Interim authorisation of Pfizer-BioNTech COVID-19 vaccine (BNT162b2) for active immunisation to prevent COVID-19 disease in Singapore

The Health Sciences Authority (HSA), in consultation with its Medicines Advisory Committee and Panel of Infectious Diseases Experts, would like to inform healthcare professionals on the interim authorisation of Pfizer-BioNTech COVID-19 Vaccine for active immunisation to prevent COVID-19 disease caused by SARS-CoV-2 virus in individuals 16 years of age and over.

HSA has granted an interim authorisation under the Pandemic Special Access Route (PSAR) for Pfizer-BioNTech COVID-19 Vaccine (BNT162b2). This regulatory pathway facilitates access to critical novel vaccines, medicines and medical devices during a pandemic such as the current COVID-19 pandemic. HSA’s interim authorisation is based on the totality of evidence from the quality, non-clinical and clinical data available to-date. HSA will continually review the regulatory recommendation as data from on-going clinical and manufacturing studies become available.

The efficacy of the vaccine is based on clinical data in subjects aged 16 to 91 from the Phase III study. The Phase III study was planned for 24 months follow-up post-Dose 2 in subjects aged 12 years and above. A total of 43,651 subjects were randomized in a 1:1 ratio to either the vaccine group or placebo group. The primary vaccine efficacy analyses comprised subjects aged ≥ 16 who received the vaccine (N=19,965) or placebo (N=20,172), based on data accrued 2 months post-Dose 2. The results available to-date showed that the vaccine, when given as a 2-dose regimen 21 days apart, achieved 95.0% (95% CI: 90.3% to 97.6%) efficacy against laboratory confirmed symptomatic COVID-19 disease, based on data collected more than 7 days after completion of vaccination in subjects who were sero-negative at baseline. The study is still on-going and data in adolescents 12 to 15 years old is not available yet.

The safety analysis comprised data from more than 20,000 patients who had received at least one dose of the vaccine. Duration of follow-up was more than 2 months for approximately 45% of subjects and more than 1 month for approximately 80% of subjects. The most common solicited adverse reactions were injection site reactions, fatigue, headache, muscle pain, chills, joint pain, fever, diarrhoea, and vomiting. A 2-month duration allows reasonable time for assessing solicited local and systemic events, as well as potential immune-mediated adverse events, which generally have an onset within 6 weeks following vaccination. However, a longer duration of safety follow-up will allow further characterisation of serious adverse events and adverse events of special interest.

The company will be required to submit on-going data to HSA to ensure the continued efficacy and safety of the vaccine. Healthcare professionals are required to specify the brand name and batch number of the vaccine administered to individuals when submitting notification on COVID-19 vaccinations and to report any suspected serious adverse events observed with the use of Pfizer-BioNTech COVID-19 vaccine to HSA as soon as possible. HSA will actively monitor the adverse events associated with the vaccine in the local population and keep healthcare professionals informed of significant safety signals associated with the vaccine.

Please refer to the letter for details.

Published: 14 Dec 2020

Dear Healthcare Professional Letters