The FDA, the Johnson & Johnson vaccine review body, says it has important benefits


The FDA, known as the Advisory Committee on Vaccines and Related Biological Products, will vote on the merits of the shot on Friday; the agency is not bound by the group’s recommendations, but often adheres to them.

But despite the indication that the board will vote in favor of the J&J vaccine, questions remain about its effectiveness in older people who have general health problems.

The company’s limited data on how the vaccine protects people over the age of 60 with risk factors such as obesity, heart problems and diabetes suggests that the shot may be only about 42 percent effective in this group. Both the FDA and the manufacturer believe that sparse data may skew these results, and recording may prove more effective once additional data has been collected.

Blood clots in people receiving the vaccine are also a cause for concern, although most of them had a medical condition in the past. J&J insists there is no attachment to the shot, but the FDA says it is worth monitoring how often blood clots occur in the wider population to get solid answers about what happened to such people, including a 25-year-old without prior medical condition. .

These issues may have a more limited use of the vaccine than their predecessors Pfizer / BioNTech and Moderna. Both vaccines, based on messenger RNA technology, are being deleted for adults of all ages without serious concerns about side effects.

The J&J vaccine uses another technique that relies on an adenovirus that modifies the pumping of harmless copies of the spike protein that the coronavirus attaches to the cells.

Data from 193,000 people who have received other J&J vaccines using the same technology, such as an approved Ebola shot, suggest it should be safe for the elderly, pregnant women and people like HIV / AIDS, said Johan Van Hoof. global therapeutic therapy for these types of vaccines turns to J&J Janssen’s pharmaceutical unit at an FDA meeting.

Vaccination experts and health care providers insist that the J&J shot could play a key role in curbing hospital care and mortality for Covid-19. While the vaccine is less effective than its authorized counterparts, it is extremely effective in controlling serious diseases in its broad prevention of infections – and significantly less effective against B.1.351, the first version found in South Africa.

J&J executives are happy to emphasize this advantage.

“This fear of actually getting sick and getting quite ill could potentially turn to a doctor and go so far as to possibly go to the hospital or even die,” said Mathai Mammen, Janssen’s global head of research and development. investor call in January. “Success against a serious illness is by far the most important characteristic from a public health perspective.”

Experts from the FDA seem to agree that this is a key advantage – insofar as it can be considered a primary goal or endpoint in vaccine trials, in addition to the current goal, to demonstrate broader protection.

“All vaccines appear to be equally effective in preventing very serious illness, intensive care and death. The FDA thought that another endpoint might need to be considered [emergency use authorization] in the future? “asked Cody Meissner, a panel member and director of pediatrics at Tufts University School of Medicine. The FDA spokesman said the agency’s expectations have not changed.