FDA Authorizes Moderna, Johnson and Johnson COVID Boosters and Mix-and-Match Vaccines

The U.S. Food and Drug Administration (FDA) announced Wednesday that it had authorized booster doses for both the Moderna and Johnson & Johnson COVID-19 vaccines.

The FDA also authorized the use of "mix-and-match" booster shots for currently available COVID-19 vaccines. This allows people to get a single booster dose of a different vaccine than the one they originally received.

For example, a person who received an initial Johnson & Johnson vaccine may receive a dose of either the Pfizer or Moderna vaccine for their second shot.

Guidelines were released by the FDA for the distribution and use of booster vaccines by various at-risk groups, mainly including the elderly and those with significant pre-existing conditions.

Boosters of the Moderna vaccine may be given six months after the initial vaccination was completed to those:

  • 65 years of age and older
  • 18 through 64 years of age at high risk of severe COVID-19
  • 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2

The Johnson & Johnson vaccine booster may be given two months after the initial vaccination was completed to people 18 and older.

Additionally, a booster dose of the Pfizer vaccine may be given six months after the initial vaccination was completed to individuals 18 through 64 years of age with "frequent institutional or occupational exposure to SARS-CoV-2," such as healthcare workers.

"As the pandemic continues to impact the country, science has shown that vaccination continues to be the safest and most effective way to prevent COVID-19, including the most serious consequences of the disease, such as hospitalization and death," said acting FDA commissioner Janet Woodcock. "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."

Covid Moderna vial
Here, a vial of a Moderna COVID-19 vaccine can be seen. Fred Tanneau/Getty

The FDA has performed a variety of clinical studies testing the efficacy of the various COVID booster shots. The agency also provided fact sheets related to each vaccine and their emergency use authorization on their website.

In the case of the Moderna study, all 149 participants showed a boosted antibody response against COVID 29 days after receiving the dose. Similarly, all 39 participants of the Johnson & Johnson study showed a boosted antibody response against COVID.

The Johnson & Johnson, unlike the Moderna and Pfizer shots, are one-dose vaccines. The FDA said that approximately 9,000 clinical study participants have received a second dose of the Johnson & Johnson shot.

Out of those 9,000, the FDA said that they had not identified any new concerns over the shot's safety.

In an email to Newsweek, Johnson & Johnson's Chief Scientific Officer, Paul Stoffels, said that the company "welcome the FDA's decision to authorize emergency use of our COVID-19 vaccine as a booster."

"Our data support a schedule that provides benefit to individuals based on their risks associated with COVID-19, whether administered as a single dose for an efficient response to the pandemic or as a booster dose after at least two months – to protect against symptomatic COVID-19," Stoffels continued.

Johnson & Johnson's Global Head of Research and Development, Mathai Mammen, stated that "it is now even clearer that Johnson & Johnson's vaccine booster can play an important role in maintaining protection against COVID-19."

Updated 10/20/2021, 6:43 p.m. ET: This story has been updated with a statement from Johnson & Johnson and additional information.