the broader economy to reopen.
Scientists and vaccine makers have long said that a handful of vaccines could be available by the end of the year, if everything goes according to plan. But in recent weeks, President Trump has insisted that a vaccine will be ready before the presidential election on Nov. 3, raising fears that one could be rushed against the advice of scientists and regulators.
Testing and producing a vaccine is a complex process with a lot of uncertainties. But the best guess for now, experts say, is this: If every aspect of the vaccines’ development and distribution goes exactly as planned — and history has shown that rarely happens — certain people in high-risk groups could get vaccinated this year. Most other Americans, however, will quite likely have to wait until well into next year.
What has President Trump said?
At a news conference on Wednesday evening, Mr. Trump doubled down on that unrealistic timeline, saying that a vaccine could be ready by mid-October and that it would then be made available “immediately” to the general public.
“We’re not looking to say, ‘Gee, in six months, we’re going to start giving it to the general public,’” he said. “No, we want to go immediately.”
In doing so, he contradicted his own director of the Centers for Disease Control and Prevention, Dr. Robert R. Redfield, who had testified to senators earlier in the day that a vaccine would most likely not be available until the middle of next year. Mr. Trump’s statements also contrasted with comments made Wednesday morning by officials with Operation Warp Speed, the federal effort to accelerate a vaccine, who said that supplies would be limited in the first months that a vaccine is available.
It was not the first time the president had pushed an accelerated timeline. Just the night before, at a town-hall meeting hosted by ABC News, he said one could be available in three to four weeks.
What do scientists and vaccine companies say?
Dr. Redfield’s timeline is consistent with the best guess estimates from other vaccine experts, who say that the general public won’t have access to the vaccine until February at the very earliest, and possibly more like July or August.
Of the three companies with vaccines in late-stage clinical trials in the United States, just one — Pfizer — has said that it could have initial results by the end of October. The other two companies, Moderna and AstraZeneca, have been more vague, saying only that they hope for results before the end of the year. If a coronavirus vaccine were to show results this year, it would shatter the previous record of four years for the development of a new vaccine.
Dr. Paul Offit, a professor at the University of Pennsylvania and a member of the Food and Drug Administration’s vaccine advisory panel, was skeptical that Pfizer could be so sure of its timeline. “I think it’s irresponsible — they don’t know,” he said. “I think the more responsible answer is, ‘Hopefully, we’ll know something by the beginning of next year.’ That would seem to me to be the most likely scenario.”
Moderna’s top executives said in interviews this week that they could have initial results by November. But a trial blueprint the company released on Thursday indicated an even longer timeline, suggesting that the first analysis of the trial data may not be conducted until late December, and that there may not be enough information then to determine whether the vaccine works. Later analyses, projected for March and May, are more likely to provide an answer, the company said in its blueprint. (A company spokesman said the November estimate is an updated assessment of what was in the blueprint.)
AstraZeneca’s timeline is also in question after it halted global trials this month because of a participant who had developed severe neurological symptoms after receiving the experimental vaccine. The company has not released details about the medical condition of the person, nor has it said whether the reaction was because of the vaccine. The trials have since resumed in the United Kingdom and in Brazil, but not in the United States, where it has been paused since Sept. 6.
