CDC and FDA Urge Pause on J&J Vaccine After “Rare and Severe” Blood Clots Occurred

CDC and FDA Urge Pause on J&J Vaccine After “Rare and Severe” Blood Clots Occurred


The Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) have issued a joint statement urging states to “pause” the use of the Johnson and Johnson COVID-19 vaccine after those who received it experienced severe blood clotting.

The statement reads, in part:

 CDC and FDA are reviewing data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the J&J vaccine. In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia). All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination.

The statement called the side effect “extremely rare” and said the CDC would convene a meeting of the Advisory Committee on Immunization Practices (ACIP) tomorrow to review the cases further. The FDA will review the CDC’s analysis and also plans to investigate the cases. “Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,” reads the statement.

In the past week, administration of the Johnson and Johnson vaccine was halted at four different locations in Georgia, Colorado, Iowa and North Carolina after numerous adverse reactions, such as fainting and lightheadedness, occurred.

FDA Denies That Four Volunteers Developed Bell's Palsy From Pfizer's Covid-19 Vaccine Shot


According to U.S. regulators, four people that received Pfizer’s Covid-19 vaccine in a trial developed Bell’s palsy which causes temporary facial paralysis.

The Food and Drug Administration (FDA) said Bell’s palsy could not have been caused by the vaccine but doctors should keep track of anyone else who gets it going forward.

Daily Mail reports:

This isn’t the first time it’s been linked to vaccines, but scientists have ultimately ruled that shots did not trigger Bell’s in all but one case – a Swiss flu vaccine that was sold during the 2001-2002 flu season there, then promptly taken off the market.

So far, the FDA said that the number of Bell’s palsy cases seen in the Pfizer vaccine trial was ‘consistent with the background frequency of reported Bell’s palsy in the vaccine group that is consistent with the expected background rate in the general population, and there is no clear basis upon which to conclude a causal relationship at this time,’ but will keep a close watch on future cases.

Bell's palsy typically resolves on its own but can cause one side of the face to droop rather alarmingly for weeks. It's exact cause is unknown but it's more common among pregnant women, people with diabetes and those with upper respiratory infections

The four cases of Bell’s palsy were the only side effect that the FDA saw as ‘imbalanced’ with more occurring in the vaccine group than the placebo group, and fewer than 0.5 percent of the trial participants had serious side effects.

Among the four people who developed Bell’s palsy, one saw facial paralysis or weakness within three days after they received the shot. But the participant’s face returned to normal about three days after that.

Although doctors are not sure exactly what causes Bell’s palsy, there are some factors that can leave someone more prone to getting it such as diabetes or an upper respiratory infection like the cold or flu.

They don’t believe that Pfizer’s vaccine is the cause of the issue but if given the green light to move forward, the FDA says Pfizer will be required to track data on future vaccine recipients if they develop temporary facial paralysis.

 

Report: Biden Admin Working On Scannable Vaccine Passports


Coronavirus vaccine passports are reportedly being developed by the Biden Administration that would allow Americans to prove they have been vaccinated.

It is too soon to know how it would play out legally but some businesses have indicated that they will require proof of vaccination for people to enter their businesses.

Daily Wire reports:

“The administration’s initiative has been driven largely by arms of the Department of Health and Human Services, including an office devoted to health information technology, said five officials who spoke on the condition of anonymity to discuss the effort,” The Washington Post reported. “The White House this month took on a bigger role coordinating government agencies involved in the work, led by coronavirus coordinator Jeff Zients, with a goal of announcing updates in coming days.”

The report said that a digital version of the vaccine passport would be available through smartphone apps and “could display a scannable code similar to an airline boarding pass.”

Developers told the Post that people should also have the option of printing out a vaccine passport. The vaccine passports are expected to face “significant hurdles” surrounding data privacy and making sure that the passports cannot be counterfeited.

“One of the most significant hurdles facing federal officials: the sheer number of passport initiatives underway, with the Biden administration this month identifying at least 17,” the Post added. “Those initiatives — such as a World Health Organization-led global effort and a digital pass devised by IBM that is being tested in New York state — are rapidly moving forward, even as the White House deliberates about how best to track the shots and avoid the perception of a government mandate to be vaccinated.”

The leader of the Communist Party of China, Chinese President Xi Jinping has been pushing for months for a global tracking system using QR codes to monitor people who have been exposed to the coronavirus.

Click here to read more.

 

 


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