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WHO EMRO Weekly Epidemiological Monitor: Volume 14, Issue no 3; 17 January 2021

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WHO recommendations on PfizerBioNTech COVID-19 vaccine use

On 31 December 2020, WHO listed COVID-19 mRNA vaccine BNT162b2 for emergency use and published interim recommendations for its use on 8 January. It is the first vaccine to receive emergency validation from WHO since the outbreak began.

Editorial note

The COVID-19 pandemic continues to pose a threat to societies worldwide. Thus far, governments have been relying on core public health measures as well as non -pharmaceutical interventions (NPIs, e.g. universal mask wearing, physical distancing) to break chains of transmission and control the spread. The introduction of a safe and effective vaccine has been the cornerstone of every recovery strategy with the hopeful prospect of returning back to ‘normal’. To date, 6 countries in the Region have begun vaccination campaigns using the Pfizer–BioNTec vaccine after it was granted emergency use authorization in most of the them (see figure). The speed, breadth, and magnitude of the effort to develop vaccines against COVID-19 has been unprecedented. On 31 December 2020, the mRNA vaccine BNT162b2, developed by Pfizer– BioNTec, became the first vaccine to receive emergency use validation from WHO. Accordingly, the Strategic Advisory Group of Experts on Immunization (SAGE) issued specific evidence-based interim recommendations to support its use.

BNT162b2 has been shown to have an efficacy of approximately 95%, based on a median follow-up of two months. To maximize its public health impact during the initial period of limited supply, countries are advised to follow the WHO Prioritization Roadmap and WHO Values Framework, which recommend prioritizing health workers at high risk and older people with and without comorbidities. A two doses schedule is recommended, 21-28 days apart.
However, in exceptional epidemiological circumstances that merit a pragmatic approach to maximizing the number of individuals benefiting from the first dose, some countries may delay the second dose up to 42 days. Several considerations for specific risk groups are also listed in the published guidance (see list)

contraindication to vaccination is a history of severe allergic reaction to any component of the vaccine, particularly polyethylene glycol (PEG). WHO recommends the vaccine to be administered only in settings where anaphylaxis can be treated and for all vaccinees to be observed for at least 15 minutes after vaccination.

The mRNA vaccine will not affect results of nucleic acid amplification or antigen tests for diagnosis of current infection. It will also not affect the antibody tests targeting the spike protein. Only an antibody test targeting the nucleocapsid protein will be able to differentiate the natural infection. Moreover, with limited evidence available on impact of vaccination on virus transmission and indirect protection in the community, vaccinated individuals are advised to follow all national NPIs.

The SAGE recommendations are subject to the available scientific data. As more data emerge and vaccine supplies increase, the recommendations will be more refined. Ministries of health are encouraged to strengthen systems for monitoring vaccinated individuals and reporting adverse events, as well as continue addressing current knowledge gaps through further research.