A patient receives a Covid-19 booster vaccine at the Pfizer-BioNTech Vaccination Clinic in Southfield, Michigan on September 29, 2021.
Emily Elkonin | Reuters
The CDC’s independent vaccine panel has unanimously approved the Pfizer and Moderna boosters for all adults, one of the final regulatory steps before the US can officially begin distributing doses.
The Advisory Committee on Immunization Practices voted to recommend vaccinations. Earlier Friday, the FDA authorized revaccinations of both companies for everyone over 18, and CDC director Rochelle Walenski is expected to cancel doses shortly thereafter.
The group’s recommendation would open eligibility for everyone in the US ages 18 and over, but the group more strongly endorsed vaccinations for older Americans, saying that all people in their 50s and older should get a booster. Earlier it was said that people over 65 and some other high-risk people should get a third shot.
Once Walenski is out of the game, tens of millions of Americans who got their first two shots at least six months ago will be able to get their third shot this weekend.
“As a physician deeply immersed in the clinical trenches, I am very pleased that we have clarity and simplification of the recommendations so that all Americans can understand the vaccines they are currently being recommended,” said committee member Dr. Camilla Cotton after the vote.
Pfizer’s booster dose is 95% effective in preventing symptomatic infection in people who have no evidence of prior infection, said Dr. John Perez, vice president of Pfizer’s vaccine clinical research program. … Moderna did not provide data on the effectiveness of its booster, telling the group that they are still collecting data.
While over 195 million people in the US are fully vaccinated, Covid cases are on the rise in some areas as vaccine effectiveness declines over time, Dr. Sarah Oliver of the CDC told the panel.
“Overall protection remains high in severe illness and hospitalization, and the decline (efficacy) of Moderna vaccine is less pronounced compared to Pfizer,” said Oliver. However, she said the data showed a higher risk of a rare heart condition called myocarditis after Moderna’s shots compared to Pfizer, she said.
Dr. Niraw Shah, director of the Maine CDC and president of the State and Territorial Health Authorities Association, said the current recommendations are confusing and create more work for state and local health officials to determine who is eligible and who is not. The group wants the CDC to distribute vaccinations to everyone 18 and older to simplify the selection process, he said.
“This move has the advantage of relieving pressure on the State Department of Health’s immunization program staff, who are now asking a lot of questions about eligibility for booster vaccinations,” he told the group.
According to the available data, side effects from third injections of Pfizer and Moderna were mild in the vast majority of study participants, including pain at the injection site, headaches, fever, and chills.
Moderna found that the side effects from its booster doses were comparable to those experienced by patients after the initial series of two doses, including headaches, fatigue, and muscle aches.
However, the company is still collecting safety data as its clinical trials with more than 15,000 participants are ongoing, according to Rituparn Das, who spoke on behalf of Moderna during the meeting.
The Centers for Disease Control and Prevention, in a study presented Friday, found 54 preliminary cases of myocarditis and myopericarditis among nearly 26 million booster doses of Pfizer and Moderna, or about 2.1 cases per million injections. However, so far, only 12 of these reported cases have been vaccine-related, while 38 are pending and four have been excluded.
Myocarditis is inflammation of the heart muscle, and pericarditis is inflammation of the outer lining of the heart. When these two conditions occur together, they are called myopericarditis.
The CDC also found that people reported fewer side effects of any kind from the Pfizer and Moderna boosters than from the primary two-dose series.
CDC Advisory Group initially refused in September to endorse Pfizer boosters for the general public, backing instead a shortened distribution plan for older Americans and people at high risk of contracting Covid due to underlying medical conditions.
At the time, the group’s experts said the available safety data, based on studies of 306 people given the booster, was too limited to infer the risks associated with rare side effects such as myocarditis.
The group approved Moderna boosters for older Americans and people with underlying medical conditions in October, and Johnson & Johnson boosters for everyone ages 18 and older.
The widespread use of booster doses is a controversial topic in public health. The World Health Organization has repeatedly criticized rich countries for using third vaccines at a time when people in poorer countries have very limited access to vaccines.
Booster doses are also controversial in the US, with some experts questioning whether it is time to start rolling out their third vaccines now when more than 60 million Americans still have not received their first dose.
However, government officials from California to Maine has already begun issuing boosters for all adults prior to the CDC recommendation on Friday.
Many vaccinated Americans need an extra layer of protection as data increasingly show that vaccine effectiveness against infection diminishes over time. Public health experts expect infections to rise as Americans head home to escape the winter chills and gather with their families for the holidays.
Booster doses can help reduce transmission by helping to prevent breakthrough infections in people who are already vaccinated.