A panel of advisers from the U.S. Centers for Disease Control and Prevention (CDC) on Friday unanimously voted to recommend booster doses of Pfizer-BioNTech and Moderna COVID-19 vaccine for all adults in the United States six months after receiving the first two doses.
“As a doctor deeply diving into the clinical trenches, I am really pleased that we have clarity and streamlining of the recommendations so that all Americans can understand the vaccines they are currently being recommended,” said CDC team member Dr. Camilla Cotton. 11–0 votes.
Dr. Nirav Shah, director of the Maine Centers for Disease Control and Prevention, told the group that the current federal “guidelines, while well-intentioned and thoughtful … create confusion.”
The move follows the recent FDA decision on Friday to issue an emergency permit for the distribution of Pfizer and Moderna boosters to all adults.
“COVID-19 vaccines have proven to be the best and most effective protection against COVID-19,” Acting FDA Commissioner Janet Woodcock said in a statement of the decision. Woodcock said the boosters will provide protection from hospitalization and death from COVID-19.
Boosters were previously approved for people 65 years of age or older who had been vaccinated with Pfizer or Moderna vaccines at least six months prior. They have also been approved for some adults at high risk of infection.
“The FDA has determined that the data currently available supports an expansion of the eligibility for a single booster dose of Moderna and Pfizer-BioNTech COVID-19 vaccines for those aged 18 and over,” said the head of the Evaluation Center. and FDA Biologicals Research Peter. Marks in Friday’s statement.
According to the FDA, the Moderna emergency booster authorization states that it is “administered as half the primary batch dose,” whereas the Pfizer booster dose appears to be the same as the primary batch dose.
The FDA said that when using a booster dose of Moderna and Pfizer, people who were observed in the studies “showed a booster response” about a month after receiving it.
Although authorization for emergency use was granted, the FDA said that after Moderna and Pfizer-BioNTech initially submitted safety and efficacy data to the agency, “additional real data is available on the recent increasing number of COVID-19 cases in USA. USA and the risk of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the outer lining of the heart) after vaccination with these vaccines.
The agency said that despite reports of heart inflammation, it determined the benefits outweigh the risks. Several European countries, including France and Germany, have advised against giving the Modern vaccine to adults and younger children in recent days due to the potential risk of myocarditis or pericarditis.
The introduction of boosters around the world has also raised concerns that governments and businesses will not consider a person “fully vaccinated” unless they have received a booster dose.
In Israel, for example, the government considers a person to be incompletely vaccinated if they have not received a booster vaccination six months after receiving the first two doses. Israel also requires people to show proof that they are fully vaccinated to visit various businesses and places.
CDC Director Rochelle Valenxi must now sign the group’s recommendation before boosters can be authorized for all adults over 18. Generally, Walenski followed the advisory group’s recommendation, although she caused confusion in September when she overturned part of the September Booster Commission decision.
Booster doses of Johnson & Johnson’s vaccine, which uses 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 vaccinated with J&J to mix and match booster doses.