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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 grownups who can not or decline to get the Pfizer-BioNTech or Moderna vaccines, pointing out safety issues.

The company said 60 cases of a rare however severe blood-clotting disorder have actually been recognized, including 9 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 versus the benefits, it had chosen to restrict its usage to grownups who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “scientifically appropriate.” One example would be individuals who experienced a severe allergy to the other two vaccines, the agency stated.

It stated the vaccine could also be offered to adults 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 officials have said the mRNA vaccines produced by those companies are both safer and more effective. In a declaration, Johnson & & Johnson said the F.D.A.’s action showed the already-known threat of the adverse effects, not new data on the rate at which it happens. In a sign of the firm’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 thrombosis with thrombocytopenia syndrome have bedeviled it from early on. In April 2021, not long after it was approved for emergency situation usage, federal authorities stopped briefly circulation of the vaccine for a security evaluation. Regulators lifted the time out 10 days later however included a cautioning to directions for its usage.

In December, the C.D.C. recommended that adults looking for a booster shot pick Moderna or Pfizer rather of Johnson & & Johnson, citing more advantages and lower threats. Combined with a host of producing difficulties in the United States, some experts said, the company’s judgment showed that the federal government had actually all but written 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 4 times as many as were reported when in 2015’s pause in circulation was raised. In the interim, the variety of Johnson & & Johnson doses administered has slightly more than doubled, while the variety of Pfizer and Moderna receivers has actually increased.

The variety of deaths credited to the disorder triggered by the Johnson & & Johnson’s vaccine does not appear to have increased much, if at all. But there have actually been far less, if any, presumed deaths due to negative effects from the mRNA vaccines, federal health authorities have stated.

In its statement, the F.D.A. mentioned more than 6 cases and close to 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 actually 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 comparison, more than 200 million Americans have actually gotten at least 2 doses of either Moderna’s or Pfizer’s vaccine.

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