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

The company said 60 cases of a major however unusual 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 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 against the advantages, it had actually chosen to limit its use to grownups who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “clinically proper.” One example would be people who experienced a severe allergic reaction to the other two vaccines, the company stated.

It said the vaccine could likewise be provided to grownups who “would otherwise not receive a Covid-19 vaccine.”

Johnson & & Johnson was eclipsed long back by Pfizer and Moderna in the nation’s vaccination campaign; federal officials have stated the mRNA vaccines produced by those business are both more secure and more effective. In a statement, Johnson & & Johnson said the F.D.A.’s action reflected the already-known risk of the negative effects, not new data on the rate at which it happens. In an indication 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 activate a condition called thrombosis with thrombocytopenia syndrome have bedeviled it from early on. In April 2021, not long after it was authorized for emergency situation usage, federal authorities paused circulation of the vaccine for a safety evaluation. Regulators raised the pause 10 days later but added a cautioning to instructions for its use.

Then, in December, the C.D.C. recommended that grownups seeking a booster shot choose Moderna or Pfizer instead of Johnson & & Johnson, mentioning more advantages and lower risks. Combined with a host of producing problems in the United States, some professionals stated, the company’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 many as were reported when in 2015’s time out 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 actually skyrocketed.

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

In its announcement, the F.D.A. pointed out more than 6 cases and near one death associated to the blood-clotting condition for each 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 gotten at least two dosages of either Moderna’s or Pfizer’s vaccine.

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