The US Food and Drug Administration (FDA) has granted full approval of Pfizer-BioNTech COVID-19 vaccine for individuals 16 years of age and above. The mRNA vaccine was first approved under emergency use authorisation back in December 2020, and is currently the first and only COVID-19 vaccine to receive full authorisation for use.

Pfizer CEO Albert Bourla said in a statement the FDA’s approval “affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed.”

All FDA-approved vaccines undergo a rigorous standard process for reviewing the quality, safety, and effectiveness. For Comirnaty, new clinical data is used in conjunction with existing information submitted during the initial EUA stage. The FDA’s approval process concluded that the vaccine was 91% effective in preventing COVID-19 disease based on the evaluation of approximately 20,000 vaccine recipients as well as 20,000 placebo recipients aged 16 years and above. Furthermore, to better assess the long term safety outcomes, approximately 12,000 recipients were monitored for an additional 6 months following their second dose of the vaccine. Conclusively, results suggest that the vaccines show an increased risk of myocarditis and pericarditis, particularly among males under the age of 40, following their second jab. The FDA and Centers for Disease Control and Prevention along with the company will continue to monitor the safety and effectiveness of the Comirnaty vaccines, to ensure any concerns continue to be identified and evaluated in a timely manner.

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