US Drug Regulator Adds Heart Inflammation Risk Warning To Pfizer, Moderna Vaccines

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Heart inflammation risk warning added to Pfizer, Moderna:  The drug regulator of the United States has added a warning to the fact sheets that accompany the COVID vaccine shots of Pfizer Inc and Moderna to indicate a rare risk of heart inflammation after its use.

According to the Food and Drug Administration (FDA), the fact sheets for each vaccine has been revised to include a warning about the reports of adverse events that suggest increased risks of myocarditis (inflammation of the heart muscle), and pericarditis (swelling and irritation of the tissue around the heart), majorly after the second dose of the vaccines. The FDA also said that these symptoms occur within a few days after taking the dose of the vaccine and more commonly seen in young males.

In the U.S., more than 1,200 cases of these heart disorders have been reported to the Vaccine Adverse Event Reporting System (VAERS) as of June 11. These cases have emerged out of a total of 300 million mRNA vaccine doses administered.

The cases of myocarditis and pericarditis have been higher in males than in females a week after the second dose of vaccination. Previously, in a study done on the role of sex in the efficiency of the vaccines, it was reported that the COVID-19 vaccines made by Moderna and Pfizer work better in men than in women.

In the study, it was also concluded that the vaccines that use nanoparticles (a small particle that ranges between 1 to 100 nanometres in size), as in the case of Pfizer and Moderna, affect patients differently depending on their sex.

Pfizer Vaccine Trials For Children below 12

On June 9, Pfizer announced that it will start testing its COVID-19 vaccine in a larger group of children under the age of 12 and has already been authorised for use in children above the age of 12. However, in the testing carried out in children, a lower dose of the vaccine shot is being used, calculated based on results from the early stage of the trial.

Will Pfizer Vaccine Be Available In India?

Albert Bourla, the CEO of Pfizer said that the vaccine is in its final stage for its approval in India. When the US-based company gets the approval for its COVID-19 vaccine, it will supply two billion doses of the vaccine to India, in which one billion doses will be supplied in 2021.

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