Rare Spinal Cord Condition Flagged as Potential Adverse Effect of COVID-19 Vaccines: EU Drug Regulator

Contact Your Elected Officials

The European Union’s drug regulator has indicated that a change to the product information for COVID-19 vaccines from AstraZeneca and Johnson & Johnson has been recommended to include a warning of a rare spinal cord condition called transverse myelitis.

TM is a rare condition that involves inflammation of one or both sides of the spinal cord. Symptoms can include weakness in the limbs, and tingling, numbness, pain or loss of pain sensation, or issues with bladder and bowel function.

The Pharmacovigilance and Risk Assessment Committee (PRAC), the European Medicines Agency’s (EMA) committee that assesses the safety of human medicines, recommended the change on Jan. 14 after concluding that a causal link between the two vaccines and TM is “at least a reasonable possibility.”

It recommends changing the product information for the COVID-19 shots—AstraZeneca’s Vaxzevria and Johnson & Johnson’s Janssen–to include a warning of “very rare cases of transverse myelitis (TM) reported following vaccination.” TM will also be added as an adverse reaction with an unknown frequency to the vaccine profile.

The committee, over three days of meetings, reviewed information on globally reported cases for both vaccines, including data from the scientific literature as well as information from the European database for suspected vaccine side effects.

The PRAC said it considered that a total of 38 TM cases were reported globally—25 with Vaxzevria, 13 with Janssen. “These numbers refer to suspected and not adjudicated cases of TM.” This is out of 1.391 billion doses for Vaxzevria and 33,584,049 doses for Janssen that have been estimated to have been administered globally, it said.

“Health care professionals should be alert to signs and symptoms of TM, allowing early diagnosis, supportive care, and treatment,” the EMA announced. “People receiving either of these vaccines are advised to seek immediate medical attention if they develop symptoms of the condition.”

The risk-benefit profile of both vaccines remains unchanged, the EMA noted.

By Mimi Nguyen Ly

Read Full Article on TheEpochTimes.com

The Thinking Conservative
The Thinking Conservativehttps://www.thethinkingconservative.com/
The goal of THE THINKING CONSERVATIVE is to help us educate ourselves on conservative topics of importance to our freedom and our pursuit of happiness. We do this by sharing conservative opinions on all kinds of subjects, from all types of people, and all kinds of media, in a way that will challenge our perceptions and help us to make educated choices.

James Franklin’s contract fallout

Penn State’s decision to fire head coach James Franklin after a disappointing 22–21 home loss to Northwestern will cost an estimated $56 million buyout. 

Trump’s Middle East Trip Led to Historic Breakthroughs

Trump’s bold, unconventional strategy helped end the Israel-Hamas war and set the stage for a more stable, prosperous Middle East.

Pretending Really Hard

The world is real and so are its problems, too. Reality is the enemy of liberals, even though they are pretending, really hard, that it is not.

Trump 2.0’s Eurasian Balancing Act Has Failed

Trump's Eurasian balancing act has failed due to his arrogant and aggressive approach towards all three countries.

Should Palestinian clans rebelling against Hamas be given Gaza?

Hamas’s October 7 attack exposed its violent ideology, showing cruelty toward its enemies and also against the Palestinian people it claims to defend.

Trump, Patel Confirm FBI Special Agents Will Get Paid During Shutdown

FBI special agents will receive their paychecks despite the government shutdown, according to President Donald Trump and FBI Director Kash Patel.

Trump Admin Withholds $41 Million From California Over English-Language Trucking Rules

Trump admin withholds $40.6M in California transportation funds, citing failure to meet federal English proficiency rules for truck drivers.

An Inconvenient Study – Feature Film

Journalist Del Bigtree challenged a top infectious disease expert in 2016 to a vaxxed vs. unvaxxed study. The long-hidden results are finally revealed.

Federal Judge Temporarily Blocks Trump Admin’s Shutdown-Related Layoffs

A federal judge on Oct. 15 temporarily blocked President Donald Trump’s plan to lay off certain federal employees during the government shutdown. 

Trump Posthumously Awards Charlie Kirk the Presidential Medal of Freedom

President Trump posthumously awarded Charlie Kirk the Presidential Medal of Freedom in the White House Rose Garden on Oct 14, Charlie's birthday.

Trump Names Longtime Adviser Dan Scavino to Key Personnel Position

One of President Trump’s longtime advisers, Dan Scavino, is going to be in charge of selecting and appointing key positions within the executive branch.

First Lady’s Effort Helped Reunite 8 War-Displaced Children With Their Families

First lady Melania Trump said 8 children impacted by the fighting between Ukraine and Russia were reunited with their families on Oct. 9.

Trump to Impose New 100 Percent Tariff on China on Nov. 1

President Trump said that the US will impose an additional 100 percent tariffs on Chinese goods and export controls on critical software starting on Nov. 1.
spot_img

Related Articles

Popular Categories

MAGA Business Central