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

The agency stated 60 cases of a unusual however major blood-clotting disorder have actually been identified, including nine deaths, out of about 18 million doses administered. The action comes about 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 threats of Johnson & & Johnson’s vaccine versus the advantages, 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 “scientifically proper.” One example would be individuals who experienced a severe allergy to the other 2 vaccines, the company said.

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

Johnson & & Johnson was eclipsed long ago by Pfizer and Moderna in the nation’s vaccination project; federal authorities have said the mRNA vaccines produced by those business are both more secure and more reliable. In a declaration, Johnson & & Johnson stated the F.D.A.’s action showed the already-known threat of the negative effects, not new information on the rate at which it occurs. However in an indication of the firm’s own flagging interest in its vaccine, it has stopped supplying sales outlooks for the shot to investors.

Reports that the vaccine can activate a condition referred to as apoplexy with thrombocytopenia syndrome have actually bedeviled it from early on. In April 2021, not long after it was authorized for emergency situation use, federal authorities stopped briefly distribution of the vaccine for a security examination. Regulators lifted the pause 10 days later however added a warning to directions for its use.

In December, the C.D.C. suggested that grownups seeking a booster shot select Moderna or Pfizer rather of Johnson & & Johnson, citing more benefits and lower risks. Paired with a host of producing troubles in the United States, some professionals said, the firm’s judgment illustrated that the federal government had 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 many as were reported when last year’s pause in circulation was lifted. In the interim, the number of Johnson & & Johnson dosages administered has a little more than doubled, while the variety of Pfizer and Moderna receivers has skyrocketed.

The number of deaths credited to the disorder triggered by the Johnson & & Johnson’s vaccine does not appear to have increased much, if at all. There have actually been far less, if any, suspected deaths due to side results from the mRNA vaccines, federal health authorities have stated.

In its announcement, the F.D.A. mentioned more than 6 cases and near one death credited to the blood-clotting disorder 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 dosage, according to the C.D.C.’s information. By comparison, more than 200 million Americans have actually gotten at least 2 doses of either Moderna’s or Pfizer’s vaccine.

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