The FDA panel, known as the Advisory Committee on Vaccines and Related Biologics, will vote on the merits of the shot on Friday; the agency is not bound by the group’s recommendations but often follows them.
But despite signs that the panel will vote in favor of the J&J vaccine, questions remain about its effectiveness in older people with common health problems.
The company’s limited data on how the vaccine protects people over age 60 with risk factors – conditions such as obesity, heart problems, and diabetes – suggests the vaccine would only be effective for years. ‘about 42% in this group. The FDA and the manufacturer say sparse data could skew these results, and the shot could prove to be more effective after additional data is collected.
Blood clots are also a concern in people who have received the vaccine, although most of them had health problems. J&J insists there is no connection to the shooting, but the FDA has said it’s worth monitoring how often blood clots occur in the wider population for answers solid on what happened to these people, including a 25-year-old with no previous medical condition.
These questions could set the vaccine up for more limited use than its predecessors from Pfizer / BioNTech and Moderna. Both of these vaccines – based on messenger RNA technology – are licensed for adults of all ages, without serious concern for side effects.
The J&J vaccine uses a different technique that relies on a modified adenovirus to pump harmless copies of the spike protein that the coronavirus uses to attach itself to cells.
Data on 193,000 people who have received other J&J vaccines made with the same technology – such as an approved Ebola vaccine – suggests that it should be safe in the elderly, pregnant women, and people with diseases like HIV / AIDS, said Johan Van Hoof, Global Therapeutics Head For These Types Of Vaccines At J&J Pharmaceutical Unit, Janssen, At The FDA Meeting.
Vaccine experts and healthcare providers insist the J&J vaccine could play a key role in reducing hospitalizations and deaths from Covid-19. Although the vaccine is less effective than its licensed peers in preventing infection overall – and significantly less effective against B.1.351, the variant first found in South Africa – it is extremely effective in curbing serious disease.
J&J executives are keen to stress this advantage.
“It’s about the fear of getting really sick and getting sick enough to see a doctor, and to the point where one might need to go to the hospital or even die,” said Mathai Mammen, Global Head of Research and Development at Janssen. a call to investors in January. “Success against serious illness is by far the most important characteristic from a public health point of view.”
Experts on the FDA panel seem to largely agree that this is a key benefit – to the point that it could even be seen as a primary goal, or an end point, in vaccine trials with the goal. current to prove broader protection.
“All vaccines appear to be equally effective in preventing very serious illness, intensive care needs and death. Did the FDA consider that perhaps a different endpoint should be considered for granting a [emergency use authorization] in the future? ”asked Cody Meissner, panel member and director of pediatric diseases at Tufts University School of Medicine. An FDA representative said the agency’s expectations had not changed .