FDA Approves Emergency Use Authorization for Johnson & Johnson Single-Dose COVID-19 Vaccine

Johnson & Johnson has been awarded an emergency use authorization (EUA) for its single-dose COVID-19 vaccine, which experts say will greatly improve access and the ability of health professionals to administer vaccines to hard-to-reach populations.

This is the third approved vaccine for COVID-19, following the EUA for Pfizer and BioNTech’s vaccine on December 12, 2020, and the EUA for Moderna’s vaccine on December 19.

On Wednesday, a released FDA analysis confirmed that the vaccine provides strong protection against severe disease and may reduce transmission of the virus. It is a replication-incompetent adenovirus type 26 vectored vaccine with a stabilized variant of the SARS-CoV-2 S protein and is approved for adults 18 years of age and older.¹

The single-dose approach will enable vaccination of hard-to-reach populations, such as homeless individuals and those in rural communities. The vaccine is also easier to store, remaining stable at normal refrigeration temperatures for up to 3 months.¹ According to CDC officials in a press briefing on Wednesday, these accessibility improvements could be a game-changer.²

“A Johnson & Johnson vaccine is a single-dose vaccine, doesn’t require cold-chain logistics, you don’t have to sit there for 15 minutes—that’s something you can do much quicker,” said Amesh Adalja, MD, FIDSA, senior scholar at the Johns Hopkins University Center for Health Security, in an interview with Pharmacy Times. “You can bring it closer to patients, so you can basically have mobile [clinics] pull up in someone’s neighborhood and everybody can go outside and get vaccinated. So, things will be much more rapid in the summer than we are in the winter during this period of time where there’s limited numbers [and] they’re still fussing over priority groups.”³

The EUA is based on a primary analysis evaluating co-primary endpoints of confirmed moderate-to-severe COVID-19 with onset at least 14 and 28 days, respectively, after vaccinations in participants without evidence of SARS-CoV-2 infection. For the vaccine and placebo groups, there were 116 and 348 cases, respectively, of COVID-19 occurring at least 14 days after vaccination, and 66 and 193 cases, respectively, that occurred at least 28 days after vaccination.¹

Analyses of the secondary endpoints found 76.7% efficacy against severe or critical COVID-19 occurring at least 14 days after vaccination, and 85.4% efficacy against severe or critical COVID-19 occurring at least 28 days after vaccination. Notably, the vaccine was also effective against the COVID-19 variant found in South Africa, with a 64% overall efficacy rate according to the FDA report.¹

Across all geographic areas in which the trial was conducted, the researchers found a 66.9% efficacy when considering cases occurring at least 14 days after vaccination and a 66.1% efficacy in cases occurring at least 28 days after vaccination.¹

A post hoc analysis also found that the vaccine provides some protection against COVID-19-related hospitalization starting 14 days after vaccination. In non-centrally confirmed cases, researchers found there were 2 cases of hospitalization in the vaccine group and none after 28 days, compared to 29 in the placebo group with 16 cases after 28 days.¹

According to the FDA report, approximately 2 million doses are ready to ship and supply is expected to sharply increase, with up to 20 million doses available by the end of March.¹

“The addition of a new vaccine is another tool in our toolbelt that will help us vaccinate more equitably and with greater velocity,” said Nirav Shah, MD, JD, director of the Maine Center for Disease Control and Prevention, during the CDC press briefing on Wednesday.²

REFERENCES

• FDA Analysis Finds Johnson & Johnson Single Shot COVID-19 Vaccine Protects Against Severe Illness, May Reduce Transmission. Pharmacy Times; February 24, 202 https://www.pharmacytimes.com/news/fda-analysis-finds-johnson--johnson-single-shot-covid-19-vaccine-protects-against-severe-illness-may-reduce-transmission. Accessed February 26, 202
• Expert Says Johnson & Johnson COVID-19 Vaccine “Is Going to Be Huge.” Pharmacy Times; February 24, 2021. https://www.pharmacytimes.com/news/expert-says-johnson--johnson-covid-19-vaccine-is-going-to-be-huge. Accessed February 26, 2021.
• Expert Says Release of the Johnson & Johnson Single-Dose COVID-19 Vaccine ‘Will Change the Conversation.’ Pharmacy Times; February 10, 2021. https://www.pharmacytimes.com/news/expert-says-release-of-the-johnson--johnson-single-dose-covid-19-vaccine-will-change-the-conversation. Accessed February 26, 2021.