US restricts J&J COVID jab due to blood clot risk
WASHINGTON, May 7, (AP): US regulators on Thursday strictly limited who can receive Johnson & Johnson’s COVID-19 vaccine due to 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 specifically request J&J’s vaccine. US authorities for months have recommended that Americans get Pfizer or Moderna shots instead of J&J’s vaccine.
FDA’s vaccine chief Dr. Peter Marks said the agency decided to restrict the vaccine after taking another look at the data on the risks of life-threatening blood clots and concluding that they are limited to J&J’s vaccine.
“If there’s an alternative that appears to be equally effective in preventing severe outcomes from COVID-19, we’d rather see people opting for that,” Marks said. “But we’ve been careful to say that-- compared to no vaccine-- this is still a better option.”
The problem occurs in the first two weeks after vaccination, he added: “So if you had the vaccine six months ago you can sleep soundly tonight knowing this isn’t an issue.”
The FDA authorized J&J’s shot in February last year for adults 18 and up.
The vaccine was initially considered an important tool in fighting the pandemic because it required only one shot. But the single-dose option proved less effective than two doses of the Pfizer and Moderna vaccines.
In December, the Centers for Disease Control and Prevention recommended Moderna and Pfizer shots over J&J’s because of its safety issues.
As of mid-March, federal scientists had identified 60 cases of the side effect, including nine that were fatal. That 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 roughly 1 per million shots, according to Marks.
Marks said the FDA spent extra time analyzing the problem to be sure it wasn’t connected to a separate issue, such as women taking birth control medications that raise their risk of clotting.
The J&J vaccine will carry a starker warning about potential “long-term and debilitating health consequences” of the side effect.
Under the new FDA instructions, J&J’s vaccine could still be given to people who had a severe allergic reaction to one of the other vaccines and can’t receive an additional dose. J&J’s shot could also be an option for people who refuse to receive the mRNA vaccines from Pfizer and Moderna, and therefore would otherwise remain unvaccinated, the agency said.
A J&J spokesman said in an emailed statement: “Data continue to support a favorable benefit-risk profile for the Johnson & Johnson COVID-19 vaccine in adults, when compared with no vaccine.”
The clotting problems first came up last spring, with the J&J shot in the US and with a similar vaccine made by AstraZeneca that is used in other countries. At that time, US regulators decided the benefits of J&J’s oneand-done vaccine outweighed what was considered a very rare ri sk - as long as recipients were warned.
COVID-19 causes deadly blood clots, too. But the vaccine-linked kind is different, believed to form because of a rogue immune reaction to the J&J and AstraZeneca vaccines because of how they’re made. Clots form in unusual places, such as veins that drain blood from the brain, and in patients who also develop abnormally low levels of the platelets that form clots. Symptoms of the unusual clots include severe headaches a week or two after the J&J vaccination - not right away - as well as abdominal pain and nausea.
NEW YORK: A hit-and-run driver pleaded guilty Friday in a suburban New York a suburban New York crash that killed the father of Nicki Minaj and was promised a year or less in jail, disappointing prosecutors and the hip hop star’s mother.
In state court in Long Island’s Nassau County, businessman Charles Polevich admitted leaving the scene of the February 2021 accident that fatally injured Robert Maraj as he walked along a road in Mineola.
Polevich initially got out of his car and looked at the injured man on the ground, but then drove off, didn’t call 911, garaged his car and covered it with a tarp, authorities said. Polevich pleaded guilty to tampering with evidence by concealing the car.
Maraj, 64, died at a hospital the next day.
Judge Howard Sturim said
Polevich would get “no more than one year in jail,” along with community service and a suspended license. The 71-year-old is due to be sentenced Aug 3.
The victim’s widow, Carol Maraj, told reporters she was “not happy” with the planned sentence. The widow, who is suing Polevich, said seeing him in court left her shaking at the memory of her husband fighting for his life in the hospital.
Prosecutors, who sought a one-to-three-year prison sentence, also took issue with the planned penalty.
“Given the severity of the defendant’s conduct, we disagree with the sentencing commitment from the court,” Nassau County District Attorney’s office spokesperson Brendan Brosh said in a statement.
Polevich’s lawyer, Marc Gann, called the hit-and-run “completely out of character” for his client, who hails from Long Island but has a drilling and water purification business in Guam.
“He does feel tremendous empathy for Mr Maraj’s family and tremendous remorse for any role he played in his death,” Gann said by phone after court. He suggested that Polevich might have had a medical problem that made him not “fully aware of what he was doing,” while noting that it wasn’t a legal justification. (AP)