FDA restricts J&J’s COVID-19 vaccine due to blood clot risk

Washington, May 6 (BUS): US regulators on Thursday set a strict limit on who can receive the COVID-19 vaccine from Johnson & Johnson due to the ongoing risk of rare but dangerous blood clots, according to the Associated Press.

The Food and Drug Administration said the shot should only be given to adults who cannot receive a different vaccine or specifically request the J&J vaccine.

US authorities have recommended for months that Americans get the Pfizer or Moderna vaccines instead of the J&J vaccine.
The FDA’s head of vaccines, Dr. Peter Marks, said the agency decided to restrict the vaccine after taking another look at data on the risk of life-threatening blood clots and concluding that it was limited to the J&J vaccine.

“If there is an alternative that appears to be equally effective in preventing dangerous outcomes of COVID-19, we would prefer to see people choose that,” Marks said. “But we’ve been careful to say that – compared to no vaccine – this is still a better option.”

He added that the problem occurs in the first two weeks after vaccination: “So if you received the vaccine six months ago, you can sleep peacefully tonight knowing that this is not a problem.”

The FDA approved J&D’s shots in February of last year for adults 18 and older.

The vaccine was initially considered an important tool in the fight against the epidemic because it required only one injection. However, the single-dose option has been shown to be less effective than two doses of Pfizer and Moderna vaccines.

In December, the Centers for Disease Control and Prevention recommended Moderna and Pfizer shots on J&J due to safety issues.

As of mid-March, federal scientists have identified 60 cases of side effects, including nine fatal. This equates to 3.23 blood clots per million injections per J&J. The problem is more common in women under 50, with a death rate of about 1 per million shots, according to Marks.

Marks said the FDA spent extra time analyzing the problem to make sure it wasn’t linked to a separate problem, such as women taking birth control medications that increase the risk of clotting.

The Johnson & Johnson vaccine will carry a more severe warning about the potential “long lasting and debilitating” side effects.
Under new Food and Drug Administration instructions, the J&J vaccine can still be given to people who have had a severe allergic reaction to one of the other vaccines and cannot receive an extra dose.

The agency said the J&J injection may also be an option for people who decline to receive mRNA vaccines from Pfizer and Moderna and would therefore remain unvaccinated otherwise.

Pfizer and Moderna have provided the vast majority of COVID-19 vaccines in the United States, more than 200 million Americans have been fully vaccinated with the company’s two doses while fewer than 17 million Americans have received the J&J vaccine.

insult