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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, pointing out security issues.

The company said 60 cases of a uncommon but serious blood-clotting condition have been identified, consisting of 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. said that weighing the dangers of Johnson & & Johnson’s vaccine against the advantages, 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 “clinically proper.” One example would be people who experienced a severe allergy to the other 2 vaccines, the company said.

It said the vaccine could likewise 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 authorities have said the mRNA vaccines produced by those companies are both much safer and more efficient. In a statement, Johnson & & Johnson said the F.D.A.’s action showed the already-known risk of the adverse effects, not brand-new information on the rate at which it occurs. But 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 activate 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 situation use, federal authorities paused distribution of the vaccine for a safety assessment. Regulators raised the pause 10 days later however added a warning to guidelines for its usage.

In December, the C.D.C. recommended that adults looking for a booster shot select Moderna or Pfizer instead of Johnson & & Johnson, mentioning more benefits and lower risks. Paired with a host of making difficulties in the United States, some experts stated, the firm’s judgment highlighted that the federal government had 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 disorder– or four 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 a little more than doubled, while the number of Pfizer and Moderna recipients has actually skyrocketed.

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

In its announcement, the F.D.A. mentioned more than six cases and near one death attributed to the blood-clotting disorder for each 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 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 brand-new limitations in a positive light, Johnson & & Johnson said: “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 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, mentioning safety issues.

The firm stated 60 cases of a rare however serious blood-clotting disorder have been recognized, consisting of 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 dangers of Johnson & & Johnson’s vaccine versus the advantages, it had decided to limit its use 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 an extreme allergic reaction to the other two vaccines, the company stated.

It stated the vaccine might also be provided to grownups 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 authorities have said the mRNA vaccines produced by those business are both much safer and more effective. In a declaration, Johnson & & Johnson stated 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 occurs. 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 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 usage, federal authorities stopped briefly distribution of the vaccine for a security examination. Regulators lifted the pause 10 days later on but included an alerting to instructions for its use.

Then, in December, the C.D.C. advised that grownups looking for a booster shot pick Moderna or Pfizer rather of Johnson & & Johnson, citing more benefits and lower dangers. Coupled with a host of manufacturing troubles in the United States, some experts said, the agency’s judgment showed 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 condition– or 4 times as many as were reported when last year’s pause in circulation was lifted. In the interim, the number of Johnson & & Johnson dosages administered has slightly more than doubled, while the variety of Pfizer and Moderna receivers has escalated.

The number of deaths associated 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, suspected deaths due to side impacts from the mRNA vaccines, federal health officials have said.

In its announcement, the F.D.A. cited 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 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 comparison, 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 positive light, Johnson & & Johnson said: “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 grownups who can not or decline 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 been recognized, including nine 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. stated that weighing the dangers of Johnson & & Johnson’s vaccine against the advantages, 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 suitable.” One example would be individuals who experienced an extreme allergic reaction to the other 2 vaccines, the company said.

It said the vaccine could likewise 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 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 showed the already-known risk of the negative 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 financiers.

Reports that the vaccine can set off 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 circulation of the vaccine for a safety evaluation. Regulators raised the time out 10 days later however included a warning to instructions for its use.

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 dangers. Coupled with a host of manufacturing problems in the United States, some experts stated, 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 disorder– or 4 times as many as were reported when last year’s time out in distribution was raised. In the interim, the number of Johnson & & Johnson doses 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 activated by the Johnson & & Johnson’s vaccine does not appear to have actually increased much, if at all. However there have actually been far fewer, if any, thought deaths due to adverse effects from the mRNA vaccines, federal health authorities have actually stated.

In its announcement, the F.D.A. pointed out more than 6 cases and near to one death attributed to the blood-clotting disorder for each 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 dose, 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 favorable benefit-risk profile for the Johnson & & Johnson COVID-19 vaccine in adults, when compared with no vaccine.”