The FDA panel, known as the Advisory Committee on Vaccines and Related Biological Products, will vote Friday on the merits of the shot; the agency is not bound by the group’s recommendations, but follows them regularly.
But despite signs that the panel will vote in favor of the J&J vaccine, there are still questions about its effectiveness in older people with general health problems.
The company’s limited data on how well the vaccine protects people over the age of 60 with risk factors – conditions such as obesity, heart problems and diabetes – suggests that the shot can only be effective in about 42 percent of the group. Both the FDA and the manufacturer say that the sparse data can skew the results and that the survey can be more effective after additional data has been collected.
There are also concerns about blood clots in people who have received the vaccine, although most of them have had health conditions in the past. J&J maintains that there is no connection to the shot, but the FDA said it was worth monitoring how often blood clots occur in the wider population to get good answers about what happened to those people, including ‘ a 25-year-old without medical conditions.
These questions may use the vaccine more limitedly than the predecessors of Pfizer / BioNTech and Moderna. Both vaccines, based on messenger RNA technology, are purified for adults of all ages, without serious concern about side effects.
The J&J vaccine uses another technique that relies on an adenovirus that is adapted to pump out harmful copies of the vein protein that the coronavirus uses to attach to cells.
Data on 193,000 people who have received other J&J vaccines made with the same technology – such as an approved Ebola shot – suggest that it should be safe in the elderly, pregnant women and people with conditions such as HIV / Aids. Johan Van Hoof, global therapeutic, said. go for this type of vaccine at the pharmaceutical unit Janssen of J&J, during the FDA meeting.
Vaccination experts and healthcare providers insist the J&J shot could play a key role in limiting hospitalizations and deaths on Covid-19. Although the vaccine is less effective than its authorized counterparts in preventing infection in general – and significantly less effective against B.1.351, the variant first found in South Africa – it is very effective in controlling serious diseases. keep.
J&J executives would like to emphasize this benefit.
“It’s all about the fear of getting really sick and getting sick enough to get medical help, and to the point where you might have to go to the hospital or even die,” said Mathai Mammen, Janssen’s worldwide researcher. and head of development, over an investor call in January. “Success against serious diseases is by far the most important feature from the point of view of public health.”
Experts from the FDA panel seem to largely agree that this is a major benefit – to the point that it can even be considered a primary goal, or endpoint, in vaccine trials, coupled with the current goal of broader protection proof.
‘All the vaccines seem to be equally effective in preventing very serious diseases, intensive care needs and death. Does the FDA consider that perhaps a different endpoint should be considered in terms of granting a [emergency use authorization] in the future? “asks Cody Meissner, a panel member and director of pediatric diseases at Tufts University School of Medicine. An FDA representative said the agency’s expectations have not changed.