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

The agency said 60 cases of a severe however rare blood-clotting disorder have been determined, including 9 deaths, out of about 18 million doses administered. The action happens 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 threats of Johnson & & Johnson’s vaccine against the benefits, it had actually decided to limit its use to adults who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “clinically proper.” One example would be people who experienced a severe allergic response to the other 2 vaccines, the firm said.

It said the vaccine could 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 country’s vaccination campaign; federal authorities have said the mRNA vaccines produced by those companies are both safer and more effective. In a declaration, Johnson & & Johnson stated the F.D.A.’s action reflected the already-known danger of the negative effects, not brand-new information on the rate at which it happens. In an indication 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 activate a condition known as apoplexy with thrombocytopenia syndrome have 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 security examination. Regulators lifted the time out 10 days later on however added a cautioning to instructions for its usage.

Then, in December, the C.D.C. suggested that grownups seeking a booster shot choose Moderna or Pfizer rather of Johnson & & Johnson, pointing out more advantages and lower dangers. Combined with a host of manufacturing difficulties in the United States, some specialists stated, the firm’s judgment highlighted that the federal government had actually all but written off Johnson & & Johnson’s vaccine.

According to the F.D.A. announcement on Thursday, federal authorities now have 60 reports of the blood-clotting disorder– or four times as lots of as were reported when last year’s time out in circulation was lifted. In the interim, the number of Johnson & & Johnson dosages administered has a little more than doubled, while the variety of Pfizer and Moderna receivers has actually escalated.

The variety of deaths attributed to the disorder set off by the Johnson & & Johnson’s vaccine does not appear to have increased much, if at all. There have actually been far fewer, if any, thought deaths due to side effects from the mRNA vaccines, federal health officials have stated.

In its statement, the F.D.A. cited more than six cases and close to one death credited to the blood-clotting disorder for every single 2 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 actually gotten a booster dose, according to the C.D.C.’s information. By comparison, 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 said: “Data continue to support a beneficial benefit-risk profile for the Johnson & & Johnson COVID-19 vaccine in adults, when compared to no vaccine.”