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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, pointing out security concerns.

The agency stated 60 cases of a serious however uncommon blood-clotting condition have been identified, consisting of nine 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 against the benefits, it had 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 people who experienced an extreme allergic reaction to the other two vaccines, the agency stated.

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

Johnson & & Johnson was eclipsed long earlier by Pfizer and Moderna in the country’s vaccination project; federal authorities have stated the mRNA vaccines produced by those companies are both safer and more efficient. In a statement, Johnson & & Johnson said the F.D.A.’s action reflected the already-known threat of the adverse effects, not new information on the rate at which it occurs. 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 known 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 stopped briefly distribution of the vaccine for a safety evaluation. Regulators lifted the pause 10 days later however included a warning to instructions for its usage.

In December, the C.D.C. advised that adults seeking a booster shot choose Moderna or Pfizer rather of Johnson & & Johnson, citing more benefits and lower risks. Coupled with a host of making difficulties in the United States, some specialists stated, the company’s judgment illustrated 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 disorder– or 4 times as many as were reported when in 2015’s pause 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 receivers has escalated.

The number of deaths attributed to the condition triggered by the Johnson & & Johnson’s vaccine does not appear to have increased much, if at all. But there have been far fewer, if any, presumed deaths due to negative effects from the mRNA vaccines, federal health officials have actually stated.

In its announcement, the F.D.A. mentioned more than six cases and near to one death associated to the blood-clotting condition for every single 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 actually gotten at least two dosages of either Moderna’s or Pfizer’s vaccine.

Trying to cast the tight brand-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.”

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

The firm said 60 cases of a uncommon but major blood-clotting disorder have been recognized, consisting of nine deaths, out of about 18 million dosages 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 risks of Johnson & & Johnson’s vaccine versus the benefits, it had chosen 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 reaction to the other 2 vaccines, the agency said.

It said the vaccine might likewise be offered to adults 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 authorities have stated the mRNA vaccines produced by those companies are both more secure and more reliable. In a declaration, Johnson & & Johnson said the F.D.A.’s action reflected the already-known danger of the negative effects, not new information on the rate at which it happens. 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 called 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 evaluation. Regulators raised the pause 10 days later on but included an alerting to instructions for its usage.

Then, in December, the C.D.C. suggested that grownups seeking a booster shot pick Moderna or Pfizer instead of Johnson & & Johnson, mentioning more benefits and lower threats. Paired with a host of producing troubles in the United States, some experts said, the firm’s judgment showed that the federal government had 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 four times as many as were reported when in 2015’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 actually skyrocketed.

The variety 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 been far less, if any, thought deaths due to side impacts from the mRNA vaccines, federal health officials have stated.

In its announcement, the F.D.A. cited more than 6 cases and near one death associated to the blood-clotting condition for each 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 gotten a booster dose, according to the C.D.C.’s data. By contrast, more than 200 million Americans have actually gotten at least two doses 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 favorable 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 restricted its usage to grownups who can not or refuse to get the Pfizer-BioNTech or Moderna vaccines, citing safety issues.

The agency said 60 cases of a major but uncommon blood-clotting disorder have actually been determined, consisting of nine deaths, out of about 18 million doses administered. The action comes about 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 risks of Johnson & & Johnson’s vaccine versus the benefits, it had actually decided to limit its usage 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 individuals who experienced a severe allergic response to the other 2 vaccines, the firm stated.

It stated 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 project; federal authorities have said the mRNA vaccines produced by those companies are both safer and more effective. 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 takes place. However in a sign 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 approved for emergency usage, federal authorities stopped briefly circulation of the vaccine for a safety assessment. Regulators raised the pause 10 days later on however added a warning to directions for its usage.

Then, in December, the C.D.C. suggested that adults looking for a booster shot choose Moderna or Pfizer instead of Johnson & & Johnson, citing 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 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 lots of as were reported when last year’s pause in circulation was lifted. In the interim, the number of Johnson & & Johnson doses administered has a little more than doubled, while the variety of Pfizer and Moderna recipients has actually 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, suspected deaths due to negative effects from the mRNA vaccines, federal health officials have actually stated.

In its announcement, the F.D.A. pointed out 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 actually now gotten one dose 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.

Trying 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 grownups, when compared with no vaccine.”