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

The agency stated 60 cases of a unusual however major blood-clotting disorder have been recognized, including 9 deaths, out of about 18 million dosages administered. The action comes about 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 versus the benefits, it had actually decided 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 individuals who experienced a severe allergy to the other 2 vaccines, the company said.

It stated 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 campaign; federal officials have said the mRNA vaccines produced by those companies are both much safer and more effective. In a declaration, Johnson & & Johnson stated the F.D.A.’s action showed the already-known danger of the side effect, not brand-new data on the rate at which it occurs. However in an indication of the company’s own flagging interest in its vaccine, it has stopped supplying sales outlooks for the shot to investors.

Reports that the vaccine can trigger a condition called thrombosis with thrombocytopenia syndrome have actually bedeviled it from early on. In April 2021, not long after it was approved for emergency usage, federal authorities paused distribution of the vaccine for a safety examination. Regulators raised the pause 10 days later however included a warning to directions for its usage.

In December, the C.D.C. advised that adults seeking a booster shot select Moderna or Pfizer rather of Johnson & & Johnson, pointing out more advantages and lower threats. Combined with a host of manufacturing difficulties in the United States, some professionals stated, the company’s judgment showed that the federal government had actually 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 four times as numerous as were reported when last year’s time out in circulation was raised. In the interim, the number of Johnson & & Johnson dosages administered has a little more than doubled, while the number of Pfizer and Moderna recipients has actually escalated.

The number of deaths credited to the disorder set off 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 impacts from the mRNA vaccines, federal health officials have stated.

In its statement, the F.D.A. cited more than 6 cases and close to one death credited to the blood-clotting condition 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 comparison, more than 200 million Americans have gotten at least 2 doses of either Moderna’s or Pfizer’s vaccine.

Trying to cast the tight new constraints 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.”

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 decline to get the Pfizer-BioNTech or Moderna vaccines, citing safety issues.

The company said 60 cases of a major however unusual blood-clotting condition have been identified, including 9 deaths, out of about 18 million doses administered. The action comes about 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 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 proper.” One example would be people who experienced a severe allergic reaction to the other two vaccines, the company stated.

It said the vaccine could likewise be provided to grownups 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 stated the mRNA vaccines produced by those business are both more secure 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 new data on the rate at which it happens. In an indication of the firm’s own flagging interest in its vaccine, it has stopped providing sales outlooks for the shot to investors.

Reports that the vaccine can activate a condition called thrombosis with thrombocytopenia syndrome have bedeviled it from early on. In April 2021, not long after it was authorized for emergency situation usage, federal authorities paused circulation of the vaccine for a safety evaluation. Regulators raised the pause 10 days later but added a cautioning to instructions for its use.

Then, in December, the C.D.C. recommended that grownups seeking a booster shot choose Moderna or Pfizer instead of Johnson & & Johnson, mentioning more advantages and lower risks. Combined with a host of producing problems in the United States, some professionals stated, the company’s judgment showed that the federal government had actually all however 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 condition– or four times as many as were reported when in 2015’s time out in circulation was raised. In the interim, the variety of Johnson & & Johnson dosages administered has slightly more than doubled, while the number of Pfizer and Moderna receivers has actually skyrocketed.

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

In its announcement, the F.D.A. pointed out more than 6 cases and near one death associated to the blood-clotting condition 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 gotten a booster dose, according to the C.D.C.’s data. By contrast, more than 200 million Americans have gotten at least two dosages of either Moderna’s or Pfizer’s vaccine.

Trying to cast the tight 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 grownups, when compared to no vaccine.”

WASHINGTON– In yet another setback 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, citing safety concerns.

The firm said 60 cases of a rare however major blood-clotting disorder have been determined, including 9 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. stated that weighing the risks of Johnson & & Johnson’s vaccine versus the advantages, it had decided to restrict its use to grownups who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “medically proper.” One example would be people who experienced a severe allergy to the other 2 vaccines, the agency stated.

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

Johnson & & Johnson was eclipsed long back by Pfizer and Moderna in the country’s vaccination campaign; federal officials have stated the mRNA vaccines produced by those business are both much safer and more reliable. In a statement, Johnson & & Johnson said the F.D.A.’s action showed the already-known risk of the negative effects, not new data on the rate at which it happens. But in an indication of the firm’s own flagging interest in its vaccine, it has stopped supplying sales outlooks for the shot to financiers.

Reports that the vaccine can activate a condition called thrombosis 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 circulation of the vaccine for a safety assessment. Regulators raised the time out 10 days later on however included a warning to directions for its usage.

Then, in December, the C.D.C. suggested that adults looking for a booster shot select Moderna or Pfizer instead of Johnson & & Johnson, mentioning more benefits and lower threats. Coupled with a host of making problems in the United States, some specialists said, the firm’s judgment illustrated that the federal government had actually all but crossed out 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 numerous as were reported when last year’s pause in circulation was lifted. In the interim, the variety of Johnson & & Johnson dosages administered has slightly more than doubled, while the number of Pfizer and Moderna recipients has skyrocketed.

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

In its statement, the F.D.A. pointed out more than 6 cases and close to one death credited 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 dosage 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 actually gotten at least two dosages of either Moderna’s or Pfizer’s vaccine.

Trying to cast the tight 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 grownups, when compared with no vaccine.”

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

The company said 60 cases of a major but uncommon blood-clotting disorder have actually been identified, 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. stated that weighing the threats of Johnson & & Johnson’s vaccine versus the benefits, it had decided to restrict its usage 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 people who experienced a severe allergic response to the other two vaccines, the firm said.

It said the vaccine could likewise be given to grownups who “would otherwise not get a Covid-19 vaccine.”

Johnson & & Johnson was eclipsed long back by Pfizer and Moderna in the nation’s vaccination campaign; federal authorities have said the mRNA vaccines produced by those business are both safer and more effective. In a declaration, Johnson & & Johnson stated the F.D.A.’s action showed the already-known risk of the adverse effects, not new information on the rate at which it takes place. In a sign of the firm’s own flagging interest in its vaccine, it has stopped providing sales outlooks for the shot to investors.

Reports that the vaccine can activate a condition called apoplexy with thrombocytopenia syndrome have bedeviled it from early on. In April 2021, not long after it was approved for emergency usage, federal authorities stopped briefly circulation of the vaccine for a safety assessment. Regulators raised the pause 10 days later but included an alerting to directions for its usage.

Then, in December, the C.D.C. advised that adults looking for a booster shot pick Moderna or Pfizer instead of Johnson & & Johnson, pointing out more advantages and lower dangers. Paired with a host of producing problems in the United States, some specialists stated, the company’s judgment showed that the federal government had actually all however 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 numerous as were reported when last year’s pause in circulation was raised. 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 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 actually been far fewer, if any, thought deaths due to side effects from the mRNA vaccines, federal health officials have actually stated.

In its statement, the F.D.A. cited more than six cases and near to one death credited to the blood-clotting disorder for each two million shots of Johnson & & Johnson vaccine administered in the United States.

About 17 million Americans have actually now gotten one dosage of Johnson & & Johnson’s vaccine, and another 1.5 million have gotten a booster dosage, according to the C.D.C.’s data. By contrast, 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 beneficial benefit-risk profile for the Johnson & & Johnson COVID-19 vaccine in adults, when compared to no vaccine.”