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 agency stated 60 cases of a rare however serious blood-clotting disorder have actually been identified, including nine deaths, out of about 18 million doses administered. The action happens 5 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. stated that weighing the threats of Johnson & & Johnson’s vaccine versus the advantages, it had actually chosen to restrict 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 a severe allergic reaction to the other two vaccines, the company stated.

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

Johnson & & Johnson was eclipsed long back by Pfizer and Moderna in the nation’s vaccination project; federal officials have said the mRNA vaccines produced by those companies are both more secure and more reliable. In a declaration, Johnson & & Johnson stated the F.D.A.’s action showed the already-known risk of the adverse effects, not brand-new information on the rate at which it takes place. But 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 set off a condition referred to as apoplexy with thrombocytopenia syndrome have bedeviled it from early on. In April 2021, not long after it was authorized for emergency use, federal authorities stopped briefly distribution of the vaccine for a safety assessment. Regulators raised the time out 10 days later however included a warning to directions for its usage.

Then, in December, the C.D.C. recommended that adults looking for a booster shot choose Moderna or Pfizer rather of Johnson & & Johnson, mentioning more advantages and lower dangers. Coupled with a host of manufacturing problems in the United States, some specialists stated, the firm’s judgment highlighted that the federal government had actually all but composed off Johnson & & Johnson’s vaccine.

According to the F.D.A. statement on Thursday, federal authorities now have 60 reports of the blood-clotting condition– or four times as numerous as were reported when last year’s time out 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 escalated.

The number of deaths credited to the disorder set off by the Johnson & & Johnson’s vaccine does not appear to have actually risen much, if at all. There have been far fewer, if any, believed deaths due to side impacts from the mRNA vaccines, federal health officials have said.

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 two 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 data. By comparison, more than 200 million Americans have gotten at least 2 doses of either Moderna’s or Pfizer’s vaccine.

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