CDC director defends decision to overrule expert panel on Covid booster shots for health and other frontline workers

Rochelle Walensky, director of the Centers for Disease Control and Prevention, on Thursday defended her decision to overrule an expert panel on whether health care workers and other frontline workers should be offered Covid-19 booster shots, saying it was based on how she would have voted, had she been able to cast a vote.

Walensky insisted she made the call without consulting the White House, which had announced in mid-August a plan to give booster shots to all Americans 16 years of age and older, even though regulators had not yet approved any company’s booster shots. Currently only one booster jab has been authorized — the one made by Pfizer and BioNTech.

“I know that if I had been in the room voting, I would have voted to offer boosters to that group, and that’s ultimately where I laid,” Walensky said during a question and answer session with reporters hosted by the Health Coverage Fellowship, a training program for journalists.

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“I consider myself part of the scientific community. I consider myself scientifically able to understand,” she said. “This was not Rochelle Walensky as a citizen, this was not Rochelle Walensky as a health care worker. This was Rochelle Walensky as a CDC director, public health servant to the United States of America. And I made the decision,” said Walensky, who was an infectious diseases physician at Massachusetts General Hospital before taking the CDC job earlier this year.

An advisory panel to the Food and Drug Administration that met on Sept. 17 voted against recommending all Americans 16 and older be offered a booster shot six months or longer after they had completed their primary Covid vaccination series, with an utter lack of data on the safety or effectiveness of a booster in 16- and 17-year olds clearly playing a role in the outcome.

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That vote would have effectively dashed the White House’s announced plan. But the committee later agreed unanimously to recommend boosters for people 65 years of age and older and individuals at high risk of severe Covid-19 — even though the latter group was not defined. After the second vote, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, asked for an informal poll of the group to see if members supported offering boosters for people at high risk of Covid because of occupational exposures, explaining that the FDA would conclude a “Yes” meant support for boosters for health workers, frontline workers, teachers, and “potentially” some essential infrastructure workers. All members indicated they supported it.

When the FDA issued the emergency use authorization for the booster, its leadership had interpreted who should be eligible very broadly. Too broadly, it turned out, for the CDC’s vaccines expert panel, the Advisory Committee on Immunization Practices.

When the ACIP, as it is known, met the following week, its members voted to recommend that  some groups — people 65 and older, people 18 to 64 with chronic health conditions — should be offered boosters, if they were originally vaccinated with the Pfizer vaccine. The groups represent a wide swath of Americans, and include any health care workers with health conditions that increase their risk of developing a severe Covid infection if they contract the SARS-CoV-2 virus.

But by a 6-to-9 vote, the ACIP declined to recommend boosters for people 18 and older who are at high risk from Covid because of where they live or work. As set out by the FDA, the group would have encompassed tens of millions of Americans — people who live in group homes, prisons or homeless shelters, for example, as well as health workers, frontline workers, grocery store employees, teachers and daycare workers, prison guards, and people who work in homeless shelters.

During the debate over whether this group needed booster shots at this time, some ACIP members pleaded for a yes vote to protect health workers. But others said the available data do not support the need for boosting this group at present.

Walensky appeared to have seized on that, and on the split nature of the vote. “That was not about no. It was more about ‘not yet,’’’ she said in Thursday’s session.

“There was very clear scientific equipoise,” she said, using a scientific term that means a question has not yet been answered. “I was going to have dissension, whatever it is I did. I was going to own it, so I needed to be able to scientifically defend it.’’

Walensky said the CDC had been hearing from state health officials that they have had to close intensive care units because they don’t have enough health workers. She did not directly state that health workers were in short supply because they have been contracting Covid. In some places, health worker ranks have been thinned because of burnout; some hospitals are in the process of firing staff who refuse to get vaccinated against Covid.

“The FDA [advisory committee] had voted in a way that was different from the way the ACIP voted. And so I went with what I thought was right and how I would have voted in the room,” Walensky said to explain her late-night decision to overrule the ACIP and recommend booster shots for those at risk because of where they live and work.

The FDA’s advisory committee, the Vaccines and Related Biological Products Advisory Committee or VRBPAC, will meet next week to study data submitted by Moderna and Johnson & Johnson to support their applications for booster shots for their vaccines. The ACIP is expected to meet shortly after the FDA rules on whether boosters from those companies will be authorized.

Source: STAT