A report titled “Considerations in boosting COVID-19 vaccine immune responses” published in the scientific journal The Lancet determined that booster doses of the COVID-19 (also called CCP virus) vaccine are unnecessary for the general public.

The scientists’ conclusion, including two senior officials from the Food and Drug Administration (FDA) and the World Health Organization (WHO), was published on Monday, Sept. 13.

The scientists said the effectiveness of the COVID vaccine against mild disease might diminish over time; however, protection against severe disease may 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.”

They also said that there are risks in giving boosters too early, mainly because of the side effects seen, mainly after the second dose of mRNA (messenger RNA) technology vaccines. Among these, they named inflammation in the heart called myocarditis, which primarily affects young people, and Guillain-Barré syndrome, which causes body paralysis.

“If unnecessary boosting causes significant adverse reactions, there could be implications for vaccine acceptance that go beyond COVID-19 vaccines,” they wrote.

However, they said booster doses might be needed if the effectiveness of the vaccines continues to decline or if a variant emerges and the vaccine is ineffective.

According to CNBC, the news caused shares of COVID vaccine maker BioNTech to fall more than 5% in intraday trading.

Biden plans boosters for all

The Biden administration plans to begin administering booster shots of the COVID vaccine to the general public beginning Sept. 20. An FDA advisory group will meet Friday, Sept. 17, to discuss data supporting the widespread use of boosters.

Those who received the two-dose Pfizer-BioNTech and Moderna vaccines will be able to receive the injection eight months after receiving the second dose. Booster shots for Johnson & Johnson’s single-dose vaccine are still being decided.

Biden’s decision comes on the heels of studies published by the Centers for Disease Control and Prevention, which showed that protection from the COVID vaccines declined for several consecutive months, primarily against the Delta variant so that that booster doses would be needed.

Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and a government advisor on coronavirus issues, said in a Sept. 2 statement: “from my own experience as an immunologist, I would not at all be surprised that the adequate, full regimen for vaccination will likely be three doses.”

President Joe Biden did not wait for the FDA and CDC to advise all U.S. adults to get the third dose eight months after the previous dose. This drew strong criticism from federal regulators, along with concern that the White House’s booster campaign was moving too quickly.

According to reports, Marion Gruber, director of the FDA’s Office of Vaccine Research and Review, and deputy director Phil Krause will leave the FDA this year because they were frustrated with the regulatory agency’s decision to support booster doses.

Both officials were involved in the revised report published in The Lancet today (Sept. 13), which indicates that booster doses are unnecessary.

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