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

The agency said 60 cases of a rare however severe blood-clotting disorder have actually been determined, including nine deaths, out of about 18 million doses 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. said that weighing the dangers of Johnson & & Johnson’s vaccine versus the advantages, it had decided to limit its use to adults who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “medically proper.” One example would be individuals who experienced an extreme allergic reaction to the other 2 vaccines, the agency stated.

It stated the vaccine could likewise be given to adults who “would otherwise not get a Covid-19 vaccine.”

Johnson & & Johnson was eclipsed long back by Pfizer and Moderna in the country’s vaccination project; federal authorities have said the mRNA vaccines produced by those business are both much safer and more efficient. In a declaration, Johnson & & Johnson stated the F.D.A.’s action reflected the already-known danger of the negative effects, not new information on the rate at which it takes place. However in an indication of the company’s own flagging interest in its vaccine, it has stopped offering sales outlooks for the shot to financiers.

Reports that the vaccine can trigger a condition called apoplexy with thrombocytopenia syndrome have 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 assessment. Regulators lifted the time out 10 days later on however added a warning to guidelines for its usage.

Then, in December, the C.D.C. advised that adults seeking a booster shot choose Moderna or Pfizer rather of Johnson & & Johnson, citing more advantages and lower threats. Paired with a host of producing difficulties in the United States, some specialists said, the company’s judgment showed that the federal government had all but 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 numerous as were reported when in 2015’s time out in distribution was raised. In the interim, the variety of Johnson & & Johnson doses administered has slightly more than doubled, while the variety of Pfizer and Moderna recipients has actually increased.

The number of deaths credited to the disorder set off by the Johnson & & Johnson’s vaccine does not appear to have increased much, if at all. But there have been far fewer, if any, believed deaths due to side impacts from the mRNA vaccines, federal health authorities have actually said.

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

Attempting to cast the tight new constraints in a positive light, Johnson & & Johnson said: “Data continue to support a beneficial benefit-risk profile for the Johnson & & Johnson COVID-19 vaccine in adults, when compared to no vaccine.”