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
All US adults are now eligible to receive Pfizer and Moderna’s Covid vaccine boosters after the Centers for Disease Control and Prevention approved vaccinations to the general public on Friday. The move allows an extra dose of protection for tens of millions of fully vaccinated Americans as cases surge and officials fear the nation could face another surge this winter.
CDC director Rochelle Walensky approved the booster hours after the agency’s independent panel of vaccine scientists unanimously approved that anyone aged 18 and over should be eligible for at least six months after receiving their second dose.
The Food and Drug Administration approved both companies’ booster vaccines for all US adults early Friday.
“Following a critical scientific assessment, today’s unanimous decision has the current status of the pandemic, the latest data on the vaccine’s effectiveness over time, and a review of the safety data of people who have already received a COVID-19 primary vaccine series and booster, carefully considered, “said Walensky in a statement on Friday evening.
“Booster vaccinations have shown that they can safely increase people’s protection against infections and serious consequences and are an important public health tool to strengthen our defenses against the virus when we go on winter vacation. Based on the compelling evidence, all adults over the age of 18 should now have fair access to a COVID-19 booster dose, “Walensky said.
The CDC also said people over 50 should get a booster vaccination, a stronger recommendation for that age group than before. The panel limited its strongest guidelines to date to those over 65 and other people at high risk.
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 serious illnesses and hospital stays and is dwindling [effectiveness] appears to be less pronounced for the Moderna vaccine compared to Pfizer, “Oliver said. However, she said evidence suggests that after injecting Moderna, compared to Pfizer, there is a higher risk of developing a rare heart disease called myocarditis.
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 determine who is eligible. 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 booster vaccination,” he told the panel.
“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.
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.
The CDC found 54 preliminary cases of myocarditis and myopericarditis among nearly 26 million Pfizer and Moderna booster doses administered, 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 wall of the heart. When both conditions occur together, they are 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 and instead endorsed 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.
Some experts in the US also wonder if now is the time to start giving third syringes, if more than 60 million Americans have still not received their first dose.
However, state officials from California to Maine had begun introducing boosters for all adults even before the CDC’s approval on Friday.
Many vaccinated Americans want extra protection as data increasingly shows that vaccines are less effective against infection over time. Public health experts anticipate a surge in infections 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.