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November 19, 2021

FDA authorizes Pfizer and Moderna booster shots for all adults

Daily Briefing

    FDA on Friday authorized booster shots of the Pfizer-BioNTech and Moderna Covid-19 vaccines for everyone ages 18 and older, a move that has drawn a mixed response from health experts.

    Radio Advisory episode: The unanswered vaccine questions you should be tracking

    FDA authorizes booster shots for all adults

    The authorization means tens of millions of fully vaccinated adults will be eligible to receive a booster shot of a Covid-19 vaccine six months after their second dose of a Pfizer-BioNTech or Moderna vaccine. (Those who received the Johnson & Johnson vaccine are already eligible for a booster after two months.)

    CDC still must act to recommend the broader use of booster shots, and CDC Director Rochelle Walensky on Wednesday said the agency would "quickly review the safety and effectiveness data and make recommendations as soon as we hear from FDA."

    The authorization comes as many states have already expanded booster access. Arkansas, California, Colorado, Kansas, Kentucky, Maine, Massachusetts, New Mexico, Rhode Island, and Vermont all previously acted to expand booster shot eligibility to all adults.

    New York City also expanded its booster eligibility, with Mayor Bill de Blasio (D) arguing that the federal rules for booster shots were too complicated.

    "The rules weren't clear enough and the numbers weren't big enough. That's the bottom line," he said. "It's much easier and clearer to say, 'Everyone come and get a booster.'"

    Experts have mixed response to booster shot eligibility expansion

    Some public health and immunology experts echoed de Blasio's argument, saying the federal government's eligibility criteria were too complicated.

    "This decision by FDA is overdue," Elizabeth McNally, director of the Center for Genetic Medicine at Northwestern University's Feinberg School of Medicine, said.

    "Many people had trouble understanding whether they should or shouldn't get boosters," she added. "The message is much clearer—get a booster!"

    Jason Schwartz, an associate professor of health policy at the Yale School of Public Health, said FDA's authorization was "a recognition that the current approach to booster recommendations just isn't working."

    "It's so confusing that I think the public has sort of shrugged at the importance of boosters," he said. "And the groups for whom it's really important to get boosters—the older individuals, the long-term care residents, folks with medical conditions—aren't getting boosters at the rates they should. It's time for a reset."

    Other experts argued that evidence increasingly shows boosters can reduce coronavirus infections in the general population. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, cited a study from the United Kingdom showing that a Pfizer-BioNTech booster increased protection from infection from 62.5% to 94%.

    "Look what other countries are doing now about adopting a booster campaign virtually for everybody," Fauci said.

    "I think if we do that, and we do it in earnest, I think by the spring we can have pretty good control of this. ... [E]ndemicity means a lot more people get vaccinated, a lot more people get boosted, and although you don't eliminate or eradicate it, that infection is not dominating your life," he added.

    However, other experts argued that boosters could be a distraction from getting unvaccinated people their first shots.

    "The evidence isn't there that a large rollout of boosters is really going to have that much impact on the epidemic," Ira Longini Jr., a vaccine expert and professor of biostatistics at the University of Florida, said.

    Longini added that booster shots may increase a person's protection against the coronavirus, at least temporarily, but it won't do much to stop population-wide transmission, which is largely being driven by the unvaccinated. (LaFraniere/Weiland, New York Times, 11/19; Kimball, CNBC, 11/19; Hopkins/Schwartz, Wall Street Journal, 11/19; Cohen, Roll Call, 11/17; Breslin, The Hill, 11/18; Gardner, Politico, 11/18; Syal, NBC News, 11/17; Axios, 11/17; Levin, New York Times, 11/19)

     

    Advisory Board's take

    5 key considerations for the expanded booster shot rollout

    Pamela DivackBy Pamela Divack, consultant 

    FDA's expanded authorization for booster doses of Pfizer and BioNtech and Moderna's Covid-19 vaccine significantly increases the number of Americans eligible for a booster shot. While some states—especially those concerned about waning immunity (like Colorado, California, and Vermont)—have already expanded booster shot eligibility to all adults who want one, this authorization is an important milestone in our pandemic response.

    As a next step, CDC must officially recommend the shots before they could be widely administered. However, there are five things all health care leaders must keep in mind today:

    1. Ensure a swift booster rollout, but don't forget about getting unvaccinated adults and kids their first shots.

    Despite the positive booster news and authorizations, our best tool to fight the virus is still getting as many people vaccinated as possible. However, recent CDC data has shown that more fully vaccinated people are getting their booster shots of Covid-19 vaccines than unvaccinated people getting their first shots. Efforts to roll out boosters should not detract from trying to improve vaccine uptake overall.

    2. Proactive and consistent communication is (still) critical for vaccine uptake—including boosters.

    People may have questions about why it's important to boost immunity and whether there are potential side effects, as well as hesitance to take off work or dedicate time to getting the additional shot. Additionally, reaching originally hesitant and hard-to-reach populations and convincing them to take a booster may be a challenge—especially with effective Covid-19 treatments on the horizon, which may discourage some people from getting vaccinated. Successful booster rollout will require proactive outreach efforts from all parts of the health care industry.

    3. National data collection will be essential to understanding boosters' impact on immunity.

    The United States has relied mainly on data from other countries—primarily Israel and the UK—for its Covid-19 booster strategy and understanding of vaccine effectiveness over time. However, FDA advisors and regulators are not always convinced by international data, citing that it does not apply to the United States which has different population characteristics, definitions of breakthrough cases, and health care system infrastructure. With boosters rolling out more broadly—and mixing and matching becoming more prevalent—national data collection will be essential to informing future questions and decisions such as: whether we will need yearly boosters, which vaccine regimens are most effective in certain subpopulations (e.g., high-risk, immunocompromised), optimal timing of vaccination, effectiveness against different variants, and more.

    4. True success in booster rollout revolves around strong equity efforts.

    We've said this before and will say it again: equity must be embedded into every aspect of the battle against Covid-19. Providers, pharmacies, and clinics must not lose sight of lessons learned during the initial phase of rollout—such as offering boosters at convenient hours, so people don't need to take off work or bringing the shots directly into the community.

    5. It may be time for regulators and health care leaders to consider the definition of 'fully vaccinated'.

    The widespread availability of boosters raises a myriad of questions including: Does the term "fully vaccinated" now also include receiving an eligible booster shot? Will individuals who have had a diagnosed Covid-19 infection also be required under mandates to receive the booster? These are just some of the many questions that should be expected in the coming weeks and months. However, some countries and states are already thinking ahead. Prime Minister Boris Johnson recently announced that the U.K. will adjust the definition to include booster shots; New Mexico is actively discussing changing the definition of fully vaccinated.

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