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

The company stated 60 cases of a serious however uncommon blood-clotting disorder have been identified, including nine deaths, out of about 18 million dosages 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. said that weighing the dangers of Johnson & & Johnson’s vaccine against the benefits, it had decided to restrict its usage to grownups who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “clinically suitable.” One example would be people who experienced a severe allergy to the other 2 vaccines, the firm stated.

It stated the vaccine might also be offered to adults who “would otherwise not receive a Covid-19 vaccine.”

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

Reports that the vaccine can set off a condition called apoplexy with thrombocytopenia syndrome have bedeviled it from early on. In April 2021, not long after it was approved for emergency use, federal authorities stopped briefly circulation of the vaccine for a safety assessment. Regulators raised the time out 10 days later but included an alerting to directions for its usage.

In December, the C.D.C. recommended that adults seeking a booster shot select Moderna or Pfizer instead of Johnson & & Johnson, pointing out more advantages and lower dangers. Coupled with a host of making difficulties in the United States, some specialists said, the firm’s judgment highlighted that the federal government had actually 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 condition– or four times as lots of as were reported when in 2015’s time out 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 recipients has actually increased.

The variety of deaths associated to the condition triggered by the Johnson & & Johnson’s vaccine does not appear to have actually increased much, if at all. However there have been far fewer, if any, thought deaths due to adverse effects from the mRNA vaccines, federal health authorities have actually stated.

In its statement, the F.D.A. cited more than six cases and close to one death credited to the blood-clotting condition for every single two million shots of Johnson & & Johnson vaccine administered in the United States.

About 17 million Americans have actually now gotten one dose 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 gotten at least two dosages of either Moderna’s or Pfizer’s vaccine.

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