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

The firm said 60 cases of a rare however major blood-clotting disorder have actually been recognized, consisting of 9 deaths, out of about 18 million dosages 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 dangers of Johnson & & Johnson’s vaccine against the advantages, it had actually decided to restrict its use to adults 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 an extreme allergic response to the other two vaccines, the firm stated.

It said the vaccine might likewise be offered to grownups who “would otherwise not receive 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 much safer and more effective. In a statement, Johnson & & Johnson stated the F.D.A.’s action showed the already-known threat of the negative effects, not new data on the rate at which it takes place. In an indication of the company’s own flagging interest in its vaccine, it has stopped offering sales outlooks for the shot to investors.

Reports that the vaccine can set off a condition called apoplexy with thrombocytopenia syndrome have actually bedeviled it from early on. In April 2021, not long after it was approved for emergency use, federal authorities stopped briefly circulation of the vaccine for a safety assessment. Regulators raised the pause 10 days later on but added a cautioning to directions for its use.

In December, the C.D.C. suggested that grownups seeking a booster shot choose Moderna or Pfizer instead of Johnson & & Johnson, mentioning more benefits and lower dangers. Combined with a host of producing troubles in the United States, some specialists said, the agency’s judgment highlighted that the federal government had all however composed off 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 four times as many as were reported when in 2015’s time out in circulation was raised. In the interim, the number of Johnson & & Johnson doses administered has a little more than doubled, while the number of Pfizer and Moderna receivers has actually escalated.

The number of deaths credited to the disorder activated by the Johnson & & Johnson’s vaccine does not appear to have risen much, if at all. There have been far less, if any, suspected 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 six cases and near to one death attributed to the blood-clotting disorder for every single 2 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 dose, according to the C.D.C.’s information. By comparison, more than 200 million Americans have actually 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 said: “Data continue to support a beneficial benefit-risk profile for the Johnson & & Johnson COVID-19 vaccine in grownups, when compared with no vaccine.”