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

The company stated 60 cases of a serious however unusual blood-clotting condition have actually been recognized, including 9 deaths, out of about 18 million doses administered. The action comes about 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. said that weighing the risks of Johnson & & Johnson’s vaccine versus the benefits, it had decided to limit its use to grownups who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “scientifically appropriate.” One example would be individuals who experienced an extreme allergy to the other 2 vaccines, the company said.

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

Johnson & & Johnson was eclipsed long back by Pfizer and Moderna in the nation’s vaccination campaign; federal officials have said the mRNA vaccines produced by those companies are both safer and more effective. In a statement, Johnson & & Johnson stated the F.D.A.’s action showed the already-known threat of the negative effects, not brand-new data on the rate at which it happens. In a sign of the company’s own flagging interest in its vaccine, it has stopped providing sales outlooks for the shot to investors.

Reports that the vaccine can trigger a condition called apoplexy with thrombocytopenia syndrome have bedeviled it from early on. In April 2021, not long after it was authorized for emergency use, federal authorities paused circulation of the vaccine for a safety evaluation. Regulators raised the time out 10 days later on however added a warning to guidelines for its use.

In December, the C.D.C. suggested that adults seeking a booster shot select Moderna or Pfizer instead of Johnson & & Johnson, pointing out more benefits and lower risks. Combined with a host of producing difficulties in the United States, some professionals said, the firm’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 four times as lots of as were reported when in 2015’s time out in circulation was lifted. In the interim, the variety of Johnson & & Johnson doses administered has somewhat more than doubled, while the variety of Pfizer and Moderna recipients has actually increased.

The number of deaths attributed to the condition set off by the Johnson & & Johnson’s vaccine does not appear to have increased much, if at all. However there have been far less, if any, thought deaths due to adverse effects from the mRNA vaccines, federal health officials have said.

In its announcement, the F.D.A. pointed out more than 6 cases and close 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 dosage, according to the C.D.C.’s information. By contrast, more than 200 million Americans have actually gotten at least 2 dosages of either Moderna’s or Pfizer’s vaccine.

Attempting to cast the tight brand-new limitations 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.”

WASHINGTON– In yet another obstacle 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, mentioning safety issues.

The company said 60 cases of a rare however serious blood-clotting condition have actually been identified, consisting of nine deaths, out of about 18 million dosages administered. The action comes about 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. said that weighing the dangers of Johnson & & Johnson’s vaccine versus the benefits, it had actually chosen to limit its use to grownups who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “clinically suitable.” One example would be individuals who experienced an extreme allergic reaction to the other two vaccines, the company stated.

It said the vaccine might also 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 project; federal officials have said the mRNA vaccines produced by those business are both much safer and more efficient. In a statement, Johnson & & Johnson said the F.D.A.’s action reflected the already-known threat of the negative effects, not brand-new information on the rate at which it occurs. But in a sign of the company’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 referred to as apoplexy 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 security evaluation. Regulators lifted the pause 10 days later however included a warning to instructions 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 advantages and lower dangers. Coupled with a host of manufacturing difficulties in the United States, some professionals said, the company’s judgment highlighted that the federal government had all however composed off 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 four times as lots of as were reported when last year’s pause in circulation was raised. In the interim, the number of Johnson & & Johnson dosages administered has slightly more than doubled, while the number of Pfizer and Moderna recipients has increased.

The number of deaths credited to the condition triggered by the Johnson & & Johnson’s vaccine does not appear to have risen much, if at all. There have been far fewer, if any, thought deaths due to side results from the mRNA vaccines, federal health authorities have actually stated.

In its announcement, the F.D.A. pointed out more than six cases and near to one death associated to the blood-clotting disorder for every 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 data. By comparison, 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 constraints in a favorable light, Johnson & & Johnson stated: “Data continue to support a favorable benefit-risk profile for the Johnson & & Johnson COVID-19 vaccine in adults, when compared to no vaccine.”

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

The firm said 60 cases of a uncommon however severe blood-clotting disorder have been recognized, including 9 deaths, out of about 18 million doses administered. The action happens 5 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. said that weighing the risks of Johnson & & Johnson’s vaccine against the benefits, it had chosen to restrict its usage to grownups who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “scientifically suitable.” One example would be people who experienced a severe allergy to the other 2 vaccines, the firm said.

It stated the vaccine could also be provided to grownups who “would otherwise not get a Covid-19 vaccine.”

Johnson & & Johnson was eclipsed long earlier by Pfizer and Moderna in the country’s vaccination project; federal officials have said the mRNA vaccines produced by those companies are both more secure and more effective. In a declaration, Johnson & & Johnson stated the F.D.A.’s action reflected the already-known risk of the adverse effects, not brand-new information on the rate at which it happens. But 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 set off 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 situation usage, federal authorities stopped briefly circulation of the vaccine for a security evaluation. Regulators lifted the pause 10 days later however added an alerting to directions for its usage.

Then, in December, the C.D.C. recommended that adults seeking a booster shot pick Moderna or Pfizer instead of Johnson & & Johnson, mentioning more benefits and lower dangers. Combined with a host of making problems in the United States, some experts stated, the company’s judgment highlighted that the federal government had actually all but 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 disorder– or four times as many as were reported when last year’s time out in circulation was raised. In the interim, the number of Johnson & & Johnson dosages administered has somewhat more than doubled, while the variety of Pfizer and Moderna receivers has escalated.

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 been far fewer, if any, presumed deaths due to side impacts from the mRNA vaccines, federal health officials have actually said.

In its statement, the F.D.A. mentioned more than six cases and near one death associated to the blood-clotting disorder for every single 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 dosage, according to the C.D.C.’s information. 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 new constraints in a positive 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.”