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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, pointing out safety issues.

The agency stated 60 cases of a uncommon however major blood-clotting condition have actually been determined, consisting of nine deaths, out of about 18 million doses administered. The action happens 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 against the benefits, it had actually decided to restrict 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 2 vaccines, the company said.

It stated the vaccine could likewise be given 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 project; federal authorities have stated the mRNA vaccines produced by those companies are both much safer and more reliable. In a declaration, Johnson & & Johnson stated the F.D.A.’s action reflected the already-known threat of the negative effects, not new data on the rate at which it happens. In a sign of the firm’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 called apoplexy with thrombocytopenia syndrome have actually bedeviled it from early on. In April 2021, not long after it was approved for emergency usage, federal authorities stopped briefly circulation of the vaccine for a security evaluation. Regulators raised the pause 10 days later on but included an alerting to instructions for its usage.

In December, the C.D.C. recommended that grownups looking for a booster shot select Moderna or Pfizer rather of Johnson & & Johnson, mentioning more benefits and lower dangers. Combined with a host of producing troubles in the United States, some specialists said, the firm’s judgment showed that the federal government had 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 condition– 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 slightly more than doubled, while the variety of Pfizer and Moderna receivers has actually increased.

The number of deaths associated to the condition triggered by the Johnson & & Johnson’s vaccine does not appear to have increased much, if at all. But there have actually been far fewer, if any, believed deaths due to adverse effects from the mRNA vaccines, federal health officials have actually said.

In its announcement, the F.D.A. pointed out more than six cases and near to 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 actually 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 dosages of either Moderna’s or Pfizer’s vaccine.

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