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

The firm said 60 cases of a rare but severe blood-clotting disorder have actually been determined, including nine 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. stated that weighing the threats of Johnson & & Johnson’s vaccine against the advantages, it had actually decided to restrict its use to adults who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “scientifically suitable.” One example would be individuals who experienced a severe allergy to the other 2 vaccines, the company said.

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

Johnson & & Johnson was eclipsed long earlier by Pfizer and Moderna in the country’s vaccination project; federal officials have said the mRNA vaccines produced by those business are both much safer and more efficient. In a declaration, Johnson & & Johnson said the F.D.A.’s action reflected the already-known danger of the negative effects, not brand-new information on the rate at which it occurs. But in an indication of the firm’s own flagging interest in its vaccine, it has stopped supplying sales outlooks for the shot to investors.

Reports that the vaccine can activate a condition called apoplexy with thrombocytopenia syndrome have actually bedeviled it from early on. In April 2021, not long after it was authorized for emergency usage, federal authorities stopped briefly circulation of the vaccine for a security examination. Regulators lifted the pause 10 days later on but included an alerting to directions for its usage.

In December, the C.D.C. recommended that grownups seeking a booster shot select Moderna or Pfizer rather of Johnson & & Johnson, pointing out more benefits and lower threats. Paired with a host of manufacturing problems in the United States, some professionals said, the company’s judgment illustrated that the federal government had 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 in 2015’s time out in distribution was lifted. In the interim, the number of Johnson & & Johnson dosages administered has a little more than doubled, while the number of Pfizer and Moderna recipients has actually escalated.

The variety 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 been far fewer, if any, thought deaths due to side effects from the mRNA vaccines, federal health officials have stated.

In its announcement, the F.D.A. pointed out more than 6 cases and near to one death credited to the blood-clotting condition for every 2 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 dose, according to the C.D.C.’s data. By contrast, more than 200 million Americans have gotten at least 2 doses of either Moderna’s or Pfizer’s vaccine.

Attempting to cast the tight brand-new restrictions 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 with no vaccine.”