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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, mentioning security concerns.

The firm stated 60 cases of a rare however major blood-clotting disorder have been identified, including nine deaths, out of about 18 million doses administered. The action comes about five 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. said that weighing the threats of Johnson & & Johnson’s vaccine against 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 “clinically proper.” One example would be individuals who experienced an extreme allergic reaction to the other 2 vaccines, the firm said.

It said the vaccine might also be offered to adults who “would otherwise not receive a Covid-19 vaccine.”

Johnson & & Johnson was eclipsed long back by Pfizer and Moderna in the nation’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 negative effects, not brand-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 supplying sales outlooks for the shot to financiers.

Reports that the vaccine can activate a condition understood as apoplexy with thrombocytopenia syndrome have 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 examination. Regulators raised the time out 10 days later however included a warning to directions for its use.

In December, the C.D.C. suggested that grownups seeking a booster shot select Moderna or Pfizer instead of Johnson & & Johnson, pointing out more advantages and lower risks. Paired with a host of making difficulties in the United States, some experts stated, the company’s judgment highlighted that the federal government had actually all however crossed out 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 4 times as many as were reported when last year’s time out in circulation 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 skyrocketed.

The variety of deaths credited to the condition set off by the Johnson & & Johnson’s vaccine does not appear to have increased much, if at all. However there have actually been far less, if any, believed deaths due to negative effects from the mRNA vaccines, federal health authorities have stated.

In its announcement, the F.D.A. cited more than six cases and close to one death attributed to the blood-clotting condition for every two 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 dosage, according to the C.D.C.’s data. By comparison, more than 200 million Americans have actually 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 said: “Data continue to support a favorable benefit-risk profile for the Johnson & & Johnson COVID-19 vaccine in grownups, when compared with no vaccine.”