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

The company said 60 cases of a uncommon but major 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 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 chosen to limit 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 an extreme allergy to the other 2 vaccines, the agency 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 back by Pfizer and Moderna in the country’s vaccination campaign; federal authorities have said the mRNA vaccines produced by those companies are both more secure and more efficient. In a statement, Johnson & & Johnson stated the F.D.A.’s action reflected the already-known threat of the negative effects, not brand-new information on the rate at which it happens. 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 activate a condition known as 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 distribution of the vaccine for a safety assessment. Regulators raised the time out 10 days later on however included a warning to guidelines for its usage.

Then, in December, the C.D.C. advised that adults looking for a booster shot select Moderna or Pfizer rather of Johnson & & Johnson, mentioning more benefits and lower threats. Combined with a host of manufacturing problems in the United States, some specialists said, the firm’s judgment illustrated that the federal government had all however 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 disorder– or 4 times as lots of as were reported when last year’s time out in circulation was lifted. In the interim, the variety of Johnson & & Johnson doses administered has slightly more than doubled, while the variety of Pfizer and Moderna receivers has escalated.

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

In its statement, the F.D.A. pointed out more than six cases and close 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 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 restrictions in a favorable light, Johnson & & Johnson said: “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 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 safety issues.

The company said 60 cases of a rare however severe blood-clotting disorder have actually been recognized, including 9 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. stated that weighing the dangers of Johnson & & Johnson’s vaccine versus 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 “scientifically appropriate.” One example would be individuals who experienced a severe allergy to the other two vaccines, the agency stated.

It stated the vaccine could also be offered to adults who “would otherwise not receive 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 companies are both safer 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 new data on the rate at which it happens. 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 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 usage, federal authorities stopped briefly circulation of the vaccine for a security evaluation. Regulators lifted the time out 10 days later however included a cautioning to directions for its usage.

In December, the C.D.C. recommended that adults looking for a booster shot pick Moderna or Pfizer rather of Johnson & & Johnson, citing more advantages and lower threats. Combined with a host of producing difficulties in the United States, some experts said, the company’s judgment showed 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 4 times as many as were reported when in 2015’s pause in circulation was raised. In the interim, the variety of Johnson & & Johnson doses administered has slightly more than doubled, while the variety 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 increased much, if at all. But there have actually been far less, if any, presumed deaths due to negative effects from the mRNA vaccines, federal health authorities have stated.

In its statement, the F.D.A. mentioned 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 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 information. By comparison, 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 restrictions 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 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, pointing out security concerns.

The company stated 60 cases of a rare however major blood-clotting disorder have been identified, consisting of 9 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 dangers of Johnson & & Johnson’s vaccine against the benefits, it had actually 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 individuals who experienced an extreme allergic reaction to the other two vaccines, the company stated.

It said the vaccine might likewise be provided 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 campaign; federal officials have stated the mRNA vaccines produced by those business are both safer and more reliable. In a statement, Johnson & & Johnson stated 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 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 investors.

Reports that the vaccine can trigger a condition called thrombosis 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 examination. Regulators lifted the pause 10 days later however included an alerting to guidelines for its use.

Then, in December, the C.D.C. advised that grownups looking for a booster shot choose Moderna or Pfizer instead of Johnson & & Johnson, pointing out more benefits and lower risks. Combined with a host of making troubles in the United States, some specialists stated, the firm’s judgment highlighted 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 disorder– or 4 times as many as were reported when in 2015’s pause in circulation was lifted. In the interim, the variety of Johnson & & Johnson dosages administered has somewhat more than doubled, while the variety of Pfizer and Moderna receivers has actually increased.

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

In its statement, the F.D.A. cited more than 6 cases and near 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 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 two doses of either Moderna’s or Pfizer’s vaccine.

Attempting to cast the tight new restrictions in a favorable 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 obstacle 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 concerns.

The agency stated 60 cases of a uncommon however severe blood-clotting disorder have been recognized, 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 risks of Johnson & & Johnson’s vaccine versus the benefits, it had actually 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 two vaccines, the company said.

It said the vaccine might also be provided to adults 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 officials have said the mRNA vaccines produced by those business are both much safer and more effective. In a declaration, 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 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 authorized for emergency use, federal authorities stopped briefly circulation of the vaccine for a safety assessment. Regulators lifted the time out 10 days later however included a warning to instructions for its use.

Then, in December, the C.D.C. recommended that grownups seeking a booster shot pick Moderna or Pfizer instead of Johnson & & Johnson, pointing out more advantages and lower dangers. Paired with a host of making problems in the United States, some experts said, the company’s judgment showed that the federal government had all however 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 numerous as were reported when last year’s pause in circulation was lifted. 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 actually skyrocketed.

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

In its announcement, 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 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 information. By contrast, more than 200 million Americans have actually gotten at least 2 dosages of either Moderna’s or Pfizer’s vaccine.

Attempting to cast the tight new restrictions 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.”