FDA simply cleared extra COVID-19 booster doses and weighed in on mix-and-match technique


Today, the United States Food and Drug Administration (FDA) cleared COVID-19 booster shots for certain groups of people who have received the Moderna two-dose and single-dose Johnson and Johnson COVID-19 vaccines.

The Moderna vaccine emergency use authorization (EUA) applies to already fully vaccinated adults aged 65 and over, as well as adults aged 18 to 64 who are at higher risk of serious illness because they have an underlying health problem or work that increases their risk of exposure to COVID-19. For the Johnson and Johnson COVID-19 vaccine (also known as the Janssen vaccine), the EUA allows people aged 18 and over to receive a second dose as early as two months after their first dose.

Additionally, the FDA has cleared the use of the mixed (heterologous) vaccination strategy, which means people eligible for additional doses may receive a COVID-19 booster of a different vaccine than their primary series. So, for example, someone who initially received two doses of Pfizer might get a Moderna booster. Or, someone who has received the single dose Johnson and Johnson vaccine could be given a Pfizer or Moderna booster dose.

« Today’s actions demonstrate our commitment to public health in the proactive fight against the COVID-19 pandemic, » Janet Woodcock, MD, acting commissioner of the FDA, said in a statement. declaration. “As the pandemic continues to impact the country, science has shown that vaccination continues to be the safest and most effective way to prevent COVID-19, including the most serious consequences of illness, such as hospitalization and death. Available data suggest a decrease in immunity in some fully vaccinated populations. The availability of these licensed boosters is important for continued protection against COVID-19 disease. « 

Moderna EUA was passed after the FDA’s Advisory Committee on Vaccines and Related Biologics unanimously agreed last week that booster shots would be safe and effective for people in these groups. The third injection of Moderna mRNA vaccine should be given at least six months after their initial vaccination and contain half the amount of vaccine as each of the first two doses. Moderna’s COVID-19 vaccine booster EUA is very similar to the booster EUA that Pfizer / BioNTech vaccine received. (A third dose of Moderna and Pfizer / BioNTech COVID-19 vaccines had already been authorized in August for use in severely immunocompromised people at least 28 days after their second injection.)

Despite the unanimous vote, some committee members criticized the lack of more solid data supporting the need for a booster for the Moderna vaccine, the New York Times reported. Some of the real-world data that we have indicates that the effectiveness of the Moderna vaccine is holding up quite well. (Not to mention that a number of experts question the demonstrated benefit of boosters, especially for people who are not elderly or immunocompromised.)

For example, a study published by the CDC in September, examination of 3,689 hospitalized adults (without immunocompromised conditions) found that the effectiveness of the Pfizer / BioNTech vaccine in preventing hospitalizations due to COVID-19 increased from 91% to 77% after four months of vaccination complete, while the vaccine effectiveness rate of Moderna vaccine barely dipped, from 93% to 92%.

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