COVID-19 vaccine: FDA pushes back against delaying second dose as US officials, health experts weigh in on debate
The U.S. Food and Drug Administration weighed in on a debate over when the first and second doses of the COVID-19 vaccine should be administered.
The FDA said in a statement Monday there is no adequate scientific evidence that supports changing the authorized COVID-19 vaccine schedule or dosing.
"Without appropriate data supporting such changes in vaccine administration, we run a significant risk of placing public health at risk, undermining the historic vaccination efforts to protect the population from COVID-19," the FDA said in a statement.
The agency said it has followed discussions and reports about reducing the number of doses, extending the length of time between doses, cutting the dosage in half or mixing and matching vaccines to get more people vaccinated.
For maximum effectiveness, the Moderna and Pfizer-BioNTech vaccines require a second dose a few weeks after the first. Some experts have argued that second doses should be deferred so more Americans can get one.
In a co-written opinion piece in Sunday’s Washington Post, Dr. Ashish Jha, dean of Brown University’s School of Public Health, argued that changing circumstances led experts to endorse a new policy.
“What changed?” wrote Jha and Robert Wachter, chair of the department of medicine at the University of California-San Francisco. “First, there’s simply a supply constraint. We hoped that additional vaccines would be available by now. But only the Pfizer and Moderna vaccines have been authorized, and they’re being produced more slowly than hoped. Even more worrisome are the distribution bottlenecks that are making it difficult to vaccinate people as quickly as possible."
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The debate gained momentum when Operation Warp Speed's chief science adviser Moncef Slaoui told CBS’ “Face the Nation” Sunday that data suggests two half-doses of the Moderna vaccine might work.
Slaoui said a lower dose sparked a good immune reaction in people ages 18 to 55, referring to early-stage studies that explored doses in a very small number of people. The FDA allowed emergency use of Moderna’s vaccine based on a 30,000-person study that found two full doses 28 days apart are about 95% protective against COVID-19.
Anthony Fauci, the nation's leading infectious disease expert, advised against delaying the second dose in an interview with CNN on Friday and again Sunday on NBC’s “Meet the Press.”
“The issue of giving it to people and not having a guarantee you're going to get a second shot goes against the science,” he said. “We want to do it according to the science. You give a first dose. If you have a Pfizer, 21 days later, you get a boost. If you have the Moderna, 28 days later, you get the boost.”
He argued stretching out the first dose would make sense only if the United States didn’t have enough vaccine, which isn’t a problem.
Officials said the pace of COVID-19 vaccinations should pick up in the coming weeks. They pointed to a host of reasons for the lag, including vaccination systems still gearing up, federal funding that hasn't been disbursed to states and a requirement that states set aside vaccine for long-term-care facilities.
Add to that two holidays and three major snowstorms, Operation Warp Speed's Gen. Gustave Perna said at a briefing last Wednesday.
Though the vaccine rollout has been challenging, he said, problems with the system are being addressed.
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Last week, British health officials decided it was OK to delay the second dose as long as 12 weeks, surprising experts as none of the coronavirus vaccine studies was designed to test such a gap between doses.
British officials said postponing booster doses meant they could give more people at least some protection with a first shot. They said unpublished data from an AstraZeneca study suggested waiting a little longer between doses might be better in the long run, but they provided no details.
Contributing: Elizabeth Weise, USA TODAY; G. Wayne Miller, The Providence Journal; The Associated Press
Follow Adrianna Rodriguez on Twitter: @AdriannaUSAT.
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