Pfizer seeks USFDA’s approval for COVID vaccine in adolescents

Pfizer seeks USFDA’s approval for using its COVID – 19 vaccine in adolescents aged 12 to 15 years old

On 9 April 2021, Pfizer – BioNTech sought the USFDA^[1] to authorization its COVID – 19 vaccine. This was for the use of the vaccine for 12 to 15 years old in the United States.

Pfizer put forth this request after the phase 3 clinical trials of the vaccine conducted on 12 to 15 years old revealed positive results. This study showed that the vaccine was 100 % effective in preventing the disease in adolescents belonging to this age group. These results were published in later March 2021. ¹

Over 2,260 adolescents in the US were enrolled in this study. The companies revealed that the subjects showed “robust antibody responses” post-vaccination. Read Pfizer COVID – 19 vaccine in India Update

The company also stated that the side effects developed were consistent with those seen in participants aged 16 – 25 years. It revealed this statement on 9 April 2021.

At present, Pfizer’s vaccine has emergency authorization and can be used in people aged 16 years and above. Read about Pfizer’s COVID – 19 vaccine in Brazil

Pfizer seeks USFDA’s approval: More priority has been given to vaccinating older people as the chances of children getting infected with severe COVID – 19 are bleak.

Pfizer’s vaccine was the first COVID – 19 vaccine to be approved in the West in late 2020. This shot is based on the novel mRNA^[2] technology.

Currently, the companies plan to make similar requests to get authorization for using the vaccine in adolescents in other countries. They plan to contact the regulatory authorities worldwide soon.

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