Pfizer’s vaccine had been authorized for boosters for millions of Amerians back on September 24, 2021. Now, about a month later on Wednesday, October 20, 2021, the US Food & Drug Administration (FDA) authorized boosters for Moderna and Johnson & Johnson (J&J) COVID-19 vaccines. The Centers for Disease Control & Prevention (CDC) followed the next day with their formal authorization of the FDA’s recommendations.
- Note Moderna’s authorization is for a half-dose, while the Pfizer and J&J vaccines have authorization for a full-dose booster.
- They have also clarified that in most cases the booster can be a different brand of vaccine from the primary regimen vaccine someone obtained.
In the announcement, the FDA says “the available data suggest waning immunity in some populations who are fully vaccinated. The availability of these authorized boosters is important for continued protection against COVID-19 disease.”
Non-grandfathered health plans are required to immediately cover these without cost-sharing, but note the vaccines themselves continue to be paid for by the federal government even for boosters, so plans are responsible to handle costs to administer the vaccine.
- A single booster of any of the three vaccines may be administered at least 6 months after completion of the primary series of mRNA vaccines from Pfizer or Moderna to individuals:
- Age 65+
- Age 18+ at high risk of severe COVID-19 due to underlying medical conditions (such as immunocompromised individuals)
- Age 18+ with frequent institutional or occupational exposure to SARS-CoV-2 (those living in a long-term care, prison, or homeless shelter setting, and those working in health care, education, daycare, grocery stores, etc.)
- Any of the 15 million individuals age 18+ who obtained the single-regimen J&J vaccine may obtain a single booster dose of any of the three vaccines at least 2 months after completion of the single-dose primary regimen
- Certain immunocompromised individuals are authorized to get a booster as a fourth shot six months after their third mRNA dose from Pfizer or Moderna
- This means each of the available COVID-19 vaccines is formally available as a heterologous (or “mix and match”) booster dose in eligible individuals following completion of primary vaccination with a different available COVID-19 vaccine (so any booster is available 6 months after the mRNA vaccines from Pfizer or Moderna, or 2 months after the J&J vaccine)
- Previous authorizations also remain, including the following:
- Pfizer’s Comirnaty vaccine is fully authorized as a 2-dose primary regimen for anyone age 16+
- Pfizer’s vaccine is emergency use authorized for anyone ages 12-15
- Pfizer’s vaccine is emergency use authorized for a third dose 28 days following the second dose for certain immunocompromised individuals
There is expectation following an FDA panel’s October 26 recommendation that vaccines will be authorized in a lower dose for children age 5+ soon, with the federal government anticipating it will happen and making preparations to administer those nationwide as early as the first half of November if authorized.
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.