The US Food and Drug Administration authorized Johnson & Johnson’s Covid-19 vaccine Saturday. It is the first single-dose Covid-19 vaccine available in the US and is one that “checks nearly all the boxes.”
With more than 28.5 million confirmed Covid-19 cases and over 511,000 reported deaths in the US since the start of the pandemic, and while the demand for vaccines still far exceeds supply, these vaccines can’t come soon enough.
“A third safe and effective vaccine is very welcome news,” Andy Slavitt, the White House’s senior for Covid Response, tweeted on Friday.
The vaccine, made by Janssen, J&J’s vaccine arm, is safe and effective, and it’s considered flexible. It’s a single dose, and it doesn’t require special storage.
The vaccine is authorized for people ages 18 and older.
“We need a vaccine that can be quickly mass-produced,” Dr. Greg Poland, head of the Mayo Clinic’s Vaccine Research Group, said Friday. “We’d want to see a reasonable duration of efficacy and protection.
“The Janssen vaccine candidate checks nearly all the boxes.”
The vaccine was tested in more than 44,000 people in the US, South Africa, and Latin America.
“One dose will keep you out of the hospital, keep you out of the intensive care unit, and keep you out of the morgue,” Dr. Paul Offit, a vaccine adviser to the FDA, told CNN’s Wolf Blitzer on Friday.
The vaccine comes with few side effects, most of which are mild, including pain at the injection site, headache, fatigue, and muscle pain.
Overall, according to the FDA’s analysis, non-fatal serious adverse events were infrequent, and there were no reported cases of anaphylaxis following vaccination in the trial. There have been a small number of severe allergic reactions with the Moderna and Pfizer/BioNTech vaccines. For example, in the first week of the Pfizer vaccine rollout, there were only 29 cases out of 1.9 million doses administered.
More research is needed, but the FDA analysis also hinted that the J&J vaccine might help prevent asymptomatic infections.