My Blog

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

The company said 60 cases of a rare however serious blood-clotting condition have actually been identified, consisting of 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 versus the benefits, it had actually chosen to limit its use 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 individuals who experienced an extreme allergic reaction to the other two vaccines, the company stated.

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

Johnson & & Johnson was eclipsed long ago by Pfizer and Moderna in the nation’s vaccination project; federal officials have said the mRNA vaccines produced by those business are both much safer and more efficient. In a statement, Johnson & & Johnson said the F.D.A.’s action reflected the already-known threat of the negative effects, not brand-new information on the rate at which it occurs. 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 referred to as apoplexy with thrombocytopenia syndrome have bedeviled it from early on. In April 2021, not long after it was approved for emergency use, federal authorities paused circulation of the vaccine for a security evaluation. Regulators lifted the pause 10 days later however included a warning to instructions for its usage.

In December, the C.D.C. recommended that adults looking for a booster shot pick Moderna or Pfizer instead of Johnson & & Johnson, pointing out more advantages and lower dangers. Coupled with a host of manufacturing difficulties in the United States, some professionals said, the company’s judgment highlighted that the federal government had all however composed off Johnson & & Johnson’s vaccine.

According to the F.D.A. announcement on Thursday, federal authorities now have 60 reports of the blood-clotting disorder– or four times as lots of as were reported when last year’s pause in circulation was raised. In the interim, the number of Johnson & & Johnson dosages administered has slightly more than doubled, while the number of Pfizer and Moderna recipients has increased.

The number of deaths credited to the condition triggered by the Johnson & & Johnson’s vaccine does not appear to have risen much, if at all. There have been far fewer, if any, thought deaths due to side results from the mRNA vaccines, federal health authorities have actually stated.

In its announcement, the F.D.A. pointed out more than six cases and near to one death associated to the blood-clotting disorder for every 2 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 dose, according to the C.D.C.’s data. 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 brand-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 adults, when compared to no vaccine.”