FDA Further Limits Johnson & Johnson Covid Vaccine
WASHINGTON– In yet another problem for Johnson & & Johnson’s coronavirus vaccine, the Food and Drug Administration on Thursday restricted its usage to grownups who can not or decline to get the Pfizer-BioNTech or Moderna vaccines, citing security issues.
The firm said 60 cases of a major but unusual blood-clotting condition have been determined, including nine deaths, out of about 18 million doses administered. The action happens 5 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 versus the benefits, it had 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 a severe allergic response to the other two vaccines, the agency said.
It stated the vaccine might likewise be provided to grownups who “would otherwise not get a Covid-19 vaccine.”
Johnson & & Johnson was eclipsed long ago by Pfizer and Moderna in the nation’s vaccination campaign; federal officials have said the mRNA vaccines produced by those business are both safer and more effective. In a statement, Johnson & & Johnson said the F.D.A.’s action reflected the already-known risk of the negative effects, not brand-new information on the rate at which it occurs. In an indication of the company’s own flagging interest in its vaccine, it has stopped providing sales outlooks for the shot to financiers.
Reports that the vaccine can set off a condition understood as apoplexy with thrombocytopenia syndrome have bedeviled it from early on. In April 2021, not long after it was authorized for emergency situation use, federal authorities paused distribution of the vaccine for a safety examination. Regulators raised the pause 10 days later on but added an alerting to instructions for its usage.
Then, in December, the C.D.C. advised that adults looking for a booster shot select Moderna or Pfizer rather of Johnson & & Johnson, pointing out more benefits and lower dangers. Combined with a host of producing troubles in the United States, some specialists stated, the agency’s judgment highlighted that the federal government had actually all but written off 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 lots of as were reported when last year’s time out in circulation was raised. In the interim, the variety of Johnson & & Johnson dosages administered has a little more than doubled, while the variety of Pfizer and Moderna recipients has skyrocketed.
The variety of deaths attributed to the condition activated by the Johnson & & Johnson’s vaccine does not appear to have increased much, if at all. There have actually been far fewer, if any, presumed deaths due to side effects from the mRNA vaccines, federal health authorities have said.
In its announcement, the F.D.A. mentioned more than six cases and near one death credited to the blood-clotting condition for every two million shots of Johnson & & Johnson vaccine administered in the United States.
About 17 million Americans have 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 2 dosages of either Moderna’s or Pfizer’s vaccine.
Attempting to cast the tight new constraints in a favorable light, Johnson & & Johnson said: “Data continue to support a favorable benefit-risk profile for the Johnson & & Johnson COVID-19 vaccine in adults, when compared with no vaccine.”
Johnson & & Johnson was eclipsed long earlier by Pfizer and Moderna in the nation’s vaccination project; federal officials have said the mRNA vaccines produced by those business are both safer and more effective. In a statement, Johnson & & Johnson stated the F.D.A.’s action reflected the already-known threat of the side effect, not brand-new data on the rate at which it occurs. The number of deaths attributed to the condition triggered by the Johnson & & Johnson’s vaccine does not appear to have risen much, if at all. About 17 million Americans have 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.