The FDA could issue an emergency use authorization as soon as this weekend for the single-shot COVID-19 vaccine.
A new analysis by the FDA has found that the coronavirus disease 2019 (COVID-19) single-shot vaccine candidate by Johnson & Johnson provides strong protection against severe disease and may reduce the spread of the virus.1
The vaccine is a replication-incompetent adenovirus type 26 vectored vaccine with a stabilized variant of the severe acute respiratory coronavirus 2 (SARS-CoV-2) S protein. According to the FDA report, the proposed use under emergency use authorization (EUA) is for adults 18 years of age and older.1
“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,” Amesh Adalja, MD, FIDSA, senior scholar at the Johns Hopkins University Center for Health Security, told 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.”
The EUA request is based on a primary analysis that evaluated co-primary endpoints of confirmed moderate-to-severe COVID-19 with onset at least 14 and 28 days, respectively, after vaccination in participants without evidence of SARS-CoV-2 infection. The analysis included 39,321 randomized participants with a median follow-up time of 2 months post-vaccination.1
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’s report. The single-shot vaccine also had 86% efficacy against severe forms of COVID-19 in the United States.1 Across all geographic areas in which the trial was conducted, investigators found a 66.9% efficacy when considering cases occurring at least 14 days after vaccination and an efficacy of 66.1% when considering cases occurring at least 28 days after vaccination.1
For the vaccine and placebo groups, respectively, there were 116 and 348 cases of COVID-19 occurring at least 14 days after vaccination, and 66 and 193 cases that occurred at least 28 days after vaccination. Analyses of the secondary endpoints demonstrated 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.1
A post hoc analysis also found that the vaccine provides some protection against COVID-19-related hospitalization starting 14 days after vaccination. Researchers found that in non-centrally confirmed cases, there were 2 in the vaccine group and none after 28 days, compared to 29 in the placebo group with 16 cases after 28 days.1
Safety analyses included 43,783 randomized participants with a 2-month median follow-up. The findings supported a favorable safety profile with no specific safety concerns that would preclude issuance of an EUA, according to the FDA report.1
According to The Washington Post, the FDA could issue the EUA as soon as this weekend.2 Approximately 2 million doses will be available to ship once the EUA is issued, according to the report, and supply will increase with up to 20 million doses available by the end of March.2
Despite access concerns, the vaccine may offer easier storage and administration options once available. The vaccine can be stored at normal refrigeration temperatures for at least 3 months, which could make it much easier to stock in normal retail pharmacies or in rural areas.
Furthermore, the single-shot approach could also be an important step in the pandemic response, enabling a more efficient vaccine roll-out without the 2-week waiting period between shots.1