U.S. regulators found Johnson & Johnson’s Covid-19 vaccine to be safe and effective, Bloomberg reports.
Why It Matters: While the U.S. only has two approved vaccines right now — Pfizer-BioNTech and Moderna — the introduction of J&J’s shot is “a key milestone on the path toward giving Americans access to the first such shot to work in a single dose.”
- The shot was 72% effective in a U.S. clinical trial.
- There were no Covid-related deaths in the vaccinated group.
- FDA officials will convene Friday to make their official recommendation on whether the vaccine should be authorized.
- The analysis prepared in the advance supported a “favorable safety profile with no specific safety concerns identified that would preclude issuance of an EUA.”
“If J&J’s shot is quickly authorized after Friday’s advisory panel meeting, as the other two vaccines were, the company will initially be able to provide 4 million doses, according to Richard Nettles, the vice president of U.S. medical affairs for J&J’s Janssen Infectious Diseases and Vaccines unit.”
- Nettles also said J&J would likely produce enough of its vaccine to inoculate more than 20 million Americans by the end of March.
- J&J has a contract to deliver 100 million doses by the end of June.
Easier Distribution: In addition to being only one shot, J&J’s vaccine can also be stored at refrigerator temperatures for up to three months.
- “J&J’s vaccine is made from a cold virus that doesn’t replicate but helps the body develop an immune response and prepare for a Covid-19 infection.”
Looking Ahead: Adding a third vaccine to the mix would be a huge boost to rolling out shots. But in the time since the first two vaccines were released, mutant coronavirus variants have become a major concern. J&J’s shot has been found to be “less effective in South Africa and Latin America, where two quickly-spreading versions were identified.”
- Another variant, first identified in the U.K., has been seen at higher levels in the U.S.
Despite being less effective than the two-shot competitors from Moderna and Pfizer BioNTech, the ease of use for J&J’s shot may make a huge difference in adoption. And as a reminder, the flu vaccine is typically only 40-60% effective, yet shields us from flu pandemics.