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

The firm said 60 cases of a rare however serious blood-clotting condition have actually been identified, consisting of nine deaths, out of about 18 million doses 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 dangers of Johnson & & Johnson’s vaccine against the advantages, it had chosen to restrict its use to grownups 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 a severe allergy to the other two vaccines, the company said.

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

Johnson & & Johnson was eclipsed long back by Pfizer and Moderna in the country’s vaccination project; federal officials have stated the mRNA vaccines produced by those companies are both more secure and more effective. In a statement, Johnson & & Johnson said the F.D.A.’s action showed the already-known risk of the adverse effects, not brand-new data on the rate at which it takes place. In an indication of the company’s own flagging interest in its vaccine, it has stopped providing sales outlooks for the shot to financiers.

Reports that the vaccine can trigger a condition known as thrombosis with thrombocytopenia syndrome have actually bedeviled it from early on. In April 2021, not long after it was approved for emergency usage, federal authorities paused circulation of the vaccine for a safety examination. Regulators raised the time out 10 days later on however included an alerting to instructions for its usage.

Then, in December, the C.D.C. recommended that grownups looking for a booster shot pick Moderna or Pfizer instead of Johnson & & Johnson, pointing out more advantages and lower threats. Paired with a host of manufacturing problems in the United States, some experts stated, the agency’s judgment showed that the federal government had actually all but crossed out 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 many as were reported when in 2015’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 increased.

The variety of deaths credited to the condition activated by the Johnson & & Johnson’s vaccine does not appear to have actually risen much, if at all. There have actually been far less, if any, presumed deaths due to side effects from the mRNA vaccines, federal health authorities have stated.

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

Trying to cast the tight brand-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.”