By Sue-Ann Wayow
THE Pfizer/BioNTech vaccine is the first to receive emergency validation from the World Health Orgnisation (WHO) since the Covid-19 outbreak began a year ago.
The Comirnaty COVID-19 mRNA vaccine received its validation on Thursday.
In a statement by WHO on Thursday, WHO Assistant-Director General for Access to Medicines and Health Products Dr Mariângela Simão said, “This is a very positive step towards ensuring global access to Covid-19 vaccines. But I want to emphasise the need for an even greater global effort to achieve enough vaccine supply to meet the needs of priority populations everywhere. WHO and our partners are working night and day to evaluate other vaccines that have reached safety and efficacy standards. We encourage even more developers to come forward for review and assessment. It’s vitally important that we secure the critical supply needed to serve all countries around the world and stem the pandemic.”
The WHO’s Emergency Use Listing (EUL) opens the door for countries to expedite their own regulatory approval processes to import and administer the vaccine. It also enables (United Nations Children’s Fund (UNICEF) and the Pan-American Health Organization to procure the vaccine for distribution to countries in need.
WHO stated, “Regulatory experts convened by WHO from around the world and WHO’s own teams reviewed the data on the Pfizer/BioNTech vaccine’s safety, efficacy and quality as part of a risk-versus-benefit analysis. The review found that the vaccine met the must-have criteria for safety and efficacy set out by WHO, and that the benefits of using the vaccine to address Covid-19 offset potential risks.”
The vaccine is also under policy review WHO stated. WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) will convene on January 5, 2021, to formulate vaccine specific policies and recommendations for this product’s use in populations, drawing from the SAGE population prioritization recommendations for Covid-19 vaccines in general which was issued in September.
The Comirnaty vaccine requires storage using an ultra-cold chain meaning it needs to be stored at -60°C to -90°C degrees. This requirement makes the vaccine more challenging to deploy in settings where ultra-cold chain equipment may not be available or reliably accessible and WHO stated that it was working to support countries in assessing their delivery plans and preparing for use where possible.
The organisation stated that once a vaccine has been listed for WHO emergency use, WHO engages its regional regulatory networks and partners to inform national health authorities on the vaccine and its anticipated benefits based on data from clinical studies to date.
In addition to the global, regional, and country regulatory procedures for emergency use, each country undertakes a policy process to decide whether and in whom to use the vaccine, with prioritisation specified for the earliest use. Countries also undertake a vaccine readiness assessment which informs the vaccine deployment and introduction plan for the implementation of the vaccine under the EUL.
And as part of the EUL process, the company producing the vaccine must commit to continue to generate data to enable full licensure and WHO prequalification of the vaccine. The WHO prequalification process will assess additional clinical data generated from vaccine trials and deployment on a rolling basis to ensure the vaccine meets the necessary standards of quality, safety and efficacy for broader availability.