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The FDA limits Johnson & Johnson’s COVID-19 vaccine due to the rare but serious risk of blood clots

Washington-Thursday US regulators have severely restricted who can be vaccinated with the Johnson & Johnson COVID-19 vaccine due to the ongoing risk of a rare but serious blood clot.

The Food and Drug Administration said injections should only be given to adults who cannot be vaccinated with another vaccine, or specifically those who cannot request a J & J vaccine. For months, US officials have recommended that Americans starting COVID-19 vaccination use Pfizer or Modelnashot instead.

FDA officials said in a statement that they decided to limit J & J’s vaccine after reviewing data on the risk of life-threatening blood clots within two weeks of vaccination.

The J & J vaccine was initially considered an important tool for combating pandemics, as it requires only one dose. However, the single dose option proved to be less effective than the double dose of the Pfizer and Moderna vaccines.

Details | J & J booster shots produce huge spikes of antibodies, the company says

In December, the US Centers for Disease Control and Prevention recommended prioritizing Moderna and Pfizer shots over J & J due to safety concerns. Previously, US authorities treated all three vaccines in the same way. This is because each has been shown to provide strong defenses.

However, follow-up studies have consistently shown that J & J’s vaccines are less effective. And while the blood clots seen in J & J shots are rare, authorities say they are still occurring.

As of mid-March, federal scientists have identified 60 cases, including 9 fatal cases. This corresponds to one case of thrombosis for every 3.23 million J & J shots administered, the FDA said Thursday. Vaccines carry harsh warnings about the potential “long-term and debilitating health effects” of side effects.

See: What do we know about COVID-19 booster shots?

Under the new FDA’s instructions, the J & J vaccine can continue to be given to people who have a severe allergic reaction to one of the other vaccines and cannot receive additional vaccinations. J & J’s shots could also be an option for those who refuse to be vaccinated with mRNA from Pfizer and Moderna, otherwise they will remain unvaccinated, the agency said.

A J & J spokesman said in an email statement:

Despite the restrictions, FDA Vaccine Director Dr. Peter Markes said J & J’s vaccine “still plays a role in the current pandemic response across the US and global communities.”

The FDA has made decisions based on “our safety monitoring system and our commitment to ensure that science and data guide our decisions.”

The coagulation problem first occurred last spring with J & J Shot in the United States and a similar vaccine made by AstraZeneca used in other countries. At that time, US regulatory agencies determined that the benefits of J & J’s one-time vaccine outweighed what was considered a very rare risk, as long as the recipient was warned.

COVID-19 also causes a deadly blood clot. However, the vaccine-related varieties are different and are thought to be formed due to the improper immune response of the J & J and AstraZeneca vaccine manufacturing methods. It is also formed in abnormal locations, such as veins that drain blood from the brain, and in patients with abnormally low levels of platelets that form clotting. Symptoms of abnormal blood clots include severe headache (not immediately), abdominal pain, and nausea 1-2 weeks after J & J vaccination.

The company, based in New Brunswick, NJ, announced last month that it was not expecting any profit from this year’s vaccine and was suspending sales forecasts.

The company’s vaccine deployment was hit by a series of problems, including manufacturing issues at the Baltimore plant, which forced J & J to import millions of doses from abroad.

In addition, regulators have added warnings about blood clots and a rare neural reaction called Guillain-Barré syndrome.

Pfizer and Moderna provide the majority of COVID-19 vaccines in the United States. Over 200 million Americans have been fully vaccinated with two company vaccinations, and less than 17 million Americans have been vaccinated with the J & J vaccine.
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The Associated Press’s Department of Health Sciences is supported by the Science Education Department of the Howard Hughes Medical Institute. AP is solely responsible for all content.

Copyright © 2022 By AP communication. all rights reserved.



The FDA limits Johnson & Johnson’s COVID-19 vaccine due to the rare but serious risk of blood clots

Source link The FDA limits Johnson & Johnson’s COVID-19 vaccine due to the rare but serious risk of blood clots

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