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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 refuse to get the Pfizer-BioNTech or Moderna vaccines, mentioning security issues.

The agency said 60 cases of a major however unusual blood-clotting condition have been recognized, including 9 deaths, out of about 18 million dosages administered. The action happens 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 versus the benefits, it had chosen 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 individuals who experienced a severe allergy to the other two vaccines, the firm said.

It said the vaccine might also 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 nation’s vaccination project; federal officials have stated the mRNA vaccines produced by those companies are both more secure and more effective. In a declaration, Johnson & & Johnson said the F.D.A.’s action reflected the already-known threat of the side result, not brand-new information on the rate at which it occurs. However in a sign of the firm’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 referred to as apoplexy 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 distribution of the vaccine for a safety examination. Regulators lifted the pause 10 days later on however added an alerting to instructions for its usage.

In December, the C.D.C. recommended that adults seeking a booster shot pick Moderna or Pfizer instead of Johnson & & Johnson, pointing out more benefits and lower dangers. Combined with a host of manufacturing problems in the United States, some specialists said, the firm’s judgment highlighted that the federal government had all however written 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 numerous as were reported when in 2015’s pause in circulation was lifted. In the interim, the variety of Johnson & & Johnson dosages administered has somewhat more than doubled, while the number of Pfizer and Moderna receivers has skyrocketed.

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

In its statement, the F.D.A. cited more than six cases and near one death associated to the blood-clotting condition for every single 2 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 restrictions in a positive 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.”