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WASHINGTON– In yet another setback 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 security issues.

The firm said 60 cases of a uncommon but serious blood-clotting disorder have been recognized, consisting of nine deaths, out of about 18 million dosages 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. stated that weighing the threats of Johnson & & Johnson’s vaccine versus the benefits, it had actually chosen to limit its use to adults who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “scientifically appropriate.” One example would be individuals who experienced a severe allergic reaction to the other 2 vaccines, the company said.

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

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

Reports that the vaccine can set off a condition called thrombosis with thrombocytopenia syndrome have actually bedeviled it from early on. In April 2021, not long after it was approved for emergency use, federal authorities paused circulation of the vaccine for a safety evaluation. Regulators lifted the time out 10 days later but included a warning to instructions for its use.

In December, the C.D.C. advised that adults seeking a booster shot pick Moderna or Pfizer rather of Johnson & & Johnson, citing more advantages and lower threats. Paired with a host of manufacturing difficulties 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. announcement on Thursday, federal authorities now have 60 reports of the blood-clotting disorder– or 4 times as many as were reported when in 2015’s pause in distribution was raised. In the interim, the number of Johnson & & Johnson doses administered has somewhat more than doubled, while the number of Pfizer and Moderna receivers has skyrocketed.

The variety of deaths attributed to the disorder triggered by the Johnson & & Johnson’s vaccine does not appear to have risen much, if at all. But there have actually been far less, if any, thought deaths due to adverse effects from the mRNA vaccines, federal health authorities have said.

In its announcement, the F.D.A. mentioned more than six cases and near to one death credited to the blood-clotting disorder for every single two 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 contrast, more than 200 million Americans have gotten at least two dosages of either Moderna’s or Pfizer’s vaccine.

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