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WASHINGTON– In yet another problem for Johnson & & Johnson’s coronavirus vaccine, the Food and Drug Administration on Thursday limited its use to adults who can not or refuse to get the Pfizer-BioNTech or Moderna vaccines, mentioning security issues.

The firm said 60 cases of a major however rare blood-clotting condition have been identified, consisting of nine deaths, out of about 18 million doses administered. The action comes about 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 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 “medically proper.” One example would be individuals who experienced an extreme allergic response to the other 2 vaccines, the firm stated.

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

Johnson & & Johnson was eclipsed long earlier by Pfizer and Moderna in the nation’s vaccination project; federal authorities have said 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 showed the already-known threat of the adverse effects, not brand-new data on the rate at which it occurs. But 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 trigger a condition referred to as thrombosis with thrombocytopenia syndrome have actually bedeviled it from early on. In April 2021, not long after it was authorized for emergency use, federal authorities paused circulation of the vaccine for a safety assessment. Regulators lifted the pause 10 days later on but included an alerting to guidelines for its use.

In December, the C.D.C. advised that adults seeking a booster shot select Moderna or Pfizer rather of Johnson & & Johnson, pointing out more advantages and lower dangers. Coupled with a host of making difficulties in the United States, some specialists stated, the company’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 4 times as numerous as were reported when last year’s pause in circulation was lifted. In the interim, the number of Johnson & & Johnson dosages administered has a little more than doubled, while the variety of Pfizer and Moderna receivers has actually skyrocketed.

The number of deaths attributed to the disorder activated by the Johnson & & Johnson’s vaccine does not appear to have risen much, if at all. There have actually been far less, if any, believed deaths due to side effects from the mRNA vaccines, federal health officials have said.

In its announcement, the F.D.A. cited more than six cases and near to one death credited to the blood-clotting disorder for every 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 contrast, more than 200 million Americans have actually gotten at least two doses of either Moderna’s or Pfizer’s vaccine.

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