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

The company said 60 cases of a unusual however major blood-clotting condition have been recognized, including 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 risks of Johnson & & Johnson’s vaccine against the advantages, it had actually decided to limit its use to grownups who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “medically appropriate.” One example would be people who experienced an extreme allergy to the other two vaccines, the agency stated.

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

Johnson & & Johnson was eclipsed long back by Pfizer and Moderna in the country’s vaccination project; federal authorities have stated the mRNA vaccines produced by those companies are both more secure and more reliable. In a statement, Johnson & & Johnson stated the F.D.A.’s action showed the already-known risk of the adverse 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 supplying sales outlooks for the shot to investors.

Reports that the vaccine can set off a condition known as thrombosis 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 assessment. Regulators raised the pause 10 days later but included a warning to guidelines for its usage.

Then, in December, the C.D.C. advised that grownups seeking a booster shot choose Moderna or Pfizer rather of Johnson & & Johnson, mentioning more advantages and lower threats. Paired with a host of manufacturing problems in the United States, some experts stated, the firm’s judgment showed 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 lots of 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 recipients has skyrocketed.

The variety of deaths credited to the disorder activated by the Johnson & & Johnson’s vaccine does not appear to have actually risen much, if at all. However there have been far less, if any, thought deaths due to negative effects from the mRNA vaccines, federal health officials have stated.

In its announcement, the F.D.A. pointed out more than 6 cases and near to one death credited to the blood-clotting condition for each 2 million shots of Johnson & & Johnson vaccine administered in the United States.

About 17 million Americans have actually now gotten one dose of Johnson & & Johnson’s vaccine, and another 1.5 million have actually gotten a booster dose, according to the C.D.C.’s data. By comparison, more than 200 million Americans have actually gotten at least two dosages of either Moderna’s or Pfizer’s vaccine.

Trying to cast the tight brand-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 adults, when compared to no vaccine.”