J&J vax gets emergency OK
Johnson & Johnson’s single-shot coronavirus vaccine has been recommended for emergency use authorization by an independent advisory committee, setting it up to get the green light from the FDA and mark the third vaccine available in the United States.
“We are still in the midst of a deadly pandemic, there is a shortage of vaccines that are currently authorized and I think authorization of this vaccine will help meet the needs at the moment,” said vax panel member Dr. Archana Chatterjee of the Chicago Medical School.
The 22 members of the Vaccines and Related Biological Products Advisory Committee, which met all day on Friday voted unanimously in favor of recommending the EUA, advice that the Food and Drug Administration does not have to take but often does.
By comparison, Moderna’s vaccine was recommended 20-0 with one abstention and the committee voted 17-4 with one abstention in favor Pfizer’s vaccine.
Dr. Eric Rubin, editor-inchief of the New England Journal of Medicine said the decision was a “relatively easy call” and like many other committee members, noted the huge demand for the vaccine.
Panel member Dr. Jay Portnoy said, “There’s an urgency to get this done. We’re in a race between the virus mutating new variants coming out that can cause further disease.”
If the FDA does take the recommendation and issues an EUA, White House officials said three to four million doses will be ready to ship out starting next week.
Both Moderna and Pfizer vaccines were granted authorization mere hours following the recommendation from the advisory committee.
The Johnson & Johnson vaccine, which operates on an adenovirus vector platform and does not require ultra-cold storage, was found to be 66% effective in reducing moderate to severe coronavirus and 85% effective against the most serious illness.
Most common side effects of the vaccine include injection site pain, headache, fatigue and muscle aches. One case of severe allergic reaction has been reported in a Johnson & Johnson patient from South Africa, Macaya Douoguih of Janssen told the committee.
The J&J vaccine is also the first to have been tested as variants circulate. The FDA cautioned it’s not clear how well the vaccine works against each variant, but there was slightly lower efficacy against moderate to critical disease observed in South Africa where a mutant is now the predominant strain.
The sprawling Friday VRBPAC meeting included presentations from the FDA, CDC, Johnson & Johnson and robust public comment during which most people were supportive of the EUA and asked for more follow up of trial participants, more data on vaccination in pregnant women and impacts in communities of color.
One of the biggest topics of discussion among the committee members was regarding the one-dose status of the vaccine.
The third vaccine would provide yet another lifeline to the United States as the country tries to finally free itself from the grips of the pandemic.