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

The company said 60 cases of a severe however unusual blood-clotting disorder have actually been determined, consisting of 9 deaths, out of about 18 million dosages administered. The action happens 5 months after the Centers for Disease Control and Prevention suggested Moderna’s and Pfizer’s vaccines over Johnson & & Johnson’s for booster shots.

The F.D.A. said that weighing the risks of Johnson & & Johnson’s vaccine against the advantages, it had actually chosen to restrict 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 people who experienced an extreme allergy to the other 2 vaccines, the agency stated.

It said the vaccine could also be offered to grownups 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 officials have said the mRNA vaccines produced by those business are both much safer and more reliable. In a statement, Johnson & & Johnson said the F.D.A.’s action showed the already-known risk of the negative 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 providing sales outlooks for the shot to investors.

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 usage, federal authorities paused distribution of the vaccine for a security evaluation. Regulators raised the time out 10 days later on however included an alerting to directions for its use.

Then, in December, the C.D.C. advised 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 manufacturing troubles in the United States, some specialists stated, the company’s judgment illustrated that the federal government had actually 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 lots of as were reported when in 2015’s pause in circulation was raised. In the interim, the variety of Johnson & & Johnson dosages administered has slightly more than doubled, while the number of Pfizer and Moderna receivers has skyrocketed.

The number of deaths credited to the condition set off by the Johnson & & Johnson’s vaccine does not appear to have actually risen much, if at all. However there have been far fewer, if any, presumed deaths due to negative effects from the mRNA vaccines, federal health officials have said.

In its announcement, the F.D.A. mentioned more than six cases and near to one death associated to the blood-clotting disorder for every 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 new restrictions 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 with no vaccine.”