My Blog

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

The company stated 60 cases of a major however rare blood-clotting condition have been recognized, consisting of 9 deaths, out of about 18 million dosages administered. The action happens 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 against the advantages, it had chosen to limit its usage to adults who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “clinically appropriate.” One example would be individuals who experienced an extreme allergic reaction to the other two vaccines, the agency stated.

It stated the vaccine might also be provided 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 safer and more effective. In a statement, Johnson & & Johnson said the F.D.A.’s action reflected the already-known danger of the adverse effects, not new information on the rate at which it occurs. In a sign 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 activate a condition known as apoplexy with thrombocytopenia syndrome have 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 assessment. Regulators raised the time out 10 days later on however added a warning to directions for its use.

Then, in December, the C.D.C. recommended that grownups seeking a booster shot pick Moderna or Pfizer instead of Johnson & & Johnson, mentioning more benefits and lower threats. Paired with a host of making troubles in the United States, some professionals stated, the company’s judgment showed that the federal government had 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 condition– or 4 times as many as were reported when last year’s pause in distribution was raised. In the interim, the variety of Johnson & & Johnson doses administered has somewhat more than doubled, while the variety of Pfizer and Moderna receivers has actually skyrocketed.

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

In its statement, the F.D.A. cited more than 6 cases and near one death credited to the blood-clotting condition for every single 2 million shots of Johnson & & Johnson vaccine administered in the United States.

About 17 million Americans have now gotten one dosage of Johnson & & Johnson’s vaccine, and another 1.5 million have actually gotten a booster dose, according to the C.D.C.’s data. By comparison, more than 200 million Americans have gotten at least two doses of either Moderna’s or Pfizer’s vaccine.

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