The World Health Organisation (WHO) on Thursday listed Pfizer/BioNTech vaccine for emergency use against Covid-19.
According to a press statement issued by WHO yesterday, 31st December, 2020, the Pfizer/BioNTech vaccine is the first to receive emergency validation since the Covid-19 outbreak a year ago.
“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 and it was 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 statement reads in part.
However, through the WHO’s Emergency Use Listing (EUL), “countries are able to expedite their own regulatory approval processes to import and administer the vaccine.”
It, as WHO noted, also enables UNICEF and the Pan-American Health Organization to procure the vaccine for distribution to countries in need.
According to Dr Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products, this will ensure global access to covid-19 vaccines.
She emphasised the need for equitable global access of the vaccine.
“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,” she said.
She added that evaluation of other vaccines is also ongoing.
“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,” she further stated.
WHO revealed that the vaccine is under policy review and WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) will convene on 5 January, 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, issued in September 2020.
Despite the new development, WHO predicts challenges in storage of the vaccine, especially in settings where ultra-cold chain equipment may not be available or reliably accessible, as the vaccine requires storage using an ultra-cold chain; it needs to be stored at -60°C to -90°C degrees.
“WHO is working to support countries in assessing their delivery plans and preparing for use where possible,” the organisation revealed.