A patient will receive a booster vaccination against Covid-19 on September 29, 2021 at a Pfizer BioNTech vaccination clinic in Southfield, Michigan.
Emily Elconin | Reuters
The CDC’s independent panel of vaccine scientists unanimously endorsed Pfizer and Moderna’s all-adult boosters, one of the final regulatory steps before the US can officially begin distributing the doses.
The Advisory Committee on Vaccination Practices voted to recommend vaccinations. The Food and Drug Administration approved both companies’ vaccine boosters earlier on Friday for anyone aged 18 and over, and CDC director Rochelle Walensky is expected to release the doses soon after.
The panel’s recommendation would open eligibility for anyone over 18 in the U.S., but the group lowered the age for people they said should get a refresher to 50. Previously, it said people over 65 and some other high-risk people should get a third shot.
Once Walensky unsubscribes, millions of Americans who received their first two vaccinations at least six months ago will be eligible for a third vaccination this weekend.
“As a clinician deep in the clinical trenches, I am really pleased that we have clarity and streamlining of the recommendation so that all Americans can understand the vaccines that are currently being recommended to them,” said committee member Dr. Camille Kotton after the vote.
Effectiveness data
According to Dr. John Perez, vice president of the company’s clinical vaccine research program, told Pfizer that its booster dose was 95% effective in preventing symptomatic infection in people who had no evidence of previous infection in a clinical study of 10,000 subjects 16 years and older. Moderna has not submitted its effectiveness data for its booster and has told the panel that it is still collecting the data.
While more than 195 million people in the US are fully vaccinated, Covid cases are increasing in some areas as vaccines become less effective over time, said Dr. Sara Oliver from the CDC to the panel.
“Overall protection remains high for severe illness, and hospitalization and declines (efficacy) appear to be less pronounced with the Moderna vaccine compared to Pfizer,” said Oliver. However, she said evidence suggests there is a higher risk of a rare heart condition called myocarditis after the Moderna shots, compared to Pfizer.
Create clarity
Dr. Nirav Shah, director of the CDC in Maine and president of the Association of State and Territorial Health Officials, said the current guidelines are confusing and would mean more work for state and local health officials to decide who is eligible or not. The group wants the CDC to distribute the recordings to anyone aged 18 and over to streamline the selection process, he said.
“Such a move has the benefit of relieving pressure on the State Department of Health’s vaccination program staff, who are now asking a large number of questions about eligibility for refresher courses,” he told the panel.
The side effects of the Pfizer and Moderna third syringes were mild in the vast majority of study participants, including injection site pain, headache, fever, and chills, the data said.
Moderna found that the side effects of its booster doses were comparable to those patients experienced after the first series of two doses, including headache, fatigue, and muscle pain.
However, the company is still collecting safety data as its clinical trial with more than 15,000 participants is still ongoing, according to Rituparna Das, who presented on behalf of Moderna during the meeting.
Myocarditis Update
The Centers for Disease Control and Prevention found 54 preliminary cases of myocarditis and myopericarditis under nearly 26 million Pfizer and Moderna booster doses, or about 2.1 cases per 1 million shots administered, in a study presented Friday. To date, however, only 12 of these reported cases have been attributed to vaccines, while 38 have been reviewed and four have been excluded.
Myocarditis is inflammation of the heart muscle and pericarditis is inflammation of the outer lining of the heart. When the two conditions occur together, it is known as myopericarditis.
The CDC also found that patients with Pfizer and Moderna boosters reported fewer side effects of any kind than with the primary two-dose series.
The CDC’s advisory board originally declined to endorse Pfizer’s boosters to the general public in September, instead supporting a scaled-down distribution plan for older Americans and people at high risk of Covid infection due to underlying health conditions.
At the time, experts on the panel said the available safety data, based on research on 306 people who received boosters, were too limited to say anything about the risks posed by rare side effects such as myocarditis.
“At the time we met, less information was available. There is always a balance between safety and effectiveness,” said Dr. Ofer Levy, director of the Precision Vaccines Program at Boston Children’s Hospital and a voting member of the FDA’s vaccine advisory board, said in an interview with CNBC on Friday. “We have more data now, and the data shows, first, that myocarditis, while an unusual risk, is usually mild and treatable.”
He said the scientists also have more data on breakthrough infections in fully immunized people, suggesting that protection diminishes over time.
In October, the panel endorsed Moderna’s boosters for older Americans and people with pre-existing conditions, and Johnson & Johnson’s boosters for anyone aged 18 and over.
Dispute over boosters
The widespread use of booster doses is a controversial public health issue. The World Health Organization has repeatedly criticized rich nations for introducing third vaccinations at a time when people in poorer countries have very limited access to vaccines.
Booster doses have also been somewhat controversial in the US, with some experts questioning whether now is the time to start introducing the third dose, when more than 60 million Americans have still not received their first dose.
However, state officials from California to Maine had begun rolling out boosters for all adults ahead of the CDC’s recommendation on Friday.
Many vaccinated Americans want extra protection as data increasingly shows that vaccines are less effective against infection over time. Public health experts expect infections to surge as Americans go inside to escape the winter chill and gather with families over the holidays.
Booster doses could help reduce transmission by preventing breakthrough infections in people who have already been vaccinated.
