The FDA panel, known as the Vaccine and Related Biological Products Advisory Committee, will vote on Friday on the merits of the injection; 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, doubts remain about its effectiveness in older people with some common health problems.
The company’s limited data on how well the vaccine protects people over 60 with risk factors – conditions like obesity, heart problems and diabetes – suggest that the injection may be only about 42 percent effective in that group. Both the FDA and the manufacturer say the sparse data can distort these results and the injection can become more effective after additional data is collected.
There are also concerns about blood clots in people who received the vaccine, although most of them had previous health problems. J&J insists there is no connection to the injection, but the FDA said it is worth monitoring how often blood clots occur in the general population to get solid answers about what happened to these people, including a 25-year-old. without previous medical conditions.
These issues may set the vaccine up for more limited use than its predecessors to Pfizer / BioNTech and Moderna. Both vaccines – based on messenger RNA technology – are released to adults of all ages, without serious concerns about 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 to cells.
Data from 193,000 people who received other J&J vaccines made with the same technology – such as an approved Ebola vaccine – suggests that it should be safe for the elderly, pregnant women and people with illnesses like HIV / AIDS, said Johan Van Hoof, head of global therapy. for these types of vaccines at the J&J pharmaceutical unit, Janssen, at the FDA meeting.
Vaccine experts and healthcare professionals insist that the J&J injection can play a key role in reducing Covid-19 hospitalizations and deaths. Although the vaccine is less effective than its authorized peers in preventing infection broadly – and significantly less effective against B.1.351, the variant found for the first time in South Africa – it is extremely effective in reducing serious illnesses.
J&J executives are keen to emphasize this advantage.
“It’s all about the fear of getting really sick and getting sick enough to seek medical attention, and to the point of needing to go to the hospital or even die,” said Mathai Mammen, head of global research and development at Janssen, in a call. in January. “Success against serious illnesses is by far the most important characteristic from the point of view of public health.”
The FDA panel experts seem to agree widely that this is a key benefit – to the point that it could even be considered a primary goal, or end point, in vaccine testing, along with the current goal of proving broader protection.
“All vaccines appear to be equally effective in preventing very serious illnesses, intensive care needs and death. The FDA considered that perhaps a different end point should be considered in terms of granting a [emergency use authorization] in the future? “asked Cody Meissner, panelist and director of pediatric diseases at Tufts University School of Medicine. An FDA representative said the agency’s expectations have not changed.