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WASHINGTON– In yet another problem for Johnson & & Johnson’s coronavirus vaccine, the Food and Drug Administration on Thursday restricted its use to adults who can not or refuse to get the Pfizer-BioNTech or Moderna vaccines, pointing out security issues.

The company said 60 cases of a uncommon however severe blood-clotting disorder have actually been determined, including nine deaths, out of about 18 million dosages 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 dangers of Johnson & & Johnson’s vaccine against the advantages, it had actually chosen to restrict its use to grownups who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “clinically proper.” One example would be individuals who experienced an extreme allergic reaction to the other two vaccines, the firm stated.

It said the vaccine could likewise be offered 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 authorities have said the mRNA vaccines produced by those companies are both more secure and more efficient. In a declaration, Johnson & & Johnson said the F.D.A.’s action showed the already-known danger of the side impact, not new data on the rate at which it takes place. 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 referred to as thrombosis with thrombocytopenia syndrome have actually bedeviled it from early on. In April 2021, not long after it was approved for emergency usage, federal authorities paused distribution of the vaccine for a safety assessment. Regulators raised the time out 10 days later on but included an alerting to guidelines for its usage.

In December, the C.D.C. advised that grownups seeking a booster shot choose Moderna or Pfizer instead of Johnson & & Johnson, citing more benefits and lower risks. Combined with a host of producing problems in the United States, some specialists said, the agency’s judgment showed that the federal government had actually all but written off 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 four 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 slightly more than doubled, while the number of Pfizer and Moderna recipients has skyrocketed.

The variety of deaths associated to the condition activated by the Johnson & & Johnson’s vaccine does not appear to have risen much, if at all. There have been far fewer, if any, believed deaths due to side impacts from the mRNA vaccines, federal health officials 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 dose of Johnson & & Johnson’s vaccine, and another 1.5 million have gotten a booster dosage, according to the C.D.C.’s data. By comparison, more than 200 million Americans have actually gotten at least two dosages of either Moderna’s or Pfizer’s vaccine.

Trying to cast the tight 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.”