Do not doubt the Pfizer or Moderna vaccines

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          Le CDC étudie une association possible entre le tir de Johnson & Johnson et six cas de caillots sanguins rares.
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          <p>Pour la première fois dans le déploiement du vaccin aux États-Unis, les régulateurs ont pompé les pauses sur un vaccin autorisé contre le coronavirus.

On Tuesday, the Centers for Disease Control and Prevention and the Food and Drug Administration jointly recommended a temporary hiatus in distribution of Johnson & Johnson’s vaccine while regulators investigate six reports of unusual blood clots.

All six cases involved women between the ages of 18 and 48 who developed central venous sinus thrombosis, an extremely rare type of clot in the brain. One of the women has died and another is in critical condition.

Experts are not sure why these cases of blood clots developed – or even if there is a definite cause and effect relationship with the vaccine. But there is no reason to suspect that rare clots would be associated with other vaccines licensed in the United States, they said.

“Instead of depriving others of confidence in other vaccines, it should actually inspire more confidence in the surveillance of those vaccines and certainly should not deter people who need to receive Pfizer and Moderna vaccines from showing up for their appointments.” Dr. Vivek Cherian, an internist in Baltimore, told Insider.

About 68 million Americans have been fully immunized with the Pfizer or Moderna vaccine since December, and nearly 185 million doses have been administered in total. Meanwhile, US regulators have not discovered any significant safety concerns in people who have received these vaccines. (The CDC tracks vaccine side effects through a tool called V-safe, and healthcare providers are required to report side effects through an online system called VAERS.)

“There is a lot of scrutiny of these vaccines,” Peter Gulick, associate professor of medicine at Michigan State University, told Insider.

He added that Pfizer and Moderna’s plans are “months ahead of J&J” in production and deployment, and regulators have yet to see red flags. Even his HIV-positive patients, Gulick said, have not reported serious reactions.

J & J’s vaccine, on the other hand, was introduced more recently: it was cleared in late February and has been given to just under 7 million Americans so far.

“When you start vaccinating people, you have a much, much, much bigger sample – in the millions,” Cherian said. J & J’s clinical trial, on the other hand, had just under 44,000 people. “So when you have these extremely rare complications, sometimes you don’t see it until you’ve actually started. “

Pfizer and Moderna injections carry “virtually no risk” of clotting

Nurse Janelle Roper, left, administers the Pfizer COVID-19 vaccine to fellow nurse Kate-Alden Hartman.
John McDonnell / Le Washington Post via Getty Images

In an average year, only two to five in a million Americans develop central venous sinus thrombosis (CVST).

J & J’s vaccine has yet to exceed these normal background levels, with less than one case of CVST per 1 million doses reported so far. But the researchers also found cases of CVST in people who received the AstraZeneca coronavirus vaccine, which has many similarities to those of J&J.

By early April, European medical authorities had identified 169 cases of CVST out of more than 34 million people in the EU who had received the AstraZeneca vaccine. It’s still only five cases per 1 million shots, but it was enough for European regulators to investigate. The UK now recommends people under 30 to research other vaccines, if available.

AstraZeneca and J&J vaccines are viral vector vaccines, which introduce a coronavirus gene into the body using a genetically engineered cold virus. Some scientists wonder if the platform itself could be linked to coagulation.

Pfizer and Moderna’s vaccines, meanwhile, are based on mRNA technology, which uses an extract from the coronavirus genome to trigger an immune response.

During an American Medical Association webinar on Tuesday, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said the United States has identified only three cases of CVST among 68 million people. who received the double dose mRNA vaccines.

In a Tuesday statementModerna also said he performed his own comprehensive analysis and found no association between his injection and CVST or other types of coagulation.

“It is safe to say that there is virtually no risk in people who have received mRNA-based [vaccines], but we don’t really have that information in regards to the viral vector yet, ”Cherian said.

But he added that even with viral vector vaccines, “far, even less than 1% of people actually have these side effects. “

In comparison, a November study found that 20% of patients hospitalized with COVID-19 developed blood clots in their veins.

JOIN US THURSDAY FOR A LIVE EVENT: Experts answer your questions about coronavirus vaccines and the risk of rare and serious blood clots

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