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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 refuse to get the Pfizer-BioNTech or Moderna vaccines, citing safety issues.

The agency said 60 cases of a rare however severe blood-clotting condition have actually been recognized, including 9 deaths, out of about 18 million doses administered. The action happens 5 months after the Centers for Disease Control and Prevention advised 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 benefits, it had actually decided to restrict its usage to adults who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “clinically suitable.” One example would be individuals who experienced a severe allergy to the other 2 vaccines, the agency stated.

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

Johnson & & Johnson was eclipsed long earlier by Pfizer and Moderna in the country’s vaccination project; federal officials have stated the mRNA vaccines produced by those business are both more secure and more reliable. In a statement, Johnson & & Johnson said the F.D.A.’s action showed the already-known danger of the negative effects, not brand-new information on the rate at which it occurs. 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 trigger a condition referred to as thrombosis with thrombocytopenia syndrome have actually bedeviled it from early on. In April 2021, not long after it was approved for emergency situation use, federal authorities stopped briefly circulation of the vaccine for a security examination. Regulators lifted the pause 10 days later on but included a warning to guidelines for its usage.

Then, in December, the C.D.C. advised that adults looking for a booster shot choose Moderna or Pfizer rather of Johnson & & Johnson, mentioning more advantages and lower threats. Coupled with a host of manufacturing problems in the United States, some specialists said, the company’s judgment illustrated that the federal government had actually all but 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 variety of Johnson & & Johnson dosages administered has a little more than doubled, while the number of Pfizer and Moderna recipients has actually skyrocketed.

The number of deaths associated to the disorder set off by the Johnson & & Johnson’s vaccine does not appear to have risen much, if at all. There have actually been far less, if any, thought deaths due to side 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 associated 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 gotten a booster dosage, 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.

Attempting 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 with no vaccine.”