- According to the Food and Drug Administration, Johnson & Johnson’s single-dose COVID-19 vaccine is safe and effective, and should be approved for emergency use.
- In testing, the J&J vaccine was found to be 66% effective in preventing moderate to severe cases of the virus overall, and 72% effective in the United States.
- The FDA will hold a meeting on Friday, February 26th to discuss an EUA for the J&J vaccine.
Johnson & Johnson’s single-dose COVID vaccine is both safe and effective, according to an analysis from the U.S. Food and Drug Administration published this week. FDA scientists say that their analysis of the vaccine “supported a favorable safety profile with no specific safety concerns identified that would preclude issuance of an emergency use authorization (EUA).” With this information, an FDA advisory committee will meet on Friday, February 26th to decide whether or not to recommend the vaccine for an EUA in the United States.
As noted by CNBC, the FDA issued emergency use authorizations for vaccines from Pfizer and Moderna a day after receiving a recommendation from the Vaccines and Related Biological Products Advisory Committee. While the FDA is not required to follow the panel’s recommendations, it has throughout the pandemic.
Johnson & Johnson’s vaccine would be the third vaccine authorized for emergency use in the US, but unlike the two drugs from Pfizer and Moderna, patients only need a single shot of the J&J vaccine. The one-dose vaccine is also far easier to transport and store than either of the previously authorized vaccines. J&J plans to ship its vaccines at 36 to 46 degrees Fahrenheit, and says unpunctured vaccine vials can be stored between 47 and 77 degrees for up to 12 hours. Meanwhile, Pfizer’s vaccine has to be stored between -112 and -76 degrees Fahrenheit.
The single-dose vaccine isn’t quite as effective as two-dose vaccines, but had enough of an impact to receive the endorsement of FDA scientists. According to their analysis, the vaccine was 66% effective in preventing moderate to severe cases of COVID-19 overall, but clocked in at 72% in the US. In South Africa, where the B.1.351 variant of the virus has become the dominant strain, the FDA says the vaccine was still effective 64% of the time.
Common side effects of the vaccine include pain at the injection site, headache, fatigue, and muscle pain, but there were “no specific safety concerns […] identified in subgroup analyses by age, race, ethnicity, medical comorbidities, or prior SARS-CoV-2 infection.” There were also no reports of anaphylaxis following vaccination.
Providing the FDA does authorize the vaccine for emergency use in the coming days, Johnson & Johnson has a deal with the US to ship 100 million doses by the end of June. President Joe Biden’s Covid czar, Jeff Zients, said that there would not be “a big inventory” available when and if the authorization comes through, but Johnson & Johnson claims that 20 million doses of the vaccine should be delivered before the end of March.
