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WASHINGTON– In yet another obstacle 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, citing safety issues.

The company said 60 cases of a severe however rare blood-clotting condition have been recognized, consisting of 9 deaths, out of about 18 million doses administered. The action comes about 5 months after the Centers for Disease Control and Prevention recommended Moderna’s and Pfizer’s vaccines over Johnson & & Johnson’s for booster shots.

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

It said the vaccine could likewise be provided 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 effective. In a declaration, Johnson & & Johnson stated the F.D.A.’s action reflected the already-known risk of the negative effects, not brand-new information on the rate at which it happens. In an indication of the company’s own flagging interest in its vaccine, it has stopped providing sales outlooks for the shot to investors.

Reports that the vaccine can activate a condition known as apoplexy with thrombocytopenia syndrome have actually bedeviled it from early on. In April 2021, not long after it was authorized for emergency usage, federal authorities stopped briefly distribution of the vaccine for a security assessment. Regulators raised the time out 10 days later on however added an alerting to guidelines for its use.

Then, in December, the C.D.C. suggested that grownups looking for a booster shot select Moderna or Pfizer rather of Johnson & & Johnson, citing more advantages and lower dangers. Paired with a host of manufacturing difficulties in the United States, some professionals said, the firm’s judgment illustrated that the federal government had all however crossed out Johnson & & Johnson’s vaccine.

According to the F.D.A. announcement on Thursday, federal authorities now have 60 reports of the blood-clotting condition– or four times as many as were reported when in 2015’s pause in distribution was raised. In the interim, the variety of Johnson & & Johnson doses administered has somewhat more than doubled, while the number 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 actually increased much, if at all. There have actually been far less, if any, thought deaths due to side effects from the mRNA vaccines, federal health authorities have stated.

In its announcement, the F.D.A. cited more than six cases and near to one death credited 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 actually now gotten one dosage 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 constraints in a favorable light, Johnson & & Johnson said: “Data continue to support a beneficial benefit-risk profile for the Johnson & & Johnson COVID-19 vaccine in grownups, when compared to no vaccine.”