Newsman: The Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of recommending Johnson & Johnson’s Covid-19 vaccine authorization from the Food and Drug Administration today. An independent advisory panel to the Food and Drug Administration VRBPAC members voted Friday to recommend that the agency authorize emergency use of Johnson & Johnson’s Covid-19 vaccine for people 18 years and older.,
White House’s senior advisor on COVID-19 response & a top infectious disease experts Anthony Fauci said he’s looking forward to the FDA review of the J&J vaccine but suggested its authorization is a foregone conclusion.
“We now have three highly effective vaccines. Importantly, each of them are very effective against severe disease and virtually all have them say that you look at the data and it’s clear that you get essentially no hospitalizations, or deaths. And this is very good news,” he said in a briefing with reporters on Friday.
The FDA is not required to go along with the committee’s recommendation, but is widely expected to, and could possibly issue an emergency use authorization as soon as Friday evening or Saturday. It would be the third Covid-19 Johnson & Johnson’s vaccine, made in partnership with Janssen Pharmaceuticals, is a single shot and can be stored for three months at normal refrigeration temperatures.
Among study participants in South Africa, where a new variant has been spreading, efficacy was found to be 64 percent for moderate to severe disease. Previously released results from Phase 3 clinical trials showed the vaccine to be safe, and able to reduce moderate to severe outcomes from Covid-19 by about 72 percent in the U.S.The effectiveness increased to more than 85 percent when researchers looked only at severe outcomes.
Zero Covid-related deaths or hospitalizations were reported among study participants within a month of receiving the vaccine. This suggests the vaccine may be able to turn Covid-19 from a potentially severe or deadly viral illness, to one that can be managed largely from home.
Though Johnson & Johnson studied its vaccine as a one-dose regimen in its Phase 3 clinical trials, studies of whether a second dose would be safe and boost effectiveness are ongoing.
The Johnson & Johnson vaccine differs from the vaccines from the Moderna and Pfizer vaccines in how it works. It uses an inactivated virus, called an adenovirus, to teach the immune system to be on alert for SARS-CoV-2. The other vaccines also work to educate the immune system, but use a different lesson plan: genetic material called messenger RNA, or mRNA.
