The First Covid Vaccine Will Not Make Life Normal Again - The New York Times

Come spring, Americans may have their choice of several so-so coronavirus vaccines — with no way of knowing which one is best.

Some of this confusion is inevitable, but some is the result of how coronavirus vaccine trials were designed: Each company is running its own trial, comparing its jab with a placebo.

In the spring, when government scientists began discussing how to invest in vaccine research, some wanted to test a number of vaccines all at once, against each other — what’s known as a master protocol.

The World Health Organization organized a group of experts to start what came to be known as the Solidarity Vaccines Trial.

All of the vaccines would be tested against the same placebo group, and all of the volunteers would be living in the same circumstances.

“You have a fully valid comparison, not only of each of those vaccines against placebo, but against each other,” said Thomas Fleming, a biostatistician at the University of Washington and a member of the Solidarity Vaccines Trial group.

But Moncef Slaoui, the chief adviser of Operation Warp Speed, the multiagency effort to hasten the development of coronavirus vaccines and treatments, said in a statement that such a trial would have been impractical.

“If OWS had tested all vaccines under one master protocol, the operation would have had to wait months before starting and recruit 200,000 volunteers at the same time.”.

In the end, the government opted for what it described as a “harmonized approach.” It would allow vaccine makers to run their own trials, but only if they used protocols that followed certain guidelines and let the National Institutes of Health test all of their volunteers in the same way.

The authorization of a vaccine will depend on how much protection the vaccine provides in the Phase 3 trial — what scientists refer to as its efficacy.

Whether it goes to Pfizer or another company, that first vaccine authorization could hamper ongoing trials of its competitors.

Some volunteers, unsure of whether they had been given an experimental vaccine or a placebo, could drop out of an ongoing trial to get the authorized vaccine, slowing down the research.

John Shiver, Sanofi’s global head of vaccine research and development, agreed that this scenario might play out for the company’s vaccine trial.

The difference between two vaccines will be smaller than between a vaccine and a placebo.

The F.D.A.’s guidelines raise the possibility of testing future vaccines against an authorized one, but they don’t give a clear sense of whether the agency would change the requirements for testing.

Slaoui of Operation Warp Speed said in a statement that once a vaccine is authorized, trials that had not yet started or had just begun recruiting volunteers would be restricted to groups that were not approved to receive the authorized vaccine.

A vaccine that showed 50 percent efficacy in one trial, for example, might actually be more protective than one showing 60 percent efficacy in a different trial.

In a phone call with reporters on Friday, Paul Mango, an official at the Department of Health and Human Services, said that Operation Warp Speed was on track to have up to 700 million doses of various vaccines by March or April — enough, he said, for “all Americans who wish to get it.” As for who would get which vaccine, he said that would be left up to the Centers for Disease Control and Prevention’s vaccine advisory committee.

“They will guide us as to which vaccine is most appropriate for which class of Americans,” he said.

And more uncertainty will come about as regulators continue to look for rare but dangerous side effects in authorized vaccines.

Poland said, is for scientists to talk honestly about how vaccines are tested, and for people to learn what lies ahead