Walensky on Boosters: ‘The Scientific Process Worked’

Why did CDC Director Rochelle Walensky, MD, overrule the agency’s Advisory Committee on Immunization Practices (ACIP) regarding which populations should receive a third dose of Pfizer’s COVID-19 vaccine? There was a “a lot of consensus” between her own views and those of other expert advisors, she said in a webcast interview at The Atlantic Festival on Monday afternoon.

As to boosters of the other vaccines: “Moderna is coming, J&J is coming. It will come to the FDA, and they will treat it with urgency,” she said. “It’ll come to the CDC, we will treat it with urgency. And that will come in the next couple of weeks.”

Interviewer Katherine J. Wu, a staff writer for The Atlantic, characterized the spate of recent guidance and recommendations from the FDA, CDC, and Walensky herself as a “a little bit of messiness.”

Asked how she weighed the available data against the fact that the Biden administration had already laid out expectations around who it believed should receive boosters, Walensky explained that the reason for the administration’s public discussion of boosters was that data in August showed “waning” of vaccine protection and “we knew we needed to publicly plan because the data were going to be published.”

After FDA received new data from Pfizer, “the scientific process worked,” Walensky said.

The FDA’s Vaccines and Related Biological Products Advisory Committee met and deliberated and the CDC’s ACIP also debated the issue and gave her their own advice. Then Walensky made her recommendations, which she said showed “a lot of consensus.”

“So, after listening to all of the science, I fully endorsed vaccine boosters for people greater than 65, for people who live in long-term care facilities, and for people who are at high risk of severe illness,” she said, referring to those with underlying medical conditions.

“And where there was a scientific close call, I listened to the science, and I ultimately ended up … fully in line with what the FDA advisory panel said, and with … what many in our CDC advisory panel said as well, which was to endorse boosters for people who were in high-risk settings because of where they work or live,” which includes healthcare workers, grocery store workers, and other frontline workers, she noted. (The ACIP committee voted 6-9 against recommending boosters for these high-risk workers.)

With regard to the nuance in the latest recommendations, with certain groups told they “should” get a booster and others told they “may” get a booster, Walensky acknowledged that that difference rests on “the strength of the scientific evidence.”

Anyone who has been told they “may” get a booster, including those living and working in high-risk conditions, should consult their doctors, pharmacists, and public health officials and decide whether they are “in a place that a booster is right for [them],” she said.

Given that most flu vaccines are only 60% effective in preventing infection, which is far less effective than the available COVID vaccines, and that the COVID vaccines help prevent severe disease and hospitalization, Wu asked the question currently being posed by many other experts and researchers: “Why boost now?”

Researchers are starting to see “waning associated with the vaccine or perhaps associated with the Delta variant” that has led to some vaccinated people over age 65 being hospitalized and even some deaths, mostly in people who are on average 80 years old, Walensky noted.

As to the question of the level of protection a vaccine should provide — whether against severe illness, hospitalization, or any infection at all — Walensky said she is on the side of those who believe vaccines are meant to prevent against symptomatic disease, “because in fact, there are long-term consequences … because it keeps people out of the workplace, [and] because even moderate disease can actually be pretty severe and debilitating.”

Wu noted that, based on the official recommendations announced Friday, Walensky is herself among those for whom boosters have been recommended.

Walensky responded that she plans to get a booster shot after those in higher-risk groups than her own have gotten theirs. Given that much of the government is working remotely, she said she does not consider herself “high risk” and does not want to cut the line.

Were she still seeing patients in a hospital, she said she would “absolutely” seek a booster sooner.

Asked whether the rationale for vaccines should center on individual risks and benefits or the risks and benefits to society, Walensky argued for both.

“[M]any of our vaccine guidances have focused on the individual,” she said, “but I do believe that we also have to take into account the societal benefits.”

For example, when a healthcare worker is out sick for 2 weeks or gets so-called long COVID, there may be an ICU bed that can’t be filled as a result, because there aren’t enough hospital staff.

“So I think that there are real, tangible societal [impacts] from so many people being out of work,” she said.

Walensky also noted that some schools have had to close because so many teachers have been sick with COVID. “If we can prevent those [infections] from happening, not only do you prevent individual illness for that teacher themselves, but also you … can potentially keep the school or classroom open.”

Asked about the concern among people who have received the Johnson & Johnson or Moderna vaccine who also may be in need of booster shots, “this is a walk, don’t run situation, to go get your boost,” she said. While the vaccines continue to perform “really quite well,” she added, “due process” must be followed.