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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, pointing out safety concerns.

The firm said 60 cases of a severe but rare blood-clotting disorder have actually been determined, including nine deaths, out of about 18 million dosages 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 risks of Johnson & & Johnson’s vaccine against the advantages, it had actually decided to limit its usage to grownups 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 a severe allergic reaction to the other 2 vaccines, the company said.

It stated the vaccine could also be provided to adults 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 authorities have stated the mRNA vaccines produced by those companies are both safer and more efficient. In a declaration, Johnson & & Johnson stated the F.D.A.’s action reflected the already-known danger of the adverse effects, not new information on the rate at which it takes place. 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 trigger a condition known as thrombosis with thrombocytopenia syndrome have actually bedeviled it from early on. In April 2021, not long after it was authorized for emergency situation usage, federal authorities stopped briefly distribution of the vaccine for a safety evaluation. Regulators raised the time out 10 days later on however added a cautioning to instructions for its use.

Then, 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 dangers. Coupled with a host of making problems in the United States, some experts stated, 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. announcement on Thursday, federal authorities now have 60 reports of the blood-clotting disorder– or four times as numerous as were reported when in 2015’s time out in circulation was lifted. In the interim, the number of Johnson & & Johnson dosages administered has slightly more than doubled, while the number of Pfizer and Moderna recipients has skyrocketed.

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

In its announcement, the F.D.A. cited more than six cases and near to one death credited to the blood-clotting disorder 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 actually gotten at least 2 dosages of either Moderna’s or Pfizer’s vaccine.

Trying to cast the tight brand-new limitations in a positive light, Johnson & & Johnson stated: “Data continue to support a favorable benefit-risk profile for the Johnson & & Johnson COVID-19 vaccine in adults, when compared with no 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, pointing out safety concerns.

The firm stated 60 cases of a major but uncommon blood-clotting condition have been identified, including nine 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. stated that weighing the dangers of Johnson & & Johnson’s vaccine against the advantages, it had decided to restrict its use to adults who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “clinically appropriate.” One example would be individuals who experienced an extreme allergic response to the other two vaccines, the agency said.

It said the vaccine could also be offered to adults who “would otherwise not get a Covid-19 vaccine.”

Johnson & & Johnson was eclipsed long earlier 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 reliable. In a declaration, Johnson & & Johnson said the F.D.A.’s action showed the already-known risk of the side result, not brand-new information on the rate at which it takes place. However in a sign 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 set off 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 examination. Regulators raised the time out 10 days later but included a warning to directions for its use.

Then, in December, the C.D.C. suggested that adults seeking a booster shot pick Moderna or Pfizer instead of Johnson & & Johnson, citing more advantages and lower threats. Coupled with a host of producing difficulties in the United States, some professionals stated, the company’s judgment highlighted 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 condition– or 4 times as numerous as were reported when in 2015’s time out in distribution was lifted. In the interim, the number of Johnson & & Johnson doses administered has slightly more than doubled, while the number of Pfizer and Moderna recipients has skyrocketed.

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

In its statement, the F.D.A. mentioned more than 6 cases and close to one death attributed to the blood-clotting disorder 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 dose, according to the C.D.C.’s information. By contrast, more than 200 million Americans have actually gotten at least two doses of either Moderna’s or Pfizer’s vaccine.

Trying 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.”

WASHINGTON– In yet another problem 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 issues.

The company said 60 cases of a rare but serious blood-clotting disorder have been recognized, including 9 deaths, out of about 18 million dosages 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. stated that weighing the threats 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 “clinically suitable.” One example would be individuals who experienced a severe allergy to the other 2 vaccines, the firm stated.

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

Johnson & & Johnson was eclipsed long earlier by Pfizer and Moderna in the nation’s vaccination project; federal authorities have stated the mRNA vaccines produced by those companies are both safer and more reliable. In a statement, Johnson & & Johnson said the F.D.A.’s action reflected the already-known threat of the negative effects, not brand-new data on the rate at which it happens. But in a sign of the firm’s own flagging interest in its vaccine, it has stopped offering 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 authorized for emergency situation usage, federal authorities paused distribution of the vaccine for a security evaluation. Regulators raised the time out 10 days later but added a warning to instructions for its usage.

In December, the C.D.C. advised that adults seeking a booster shot pick Moderna or Pfizer instead of Johnson & & Johnson, mentioning more advantages and lower dangers. Paired with a host of manufacturing troubles in the United States, some professionals stated, the firm’s judgment illustrated that the federal government had 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 disorder– or four times as numerous as were reported when last year’s time out in distribution was lifted. In the interim, the variety of Johnson & & Johnson doses administered has somewhat more than doubled, while the variety of Pfizer and Moderna receivers has increased.

The variety of deaths attributed to the disorder activated by the Johnson & & Johnson’s vaccine does not appear to have actually increased much, if at all. There have been far fewer, if any, thought deaths due to side effects from the mRNA vaccines, federal health authorities have actually said.

In its statement, the F.D.A. mentioned more than six cases and close to one death associated to the blood-clotting condition 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 actually gotten a booster dose, according to the C.D.C.’s data. By contrast, more than 200 million Americans have gotten at least 2 doses of either Moderna’s or Pfizer’s vaccine.

Trying to cast the tight brand-new restrictions 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 problem for Johnson & & Johnson’s coronavirus vaccine, the Food and Drug Administration on Thursday limited its usage to grownups who can not or refuse to get the Pfizer-BioNTech or Moderna vaccines, citing safety concerns.

The company said 60 cases of a uncommon but severe blood-clotting condition have been determined, including nine deaths, out of about 18 million dosages administered. The action comes about 5 months after the Centers for Disease Control and Prevention recommended 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 chosen to limit its usage 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 a severe allergy to the other two vaccines, the agency said.

It stated the vaccine might 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 stated the mRNA vaccines produced by those companies are both much safer and more reliable. In a declaration, Johnson & & Johnson said 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 takes place. In a sign of the firm’s own flagging interest in its vaccine, it has stopped offering sales outlooks for the shot to investors.

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 assessment. Regulators lifted the pause 10 days later but included a cautioning to instructions for its usage.

Then, in December, the C.D.C. suggested that grownups looking for a booster shot pick Moderna or Pfizer instead of Johnson & & Johnson, citing more advantages and lower risks. Combined with a host of manufacturing difficulties in the United States, some specialists said, 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. statement on Thursday, federal authorities now have 60 reports of the blood-clotting condition– or 4 times as many as were reported when last year’s pause in circulation was raised. In the interim, the variety of Johnson & & Johnson dosages administered has a little more than doubled, while the number of Pfizer and Moderna recipients has actually increased.

The number of deaths credited to the condition activated by the Johnson & & Johnson’s vaccine does not appear to have increased much, if at all. However there have actually been far fewer, if any, believed deaths due to adverse effects from the mRNA vaccines, federal health officials have stated.

In its announcement, the F.D.A. pointed out more than six cases and near to one death associated to the blood-clotting condition for every 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 actually gotten a booster dose, according to the C.D.C.’s data. By comparison, more than 200 million Americans have gotten at least 2 dosages of either Moderna’s or Pfizer’s vaccine.

Trying to cast the tight 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 to no vaccine.”

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

The firm said 60 cases of a serious however unusual blood-clotting condition have been identified, consisting of nine deaths, out of about 18 million doses administered. The action comes about five months after the Centers for Disease Control and Prevention recommended 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 adults who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “medically appropriate.” One example would be individuals who experienced an extreme allergy to the other two vaccines, the company said.

It stated the vaccine could also be offered 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 project; 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 danger of the negative effects, not new information on the rate at which it occurs. In a sign 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 trigger a condition known as apoplexy with thrombocytopenia syndrome have actually bedeviled it from early on. In April 2021, not long after it was authorized for emergency situation usage, federal authorities stopped briefly circulation of the vaccine for a safety examination. Regulators lifted the pause 10 days later but added a cautioning to instructions for its usage.

Then, in December, the C.D.C. advised that grownups looking for a booster shot choose Moderna or Pfizer instead of Johnson & & Johnson, mentioning more advantages and lower risks. Paired with a host of manufacturing difficulties in the United States, some professionals stated, the agency’s judgment highlighted that the federal government had actually all but 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 condition– or 4 times as numerous as were reported when in 2015’s pause in circulation was raised. In the interim, the variety of Johnson & & Johnson dosages administered has somewhat more than doubled, while the variety of Pfizer and Moderna recipients has actually escalated.

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. There have actually 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 six cases and close to one death credited to the blood-clotting disorder for each 2 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 actually gotten a booster dose, 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.

Trying to cast the tight new restrictions 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 with no vaccine.”