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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 grownups who can not or decline to get the Pfizer-BioNTech or Moderna vaccines, citing safety issues.

The company stated 60 cases of a major however rare blood-clotting condition have actually been recognized, including nine deaths, out of about 18 million doses administered. The action comes about 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. stated that weighing the threats of Johnson & & Johnson’s vaccine versus the advantages, it had chosen to limit its use to adults who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “clinically suitable.” One example would be people who experienced a severe allergy to the other two vaccines, the agency 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 said the mRNA vaccines produced by those companies are both much safer and more effective. In a declaration, Johnson & & Johnson stated the F.D.A.’s action showed the already-known danger of the negative effects, not brand-new data on the rate at which it occurs. However in an indication of the company’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 apoplexy with thrombocytopenia syndrome have bedeviled it from early on. In April 2021, not long after it was approved for emergency situation use, federal authorities stopped briefly circulation of the vaccine for a security examination. Regulators raised the time out 10 days later however included an alerting to directions for its usage.

In December, the C.D.C. advised that adults seeking a booster shot pick Moderna or Pfizer rather of Johnson & & Johnson, mentioning more benefits and lower threats. Combined with a host of making difficulties in the United States, some specialists stated, the firm’s judgment highlighted 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 four times as numerous as were reported when in 2015’s time out in circulation was lifted. In the interim, the variety of Johnson & & Johnson doses administered has slightly more than doubled, while the number of Pfizer and Moderna recipients has increased.

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 been far less, if any, presumed deaths due to side results from the mRNA vaccines, federal health officials have stated.

In its statement, the F.D.A. pointed out more than 6 cases and near one death credited to the blood-clotting condition for each two million shots of Johnson & & Johnson vaccine administered in the United States.

About 17 million Americans have actually 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 doses of either Moderna’s or Pfizer’s vaccine.

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