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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, mentioning safety issues.

The company said 60 cases of a rare however major blood-clotting condition have been determined, including 9 deaths, out of about 18 million doses administered. The action happens 5 months after the Centers for Disease Control and Prevention recommended Moderna’s and Pfizer’s vaccines over Johnson & & Johnson’s for booster shots.

The F.D.A. said that weighing the threats 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 “scientifically appropriate.” One example would be individuals who experienced an extreme allergic reaction to the other 2 vaccines, the company stated.

It said the vaccine could also 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 threat of the negative effects, not new information on the rate at which it takes place. However in an indication of the firm’s own flagging interest in its vaccine, it has stopped offering 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 authorized for emergency usage, federal authorities paused distribution of the vaccine for a security assessment. Regulators raised the pause 10 days later on however added a warning to directions for its usage.

In December, the C.D.C. advised that adults looking for a booster shot select Moderna or Pfizer instead of Johnson & & Johnson, mentioning more advantages and lower risks. Combined with a host of manufacturing difficulties in the United States, some specialists said, the agency’s judgment illustrated 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 disorder– or 4 times as numerous 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 variety of Pfizer and Moderna recipients has increased.

The variety of deaths credited to the condition activated by the Johnson & & Johnson’s vaccine does not appear to have risen much, if at all. However there have been far less, if any, believed deaths due to adverse effects from the mRNA vaccines, federal health officials have stated.

In its announcement, the F.D.A. mentioned more than six cases and close to one death credited to the blood-clotting disorder for every 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 dose, according to the C.D.C.’s information. 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 new constraints in a positive light, Johnson & & Johnson stated: “Data continue to support a beneficial benefit-risk profile for the Johnson & & Johnson COVID-19 vaccine in adults, when compared to no vaccine.”