J&J Single-Shot Covid Vaccine Found Effective Before FDA Review

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 Details:

1. The shot was 72% effective in a U.S. clinical trial.
2. There were no Covid-related deaths in the vaccinated group.
3. FDA officials will convene Friday to make their official recommendation on whether the vaccine should be authorized.
4. 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.

Justin Oh:

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.