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

The firm said 60 cases of a uncommon but severe 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. stated that weighing the threats of Johnson & & Johnson’s vaccine against the advantages, it had actually chosen to restrict its use 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 allergic response to the other two vaccines, the firm said.

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 nation’s vaccination campaign; federal authorities have stated the mRNA vaccines produced by those business are both more secure and more reliable. In a declaration, Johnson & & Johnson said the F.D.A.’s action showed the already-known danger of the side impact, not brand-new information on the rate at which it happens. But in a sign of the company’s own flagging interest in its vaccine, it has stopped offering sales outlooks for the shot to investors.

Reports that the vaccine can trigger a condition referred to as apoplexy 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 but added a warning to guidelines for its usage.

Then, in December, the C.D.C. suggested that grownups seeking a booster shot choose Moderna or Pfizer rather of Johnson & & Johnson, citing more benefits and lower risks. Paired with a host of producing problems in the United States, some experts stated, the firm’s judgment highlighted that the federal government had all however 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 condition– or four 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 somewhat more than doubled, while the variety of Pfizer and Moderna receivers has increased.

The variety of deaths credited to the disorder activated by the Johnson & & Johnson’s vaccine does not appear to have actually risen much, if at all. However there have been far less, if any, believed deaths due to side impacts from the mRNA vaccines, federal health authorities have actually stated.

In its announcement, the F.D.A. mentioned more than six cases and near one death credited to the blood-clotting disorder for every single 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 dosage, according to the C.D.C.’s information. By comparison, more than 200 million Americans have gotten at least two doses of either Moderna’s or Pfizer’s vaccine.

Trying to cast the tight new constraints 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.”