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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 refuse to get the Pfizer-BioNTech or Moderna vaccines, citing safety concerns.

The agency stated 60 cases of a rare however serious blood-clotting condition have been recognized, consisting of nine deaths, out of about 18 million dosages 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. stated that weighing the risks of Johnson & & Johnson’s vaccine versus the advantages, it had actually chosen to limit its use to grownups 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 response to the other two vaccines, the agency stated.

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

Johnson & & Johnson was eclipsed long ago by Pfizer and Moderna in the country’s vaccination project; 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 data on the rate at which it occurs. However in a sign of the company’s own flagging interest in its vaccine, it has stopped supplying sales outlooks for the shot to investors.

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 authorized for emergency usage, federal authorities stopped briefly circulation of the vaccine for a security examination. Regulators lifted the pause 10 days later on but included a cautioning to guidelines for its use.

In December, the C.D.C. recommended that adults seeking a booster shot pick Moderna or Pfizer rather of Johnson & & Johnson, mentioning more benefits and lower dangers. Combined with a host of producing difficulties in the United States, some specialists said, the company’s judgment showed 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 4 times as lots of as were reported when last year’s time out in distribution was lifted. In the interim, the number of Johnson & & Johnson doses administered has somewhat more than doubled, while the number of Pfizer and Moderna recipients has escalated.

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. But there have actually been far fewer, if any, thought deaths due to negative effects from the mRNA vaccines, federal health authorities have stated.

In its statement, the F.D.A. mentioned more than six cases and near one death credited to the blood-clotting condition for each 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 gotten a booster dosage, according to the C.D.C.’s information. By comparison, more than 200 million Americans have gotten at least 2 dosages of either Moderna’s or Pfizer’s vaccine.

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