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

The agency stated 60 cases of a rare but serious blood-clotting condition have actually been determined, consisting of nine deaths, out of about 18 million dosages administered. The action comes about 5 months after the Centers for Disease Control and Prevention recommended Moderna’s and Pfizer’s vaccines over Johnson & & Johnson’s for booster shots.

The F.D.A. stated that weighing the dangers of Johnson & & Johnson’s vaccine against the advantages, it had actually chosen to restrict its usage to grownups 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 an extreme allergy to the other 2 vaccines, the firm said.

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

Johnson & & Johnson was eclipsed long earlier by Pfizer and Moderna in the country’s vaccination campaign; federal officials have stated the mRNA vaccines produced by those companies are both safer and more reliable. In a statement, Johnson & & Johnson said the F.D.A.’s action reflected the already-known danger of the adverse effects, not new information on the rate at which it occurs. However in an indication of the company’s own flagging interest in its vaccine, it has stopped providing sales outlooks for the shot to investors.

Reports that the vaccine can set off a condition understood as 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 distribution of the vaccine for a safety assessment. Regulators lifted the time out 10 days later on but included a cautioning to instructions for its use.

In December, the C.D.C. suggested that adults seeking a booster shot choose Moderna or Pfizer instead of Johnson & & Johnson, pointing out more advantages and lower risks. Combined with a host of manufacturing problems in the United States, some experts said, the company’s judgment illustrated that the federal government had 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 many as were reported when in 2015’s time out in circulation was lifted. In the interim, the number of Johnson & & Johnson doses administered has a little more than doubled, while the number of Pfizer and Moderna recipients has escalated.

The variety of deaths attributed to the condition triggered by the Johnson & & Johnson’s vaccine does not appear to have risen much, if at all. There have been far less, if any, thought deaths due to side impacts from the mRNA vaccines, federal health authorities have actually stated.

In its statement, 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 dosage of Johnson & & Johnson’s vaccine, and another 1.5 million have gotten a booster dose, according to the C.D.C.’s data. By contrast, more than 200 million Americans have actually gotten at least 2 dosages of either Moderna’s or Pfizer’s vaccine.

Trying to cast the tight new limitations in a favorable 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.”