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Johnson & Johnson has asked the FDA to approve its vaccine. Here’s why that’s historic

Johnson & Johnson has made the world’s first single-dose COVID-19 vaccine

This September 2020 photo provided by Johnson & Johnson shows the investigational Janssen COVID-19 vaccine. Johnson & Johnson’s long-awaited COVID-19 vaccine appears to protect against symptomatic illness with just one shot – not as strong as some two-shot rivals but still potentially helpful for a world in dire need of more doses.
This September 2020 photo provided by Johnson & Johnson shows the investigational Janssen COVID-19 vaccine. Johnson & Johnson’s long-awaited COVID-19 vaccine appears to protect against symptomatic illness with just one shot – not as strong as some two-shot rivals but still potentially helpful for a world in dire need of more doses.
Cheryl Gerber, Johnson & Johnson via AP

Johnson & Johnson asked U.S. regulators Thursday to give the all-clear for the world’s first single-dose COVID-19 vaccine, according to The Associated Press.

Specifically, the company will ask the Food and Drug Administration to approve the single-shot vaccine for widespread distribution, which would add it to the collection of vaccines from Moderna and Pfizer, The Associated Press reports.

Dr. Peter Marks, FDA’s vaccine chief, warned the data needs to be reviewed in full before we know if it’s safe or not, according to The Associated Press.

“With so much need to get this pandemic under control, I think we can’t ignore any tool in the tool chest,” he told the American Medical Association last week. “We will have to do our best to try to make sure that we find the populations that benefit the most from each of these vaccines and deploy them in a very thoughtful manner.”

Last week, Johnson & Johnson announced its single-shot coronavirus vaccine was 66% effective against COVID-19.

Johnson & Johnson said the new vaccine was on average 66% effective in protecting against moderate to severe COVID-19 symptoms during Phase 3 trials.

  • The trials were held in eight countries.
  • The vaccine was 72% effective in the U.S. but only 57% in South Africa, which is dealing with a more infectious variant of COVID-19 right now.
  • Johnson & Johnson said the virus prevented 85% of severe infections and 100% of hospitalizations and deaths overall, though.
  • That means that even though symptoms showed up, 85% of the time it stopped severe infections among participants.