The Centers for Disease Control and Prevention (CDC) on Friday said all adults may get Pfizer-BioNTech’s and Moderna’s COVID-19 vaccines.
“Booster shots have demonstrated the ability to safely increase people’s protection against infection and severe outcomes and are an important public health tool to strengthen our defenses against the virus as we enter the winter holidays,” Dr. Rochelle Walensky, the director of the CDC, said in a statement on Friday.
A CDC vaccine advisory panel hours earlier unanimously voted to advise the agency to recommend the boosters for everybody 18 and older six months after they receive their first two doses.
“As a clinician deep in the clinical trenches, I am really glad that we have clarity and streamlining of the recommendation so that all Americans can understand the vaccines that are recommended for them at this time,” CDC panel member Dr. Camille Kotton said following the 11–0 vote.
Dr. Nirav Shah, director of the Maine Center for Disease Control and Prevention, told the panel that also, the current federal “guidelines, though well-intentioned and thoughtful ... create confusion.”
“COVID-19 vaccines have proven to be the best and highly effective defense against COVID-19,” said FDA acting commissioner Janet Woodcock in a statement about the decision. Woodcock said boosters will provide protection against hospitalization and death from COVID-19.
Boosters were previously authorized for individuals who are aged 65 and older and were vaccinated with the Pfizer or Moderna vaccines at least six months prior. They were also approved for certain adults with a high risk of infection.
“The FDA has determined that the currently available data support expanding the eligibility of a single booster dose of the Moderna and Pfizer-BioNTech COVID-19 vaccines to individuals 18 years of age and older,” said FDA Center for Biologics Evaluation and Research head Peter Marks in a Friday statement.
According to the FDA, the emergency use authorization for Moderna’s booster stipulates that it be “administered as half of the dose of a primary series dose,” whereas Pfizer’s booster appears to be the same as the primary series dose.
With both the Moderna and Pfizer booster dose, individuals who were observed in studies “demonstrated a booster response” after about one month of receiving it, the FDA said.
Although the emergency use authorization was handed down, the FDA said after Moderna and Pfizer-BioNTech initially sent safety and effectiveness data to the agency, “additional real-world data have become available on the recently increasing number of cases of COVID-19 in the U.S. and on the risk of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the outer lining of the heart) following vaccination with these vaccines.”
The rollout of boosters worldwide has also triggered concerns that governments and businesses will not consider an individual “fully vaccinated” if they haven’t received the booster dose.
In Israel, for example, the government considers a person not fully vaccinated if they have not received a booster after six months after their first two doses. Israel also mandates that people show proof that they’re fully vaccinated to enter a variety of businesses and venues.
Booster doses of the Johnson & Johnson vaccine, which uses an adenovirus rather than mRNA technology, were approved under an emergency use authorization for all adults in mid-October. Around the same time, the CDC also approved people who got the J&J shot to mix-and-match booster doses.
