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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, mentioning safety concerns.

The firm stated 60 cases of a major but unusual blood-clotting disorder have actually been recognized, including nine deaths, out of about 18 million dosages administered. The action comes about 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. stated that weighing the risks of Johnson & & Johnson’s vaccine against the advantages, it had decided to limit its usage to grownups who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “scientifically proper.” One example would be individuals who experienced a severe allergy to the other two vaccines, the company said.

It stated the vaccine could likewise be offered to grownups who “would otherwise not get a Covid-19 vaccine.”

Johnson & & Johnson was eclipsed long ago by Pfizer and Moderna in the country’s vaccination campaign; federal officials have stated the mRNA vaccines produced by those business are both much safer and more reliable. In a declaration, Johnson & & Johnson said the F.D.A.’s action showed the already-known danger of the side effect, not new data on the rate at which it occurs. In an indication of the firm’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 apoplexy with thrombocytopenia syndrome have bedeviled it from early on. In April 2021, not long after it was authorized for emergency situation usage, federal authorities stopped briefly circulation of the vaccine for a safety examination. Regulators raised the pause 10 days later on however added a warning to instructions for its use.

Then, in December, the C.D.C. recommended that grownups looking for a booster shot choose Moderna or Pfizer rather of Johnson & & Johnson, citing more advantages and lower risks. Coupled with a host of manufacturing difficulties in the United States, some experts stated, the agency’s judgment illustrated that the federal government had actually 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 lots of as were reported when in 2015’s pause in distribution was lifted. 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. However there have been far fewer, if any, presumed deaths due to adverse effects from the mRNA vaccines, federal health authorities have actually said.

In its announcement, the F.D.A. pointed out more than 6 cases and near 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 now gotten one dose of Johnson & & Johnson’s vaccine, and another 1.5 million have actually gotten a booster dosage, according to the C.D.C.’s data. By comparison, more than 200 million Americans have gotten at least 2 doses of either Moderna’s or Pfizer’s vaccine.

Attempting to cast the tight new restrictions in a positive light, Johnson & & Johnson stated: “Data continue to support a beneficial benefit-risk profile for the Johnson & & Johnson COVID-19 vaccine in adults, when compared to no vaccine.”