Wednesday night, the Food and Drug Administration authorized booster shots for both Johnson & Johnson and Moderna's Covid vaccinations. This is another crucial step towards distributing additional doses to tens and millions of people.
The U.S. regulators also allowed "mixing and matching," which allows Americans to receive a booster shot from another drugmaker than that used for their first doses.
Dr. Janet Woodcock, acting FDA Commissioner, stated in a statement that "Today's actions show our commitment to public healthcare in proactively combating the COVID-19 epidemic."
She said that science continues to show that vaccination is the best and most effective way of preventing COVID-19. This includes the worst consequences, such as death, hospitalizations, and other serious complications.
FDA cleared the FDA approval, which was expected. The FDA's Vaccines and Related Biological Products Advisory Committee unanimously recommended that additional shots be given of both vaccines. The Moderna booster was recommended for elderly and at-risk adults six month after the completion of their primary series of vaccines. This aligns with the distribution plan for BioNTech and Pfizer's booster. The committee also recommended J&J boosters to anyone 18 or older who received their first shot at least two years ago.
The Centers for Disease Control and Prevention and their vaccine advisory committee will now receive the ruling. They have scheduled a Thursday meeting to discuss Moderna and J&J’s booster data. Additional shots could be given to those who are eligible if the committee makes a recommendation and Dr. Rochelle Wilensky, Director of CDC, signs off.
This authorization would allow for booster doses to be given to more than 15,000,000 people who have received J&J's shots, and more than 69,000,000 people who have been fully vaccinated with Moderna.
The ability to mix and match vaccines will be available for eligible Americans. The highly anticipated National Institutes of Health report published last week found that all combinations of boosters increase antibody levels. However, Moderna and Pfizer boosters appear to be the most effective.
Wednesday's FDA statement stated that it had identified an increase in the risk of myocarditis, myocarditis, and pericarditis following vaccination with Moderna, especially after the second dose. It stated that symptoms usually appear within a few days of vaccination. Males between the ages of 18 and 24 are at higher risk, especially those under 40.
Pfizer's boosters were approved less than a month back to a wide range of Americans, including the elderly and adults with underlying medical conditions. They also apply to those who live or work in high-risk environments, such as grocery and health-care workers.
Scientists from both the government and outside have had a heated debate about booster shots, especially since many people in the U.S. have not received a single dose of vaccines. The World Health Organization has asked wealthy countries to delay distributing boosters. Some scientists disagree that most Americans require them now.
Some members of the committee said that boosters should be used to prevent breakthrough infections. This is important for protecting health-care institutions against becoming overwhelmed. Other members stated that the third shot should protect those at risk from serious disease. Some members of the committee suggested that boosters may not be necessary for young people, since the initial shots have been successful in these groups.
Biden's administration hopes that the addition of additional doses to the U.S. population will provide long-term, durable protection against severe illness, hospitalization, and death as the rapidly-moving delta variant spreads.
J&J wanted to provide a quick solution to protect the public, rather than Moderna's two-shot messengerRNA vaccines. However, its 72% protection in the U.S. was seen as inferior to Moderna and Pfizer vaccines which boasted efficacy rates higher than 90%.
According to J&J's data to FDA, the second dose of J&J’s shot has similar performance to the other mRNA vaccines. It boosts protection against symptomatic infections to 94% when it is administered two months after the initial dose. J&J's vaccine induces an immune response using a modified version of the adenovirus.
FDA scientists still published an analysis last Wednesday on J&J’s booster application, which questioned the validity of the data. FDA stated that people could benefit from a second dose, but that the FDA had limited information and hadn't yet verified it all.
Many committee members suggested that J&J be considered a two dose vaccine, much like Moderna and Pfizer.
A few committee members asked the agency if they could delay a decision regarding boosters for J&J recipients. The agency replied that it was too early because there are still many questions. Others wondered why J&J's application was brought before the committee to verify all the data.
"Is it possible to say that it's a bit early?" "There are many issues that remain unresolved," stated Dr. Cody Meissner from Tufts University. "There are many uncertainties at this point making it difficult to vote for or against the motion tonight."
