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WASHINGTON– In yet another problem for Johnson & & Johnson’s coronavirus vaccine, the Food and Drug Administration on Thursday limited its usage to grownups who can not or refuse to get the Pfizer-BioNTech or Moderna vaccines, mentioning safety issues.

The company stated 60 cases of a severe however rare blood-clotting disorder have been identified, including nine deaths, out of about 18 million doses administered. The action comes about five months after the Centers for Disease Control and Prevention advised Moderna’s and Pfizer’s vaccines over Johnson & & Johnson’s for booster shots.

The F.D.A. stated that weighing the risks of Johnson & & Johnson’s vaccine against the advantages, it had decided to limit its use to grownups who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “medically suitable.” One example would be individuals who experienced a severe allergic reaction to the other two vaccines, the agency stated.

It stated the vaccine could also be provided to grownups who “would otherwise not receive a Covid-19 vaccine.”

Johnson & & Johnson was eclipsed long back by Pfizer and Moderna in the country’s vaccination campaign; federal authorities have stated the mRNA vaccines produced by those companies are both safer and more reliable. In a declaration, Johnson & & Johnson said the F.D.A.’s action reflected the already-known danger of the adverse effects, not brand-new data on the rate at which it happens. However in an indication of the company’s own flagging interest in its vaccine, it has stopped offering sales outlooks for the shot to investors.

Reports that the vaccine can trigger a condition called apoplexy with thrombocytopenia syndrome have bedeviled it from early on. In April 2021, not long after it was authorized for emergency situation usage, federal authorities paused circulation of the vaccine for a safety evaluation. Regulators raised the pause 10 days later but included an alerting to instructions for its usage.

Then, in December, the C.D.C. suggested that grownups seeking a booster shot choose Moderna or Pfizer instead of Johnson & & Johnson, pointing out more advantages and lower risks. Combined with a host of manufacturing troubles in the United States, some professionals stated, the agency’s judgment showed that the federal government had actually all however written off Johnson & & Johnson’s vaccine.

According to the F.D.A. statement on Thursday, federal authorities now have 60 reports of the blood-clotting condition– or 4 times as lots of as were reported when last year’s pause in circulation was raised. In the interim, the variety of Johnson & & Johnson dosages administered has a little more than doubled, while the variety of Pfizer and Moderna recipients has actually escalated.

The number of deaths associated to the disorder set off by the Johnson & & Johnson’s vaccine does not appear to have risen much, if at all. There have been far fewer, if any, believed deaths due to side impacts from the mRNA vaccines, federal health officials have actually stated.

In its statement, the F.D.A. mentioned more than 6 cases and close to one death credited to the blood-clotting condition for each two million shots of Johnson & & Johnson vaccine administered in the United States.

About 17 million Americans have now gotten one dose of Johnson & & Johnson’s vaccine, and another 1.5 million have gotten a booster dose, according to the C.D.C.’s information. By contrast, more than 200 million Americans have actually gotten at least two dosages of either Moderna’s or Pfizer’s vaccine.

Trying to cast the tight brand-new limitations in a positive light, Johnson & & Johnson stated: “Data continue to support a favorable benefit-risk profile for the Johnson & & Johnson COVID-19 vaccine in grownups, when compared to no vaccine.”