F.D.A. Expert Panel Endorses Johnson & Johnson’s Vaccine

Johnson & Johnson’s Kovid-19 commentary Friday was backed by a panel of experts advising the Food and Drug Administration, according to two people familiar with the agency’s plans, to clear the last hurdle on Saturday before a formal authorization was expected. The country’s first shipment will leave in the following days.

This would be the third shot made available to the United States in the year since the first increase of coronovirus cases in the country began washing, and would be the first vaccine to require just one dose instead of two.

Johnson & Johnson’s formulation worked well in clinical trials, particularly in spite of severe illness and hospitalization, although it was associated with sky-high efficacy rates of the first two vaccines made by Pfizer-Bayonet and Modern. Did not match.

Panel, Composed of independent infectious disease specialists, statisticians and epidemiologists, voted unanimously in favor of authorizing the vaccine.

“We’re working with an epidemic right now,” Dr. Said Jay Portnoy, Allergy at Children’s Mercy Hospital in Kansas City, MO and a board member. “It’s great that we have this vaccine.”

During Johnson & Johnson’s presentation to the panel, a virologist at Mayo Clinic and a paid external consultant for the company, Dr. Gregory Poland noted the efficacy of the vaccine, ease of use and low rate of side effects. It “checks almost all the boxes,” he said. “To me, it is clear that the known benefits far outweigh the known risks.”

The vaccine had an overall efficacy rate of 72 percent in the United States and 64 percent in South Africa, where the decline has a different form. The shot showed 86 percent efficacy against severe forms of Kovid-19 in the United States and 82 percent against critical illness in South Africa.

They are strong numbers, but lower than the approximately 95 percent efficacy rate of Pfizer-BioNotech and Modern vaccines against mild, moderate, and severe cases of Kovid.

Johnson & Johnson’s vaccine is a single dose and uses one Different types of technology Compared to authorized vaccines. And the scale and size of the Johnson & Johnson test was huge, covering eight countries, three continents, and about 45,000 participants.

Although the vaccine works with one shot, studies are underway to determine whether a second dose will enhance its protective effect.

A pediatrician and one of the panelists of the Children’s Hospital of Philadelphia, Drs. Paul Offit reported on Friday that in early summer clinical trials, Johnson & Johnson found that a second dose had increased levels of coronavirus antibodies. Were Almost three times more Compared to those produced by a single dose alone.

Results from Johnson & Johnson’s two-dose, late-stage clinical trial are not expected until July at the earliest. If those results are better than the single dose, then Drs. Offit asked, “Does this become a two-dose vaccine?”

Dr. Johnson & Johnson’s drug development arm, global head of vaccine research and development at Janssen Pharmaceuticals, Drs. Johan Van Hoof said the company decided to pursue a one-shot strategy after its study on monkeys last spring. The dose was sufficient to provide strong protection against disease.

“It is clear that in the event of an outbreak, in a raging epidemic, the major challenge is to bring the epidemic under control,” he said. “Outbreak is very well positioned to be used in outbreak situations.”

But Dr. Van Hof also mentioned that it would be important to track volunteers who received a dose to see if their immunity changes in the coming months. It may be necessary to give a booster shot for long-term preservation. “The big question mark is still, how long does conservation last?” They said.

After the vote, the FDA told Johnson & Johnson that it would “work towards rapid finalization and issuance of an emergency use authority,” according to a Statement. The FDA also said that it had informed other government agencies “so they can execute their plans for timely vaccine delivery.”

Sharon LaFranier contributed reporting.

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