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WASHINGTON– In yet another setback 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, pointing out security issues.

The agency said 60 cases of a severe however rare blood-clotting condition have been recognized, including 9 deaths, out of about 18 million doses administered. The action comes about five 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 dangers of Johnson & & Johnson’s vaccine against the advantages, it had chosen to restrict its usage to adults who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “medically proper.” One example would be individuals who experienced a severe allergic reaction to the other 2 vaccines, the agency stated.

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

Johnson & & Johnson was eclipsed long earlier by Pfizer and Moderna in the country’s vaccination campaign; federal authorities have stated the mRNA vaccines produced by those companies are both much safer and more efficient. In a statement, Johnson & & Johnson stated the F.D.A.’s action showed the already-known danger of the adverse effects, not new data on the rate at which it happens. However in an indication of the company’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 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 stopped briefly circulation of the vaccine for a safety assessment. Regulators lifted the time out 10 days later on however added a cautioning to directions for its use.

In December, the C.D.C. recommended that adults looking for a booster shot pick Moderna or Pfizer rather of Johnson & & Johnson, mentioning more advantages and lower threats. Coupled with a host of making difficulties in the United States, some specialists said, the company’s judgment highlighted that the federal government had 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 4 times as many as were reported when last year’s time out in circulation was raised. In the interim, the variety of Johnson & & Johnson doses administered has a little more than doubled, while the variety of Pfizer and Moderna receivers has actually skyrocketed.

The variety of deaths credited to the condition set off by the Johnson & & Johnson’s vaccine does not appear to have 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 statement, the F.D.A. mentioned more than 6 cases and near one death credited to the blood-clotting disorder for every 2 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 dosage, according to the C.D.C.’s information. By comparison, more than 200 million Americans have actually gotten at least two dosages of either Moderna’s or Pfizer’s vaccine.

Trying to cast the tight brand-new restrictions in a positive 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.”