My Blog

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, mentioning security concerns.

The agency said 60 cases of a severe however rare blood-clotting condition have been determined, consisting of 9 deaths, out of about 18 million dosages administered. The action happens 5 months after the Centers for Disease Control and Prevention recommended 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 against 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 people who experienced a severe allergic response to the other 2 vaccines, the agency said.

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

Johnson & & Johnson was eclipsed long earlier by Pfizer and Moderna in the nation’s vaccination project; federal authorities have said the mRNA vaccines produced by those companies are both safer and more efficient. In a statement, Johnson & & Johnson stated the F.D.A.’s action showed the already-known risk of the negative effects, not new data on the rate at which it takes place. In an indication of the firm’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 known as apoplexy with thrombocytopenia syndrome have bedeviled it from early on. In April 2021, not long after it was approved for emergency usage, federal authorities stopped briefly distribution of the vaccine for a security evaluation. Regulators raised the time out 10 days later on however included an alerting to guidelines for its use.

In December, the C.D.C. recommended that adults looking for a booster shot choose Moderna or Pfizer instead of Johnson & & Johnson, citing more benefits and lower risks. Paired with a host of making troubles in the United States, some specialists said, the company’s judgment illustrated that the federal government had all but crossed out Johnson & & Johnson’s vaccine.

According to the F.D.A. announcement on Thursday, federal authorities now have 60 reports of the blood-clotting condition– or 4 times as many as were reported when in 2015’s time out in circulation was raised. In the interim, the number of Johnson & & Johnson dosages administered has a little more than doubled, while the number of Pfizer and Moderna receivers has escalated.

The number of deaths associated to the disorder activated by the Johnson & & Johnson’s vaccine does not appear to have increased much, if at all. There have actually been far less, if any, believed deaths due to side results from the mRNA vaccines, federal health authorities have actually said.

In its announcement, the F.D.A. mentioned more than six cases and close to one death associated to the blood-clotting disorder for every single 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 dosage, according to the C.D.C.’s information. By comparison, more than 200 million Americans have actually gotten at least 2 doses of either Moderna’s or Pfizer’s vaccine.

Attempting to cast the tight 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 with no vaccine.”