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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 grownups who can not or decline to get the Pfizer-BioNTech or Moderna vaccines, pointing out safety concerns.

The agency stated 60 cases of a severe but uncommon blood-clotting condition 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 dangers of Johnson & & Johnson’s vaccine against 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 proper.” One example would be individuals who experienced an extreme allergy to the other 2 vaccines, the firm 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 ago 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 efficient. In a declaration, Johnson & & Johnson said 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 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 financiers.

Reports that the vaccine can set off 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 usage, federal authorities stopped briefly circulation of the vaccine for a security assessment. Regulators raised the time out 10 days later but included an alerting to instructions for its use.

In December, the C.D.C. suggested that adults seeking a booster shot choose Moderna or Pfizer rather of Johnson & & Johnson, mentioning more benefits and lower threats. Paired with a host of producing troubles in the United States, some experts stated, the agency’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 numerous as were reported when last year’s pause in distribution was raised. In the interim, the number of Johnson & & Johnson doses administered has somewhat more than doubled, while the number of Pfizer and Moderna receivers has escalated.

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

In its announcement, the F.D.A. cited more than six cases and near 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 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 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 restrictions 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.”

WASHINGTON– In yet another setback 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 security issues.

The company stated 60 cases of a unusual but major blood-clotting disorder 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. said that weighing the risks of Johnson & & Johnson’s vaccine versus the benefits, it had actually 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 suitable.” One example would be people who experienced an extreme allergy to the other 2 vaccines, the company said.

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

Johnson & & Johnson was eclipsed long ago by Pfizer and Moderna in the nation’s vaccination project; federal authorities have said the mRNA vaccines produced by those business are both safer and more effective. In a declaration, Johnson & & Johnson said 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. However in an indication 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 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 security assessment. Regulators lifted the time out 10 days later but added an alerting to directions for its usage.

Then, in December, the C.D.C. advised that grownups looking for a booster shot pick Moderna or Pfizer instead of Johnson & & Johnson, mentioning more benefits and lower threats. Combined with a host of producing troubles in the United States, some professionals stated, the firm’s judgment showed that the federal government had all but written off 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 many as were reported when in 2015’s pause in circulation was raised. In the interim, the number of Johnson & & Johnson doses administered has slightly more than doubled, while the number of Pfizer and Moderna receivers has escalated.

The variety 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 been far less, if any, suspected deaths due to side results from the mRNA vaccines, federal health officials have actually 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 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 actually gotten a booster dosage, according to the C.D.C.’s information. 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 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 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 use to adults who can not or refuse to get the Pfizer-BioNTech or Moderna vaccines, citing security issues.

The firm said 60 cases of a uncommon however serious blood-clotting condition have actually been determined, including 9 deaths, out of about 18 million doses administered. The action happens 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 risks of Johnson & & Johnson’s vaccine against 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 “medically appropriate.” One example would be individuals who experienced an extreme allergy to the other two vaccines, the firm stated.

It stated the vaccine could likewise 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 country’s vaccination project; federal authorities have said the mRNA vaccines produced by those companies are both more secure and more effective. In a declaration, Johnson & & Johnson said the F.D.A.’s action showed the already-known threat of the adverse effects, not brand-new data on the rate at which it takes place. In a sign of the company’s own flagging interest in its vaccine, it has stopped offering sales outlooks for the shot to investors.

Reports that the vaccine can activate 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 use, federal authorities paused distribution of the vaccine for a security evaluation. Regulators lifted the time out 10 days later but included a cautioning to guidelines for its use.

In December, the C.D.C. advised that grownups looking for a booster shot choose Moderna or Pfizer rather of Johnson & & Johnson, mentioning more benefits and lower risks. Coupled with a host of producing difficulties in the United States, some specialists stated, the agency’s judgment illustrated that the federal government had 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 4 times as lots of as were reported when last year’s time out in circulation was lifted. In the interim, the number of Johnson & & Johnson dosages administered has a little more than doubled, while the number of Pfizer and Moderna receivers has actually escalated.

The number of deaths credited to the disorder triggered 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 impacts from the mRNA vaccines, federal health authorities have said.

In its statement, the F.D.A. pointed out more than six cases and near one death credited to the blood-clotting disorder for every 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 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 brand-new limitations 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 adults who can not or refuse to get the Pfizer-BioNTech or Moderna vaccines, pointing out safety concerns.

The company said 60 cases of a severe but rare blood-clotting condition have actually been determined, including 9 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 risks of Johnson & & Johnson’s vaccine versus the advantages, 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 appropriate.” One example would be people who experienced an extreme allergic response to the other 2 vaccines, the agency stated.

It said 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 country’s vaccination campaign; federal officials have said the mRNA vaccines produced by those business are both much 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 information on the rate at which it happens. In an indication of the company’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 thrombosis with thrombocytopenia syndrome have actually 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 safety assessment. Regulators raised the time out 10 days later on however included an alerting to directions for its use.

Then, in December, the C.D.C. suggested that adults looking for a booster shot select Moderna or Pfizer rather of Johnson & & Johnson, pointing out more advantages and lower risks. Combined with a host of producing troubles in the United States, some experts stated, the agency’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 4 times as numerous as were reported when in 2015’s pause in distribution was raised. In the interim, the variety of Johnson & & Johnson doses administered has slightly more than doubled, while the variety of Pfizer and Moderna recipients has increased.

The number of deaths attributed 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 less, if any, thought deaths due to side results from the mRNA vaccines, federal health officials have actually said.

In its announcement, the F.D.A. pointed out more than 6 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 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 actually gotten at least 2 doses of either Moderna’s or Pfizer’s vaccine.

Trying to cast the tight brand-new limitations in a favorable 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.”