On Wednesday, September 22, 2021, the US Food & Drug Administration (FDA) formally recommended Pfizer boosters six months following receipt of the second dose of Pfizer’s COVID-19 vaccine for:

1. People 65 and older
2. People 18 through 64 at high risk of severe COVID-19
3. People 18 through 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

As a result, the FDA “amended the EUA [Emergency Use Authorization] for the Pfizer-BioNTech COVID-19 Vaccine to allow for a booster dose in certain populations such as health care workers, teachers and day care staff, grocery workers and those in homeless shelters or prisons, among others.”

As a reminder, the 2-dose Pfizer vaccine has been fully approved as Comirnaty for everyone age 16+, and the EUA not only covers the 3rd-shot boosters above but also a 3rd dose 28 days following the second dose for certain immunocompromised individuals, along with the 2-dose regimen for people 12-15.

Following the FDA’s review and recommendation, the Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) reviewed the data and voted on their recommendation.  Thus far, each EUA determination has been approved in full by the ACIP, but this time they did not fully agree and had some very tough deliberations.  Ultimately they voted to adopt the first two recommendations but split the second one into two distinct recommendations which we’ll distinguish below.  Also, while the ACIP voted 6 to 9 against the FDA’s final recommendation to authorize boosters for those whose frequent institutional or occupational exposure puts them at high risk, CDC director Dr. Rochelle Walensky decided to override the ACIP and keep the FDA’s recommendation.

So the CDC’s formal recommendation issued Friday, September 24, 2021, is presented in four parts with a bit more direction as follows:

1. People 65 years and older and residents in long-term care settings should receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series
2. People aged 50–64 years with underlying medical conditions should receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series
3. People aged 18–49 years with underlying medical conditions may receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series, based on their individual benefits and risks
4. People aged 18-64 years who are at increased risk for COVID-19 exposure and transmission because of occupational or institutional setting may receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series, based on their individual benefits and risks

These recommendations open up the Pfizer booster to many millions of Americans.  However, there is no data or recommendation for someone who initially got a different brand of COVID-19 vaccine to switch to the Pfizer brand for the booster.  Instead, they promise to expedite review of the data from Moderna and J&J once all the data are submitted, just as they did for Pfizer.

Non-grandfathered health plans, whether insured or self-funded, must immediately cover these authorized Pfizer booster shots in- and out-of-network without cost-sharing.  Health plans will not be able to call the health care provider’s judgment into question, so if the person meets the age recommendations, the plan must assume the health care provider administering the vaccine already determined the person met the criteria to qualify for the booster.

IMA will continue to monitor regulator guidance and offer meaningful, practical, timely information.

This material should not be considered as a substitute for legal, tax and/or actuarial advice. Contact the appropriate professional counsel for such matters. These materials are not exhaustive and are subject to possible changes in applicable laws, rules, and regulations and their interpretations.