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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 refuse to get the Pfizer-BioNTech or Moderna vaccines, citing security issues.

The firm stated 60 cases of a rare however serious blood-clotting condition have been identified, including nine deaths, out of about 18 million doses administered. The action comes about 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. stated that weighing the risks of Johnson & & Johnson’s vaccine against the benefits, it had actually chosen to restrict its usage to grownups who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “medically appropriate.” One example would be individuals who experienced a severe allergy to the other two vaccines, the agency said.

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

Johnson & & Johnson was eclipsed long ago by Pfizer and Moderna in the nation’s vaccination campaign; federal authorities have stated the mRNA vaccines produced by those companies are both safer and more effective. In a statement, Johnson & & Johnson said the F.D.A.’s action reflected the already-known danger of the adverse effects, not new information on the rate at which it occurs. But in a sign of the company’s own flagging interest in its vaccine, it has stopped providing sales outlooks for the shot to financiers.

Reports that the vaccine can trigger a condition referred to 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 paused distribution of the vaccine for a safety examination. Regulators lifted the pause 10 days later however included a cautioning 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 advantages and lower threats. Combined with a host of making difficulties in the United States, some professionals said, the firm’s judgment highlighted that the federal government had all however composed 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 four times as numerous as were reported when in 2015’s pause in distribution was raised. In the interim, the number of Johnson & & Johnson doses administered has slightly more than doubled, while the number of Pfizer and Moderna receivers has escalated.

The variety of deaths associated to the condition triggered by the Johnson & & Johnson’s vaccine does not appear to have actually risen much, if at all. However there have actually been far less, if any, believed deaths due to negative effects from the mRNA vaccines, federal health officials have actually stated.

In its statement, the F.D.A. pointed out more than six cases and near one death attributed to the blood-clotting disorder for each 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 gotten a booster dosage, according to the C.D.C.’s data. By contrast, more than 200 million Americans have gotten at least 2 doses of either Moderna’s or Pfizer’s vaccine.

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