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WASHINGTON– In yet another setback for Johnson & & Johnson’s coronavirus vaccine, the Food and Drug Administration on Thursday limited its use to grownups who can not or decline to get the Pfizer-BioNTech or Moderna vaccines, pointing out security issues.

The company stated 60 cases of a severe but rare blood-clotting disorder have actually been recognized, including nine deaths, out of about 18 million dosages administered. The action happens 5 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 dangers of Johnson & & Johnson’s vaccine versus the benefits, it had actually decided to restrict its usage to adults who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “medically proper.” One example would be people who experienced an extreme allergic reaction to the other two vaccines, the agency said.

It stated the vaccine might likewise be offered to adults who “would otherwise not receive a Covid-19 vaccine.”

Johnson & & Johnson was eclipsed long back by Pfizer and Moderna in the nation’s vaccination campaign; federal officials have said the mRNA vaccines produced by those business are both safer and more reliable. In a statement, Johnson & & Johnson said the F.D.A.’s action reflected the already-known threat of the negative effects, not brand-new information on the rate at which it takes place. In a sign of the firm’s own flagging interest in its vaccine, it has stopped providing sales outlooks for the shot to financiers.

Reports that the vaccine can trigger a condition understood as apoplexy with thrombocytopenia syndrome have actually bedeviled it from early on. In April 2021, not long after it was approved for emergency use, federal authorities paused distribution of the vaccine for a safety evaluation. Regulators raised the time out 10 days later but included a cautioning to guidelines for its usage.

Then, in December, the C.D.C. advised that adults seeking a booster shot choose Moderna or Pfizer instead of Johnson & & Johnson, citing more benefits and lower risks. Coupled with a host of making troubles in the United States, some professionals stated, the company’s judgment illustrated that the federal government had all however crossed out 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 four times as numerous as were reported when last year’s time out in circulation was raised. In the interim, the variety of Johnson & & Johnson dosages administered has somewhat more than doubled, while the variety of Pfizer and Moderna recipients has actually increased.

The number of deaths credited to the condition set off by the Johnson & & Johnson’s vaccine does not appear to have risen much, if at all. However there have been far fewer, if any, suspected deaths due to negative effects from the mRNA vaccines, federal health authorities have stated.

In its statement, the F.D.A. cited more than six 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 actually 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 comparison, more than 200 million Americans have actually gotten at least 2 doses of either Moderna’s or Pfizer’s vaccine.

Trying to cast the tight new restrictions in a favorable 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.”