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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 security concerns.

The agency stated 60 cases of a serious however uncommon blood-clotting condition have been identified, consisting of nine deaths, out of about 18 million doses administered. The action comes about 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. said that weighing the dangers of Johnson & & Johnson’s vaccine against the benefits, it had chosen to limit its use 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 people who experienced an extreme allergic reaction to the other two vaccines, the agency stated.

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

Johnson & & Johnson was eclipsed long earlier by Pfizer and Moderna in the country’s vaccination project; federal authorities have stated the mRNA vaccines produced by those companies are both safer and more efficient. In a statement, Johnson & & Johnson said the F.D.A.’s action reflected the already-known threat of the adverse effects, not new information on the rate at which it occurs. In an indication of the firm’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 known as apoplexy with thrombocytopenia syndrome have bedeviled it from early on. In April 2021, not long after it was authorized for emergency situation use, federal authorities stopped briefly distribution of the vaccine for a safety evaluation. Regulators lifted the pause 10 days later however included a warning to instructions for its usage.

In December, the C.D.C. advised that adults seeking a booster shot choose Moderna or Pfizer rather of Johnson & & Johnson, citing more benefits and lower risks. Coupled with a host of making difficulties in the United States, some specialists stated, the company’s judgment illustrated that the federal government had all however crossed out Johnson & & Johnson’s vaccine.

According to the F.D.A. announcement on Thursday, federal authorities now have 60 reports of the blood-clotting disorder– or 4 times as many 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 variety of Pfizer and Moderna receivers has escalated.

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

In its announcement, the F.D.A. mentioned more than six cases and near to one death associated to the blood-clotting condition 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 gotten a booster dosage, according to the C.D.C.’s data. By comparison, more than 200 million Americans have actually gotten at least two dosages of either Moderna’s or Pfizer’s vaccine.

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