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WASHINGTON– In yet another setback 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, citing safety issues.

The firm stated 60 cases of a rare however serious blood-clotting condition have been determined, including 9 deaths, out of about 18 million dosages administered. The action happens five months after the Centers for Disease Control and Prevention advised Moderna’s and Pfizer’s vaccines over Johnson & & Johnson’s for booster shots.

The F.D.A. said that weighing the risks of Johnson & & Johnson’s vaccine versus the benefits, it had actually decided to limit its usage to grownups who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “scientifically suitable.” One example would be people who experienced a severe allergy to the other two vaccines, the firm stated.

It said the vaccine could likewise be offered to adults who “would otherwise not get a Covid-19 vaccine.”

Johnson & & Johnson was eclipsed long ago by Pfizer and Moderna in the country’s vaccination project; federal officials have stated the mRNA vaccines produced by those companies are both more secure and more efficient. In a statement, Johnson & & Johnson stated the F.D.A.’s action showed the already-known threat of the negative effects, not brand-new data on the rate at which it takes place. In an indication of the company’s own flagging interest in its vaccine, it has stopped providing sales outlooks for the shot to investors.

Reports that the vaccine can activate a condition known as thrombosis with thrombocytopenia syndrome have bedeviled it from early on. In April 2021, not long after it was authorized for emergency use, federal authorities stopped briefly distribution of the vaccine for a security assessment. Regulators lifted the time out 10 days later but included a warning to instructions for its use.

Then, in December, the C.D.C. advised that grownups looking for a booster shot pick Moderna or Pfizer rather of Johnson & & Johnson, mentioning more advantages and lower dangers. Coupled with a host of producing problems in the United States, some specialists stated, the company’s judgment highlighted that the federal government had 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 4 times as many as were reported when in 2015’s pause in distribution was raised. In the interim, the variety of Johnson & & Johnson doses administered has slightly more than doubled, while the variety of Pfizer and Moderna recipients has escalated.

The variety of deaths attributed to the condition set off by the Johnson & & Johnson’s vaccine does not appear to have risen much, if at all. There have actually been far fewer, if any, presumed deaths due to side impacts from the mRNA vaccines, federal health authorities have 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 every single two million shots of Johnson & & Johnson vaccine administered in the United States.

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

Attempting to cast the tight new limitations in a positive 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.”