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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 refuse to get the Pfizer-BioNTech or Moderna vaccines, mentioning safety concerns.

The firm said 60 cases of a major but rare 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 threats of Johnson & & Johnson’s vaccine versus the advantages, it had decided to restrict its usage to grownups who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “scientifically suitable.” One example would be people who experienced a severe allergic reaction to the other 2 vaccines, the agency stated.

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

Johnson & & Johnson was eclipsed long earlier by Pfizer and Moderna in the nation’s vaccination project; federal authorities have said the mRNA vaccines produced by those companies are both more secure and more efficient. In a statement, Johnson & & Johnson stated the F.D.A.’s action showed the already-known risk of the negative effects, not brand-new information on the rate at which it takes place. However in a sign 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 activate a condition referred to as thrombosis with thrombocytopenia syndrome have bedeviled it from early on. In April 2021, not long after it was approved for emergency situation use, federal authorities paused distribution of the vaccine for a safety assessment. Regulators raised the time out 10 days later on however included a cautioning to instructions for its use.

Then, in December, the C.D.C. recommended that grownups seeking a booster shot select Moderna or Pfizer rather of Johnson & & Johnson, mentioning more benefits and lower dangers. Coupled with a host of manufacturing difficulties in the United States, some professionals said, the agency’s judgment showed that the federal government had actually all however 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 last year’s pause in distribution was lifted. In the interim, the variety of Johnson & & Johnson doses administered has somewhat more than doubled, while the number of Pfizer and Moderna receivers has actually increased.

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

In its statement, the F.D.A. mentioned more than 6 cases and near one death credited to the blood-clotting condition 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 data. By contrast, more than 200 million Americans have actually gotten at least two dosages of either Moderna’s or Pfizer’s vaccine.

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