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WASHINGTON– In yet another problem for Johnson & & Johnson’s coronavirus vaccine, the Food and Drug Administration on Thursday limited its usage to adults who can not or decline to get the Pfizer-BioNTech or Moderna vaccines, citing security concerns.

The firm stated 60 cases of a unusual but serious blood-clotting disorder have been identified, consisting of nine deaths, out of about 18 million doses administered. The action happens 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. said that weighing the threats of Johnson & & Johnson’s vaccine versus the advantages, it had decided to limit its use to adults who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “medically suitable.” One example would be individuals who experienced an extreme allergy to the other 2 vaccines, the company said.

It stated the vaccine might likewise 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 country’s vaccination project; federal authorities have said the mRNA vaccines produced by those business are both more secure and more efficient. In a statement, Johnson & & Johnson stated the F.D.A.’s action showed the already-known danger of the side result, not brand-new information on the rate at which it takes place. But in an indication of the company’s own flagging interest in its vaccine, it has stopped supplying sales outlooks for the shot to financiers.

Reports that the vaccine can set off a condition called 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 distribution of the vaccine for a safety evaluation. Regulators lifted the time out 10 days later but added an alerting to directions 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, pointing out more benefits and lower threats. Combined with a host of producing difficulties in the United States, some experts stated, the firm’s judgment highlighted 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 time out in circulation was raised. In the interim, the variety of Johnson & & Johnson dosages administered has somewhat more than doubled, while the number of Pfizer and Moderna recipients has actually escalated.

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

In its statement, the F.D.A. mentioned more than six cases and near to one death credited to the blood-clotting condition for every 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 gotten a booster dose, according to the C.D.C.’s information. 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 brand-new restrictions in a positive light, Johnson & & Johnson said: “Data continue to support a favorable benefit-risk profile for the Johnson & & Johnson COVID-19 vaccine in grownups, when compared to no vaccine.”