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

The company said 60 cases of a uncommon but serious blood-clotting disorder have been recognized, consisting of 9 deaths, out of about 18 million dosages administered. The action happens 5 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. stated that weighing the risks of Johnson & & Johnson’s vaccine against the advantages, it had actually chosen to limit its usage 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 individuals who experienced a severe allergy to the other 2 vaccines, the agency stated.

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

Johnson & & Johnson was eclipsed long back by Pfizer and Moderna in the nation’s vaccination project; federal officials have stated the mRNA vaccines produced by those business are both safer and more effective. In a declaration, Johnson & & Johnson stated the F.D.A.’s action reflected the already-known risk of the side impact, not brand-new data on the rate at which it occurs. In an indication of the company’s own flagging interest in its vaccine, it has stopped supplying sales outlooks for the shot to investors.

Reports that the vaccine can activate a condition referred to as thrombosis with thrombocytopenia syndrome have actually bedeviled it from early on. In April 2021, not long after it was approved for emergency situation usage, federal authorities paused circulation of the vaccine for a security examination. Regulators lifted the pause 10 days later on however included a warning to directions for its use.

In December, the C.D.C. suggested that grownups seeking a booster shot select Moderna or Pfizer instead of Johnson & & Johnson, citing more advantages and lower risks. Coupled with a host of manufacturing problems in the United States, some specialists said, the firm’s judgment highlighted 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 condition– or 4 times as many as were reported when last year’s time out in distribution was lifted. In the interim, the variety of Johnson & & Johnson dosages administered has slightly more than doubled, while the variety of Pfizer and Moderna recipients has escalated.

The variety of deaths credited to the condition triggered by the Johnson & & Johnson’s vaccine does not appear to have actually increased much, if at all. There have been far fewer, if any, believed deaths due to side impacts from the mRNA vaccines, federal health officials have said.

In its statement, the F.D.A. mentioned more than six cases and near to one death credited to the blood-clotting disorder for each 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 information. By contrast, more than 200 million Americans have gotten at least 2 dosages of either Moderna’s or Pfizer’s vaccine.

Trying to cast the tight 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 with no vaccine.”