Let’s test the one-shot vaccine strategy

Deal with COVID-19 first

When public health officials implore the public to “follow the science” in responding to the COVID-19 pandemic, a large majority of Americans respond positively. They’re not anarchists.
But with scientists sounding like the Tower of Babel after a slow vaccination rollout, how should they respond?
Should it be just one shot or the recommended two?
Some physician leaders are calling for using just a single dose of the vaccine, not the two used in the clinical trials that led to their approvals. With limited supplies for at least the next six months, single-dose vaccination allows more people to get their shots during the initial phases of the campaign.
There’s some science backing that approach. The Pfizer and Moderna vaccines, both tested in trials where volunteers took two shots a couple of weeks apart, showed efficacy north of 50% after the first shot. While that’s not the 90%-plus efficacy with the booster shot, it would have been sufficient to gain Food and Drug Administration emergency use authorization had the original trial been designed that way.
Great Britain has already adopted the one-shot strategy. And, in a post-New Year’s commentary in the Washington Post, Dr. Robert Wachter of the University of California at San Francisco and Dr. Ashish Jha, dean of Brown University’s School of Public Health, called on the U.S. to take the same approach.
They abandoned their support for strict adherence to the original protocols, in part, because of the new variant of the coronavirus now spreading in the U.S. “Although the new variant doesn’t seem deadlier at the individual level, a more infectious virus means more cases, which means more hospitalizations and deaths,” they wrote. “We need to vaccinate as many people as quickly as possible to save the most lives.”
Washington’s top public health officials vetoed the suggestion. “There really are no data on what happens if you delay the second dose by three months or four months or two months,” said Dr. Anthony Fauci, director of the
National Institute of Allergy and Infectious Diseases. “We don’t have any idea what the level of protection is and what the durability of protection is. It’s fraught with some danger.”
FDA Commissioner Dr. Stephen Hahn echoed those concerns. The available data “continue to support the use of two specified doses of each authorized vaccine at specified intervals.”
Dr. Peter Bach, director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center, came up with an innovative solution. Let academic medical centers administering the first vaccines to front-line healthcare workers conduct a trial. Vaccinate everyone once and randomize 30,000 volunteers to get either a second dose or a placebo.
Data from testing the strategy could be generated “in a few months,” he wrote in a Stat News commentary. While that’s not an immediate solution, it’s better than never getting a scientifically validated answer. 
Under FDA rules for emergency use authorizations, approvals are provisional. A consortium of academic medical centers would need to file an investigational new drug application to test the one-dose strategy. The agency also warned hospitals they do not have the authority to choose to administer just one dose on their own.
“Reducing the number of doses, extending the length of time between doses, changing the dose (half-dose), or mixing and matching vaccines in order to immunize more people against COVID-19 are reasonable questions to consider and evaluate in clinical trials,” a spokeswoman said.
Front-line personnel at the nation’s AMCs are well-versed in how to run clinical trials. Many will be eager to sign up for such a trial. Hospitals should not wait on the vaccine manufacturers to organize a trial testing the one-dose versus two-dose regimens. They should form a consortium and begin working on it immediately. 

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