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

The agency said 60 cases of a rare but severe blood-clotting condition have actually been determined, consisting of nine deaths, out of about 18 million dosages administered. The action happens five 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 threats of Johnson & & Johnson’s vaccine versus the advantages, it had decided to limit its usage to adults who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “clinically appropriate.” One example would be people who experienced an extreme allergy to the other two vaccines, the agency stated.

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

Johnson & & Johnson was eclipsed long earlier by Pfizer and Moderna in the country’s vaccination project; federal authorities have said the mRNA vaccines produced by those companies are both more secure and more reliable. In a statement, Johnson & & Johnson stated the F.D.A.’s action showed the already-known risk of the adverse effects, not brand-new information on the rate at which it takes place. But in a sign of the company’s own flagging interest in its vaccine, it has stopped supplying sales outlooks for the shot to financiers.

Reports that the vaccine can activate a condition referred to as apoplexy with thrombocytopenia syndrome have actually bedeviled it from early on. In April 2021, not long after it was authorized for emergency situation use, federal authorities stopped briefly circulation of the vaccine for a safety assessment. Regulators lifted the pause 10 days later but included an alerting to directions for its usage.

Then, in December, the C.D.C. recommended that adults seeking a booster shot choose Moderna or Pfizer instead of Johnson & & Johnson, mentioning more benefits and lower threats. Paired with a host of manufacturing troubles in the United States, some professionals stated, the firm’s judgment highlighted that the federal government had actually all however composed off 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 time out in circulation was raised. In the interim, the number of Johnson & & Johnson doses administered has somewhat more than doubled, while the variety of Pfizer and Moderna recipients has actually escalated.

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

In its announcement, the F.D.A. mentioned more than six cases and near to one death credited to the blood-clotting condition for every 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 data. By comparison, more than 200 million Americans have gotten at least two dosages of either Moderna’s or Pfizer’s vaccine.

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