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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, pointing out safety issues.

The company stated 60 cases of a uncommon however severe blood-clotting disorder have actually been recognized, consisting of 9 deaths, out of about 18 million dosages administered. The action happens 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 versus the benefits, it had decided to limit its use to grownups who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “medically appropriate.” One example would be people who experienced an extreme allergic reaction to the other two vaccines, the firm said.

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

Johnson & & Johnson was eclipsed long ago by Pfizer and Moderna in the nation’s vaccination project; federal officials have stated the mRNA vaccines produced by those companies are both much safer and more efficient. In a statement, Johnson & & Johnson said the F.D.A.’s action reflected the already-known risk of the side result, not new information on the rate at which it happens. In an indication 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 trigger 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 paused circulation of the vaccine for a security examination. Regulators raised the pause 10 days later on but included a cautioning to guidelines for its use.

In December, the C.D.C. recommended that grownups seeking a booster shot select Moderna or Pfizer instead of Johnson & & Johnson, pointing out more benefits and lower dangers. Combined with a host of making difficulties in the United States, some specialists said, the company’s judgment showed that the federal government had actually all however composed 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 4 times as many as were reported when in 2015’s pause in distribution was raised. In the interim, the variety of Johnson & & Johnson doses administered has a little more than doubled, while the variety of Pfizer and Moderna recipients has actually skyrocketed.

The variety of deaths associated to the condition activated by the Johnson & & Johnson’s vaccine does not appear to have actually risen much, if at all. However there have actually been far fewer, if any, presumed deaths due to adverse effects from the mRNA vaccines, federal health officials have actually stated.

In its announcement, the F.D.A. mentioned more than six cases and near to one death associated to the blood-clotting disorder 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 actually gotten a booster dose, according to the C.D.C.’s information. By comparison, more than 200 million Americans have actually gotten at least two dosages of either Moderna’s or Pfizer’s vaccine.

Trying to cast the tight brand-new constraints 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 to no vaccine.”