My Blog

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

The firm stated 60 cases of a serious however rare blood-clotting condition have been recognized, including nine deaths, out of about 18 million doses administered. The action comes about 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 risks of Johnson & & Johnson’s vaccine versus the benefits, it had actually decided to limit its usage to adults who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “scientifically suitable.” One example would be individuals who experienced an extreme allergy to the other 2 vaccines, the company stated.

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

Johnson & & Johnson was eclipsed long earlier by Pfizer and Moderna in the country’s vaccination campaign; federal officials have stated the mRNA vaccines produced by those business are both much safer and more efficient. In a declaration, Johnson & & Johnson said the F.D.A.’s action reflected the already-known threat of the side result, not brand-new data on the rate at which it occurs. But 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 set off a condition understood as thrombosis with thrombocytopenia syndrome have actually bedeviled it from early on. In April 2021, not long after it was approved for emergency use, federal authorities stopped briefly distribution of the vaccine for a security evaluation. Regulators raised the time out 10 days later on however included a cautioning to guidelines for its use.

In December, the C.D.C. suggested that grownups seeking a booster shot choose Moderna or Pfizer rather of Johnson & & Johnson, citing more benefits and lower threats. Paired with a host of making problems in the United States, some specialists stated, the agency’s judgment showed that the federal government had actually all but 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 disorder– or 4 times as many as were reported when in 2015’s pause in circulation was lifted. In the interim, the number of Johnson & & Johnson dosages administered has somewhat more than doubled, while the variety of Pfizer and Moderna recipients has increased.

The variety of deaths attributed to the disorder triggered by the Johnson & & Johnson’s vaccine does not appear to have actually 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 authorities have actually said.

In its announcement, the F.D.A. pointed out more than 6 cases and near to one death associated to the blood-clotting disorder for every single two million shots of Johnson & & Johnson vaccine administered in the United States.

About 17 million Americans have now gotten one dosage of Johnson & & Johnson’s vaccine, and another 1.5 million have gotten a booster dosage, according to the C.D.C.’s data. By contrast, more than 200 million Americans have actually gotten at least 2 doses of either Moderna’s or Pfizer’s vaccine.

Attempting to cast the tight new limitations in a favorable light, Johnson & & Johnson said: “Data continue to support a favorable benefit-risk profile for the Johnson & & Johnson COVID-19 vaccine in adults, when compared to no vaccine.”