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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, pointing out safety concerns.

The company stated 60 cases of a unusual but severe blood-clotting condition have been identified, including nine deaths, out of about 18 million dosages administered. The action comes about 5 months after the Centers for Disease Control and Prevention suggested Moderna’s and Pfizer’s vaccines over Johnson & & Johnson’s for booster shots.

The F.D.A. said that weighing the threats of Johnson & & Johnson’s vaccine versus the advantages, it had actually chosen to restrict 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 2 vaccines, the firm said.

It said the vaccine might likewise be provided to grownups who “would otherwise not receive a Covid-19 vaccine.”

Johnson & & Johnson was eclipsed long earlier by Pfizer and Moderna in the nation’s vaccination campaign; federal authorities have stated the mRNA vaccines produced by those business are both more secure and more reliable. In a declaration, Johnson & & Johnson stated the F.D.A.’s action showed the already-known threat of the side effect, not brand-new information on the rate at which it happens. But 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 activate a condition called thrombosis 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 distribution of the vaccine for a security examination. Regulators raised the time out 10 days later but added a warning to guidelines for its usage.

Then, in December, the C.D.C. suggested that adults seeking a booster shot select Moderna or Pfizer instead of Johnson & & Johnson, pointing out more benefits and lower dangers. Coupled with a host of producing problems in the United States, some professionals stated, the agency’s judgment showed that the federal government had actually all but 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 many as were reported when in 2015’s time out in distribution 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 variety of deaths credited to the condition activated by the Johnson & & Johnson’s vaccine does not appear to have risen much, if at all. There have been far less, if any, presumed deaths due to side effects from the mRNA vaccines, federal health authorities have actually stated.

In its announcement, the F.D.A. cited more than 6 cases and near to one death associated to the blood-clotting condition for every single two million shots of Johnson & & Johnson vaccine administered in the United States.

About 17 million Americans have actually now gotten one dosage of Johnson & & Johnson’s vaccine, and another 1.5 million have actually gotten a booster dose, according to the C.D.C.’s information. By comparison, more than 200 million Americans have gotten at least two dosages of either Moderna’s or Pfizer’s vaccine.

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