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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 decline to get the Pfizer-BioNTech or Moderna vaccines, pointing out security issues.

The agency said 60 cases of a severe however unusual blood-clotting condition have been determined, consisting of nine 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. said that weighing the risks of Johnson & & Johnson’s vaccine versus the advantages, it had decided to restrict its usage to adults 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 allergic reaction to the other two vaccines, the company stated.

It said the vaccine might also be provided 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 campaign; federal officials have said the mRNA vaccines produced by those business are both safer and more efficient. In a statement, Johnson & & Johnson said the F.D.A.’s action reflected the already-known threat of the side impact, not brand-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 financiers.

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 situation usage, federal authorities stopped briefly circulation of the vaccine for a safety evaluation. Regulators raised the pause 10 days later however added an alerting to instructions for its usage.

In December, the C.D.C. advised that adults looking for a booster shot select Moderna or Pfizer rather of Johnson & & Johnson, mentioning more advantages and lower threats. Combined with a host of producing difficulties in the United States, some specialists said, the firm’s judgment showed that the federal government had actually all however 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 4 times as numerous as were reported when last year’s time out in distribution was raised. In the interim, the variety of Johnson & & Johnson doses administered has a little more than doubled, while the number of Pfizer and Moderna receivers has increased.

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

In its statement, the F.D.A. pointed out more than 6 cases and close to one death attributed to the blood-clotting condition for every single 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 dose, 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.

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 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, citing safety concerns.

The agency said 60 cases of a unusual however severe blood-clotting condition have been identified, consisting of nine deaths, out of about 18 million doses 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 benefits, it had decided to limit its usage to adults who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “medically suitable.” One example would be people who experienced a severe allergic response to the other 2 vaccines, the firm stated.

It said the vaccine could 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 country’s vaccination project; federal officials have stated the mRNA vaccines produced by those business are both safer and more efficient. In a statement, Johnson & & Johnson stated the F.D.A.’s action showed the already-known danger of the side impact, not new data on the rate at which it occurs. However in an indication 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 activate a condition referred to as thrombosis with thrombocytopenia syndrome have bedeviled it from early on. In April 2021, not long after it was approved for emergency situation use, federal authorities stopped briefly circulation of the vaccine for a security assessment. Regulators raised the pause 10 days later on but added a warning to instructions for its usage.

Then, in December, the C.D.C. suggested that adults looking for a booster shot pick Moderna or Pfizer instead of Johnson & & Johnson, citing more advantages and lower dangers. Paired with a host of producing problems in the United States, some experts stated, the company’s judgment illustrated that the federal government had all however 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 four times as lots of as were reported when in 2015’s time out in circulation was lifted. In the interim, the number of Johnson & & Johnson doses administered has a little more than doubled, while the number of Pfizer and Moderna receivers has actually increased.

The variety of deaths credited to the disorder 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 statement, the F.D.A. pointed out more than six cases and close to one death attributed to the blood-clotting condition 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 information. By contrast, 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 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 adults, when compared to no vaccine.”

WASHINGTON– In yet another setback 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 concerns.

The firm said 60 cases of a rare however major blood-clotting condition have actually been determined, including nine deaths, out of about 18 million doses 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 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 appropriate.” One example would be individuals who experienced a severe allergy to the other 2 vaccines, the agency said.

It said the vaccine could likewise 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 country’s vaccination project; federal officials have stated the mRNA vaccines produced by those business are both more secure and more reliable. In a declaration, Johnson & & Johnson said the F.D.A.’s action reflected the already-known danger of the adverse effects, not new data on the rate at which it occurs. 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 activate a condition referred to as thrombosis with thrombocytopenia syndrome have bedeviled it from early on. In April 2021, not long after it was authorized for emergency use, federal authorities paused distribution of the vaccine for a security evaluation. Regulators raised the pause 10 days later on however included an alerting to instructions for its usage.

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. Combined with a host of manufacturing difficulties in the United States, some experts 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. statement 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 distribution 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 receivers has increased.

The variety of deaths associated to the disorder set off by the Johnson & & Johnson’s vaccine does not appear to have risen much, if at all. However there have been far fewer, if any, presumed deaths due to negative effects from the mRNA vaccines, federal health officials have actually said.

In its statement, the F.D.A. cited more than six cases and near to one death attributed to the blood-clotting condition for every 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 dosage, according to the C.D.C.’s data. By contrast, more than 200 million Americans have actually gotten at least 2 doses of either Moderna’s or Pfizer’s vaccine.

Trying to cast the tight brand-new constraints in a positive light, Johnson & & Johnson stated: “Data continue to support a beneficial benefit-risk profile for the Johnson & & Johnson COVID-19 vaccine in adults, when compared with no vaccine.”

WASHINGTON– In yet another setback 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, pointing out safety issues.

The firm said 60 cases of a serious but uncommon blood-clotting disorder have actually 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 suggested 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 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 individuals who experienced a severe allergic response to the other two vaccines, the firm stated.

It said the vaccine might likewise be offered 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 companies are both much safer and more effective. In a statement, Johnson & & Johnson stated the F.D.A.’s action reflected the already-known threat of the adverse effects, not new data on the rate at which it happens. In an indication 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 trigger a condition referred to as thrombosis with thrombocytopenia syndrome have bedeviled it from early on. In April 2021, not long after it was approved for emergency situation use, federal authorities stopped briefly circulation of the vaccine for a security examination. Regulators lifted the pause 10 days later but included an alerting to instructions for its usage.

Then, in December, the C.D.C. advised that adults looking for a booster shot pick Moderna or Pfizer rather of Johnson & & Johnson, pointing out more advantages and lower risks. Paired with a host of manufacturing problems in the United States, some professionals said, the firm’s judgment illustrated 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 last year’s time out in circulation was raised. In the interim, the number of Johnson & & Johnson doses administered has slightly more than doubled, while the variety of Pfizer and Moderna recipients has escalated.

The number of deaths associated to the condition triggered by the Johnson & & Johnson’s vaccine does not appear to have risen much, if at all. But there have actually been far fewer, if any, thought deaths due to side effects from the mRNA vaccines, federal health officials have actually said.

In its announcement, the F.D.A. cited more than 6 cases and near one death attributed to the blood-clotting disorder 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 data. By contrast, more than 200 million Americans have gotten at least two dosages of either Moderna’s or Pfizer’s vaccine.

Attempting 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 with no vaccine.”