Interim authorisation of Pfizer-BioNTech COVID-19 Vaccine extended to include use in adolescents aged 12 to 15 years
The Health Sciences Authority (HSA), in consultation with its Medicines Advisory Committee and Panel of Infectious Diseases Experts, would like to update healthcare professionals that the interim authorisation of Pfizer-BioNTech COVID-19 Vaccine has been extended to include the use in adolescents aged 12 to 15 years. The dosing regimen is the same as that for adults, i.e. two doses of 30μg given 21 days apart.
The efficacy of the Pfizer-BioNTech COVID-19 Vaccine in adolescents is based on updated immunogenicity and vaccine efficacy analyses in the 12 to 15 years age group of the ongoing Phase III study, which comprised 2,260 subjects who were randomised to receive either the vaccine or placebo. The results showed that the vaccine, when given as a two-dose regimen 21 days apart, achieved 100% (95% CI: 75.3%, 100%) efficacy for the prevention of symptomatic COVID-19 as compared with placebo. This result was consistent with the overall vaccine efficacy reported in the adults.
The safety analysis comprised data from >1,000 subjects aged 12 to 15 years who had received ≥ one dose of the vaccine. The most common solicited adverse reactions were injection site reactions, fatigue, headache, chills, muscle pain, joint pain, fever, diarrhoea and vomiting. Overall, the safety profile of the vaccine in adolescents was comparable to that observed in adults. Post-authorisation surveillance will continue to play an important role to closely monitor the safety in the younger population.
Healthcare professionals are advised to report any suspected serious adverse events, adverse events of interest and allergic reactions to HSA through the channels described in the letter.
Please refer to the Dear Healthcare Professional Letter (DHCPL) for details.
Healthcare professional, Industry member, Therapeutic Products
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Dear Healthcare Professional Letters