Labels warn of side effects on Covid-19 vaccines – VnExpress

To facilitate the screening of vaccinees and ensure safety, pharmaceutical companies add warning labels such as polyneuritis, blood clots or heart inflammation on the Covid-19 vaccine vials.

Covid-19 vaccines have been shown to be safe and effective against the virus. However, like any other drug, they always come with side effects. After a thorough evaluation process, the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the World Health Organization (WHO) have recommended that manufacturers put a warning label on it. outside of each vial of the vaccine. This makes it easier for health care workers to screen people who are allowed to be vaccinated based on underlying medical conditions.

June 25, vaccine Pfizer and Moderna Added a warning about the risks by the FDA heart inflammation rare in the attached fact sheet.

As of June 11, the US Vaccine Adverse Event Reporting System recorded more than 1,200 cases of heart inflammation or pericarditis. Cardiomyopathy cases appear more, symptoms are obvious in the second week after injection, more common in men. The Centers for Disease Control and Prevention (CDC) recorded 309 hospitalizations, most under the age of 30. The agency says patients usually recover well after receiving treatment. Currently, 295 people have been discharged from the hospital.

Dr. Tom Shimabukuro, deputy director of the CDC’s Office of Immunization Safety, said the rate of heart inflammation following the second dose of the vaccine was 12.6 per million.

“The condition is more common in younger groups, mainly teenagers and young adults around the age of 20. Men are affected more often than women. People 50 and older are mostly unaffected,” he said .

Pfizer still maintains that the rate of heart inflammation is not higher than normal. Moderna has noted this condition, and will coordinate with public health regulators to investigate further.

A nurse prepares a syringe to inject the Covid-19 vaccine in Munich, Germany, June 2021. Image: NY Times

Since March, vaccines AstraZeneca faced a lot of controversy because of the risk blood clotting, thrombocytopenia rare hiếm, European countries have to stop deploying for a while for a more in-depth assessment. Currently, most countries have resumed vaccination with this vaccine, with age restrictions and warning labels on the packaging.

Research from Germany and Norway shows that in some people with a rare biological trait, the AstraZeneca vaccine produces abnormal antibodies that cause blood clots. When vaccinated, those antibodies lead to thrombocytopenia, which causes both clotting and abnormal bleeding. The scientists suggested naming the condition “vaccine immune thrombocytopenic purpura” (VITT).

Dr. Andreas Greinacher, study author, calls this “good news” for the majority of the population, as most have no unusual biological characteristics. However, he added: “We cannot yet predict who is likely to develop this type of antibody.”

Coagulation is also present in the Johnson & Johnson vaccine, which was recognized by the EMA on April 21. The EMA believes that the Johnson & Johnson vaccine should still be used because the benefits outweigh the risks.

Second warning label on vaccine Johnson & Johnson is a syndrome Guillain-Barré (GBS) – polyneuritis after injection. GBS is a rare disorder in which the body’s immune system damages nerve cells, causing muscle weakness or paralysis. Most people develop the syndrome after a bacterial or viral infection.

Johnson & Johnson's Covid-19 vaccine is used in the US.  Photo: NY Times

Johnson & Johnson’s Covid-19 vaccine is used in the US. Image: NY Times

Although it has not been determined whether the vaccine directly causes GBS, the FDA has noted that an increasing number of people using the Johnson & Johnson vaccine are experiencing post-injection paralysis.

“FDA has updated information for users and manufacturers of the Covid-19 vaccine Johnson & Johnson. The new information includes a warning about the risk of GBS syndrome after vaccination,” the FDA announced.

According to the agency, symptoms appeared within 42 days of the injection. Of the approximately 12.8 million doses of Johnson & Johnson vaccine that have been deployed, the FDA has recorded 100 cases of GBS.

“The likelihood of this syndrome is very low,” the FDA confirmed.

If you feel tremors or tingling in your hands and feet, especially in areas where the itching spreads after vaccination, people should seek medical attention, the FDA recommends. Other symptoms of GBS include difficulty walking, speaking, chewing or swallowing, double vision, and other problems with the digestive and excretory systems.

Thuc Linh (According to the NPR, FDA, EMA, Reuters)


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