My Blog

WASHINGTON– In yet another setback 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, citing safety issues.

The agency said 60 cases of a rare but severe blood-clotting disorder have actually been identified, including nine deaths, out of about 18 million dosages 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 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 “scientifically suitable.” One example would be individuals who experienced a severe allergic reaction to the other two vaccines, the company said.

It said the vaccine might likewise be given 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 campaign; federal authorities 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 danger of the negative effects, not brand-new data on the rate at which it takes place. But in an indication 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 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 authorized for emergency situation usage, federal authorities paused circulation of the vaccine for a security examination. Regulators raised the time out 10 days later on but included a warning to guidelines for its use.

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 threats. Combined with a host of making problems in the United States, some specialists 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. 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 time out in circulation was raised. In the interim, the number of Johnson & & Johnson doses administered has somewhat more than doubled, while the number of Pfizer and Moderna recipients has actually increased.

The number 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 fewer, if any, believed deaths due to side impacts from the mRNA vaccines, federal health officials have said.

In its announcement, the F.D.A. mentioned more than six cases and near one death credited to the blood-clotting condition for every 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 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 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 restricted its use to grownups who can not or decline to get the Pfizer-BioNTech or Moderna vaccines, mentioning security issues.

The company stated 60 cases of a rare however serious blood-clotting disorder 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 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 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 proper.” One example would be individuals who experienced an extreme allergic response to the other two vaccines, the company stated.

It said the vaccine could also be given to grownups who “would otherwise not get a Covid-19 vaccine.”

Johnson & & Johnson was eclipsed long ago by Pfizer and Moderna in the country’s vaccination project; federal officials have said the mRNA vaccines produced by those companies are both much safer and more effective. In a declaration, Johnson & & Johnson stated the F.D.A.’s action showed the already-known threat of the negative effects, not brand-new data on the rate at which it happens. However 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 activate a condition known 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 paused circulation of the vaccine for a safety assessment. Regulators lifted the pause 10 days later on however included an alerting to guidelines for its usage.

In December, the C.D.C. advised that adults seeking a booster shot pick Moderna or Pfizer instead of Johnson & & Johnson, pointing out more benefits and lower dangers. Combined with a host of making troubles in the United States, some professionals stated, the firm’s judgment showed that the federal government had 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 condition– or 4 times as many 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 variety of Pfizer and Moderna recipients has escalated.

The number of deaths credited to the condition activated by the Johnson & & Johnson’s vaccine does not appear to have actually increased much, if at all. But there have been far fewer, if any, suspected deaths due to adverse effects from the mRNA vaccines, federal health authorities have stated.

In its announcement, the F.D.A. cited more than six cases and close to one death associated to the blood-clotting condition 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 gotten at least 2 doses of either Moderna’s or Pfizer’s vaccine.

Attempting to cast the tight brand-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 with 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 decline to get the Pfizer-BioNTech or Moderna vaccines, mentioning security concerns.

The company stated 60 cases of a major but unusual blood-clotting disorder have been determined, including nine deaths, out of about 18 million dosages 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 versus the benefits, it had chosen to limit its use to adults who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “clinically appropriate.” One example would be people who experienced an extreme allergy to the other 2 vaccines, the company said.

It stated the vaccine might likewise be given to grownups 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 stated the mRNA vaccines produced by those business 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 adverse effects, not new information on the rate at which it occurs. 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 called 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 paused distribution of the vaccine for a safety evaluation. Regulators lifted the time out 10 days later however added a warning to directions for its use.

In December, the C.D.C. recommended that adults seeking a booster shot select Moderna or Pfizer instead of Johnson & & Johnson, citing more benefits and lower risks. Combined with a host of producing troubles in the United States, some professionals said, the company’s judgment showed 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 condition– or 4 times as lots of as were reported when in 2015’s time out in circulation was lifted. In the interim, the variety of Johnson & & Johnson doses administered has somewhat more than doubled, while the number of Pfizer and Moderna recipients has increased.

The number of deaths associated to the disorder 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, 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 to one death credited to the blood-clotting disorder for every 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 contrast, more than 200 million Americans have actually gotten at least two dosages of either Moderna’s or Pfizer’s vaccine.

Attempting to cast the tight new restrictions in a favorable light, Johnson & & Johnson said: “Data continue to support a beneficial benefit-risk profile for the Johnson & & Johnson COVID-19 vaccine in grownups, when compared to no vaccine.”