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FDA Needs More Time To Assess Moderna’s COVID Vaccine For Teenagers

The U.S drug maker company Moderna said in a statement released on Sunday, 31st October 2021 that The Food and Drug Administration of the United States of America needs some more time to finish its thorough review of the company’s Coronavirus vaccine for teenagers in the age group of twelve to seventeen years before it can authorize emergency administration of the vaccine.

The assessment of the Moderna vaccine for teens is not likely to be complete until January 2022 next year.

FDA Needs More Time To Assess Moderna’s COVID Vaccine For Teenagers

In a statement released on Sunday, the 31st of October 2021, The United States drug-making company Moderna said that the United States of America Food and Drug Administration is going to need some more time to complete its review of the biotech firm’s Coronavirus vaccine for teenagers who fall in the age group of twelve to seventeen years.

FDA Needs More Time To Assess Moderna’s COVID Vaccine For Teenagers

Moderna further added in the statement that the United States Food and Drug Administration is particularly assessing the risk of the heart condition, myocarditis in kids in teenage age group. The assessment of the COVID 19 vaccine for teenagers is not likely to be completed before January 2022 early next year.

Myocarditis is a heart ailment that leads to the inflammation of the middle layer of the wall of the heart called as myocardium. This inflammation can bring down the heart’s capacity to pump, thus causing abnormal or rapid heart rhythms, referred to as arrhythmias. Myocarditis is usually caused by an infection from a virus. The condition can cause the heart to become weak, which can lead to chest pain, difficulty in breathing, and even sudden death in rare cases.

Moderna also claimed that the company was wholeheartedly committed to working in close quarters with The United States Food and Drug Administration with the sole purpose of providing full support to the agency’s assessment and added that it was very grateful to the U.S Food and Drug Administration for their due diligence and sincere efforts in this matter.

Moderna further added in its statement that the company has now decided to postpone filing a request for authorization of the emergency administration of a smaller dose of its COVID 19 vaccine for younger children who fall in the age group of six to eleven years while the United States of America Food and Drug Administration takes its time in finishing its assessment of the Coronavirus vaccine for teenagers by early next year.

On the 25th of May 2021, Moderna had claimed that their COVID 19 vaccine had proved to be one hundred percent effective in a trial study conducted for kids in the age group of twelve to seventeen years. Moderna’s Coronavirus vaccine was the second vaccine after Pfizer’s vaccine which proved to be highly effective for the younger age groups.

In a press release, Moderna CEO Stephane Bancel had gone on to claim that the company was encouraged by the high efficiency of the mRNA-1273 COVID 19 vaccine in helping prevent coronavirus infection amongst adolescents and added that the company was sincerely committed to doing whatever they could in the pursuit of putting an end to the ongoing COVID 19 pandemic.

After the positive outcome of the study, Moderna has applied to extend the emergency administration of the COVID 19 vaccine by increasing the number of vaccines that are available for middle and high school adolescents in June 2021, ahead of the new term in schools.

Moderna’s COVID 19 vaccine has already been approved for adults.

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