J&J one-shot vax safe, effective, FDA says

Johnson & Johnson’s single-dose coronavirus vaccine was found to be safe and 85% effective in preventing severe disease by the FDA setting up a potential emergency use authorization at the end of the week.

“The analysis supported a favorable safety profile with no specific safety concerns identified that would preclude issuance of an EUA,” reads the 62-page briefing document from the Food and Drug Administration.

The one-shot vaccine, which operates on an adenovirus platform different than the mRNA platforms of Pfizer and Moderna vaccines, is about 66% effective at preventing moderate to severe COVID-19 and about 85% effective against the most serious illness.

The most common side effects from the Johnson & Johnson vaccine are injection site pain, headache, fatigue and muscle aches, according to the report.

The vaccine is also the first to provide a look into its effectiveness against coronavirus variants.

The shot was tested in the U.S., Latin America and South Africa where different mutations are circulating, and while the FDA analysis cautioned it’s not clear how well the vaccine works against each variant, there was slightly lower efficacy against moderate to critical disease observed in South Africa where a mutant is now the predominant strain.

Iain MacLeod CEO of Aldatu Biosciences in Watertown and research fellow in the department of immunology and infectious diseases at Harvard called the FDA briefing a “glowing report card.”

“The important part is the fact that it’s phenomenally good at preventing severe disease,” MacLeod said.

The vaccine data will be scrutinized on Friday by the independent Vaccines and Related Biological Products Advisory Committee which will decide whether or not to recommend it for emergency use authorization. Four Boston doctors are on the committee.

If recommended, the FDA could issue an EUA as quickly as hours afterwards.

Jeff Zients, head of the White House COVID-19 Response Team said Wednesday if the EUA is granted, “we are ready to roll out this vaccine without delay” and three to four million doses will be allocated to states as soon as next week.

“The prospect of a potential third approved vaccine is very encouraging and will help to increase the overall vaccine supply,” Zients said.

AP ONE AND DONE: Vials of Johnson & Johnson’s Janssen COVID-19 vaccine are seen. The vaccine, unlike the first two to be approved to fight coronavirus, works with a single shot, rather than two.