By World Healthcare Journal-
The World Health Organization has now listed the Pfizer/BioNTech mRNA vaccine for emergency use, making it the first to receive emergency validation from WHO since the outbreak began a year ago.
This Emergency Use Listing (EUL) from the WHO enables countries to make their own regulatory approval processes to import and administer the vaccine much quicker. It also enables UNICEF and other NGOs to procure the vaccine for distribution to countries in need who may not have immediate access
“This is a very positive step towards ensuring global access to COVID-19 vaccines. But, I want to emphasize the need for an even greater global effort to achieve enough vaccine supply to meet the needs of priority populations everywhere,” said Dr Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products.
“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. ”
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 EUL procedure assesses the suitability of novel health products during public health emergencies. The objective is to make medicines, vaccines and diagnostics available as rapidly as possible to address the emergency, while still adhering to stringent criteria of safety, efficacy and quality.
The vaccine is also currently under policy review. WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) will convene on the 5th January to formulate vaccine-specific policies and recommendations for this product’s use in populations.
Multiple countries have already begun mass-vaccination campaigns, with many receiving individual approval from their nations of origin. Currently, the Oxford/AstraZeneca vaccine has been approved for use in the UK, the Moderna/NIAID vaccine has been approved in the US and Canada, and both China and Russia have approved multiple vaccines.
However, this EUL from the WHO makes a groundbreaking step towards ensuring vaccine supply for the whole world, and not just the nations of their creation.
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