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WASHINGTON– In yet another problem 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 security issues.

The company said 60 cases of a uncommon however severe blood-clotting disorder have actually been determined, including nine deaths, out of about 18 million dosages 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. stated that weighing the dangers of Johnson & & Johnson’s vaccine against the advantages, 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 “clinically proper.” One example would be individuals who experienced an extreme allergic reaction to the other two vaccines, the firm stated.

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

Johnson & & Johnson was eclipsed long ago 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 efficient. In a declaration, Johnson & & Johnson said the F.D.A.’s action showed the already-known danger of the side impact, not 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 supplying sales outlooks for the shot to investors.

Reports that the vaccine can trigger 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 usage, federal authorities paused distribution of the vaccine for a safety assessment. Regulators raised the time out 10 days later on but included an alerting to guidelines for its usage.

In December, the C.D.C. advised that grownups seeking a booster shot choose Moderna or Pfizer instead of Johnson & & Johnson, citing more benefits and lower risks. Combined with a host of producing problems in the United States, some specialists said, the agency’s judgment showed that the federal government had actually 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 lots of as were reported when last year’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 variety of deaths associated to the condition activated by the Johnson & & Johnson’s vaccine does not appear to have risen much, if at all. There have been far fewer, if any, believed deaths due to side impacts from the mRNA vaccines, federal health officials have stated.

In its announcement, the F.D.A. cited more than six cases and near 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 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 data. 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 adults, when compared with 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 decline to get the Pfizer-BioNTech or Moderna vaccines, mentioning safety issues.

The company said 60 cases of a rare however major blood-clotting condition have been determined, including 9 deaths, out of about 18 million doses administered. The action happens 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. said that weighing the threats of Johnson & & Johnson’s vaccine versus the advantages, 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 “scientifically appropriate.” One example would be individuals who experienced an extreme allergic reaction to the other 2 vaccines, the company stated.

It said the vaccine could also be given 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 business are both much safer and more efficient. In a declaration, Johnson & & Johnson stated the F.D.A.’s action reflected the already-known threat of the negative effects, not new information on the rate at which it takes place. However in an indication 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 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 authorized for emergency usage, federal authorities paused distribution of the vaccine for a security assessment. Regulators raised the pause 10 days later on however added a warning to directions for its usage.

In December, the C.D.C. advised that adults looking for a booster shot select Moderna or Pfizer instead of Johnson & & Johnson, mentioning more advantages and lower risks. Combined with a host of manufacturing difficulties in the United States, some specialists said, the agency’s judgment illustrated 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 disorder– or 4 times as numerous as were reported when in 2015’s time out in distribution 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 increased.

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

In its announcement, the F.D.A. mentioned more than six cases and close to 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 dose, according to the C.D.C.’s information. 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 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 to no vaccine.”

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

The company stated 60 cases of a major but rare blood-clotting condition have been identified, including 9 deaths, out of about 18 million dosages administered. The action happens 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 dangers of Johnson & & Johnson’s vaccine against the benefits, 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 “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 might also 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 efficient. In a declaration, 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. But 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 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 usage, federal authorities paused distribution of the vaccine for a safety examination. Regulators raised the time out 10 days later however added a cautioning to guidelines for its usage.

Then, in December, the C.D.C. advised that grownups looking for a booster shot select Moderna or Pfizer rather of Johnson & & Johnson, mentioning more benefits and lower threats. Paired with a host of making troubles in the United States, some experts said, the agency’s judgment illustrated 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 disorder– or four 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 slightly 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 increased much, if at all. But there have actually been far fewer, if any, presumed deaths due to side effects 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 credited 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 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 gotten at least 2 dosages of either Moderna’s or Pfizer’s vaccine.

Attempting 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 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 adults who can not or decline to get the Pfizer-BioNTech or Moderna vaccines, mentioning security concerns.

The agency said 60 cases of a rare but serious blood-clotting disorder have actually been identified, including 9 deaths, out of about 18 million doses 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. said that weighing the risks 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 “medically appropriate.” One example would be people who experienced a severe allergic response to the other two vaccines, the agency said.

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

Johnson & & Johnson was eclipsed long ago by Pfizer and Moderna in the country’s vaccination campaign; federal officials have stated the mRNA vaccines produced by those companies are both more secure and more reliable. In a declaration, Johnson & & Johnson stated the F.D.A.’s action reflected the already-known threat of the adverse effects, not brand-new information on the rate at which it happens. However 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 activate a condition known as 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 stopped briefly distribution of the vaccine for a safety evaluation. Regulators raised the pause 10 days later on however included a cautioning to instructions for its use.

In December, the C.D.C. advised that adults seeking a booster shot pick Moderna or Pfizer instead of Johnson & & Johnson, pointing out more advantages and lower risks. Coupled with a host of producing troubles in the United States, some professionals said, the firm’s judgment illustrated that the federal government had 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 lots of as were reported when in 2015’s pause 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 recipients has escalated.

The number of deaths credited to the disorder triggered by the Johnson & & Johnson’s vaccine does not appear to have risen much, if at all. But there have been far less, if any, believed deaths due to adverse effects from the mRNA vaccines, federal health authorities have actually said.

In its statement, the F.D.A. cited more than 6 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 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 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 beneficial benefit-risk profile for the Johnson & & Johnson COVID-19 vaccine in adults, when compared to no vaccine.”