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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 decline to get the Pfizer-BioNTech or Moderna vaccines, citing safety issues.

The agency said 60 cases of a unusual but major blood-clotting disorder have been recognized, including 9 deaths, out of about 18 million dosages administered. The action happens 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. stated that weighing the risks of Johnson & & Johnson’s vaccine against the advantages, it had decided to limit its use to adults 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 2 vaccines, the agency said.

It stated the vaccine might also be offered to grownups who “would otherwise not get a Covid-19 vaccine.”

Johnson & & Johnson was eclipsed long back by Pfizer and Moderna in the country’s vaccination project; federal officials have stated the mRNA vaccines produced by those business are both safer and more effective. In a statement, Johnson & & Johnson stated the F.D.A.’s action reflected the already-known danger 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 offering sales outlooks for the shot to financiers.

Reports that the vaccine can set off 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 stopped briefly circulation of the vaccine for a safety examination. Regulators lifted the pause 10 days later on however added a cautioning to guidelines for its use.

In December, the C.D.C. suggested that adults looking for a booster shot choose Moderna or Pfizer rather of Johnson & & Johnson, citing more benefits and lower dangers. Paired with a host of producing difficulties in the United States, some specialists stated, the agency’s judgment highlighted that the federal government had 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 disorder– or four times as numerous as were reported when in 2015’s time out in distribution was raised. In the interim, the variety of Johnson & & Johnson doses administered has a little more than doubled, while the number of Pfizer and Moderna recipients has skyrocketed.

The variety of deaths attributed to the condition activated by the Johnson & & Johnson’s vaccine does not appear to have risen much, if at all. But there have actually been far fewer, if any, presumed deaths due to adverse effects from the mRNA vaccines, federal health officials have actually stated.

In its announcement, the F.D.A. cited more than six cases and close to one death credited to the blood-clotting disorder for every single 2 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 data. 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 brand-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 adults, when compared to no vaccine.”