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

The agency said 60 cases of a severe however unusual blood-clotting condition have been determined, consisting of nine deaths, out of about 18 million dosages administered. The action happens 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 risks of Johnson & & Johnson’s vaccine versus the advantages, it had decided to restrict its usage to adults 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 two vaccines, the company stated.

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

Johnson & & Johnson was eclipsed long earlier by Pfizer and Moderna in the nation’s vaccination campaign; federal officials have said the mRNA vaccines produced by those business are both safer and more efficient. In a statement, Johnson & & Johnson said the F.D.A.’s action reflected the already-known threat of the side impact, not brand-new information on the rate at which it occurs. In a sign of the firm’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 called apoplexy with thrombocytopenia syndrome have bedeviled it from early on. In April 2021, not long after it was approved for emergency situation usage, federal authorities stopped briefly circulation of the vaccine for a safety evaluation. Regulators raised the pause 10 days later however added an alerting to instructions for its usage.

In December, the C.D.C. advised that adults looking for a booster shot select Moderna or Pfizer rather of Johnson & & Johnson, mentioning more advantages and lower threats. Combined with a host of producing difficulties in the United States, some specialists said, the firm’s judgment showed that the federal government had actually all however crossed out Johnson & & Johnson’s vaccine.

According to the F.D.A. statement on Thursday, federal authorities now have 60 reports of the blood-clotting disorder– or 4 times as numerous as were reported when last year’s time out in distribution was raised. In the interim, the variety of Johnson & & Johnson doses administered has a little more than doubled, while the number of Pfizer and Moderna receivers has increased.

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

In its statement, the F.D.A. pointed out more than 6 cases and close to one death attributed to the blood-clotting condition for every single 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 gotten a booster dose, according to the C.D.C.’s information. By contrast, more than 200 million Americans have gotten at least two doses 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 grownups, when compared with no vaccine.”