My Blog

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

The company stated 60 cases of a major but uncommon blood-clotting condition have been identified, including 9 deaths, out of about 18 million doses 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. said that weighing the threats of Johnson & & Johnson’s vaccine against the benefits, it had actually chosen to restrict its use to grownups who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “medically suitable.” One example would be individuals who experienced an extreme allergy to the other 2 vaccines, the firm stated.

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

Johnson & & Johnson was eclipsed long back by Pfizer and Moderna in the country’s vaccination campaign; federal authorities have stated the mRNA vaccines produced by those companies are both more secure and more effective. In a statement, Johnson & & Johnson stated the F.D.A.’s action showed the already-known risk of the side effect, not brand-new data on the rate at which it takes place. In a sign of the firm’s own flagging interest in its vaccine, it has stopped offering sales outlooks for the shot to investors.

Reports that the vaccine can set off a condition known as apoplexy with thrombocytopenia syndrome have actually bedeviled it from early on. In April 2021, not long after it was approved for emergency situation usage, federal authorities paused circulation of the vaccine for a security examination. Regulators raised the time out 10 days later on however added an alerting to directions for its use.

In December, the C.D.C. suggested that adults seeking a booster shot pick Moderna or Pfizer instead of Johnson & & Johnson, mentioning more benefits and lower risks. Paired with a host of producing problems in the United States, some specialists said, the agency’s judgment showed that the federal government had actually all however 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 4 times as lots of as were reported when in 2015’s time out in circulation was lifted. In the interim, the number of Johnson & & Johnson dosages administered has a little more than doubled, while the variety of Pfizer and Moderna receivers has escalated.

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

In its statement, the F.D.A. mentioned more than 6 cases and close to one death associated to the blood-clotting disorder for each 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 actually gotten a booster dosage, 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 limitations in a favorable light, Johnson & & Johnson said: “Data continue to support a beneficial benefit-risk profile for the Johnson & & Johnson COVID-19 vaccine in adults, when compared to no vaccine.”