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

The company said 60 cases of a severe but rare blood-clotting disorder have been identified, consisting of nine deaths, out of about 18 million doses 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. said that weighing the dangers of Johnson & & Johnson’s vaccine versus the advantages, it had decided to limit its use to grownups who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “medically suitable.” One example would be people who experienced an extreme allergy to the other two vaccines, the agency stated.

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

Johnson & & Johnson was eclipsed long earlier by Pfizer and Moderna in the country’s vaccination project; federal officials have said the mRNA vaccines produced by those business are both more secure and more effective. In a declaration, Johnson & & Johnson stated 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 offering sales outlooks for the shot to investors.

Reports that the vaccine can trigger a condition called thrombosis with thrombocytopenia syndrome have actually bedeviled it from early on. In April 2021, not long after it was approved for emergency situation usage, federal authorities paused distribution of the vaccine for a safety evaluation. Regulators lifted the time out 10 days later but added a cautioning to guidelines for its use.

Then, in December, the C.D.C. suggested that grownups seeking a booster shot select Moderna or Pfizer instead of Johnson & & Johnson, citing more advantages and lower risks. Paired with a host of producing troubles in the United States, some professionals said, the company’s judgment highlighted that the federal government had actually 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 disorder– or four times as many as were reported when in 2015’s time out in distribution was raised. In the interim, the variety of Johnson & & Johnson dosages administered has a little more than doubled, while the number of Pfizer and Moderna receivers has actually skyrocketed.

The number of deaths associated to the disorder set off by the Johnson & & Johnson’s vaccine does not appear to have actually risen much, if at all. There have been far fewer, if any, believed deaths due to side effects from the mRNA vaccines, federal health officials have stated.

In its announcement, the F.D.A. pointed out more than 6 cases and near to one death associated to the blood-clotting disorder for every 2 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 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 constraints 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 to no vaccine.”