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Expert Committee On Covid-19 Vaccination Continues To Endorse Safety And Efficacy Of Pfizer-BioNTech Covid-19 Vaccine In Individuals Aged 12 To 15 Years

21 May 2021

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         The Expert Committee on COVID-19 Vaccination recommended that the Pfizer-BioNTech COVID-19 vaccine be used in the respective population groups, including in adolescents of ages 12 to 15 years following the Health Sciences Authority's (HSA) announcement on the approval for the use of the vaccine in this age group under the Pandemic Special Access Route (PSAR) on 18 May 2021. Our assessment remains that the Pfizer-BioNTech vaccine is safe and efficacious for this age group. There is currently no credible evidence of a inactivated virus vaccine demonstrating a high vaccine efficacy and safety profile among this age group. We noted the contents of an Open Letter addressed to parents from a small group of doctors on vaccines for children. 11 of the 12 have since retracted their statement.   

2.      The Pfizer-BioNTech vaccine is currently the only COVID-19 vaccine anywhere in the world that has been authorised for use in adolescents aged 12 to 15 years. HSA and the Expert Committee had reviewed the safety and efficacy of the Pfizer-BioNTech COVID-19 vaccine based on the clinical trials for individuals in this age group. The safety profile of the vaccine is consistent with the known safety profile in the adult population and the standards set for other registered vaccines used in the immunisation against other diseases.

3.      The Singapore population, including adolescents, continue to remain at risk of COVID-19 infection, and onward transmission to their close contacts. This is seen in the recent local cases and outbreaks involving school-going children who had been infected with COVID-19 and transmitted to their family members and schoolmates. While the international experience is that COVID-19 appears milder in the younger age groups, there remains a risk of complications and long-lasting symptoms in children and adolescents. The Expert Committee therefore recommends that with the availability of a safe and efficacious vaccine, all eligible persons should receive the vaccine to attain as high a population coverage of COVID-19 vaccination as possible.

4.      COVID-19 vaccines cannot alter your DNA. The Pfizer-BioNTech COVID-19 vaccine comprises  messenger RNA ("mRNA") that contains the instructions to enable the vaccine recipient to build a protein component of the SARS-CoV-2 virus ("spike protein"). The spike protein does not cause infection, but is recognised by the body's immune system as foreign. The body then mounts an immune response and produces antibodies that protects against future infection by the virus. The vaccine mRNA is broken down by the body rapidly after the spike protein is built. The mRNA is unable to produce more copies of itself, and cannot enter the nucleus of the human cells where human genetic material ("DNA") is stored. Since the human genome is made up of DNA, it is not biologically plausible for the vaccine mRNA to be integrated or to interfere with the DNA of the vaccine recipient.

5.      Expert Committee chairperson A/Prof Benjamin Ong said, "The Committee assessed the use of the Pfizer-BioNTech COVID-19 vaccine in individuals aged 12 to 15 years to be safe and effective, after careful assessment and deliberation of the available clinical data. There is no inactivated COVID-19 vaccine approved for use in children yet."

6.      With the current administration of more than 200 million doses of the Pfizer-BioNTech COVID-19 vaccines worldwide, there is currently no evidence for rare but serious effects of the Pfizer-BioNTech COVID-19 vaccine beyond anaphylaxis. The Expert Committee and HSA will continue to monitor and review evidence and information that emerge from further ongoing studies on long-term safety and efficacy.

7.      Singapore remains at risk of a surge in cases and it is therefore important that we achieve as comprehensive a coverage of COVID-19 vaccination as possible across the entire population. We strongly encourage all persons who are medically eligible to be vaccinated when the vaccine is made available to them.

EXPERT COMMITTEE ON COVID-19 VACCINATION
21 MAY 2021