My Blog

WASHINGTON– In yet another obstacle for Johnson & & Johnson’s coronavirus vaccine, the Food and Drug Administration on Thursday restricted its use to grownups who can not or decline to get the Pfizer-BioNTech or Moderna vaccines, mentioning security concerns.

The company said 60 cases of a major however unusual blood-clotting disorder have actually been identified, including nine deaths, out of about 18 million dosages administered. The action happens 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. said that weighing the threats of Johnson & & Johnson’s vaccine against the advantages, it had actually decided to restrict its use to adults who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “scientifically proper.” One example would be people who experienced an extreme allergy to the other two vaccines, the company stated.

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

Johnson & & Johnson was eclipsed long ago by Pfizer and Moderna in the nation’s vaccination project; federal officials have said the mRNA vaccines produced by those companies are both more secure and more efficient. In a declaration, Johnson & & Johnson stated the F.D.A.’s action showed the already-known danger of the side result, not brand-new information on the rate at which it takes place. But in an indication of the firm’s own flagging interest in its vaccine, it has stopped supplying sales outlooks for the shot to investors.

Reports that the vaccine can activate 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 use, federal authorities paused circulation of the vaccine for a safety assessment. Regulators raised the time out 10 days later on however added a cautioning to directions for its usage.

In December, the C.D.C. recommended that adults looking for a booster shot pick Moderna or Pfizer instead of Johnson & & Johnson, pointing out more benefits and lower threats. Combined with a host of producing difficulties 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 disorder– or 4 times as numerous as were reported when last year’s time out in distribution was lifted. In the interim, the number of Johnson & & Johnson doses administered has a little more than doubled, while the number of Pfizer and Moderna recipients has actually escalated.

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

In its statement, the F.D.A. pointed out more than six cases and near to 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 data. By contrast, more than 200 million Americans have gotten at least two doses of either Moderna’s or Pfizer’s vaccine.

Trying to cast the tight brand-new restrictions in a favorable light, Johnson & & Johnson stated: “Data continue to support a beneficial benefit-risk profile for the Johnson & & Johnson COVID-19 vaccine in grownups, when compared with no vaccine.”