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WASHINGTON– In yet another problem for Johnson & & Johnson’s coronavirus vaccine, the Food and Drug Administration on Thursday restricted its use to adults who can not or decline to get the Pfizer-BioNTech or Moderna vaccines, pointing out safety concerns.

The company said 60 cases of a severe but uncommon blood-clotting condition have been identified, including 9 deaths, out of about 18 million doses administered. The action comes about five 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. stated that weighing the threats of Johnson & & Johnson’s vaccine against the benefits, it had actually decided to limit its usage 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 two vaccines, the agency said.

It stated the vaccine could likewise be provided to adults 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 authorities have stated the mRNA vaccines produced by those business are both more secure and more efficient. In a statement, Johnson & & Johnson said the F.D.A.’s action reflected the already-known danger of the negative effects, not brand-new data on the rate at which it takes place. But in an indication 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 activate a condition understood 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 stopped briefly distribution of the vaccine for a safety assessment. Regulators lifted the time out 10 days later on but added an alerting to directions for its usage.

Then, in December, the C.D.C. suggested that grownups seeking a booster shot pick Moderna or Pfizer rather of Johnson & & Johnson, mentioning more advantages and lower threats. Combined with a host of producing problems in the United States, some professionals stated, the company’s judgment highlighted that the federal government had actually all however written off 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 many as were reported when last year’s pause in distribution was raised. In the interim, the number of Johnson & & Johnson doses administered has a little more than doubled, while the variety of Pfizer and Moderna receivers has actually increased.

The variety of deaths attributed to the disorder activated by the Johnson & & Johnson’s vaccine does not appear to have actually risen much, if at all. There have been far less, if any, suspected deaths due to side effects from the mRNA vaccines, federal health officials have actually said.

In its statement, the F.D.A. cited more than 6 cases and close to one death associated to the blood-clotting condition for each 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 dosage, according to the C.D.C.’s data. By contrast, more than 200 million Americans have actually gotten at least 2 dosages of either Moderna’s or Pfizer’s vaccine.

Trying to cast the tight new limitations in a positive light, Johnson & & Johnson stated: “Data continue to support a beneficial benefit-risk profile for the Johnson & & Johnson COVID-19 vaccine in grownups, when compared with no vaccine.”