There is no data from COVID-19 vaccine studies that supports the need for a booster shot for the general population, a group of scientists said in a review published on Monday.
The group includes scientists from various countries and at least two from the U.S. Food and Drug Administration, The New York Times is reporting.
The review, which was published in The Lancet, comes a month after President Joe Biden announced that booster shots for the COVID-19 virus would begin on Sept. 20, pending approval by the FDA. Biden said the shots will be given eight months after a person is fully vaccinated with two mRNA vaccinations.
Moderna produces one of the two mRNA COVID-19 vaccines approved for use in the United States. Pfizer-BioNTech produces the other.
Dr. Philip Krause and Dr. Marion Gruber, two FDA scientists who announced last month that they will be leaving the agency, are among the 18 authors of the study. Krause and Gruber said they are leaving in part because they disagreed with a call for booster shots before the FDA could review the evidence in favor of an additional shot.
The FDA is scheduled to meet on Friday to discuss the possibility of approving the Pfizer vaccine for a booster shot program, which would begin next Monday.
Moderna officials say the company has not yet presented its test results to the FDA for consideration for a booster shot but expects to have the material for the agency any day.
The scientists who produced the review said that while research shows mRNA vaccine effectiveness against mild disease may decrease over time, protection against severe disease has remained strong and could persist.
“Current evidence does not, therefore, appear to show a need for boosting in the general population, in which efficacy against severe disease remains high,” the scientists wrote, adding the wide distribution of boosters is “not appropriate at this stage in the pandemic.”
The group did say that booster shots may eventually be needed for the general population if a new variant emerges that the vaccines can’t fight efficiently. Boosters may also be useful now in some people with weak immune systems, the scientists said.
The review pointed out that any advantage boosters provide would not outweigh the benefit of using those doses to protect billions around the world who are unvaccinated.
The scientists warned that those who review the research for a booster shot should remember that “Although the benefits of primary COVID-19 vaccination clearly outweigh the risks, there could be risks if boosters are widely introduced too soon, or too frequently, especially with vaccines that can have immune-mediated side-effects (such as myocarditis, which is more common after the second dose of some mRNA vaccines, or Guillain-Barre syndrome, which has been associated with adenovirus-vectored COVID-19 vaccines).”
A study published Friday by the Centers for Disease Control and Prevention showed that mRNA vaccines are effective in preventing severe illness leading to hospitalization or death.
The study showed Moderna’s vaccine was 95% effective in preventing hospitalizations due to severe symptoms of the COVID-19 virus. Pfizer’s vaccine was 80% effective in preventing hospitalizations, with the Johnson & Johnson vaccine was 60% effective against hospitalization.
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