The Centers for Disease Control and Prevention (CDC) overrode its vaccine advisory panel early Friday and said people as young as 18 who have certain jobs or living situations may get a COVID-19 vaccine booster.
The move means millions of more Americans may get a booster shot, even though experts during a meeting said there was not enough data to support boosters for many younger people.
CDC Director Dr. Rochelle Walensky, a Biden nominee, decided to reject the expert panel’s guidance and allow anybody between the ages of 18 and 64 who are at “increased risk for COVID-19 exposure and transmission because of occupational or institutional setting” to get a booster of Pfizer’s COVID-19 vaccine.
That same recommendation was voted down 9–6 during the Advisory Committee on Immunization Practices (ACIP) on Thursday.
ACIP offers advice to the CDC on vaccines.
Panel members voted to approve three sets of recommendations on boosters, including recommending boosters for anybody 65 or older. They said seniors and long-term care facility residents, and people 50 to 64 with underlying medical conditions like cancer, “should” get a booster. Those 18 to 49 with similar conditions “may” receive a booster, the panel also said.
But many said there wasn’t sufficient data to inform the fourth recommendation and that the language was so broad that it might as well be for anybody 18 or older.
“We might as well give it to everybody 18 and older. We have a really effective vaccine. And it’s like saying it’s not working. And it is working,” said Dr. Pablo Sanchez, professor of pediatrics at The Ohio State University/Nationwide Children’s Hospital, expressing dissent during the meeting.
“I really think this is a solution looking for a problem,” Dr. Jason Goldman, an assistant professor in Florida who was representing the American College of Physicians as a liaison to the panel, added later. He said the recommendation was “far afield from the data.”
Dr. Sarah Long, who works in the Section of Infectious Diseases at St. Christopher’s Hospital for Children, noted that youth are at elevated risk of getting heart inflammation after getting Pfizer’s shot. She said the risk-benefit calculus did not seem to support boosters for many young people.
CDC presenters had told members earlier that the side effects from boosters weren’t known yet because very little data exists on them.
Most of the data come from Israel, which started letting people with weak immune systems get third doses of Pfizer’s jab on July 12 and all residents 60 or older about three weeks later.
Two early studies from Israeli researchers show the boosters heightened protection against COVID-19, the disease caused by the CCP (Chinese Communist Party) virus. But the studies give limited insight into third doses, CDC officials said, with serious risks of bias and wide confidence intervals.
Some members and liaisons expressed support for the recommendation, with arguments primarily centering around the perceived benefit to others that may come if people get boosters.
But the vote ultimately failed.
The CDC’s Walensky, though, went ahead with the recommendation anyway. It’s one of the few times in history the CDC has rejected advice from ACIP.
“As CDC director, it is my job to recognize where our actions can have the greatest impact. At CDC, we are tasked with analyzing complex, often imperfect data to make concrete recommendations that optimize health. In a pandemic, even with uncertainty, we must take actions that we anticipate will do the greatest good,” Walensky said in a statement.
“I believe we can best serve the nation’s public health needs by providing booster doses for the elderly, those in long-term care facilities, people with underlying medical conditions, and for adults at high risk of disease from occupational and institutional exposures to COVID-19,” she added.
Walensky said ACIP’s discussion and deliberation informed her recommendations.
Dr. Katherine Poehling, professor of pediatrics and epidemiology prevention at the Wake Forest School of Medicine, declined to immediately comment through a spokeswoman.
The other eight panel members who voted against the fourth recommendation did not respond to requests for comment, nor did the CDC.
Walensky’s recommendation means millions of additional Americans are able to get a booster. Approximately 13.6 million seniors are now able to get a third dose, CDC officials said. Numbers weren’t given for the other populations being told they should or may get a booster. But “occupational or institutional setting” can be interpreted to mean all sorts of settings, ACIP members said during Thursday’s meeting.
President Joe Biden said Friday that the number of those now eligible for boosters is around 60 million.
The recommendation does appear to align at least somewhat with the Food and Drug Administration’s (FDA) expanded emergency use authorization for Pfizer’s shot. The expanded authorization says people 18 to 64, “whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19,” may get COVID-19.
All of the recommendations for boosters are only for people who have gotten Pfizer’s primary two-dose regimen. Additionally, at least 6 months need to have elapsed after the final dose.
Walensky and other top officials last month said emerging data show that the efficacy of vaccines against CCP virus infection wanes over time and there’s also evidence indicating reduced protection against mild and moderate disease. They said boosters would be recommended to all adults 16 and older, pending FDA authorization.
But the FDA limited boosters to certain populations after its advisory panel rejected authorizing shots for everybody.
That vote came after two top FDA scientists submitted their resignations in protest of the pre-emptive announcement by federal health officials. Those officials, Marion Gruber and Phil Krause, later wrote an article in a medical journal asserting that there’s no evidence the general population should get boosters, and the FDA separately signaled boosters may not be needed.
Jack Phillips contributed to this report.