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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 grownups who can not or refuse to get the Pfizer-BioNTech or Moderna vaccines, pointing out safety issues.

The agency said 60 cases of a major however unusual blood-clotting disorder have been determined, consisting of nine deaths, out of about 18 million dosages administered. The action comes about 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 risks of Johnson & & Johnson’s vaccine versus the advantages, it had chosen to limit its use to grownups 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 allergy to the other two vaccines, the firm stated.

It said the vaccine could also be provided to grownups who “would otherwise not get a Covid-19 vaccine.”

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

Reports that the vaccine can set off a condition referred to as thrombosis with thrombocytopenia syndrome have bedeviled it from early on. In April 2021, not long after it was approved for emergency situation usage, federal authorities stopped briefly distribution of the vaccine for a security assessment. Regulators raised the pause 10 days later on however included a cautioning to guidelines for its use.

Then, in December, the C.D.C. recommended that grownups looking for a booster shot pick Moderna or Pfizer rather of Johnson & & Johnson, citing more benefits and lower risks. Paired with a host of manufacturing problems in the United States, some experts stated, the agency’s judgment illustrated that the federal government had actually all however written 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 pause in distribution was lifted. In the interim, the variety of Johnson & & Johnson doses administered has a little more than doubled, while the number of Pfizer and Moderna receivers has skyrocketed.

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

In its statement, the F.D.A. mentioned more than six cases and near one death attributed to the blood-clotting condition for every two 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 gotten a booster dose, according to the C.D.C.’s data. By contrast, more than 200 million Americans have actually gotten at least 2 dosages of either Moderna’s or Pfizer’s vaccine.

Trying to cast the tight new limitations 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.”