Additional COVID-19 Vaccine Boosters Receive EUA; Positive Results for Pfizer Booster

Eligible Americans can now choose from one of three COVID-19 vaccines for their booster dose, after the FDA granted Emergency Use Authorization for both Moderna’s and Johnson & Johnson’s booster this week.

The FDA issued an emergency use authorization (EUA) for Moderna’s COVID-19 vaccine booster dose for people aged 65 and older; people aged 18 to 64 who are at high risk of severe COVID-19; and people aged 18 to 64 with frequent institutional or occupational exposure to the virus.

The agency also authorized a single booster dose of the Moderna’s COVID-19 vaccine for people who have completed a primary vaccination with other authorized or approved COVID-19 vaccines.

Stéphane Bancel

“This emergency use authorization is supported by robust clinical evidence that a 50 µg booster dose induces a strong immune response against COVID-19.” said Moderna CEO Stéphane Bancel in a news releasee.

Related: Advisory Committee Recommends Moderna COVID-19 Booster

The FDA issued an EUA for Johnson & Johnson’s COVID-19 vaccine as a booster for adults aged 18 and older at least two months following primary vaccination with single-shot Johnson & Johnson COVID-19 vaccine, and for eligible individuals who received a different authorized or approved COVID-19 vaccine.

The J&J booster will be the same formulation and dosage as the primary shot.

“When administered as a primary or booster dose, following initial vaccination with the company’s COVID-19 single-shot vaccine, it provided protection against symptomatic disease and was generally well-tolerated, highlighting the favorable benefit-risk profile of a booster dose in light of the ongoing pandemic,” Johnson & Johnson said in a news release.

Related: FDA Advisory Committee Recommends Approval of J&J COVID-19 Booster

Meanwhile, Pfizer and BioNTech announced an efficacy rate of 95.6% for their COVID-19 vaccine booster. The phase 3 randomized, controlled study encompassed more than 10,000 individuals 16 years and older.

Albert Bourla

“These results provide further evidence of the benefits of boosters as we aim to keep people well-protected against this disease,” Albert Bourla, Pfizer’s chairman and CEO, said in a statement.

“In addition to our efforts to increase global access and uptake among the unvaccinated, we believe boosters have a critical role to play in addressing the ongoing public health threat of this pandemic,” Bourla said. “We look forward to sharing these data with health authorities and working together to determine how they can be used to support the rollout of booster doses around the world.”

On September 22, 2021, a booster dose of the Pfizer-BioNTech COVID-19 Vaccine was authorized for emergency use by the FDA for people 65 years of age and older, people 18 through 64 years of age at high risk of severe COVID-19 or with frequent institutional or occupational exposure to the virus.