FDA Authorizes Second Booster Dose of Pfizer, Moderna COVID-19 Vaccines for Adults Over 50, Some Immunocompromised Patients

An 11-fold increase in geometric mean neutralizing antibody titers was reported at 2 weeks after the second booster compared to 5 months after the first booster dose.

Officials with the FDA have authorized a second booster dose of both the Pfizer-BioNTech and the Moderna COVID-19 vaccines for older adults and certain immunocompromised individuals.

A single booster dose was previously authorized for certain immunocompromised individuals following completion of a 3-dose primary series, according to a press release form the FDA. The new authorization will make a second booster dose available for individuals at a higher risk of severe disease, hospitalization, and death.1

The second booster dose of the Pfizer-BioNTech COVID-19 vaccine or Moderna vaccine may be administered to individuals 50 years of age and older at least 4 months after receiving a first booster dose of any authorized or approved vaccine.1

Furthermore, the second booster dose of the Pfizer-BioNTech COVID-19 vaccine may be administered to patients 12 years of age and older with certain kinds of immunocompromise at least 4 months after receiving a first booster dose. This includes patients who have undergone solid organ transplantation or who are living with conditions that have an equivalent level of immunocompromise.

The second booster dose of the Moderna COVID-19 vaccine may be administered at least 4 months after the first booster dose to individuals 18 years of age and older with the same kinds of immunocompromise.1

“Current evidence suggests some waning of protection over time against serious outcomes from COVID-19 in older and immunocompromised individuals,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in the press release. “Based on an analysis of emerging data, a second booster dose of either the Pfizer-BioNTech or Moderna COVID-19 vaccine could help increase protection levels for these higher-risk individuals.”1

Notably, this decision only applies to the Pfizer-BioNTech and Moderna mRNA COVID-19 vaccines. The authorization of a single booster dose for other age groups with these vaccines remains unchanged.1

The expanded authorization for both vaccines is based on evidence including immunogenicity data from an ongoing, open-label study of 154 health care workers 18 years of age and older at a single center in Israel who received 2 booster doses during the period when Omicron was the predominant variant.2

According to a press release from Pfizer, data showed that an approximately 11-fold increase in geometric mean neutralizing antibody titers against wild-type virus, and Delta and Omicron variants, respectively, were reported at 2 weeks after the second booster compared to 5 months after the first booster dose. No new safety concerns were noted.2

“The FDA’s endorsement of a second booster dose will allow millions of Americans to build and maintain protection against SARS-CoV-2,” said Stephane Bancel, CEO of Moderna, in a press release. “The virus continues to evolve, and we are currently on the verge of another potential wave driven by the BA.2 variant. Data continue to show that mRNA boosters remain the best defense against severe infection and death, and vaccines are a foundational part of our public health protection. Now, health care providers have the opportunity to advise higher-risk people about when and how to get boosted and build immunity in advance of future outbreaks.”3

REFERENCES

  1. Coronavirus (COVID-19) Update: FDA Authorizes Second Booster Dose of Two COVID-19 Vaccines for Older and Immunocompromised Individuals. News release. FDA; March 29, 2022. Accessed March 29, 2022. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-second-booster-dose-two-covid-19-vaccines-older-and
  2. Pfizer and BioNTech Receive Expanded US Emergency Use Authorization for an Additional COVID-19 Vaccine Booster in Individuals Aged 50 Years and Older. News release. Pfizer; March 29, 2022. Accessed March 29, 2022. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-receive-expanded-us-emergency-use
  3. Moderna Receives FDA Approval for Emergency Use Authorization of 2nd Booster Dose of Its COVID-19 Vaccine, mRNA-1273. News release. Moderna; March 29, 2022. Accessed March 29, 2022. https://investors.modernatx.com/news/news-details/2022/Moderna-Receives-FDA-Approval-for-Emergency-Use-Authorization-of-2nd-Booster-Dose-of-Its-COVID-19-Vaccine-mRNA-1273/default.aspx