My Blog

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 decline to get the Pfizer-BioNTech or Moderna vaccines, mentioning security issues.

The company said 60 cases of a major but unusual blood-clotting disorder have been recognized, consisting of 9 deaths, out of about 18 million doses administered. The action happens 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 threats of Johnson & & Johnson’s vaccine against the advantages, 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 “clinically proper.” One example would be individuals who experienced a severe allergic reaction to the other 2 vaccines, the company 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 earlier by Pfizer and Moderna in the country’s vaccination campaign; federal officials have said the mRNA vaccines produced by those companies are both more secure and more reliable. In a statement, Johnson & & Johnson stated the F.D.A.’s action reflected the already-known threat of the adverse effects, not new information 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 trigger a condition understood as apoplexy with thrombocytopenia syndrome have bedeviled it from early on. In April 2021, not long after it was approved for emergency usage, federal authorities stopped briefly circulation of the vaccine for a safety assessment. Regulators lifted the time out 10 days later on however included an alerting to guidelines for its usage.

In December, the C.D.C. suggested that adults looking for a booster shot select Moderna or Pfizer instead of Johnson & & Johnson, citing more benefits and lower dangers. Combined with a host of making difficulties in the United States, some professionals stated, the agency’s judgment showed that the federal government had all however composed off Johnson & & Johnson’s vaccine.

According to the F.D.A. announcement on Thursday, federal authorities now have 60 reports of the blood-clotting condition– or four times as numerous as were reported when in 2015’s pause 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 escalated.

The variety of deaths credited to the condition activated by the Johnson & & Johnson’s vaccine does not appear to have increased much, if at all. But there have been far fewer, if any, thought deaths due to adverse effects from the mRNA vaccines, federal health authorities have actually said.

In its announcement, the F.D.A. cited more than 6 cases and near one death associated 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 actually now gotten one dosage 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 actually gotten at least 2 dosages of either Moderna’s or Pfizer’s vaccine.

Attempting to cast the tight brand-new constraints in a favorable 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.”