Monday, December 05, 2022

FDA Restricts J&J’s COVID-19 Vaccine Because of Blood Clot Risk

WASHINGTON ( Associated Press) – US regulators on Thursday strictly limited who can receive Johnson & Johnson’s COVID-19 vaccine because of the ongoing risk of rare but serious blood clots.

The Food and Drug Administration said the shot should only be given to adults who cannot receive a different vaccine or request a vaccine specifically for J&K. US officials have recommended for months that Americans get the Pfizer or Moderna shots instead of the J&J vaccine.

The FDA’s head of vaccines, Dr. Peter Marks, said the agency had taken another look at the data on the risks of life-threatening blood clots and concluded that they were limited to the J&J vaccine. decided to ban.

“If there is an alternative that appears to be equally effective in preventing the dire consequences from COVID-19, we will see people opting for it,” Marks said. “But we are careful to say that – compared to no vaccine at all – it is still a better option.”

The problem occurs in the first two weeks after vaccination, he said: “So if you had the vaccine six months ago you can sleep soundly tonight knowing it’s not a problem.”

The FDA authorized the J&J shot in February last year for adults 18 years of age and older.

The vaccine was initially considered a vital tool in fighting the pandemic as it required only one shot. But the single-dose option proved less effective than the two doses of Pfizer and Moderna Vaccines.

In December, the Centers for Disease Control and Prevention recommended Moderna and Pfizer targeted him because of the security issues of Jammu and Kashmir.

By mid-March, federal scientists had identified 60 cases of the side effect, nine of which were fatal. This amounts to 3.23 blood clot cases per 1 million J&J shots. The problem is more common in women under 50, where the death rate was about 1 per million shots, according to Marks.

Marks said the FDA spent additional time analyzing the problem to make sure it wasn’t linked to an isolated issue, such as women taking contraceptive drugs that increase the risk of clots.

J&J will put out a stern warning about the potential “long-term and debilitating health consequences” of vaccine side effects.

Under new FDA directives, the J&J vaccine can still be given to people who have had a severe allergic reaction to one of the other vaccines and who cannot receive additional doses. The agency said J&J’s shot could also be an option for people who refuse to receive mRNA vaccines from Pfizer and Moderna, and therefore would otherwise be unaffected.

A J&J spokesperson said in an emailed statement: “The data continue to support a favorable benefit-risk profile for the Johnson & Johnson COVID-19 vaccine in adults, compared to no vaccine.”

The clotting problem first emerged last spring, with the J&J shot in the US and a similar vaccine made by AstraZeneca being used in other countries. At the time, US regulators decided that the benefits of the J&J vaccine were considered too scarce. sk – as long as the recipients were warned.

COVID-19 also causes fatal blood clots. But the vaccine-linked type is different, believed to be caused by a rogue immune response to the J&J and AstraZeneca vaccines because of how they are made. Clots form in abnormal places, such as the veins that drain blood from the brain, and in patients who develop abnormally low levels of clotting platelets. Symptoms of abnormal clotting include severe headache a week or two after the J&J vaccination — not immediately — as well as abdominal pain and nausea.

The New Brunswick, New Jersey-based company announced last month that it did not expect to profit from the vaccine this year and was suspending sales projections.

The company’s vaccine rollout was hurt by a number of troubles, including manufacturing problems at the Baltimore factory, which forced J&J to import millions of doses from overseas.

Additionally, regulators warned about blood clots and a rare neurological reaction called Guillain-Barré syndrome.

Pfizer and Moderna have provided most of the COVID-19 vaccines in the US. More than 200 million Americans have been fully vaccinated with the companies’ two-dose shots, while less than 17 million Americans have received the J&J shot.

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