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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 grownups who can not or decline to get the Pfizer-BioNTech or Moderna vaccines, citing safety issues.

The agency stated 60 cases of a uncommon however serious blood-clotting disorder have actually been recognized, consisting of nine deaths, out of about 18 million doses administered. The action comes about five 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 benefits, it had chosen to restrict its use to grownups who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “medically proper.” One example would be people who experienced an extreme allergic response to the other 2 vaccines, the company stated.

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

Johnson & & Johnson was eclipsed long earlier by Pfizer and Moderna in the nation’s vaccination campaign; federal authorities have said the mRNA vaccines produced by those companies are both more secure and more efficient. In a declaration, Johnson & & Johnson stated the F.D.A.’s action reflected the already-known risk of the negative effects, not new data on the rate at which it happens. In a sign of the firm’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 called thrombosis with thrombocytopenia syndrome have actually bedeviled it from early on. In April 2021, not long after it was approved for emergency situation usage, federal authorities paused circulation of the vaccine for a security assessment. Regulators lifted the pause 10 days later however included a warning to guidelines for its use.

In December, the C.D.C. suggested that adults seeking a booster shot pick Moderna or Pfizer instead of Johnson & & Johnson, mentioning more benefits and lower risks. Combined with a host of producing difficulties in the United States, some professionals stated, the company’s judgment illustrated that the federal government had actually all however crossed out Johnson & & Johnson’s vaccine.

According to the F.D.A. announcement on Thursday, federal authorities now have 60 reports of the blood-clotting disorder– or 4 times as lots of as were reported when in 2015’s pause in circulation was lifted. In the interim, the number of Johnson & & Johnson dosages administered has slightly more than doubled, while the variety of Pfizer and Moderna receivers has escalated.

The number of deaths associated to the disorder activated by the Johnson & & Johnson’s vaccine does not appear to have actually increased much, if at all. However there have actually been far less, if any, presumed deaths due to negative effects from the mRNA vaccines, federal health authorities have actually said.

In its statement, the F.D.A. pointed out more than six cases and close to one death associated 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 gotten a booster dose, according to the C.D.C.’s data. By comparison, more than 200 million Americans have gotten at least 2 dosages of either Moderna’s or Pfizer’s vaccine.

Attempting to cast the tight new restrictions in a favorable 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.”