Posted: Friday, February 26, 2021. 7:22 pm CST.
By Aaron Humes: Johnson & Johnson’s COVID-19 vaccine is on the road to approval by U.S. regulators, the first such shot to work in a single dose, reports Bloomberg.
The vaccine was 72% effective in the U.S.-based portion of a global study that enrolled more than 43,000 people, Food and Drug Administration (FDA) staff wrote in a document that summarized the company’s results and confirmed findings released earlier this month.
The shot was highly effective against severe disease in all regions where it was tested and worked better against mutant coronavirus strains than previously reported, the document showed.
There were no Covid-related deaths among people who received the vaccine in the trial, the FDA staff wrote in their analysis, and no safety concerns that would preclude an emergency-use authorization. The agency lacked data to determine whether the vaccine prevented asymptomatic cases, the report said.
Agency officials prepared the document ahead of a meeting today, Friday, where a committee of external advisers will make a nonbinding recommendation as to whether the vaccine should be authorized. The committee is expected to discuss the effect of COVID-19 variants at length.
If the Johnson and Johnson vaccine is quickly authorized after the advisory panel meeting, as the other two vaccines were, the company will initially be able to provide 3 million to 4 million doses next week, a Biden administration official said, short of the initially promised 12 million by the end of February.
Unlike the Moderna and Pfizer-BioNTech vaccines that require two doses given three to four weeks apart and must be frozen, Johnson and Johnson’s single shot can be stored at refrigerator temperatures for as long as three months. It’s made from a cold virus that doesn’t replicate but helps the body develop an immune response and prepare for a COVID-19 infection.
The most frequent side effects included fever, fatigue, headache, muscle pain, and injection-site pain, FDA staff wrote. One serious hypersensitivity reaction that began two days after vaccination was likely related to the shot, the FDA said.
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