The Pfizer-BioNTech coronavirus vaccine has been approved for emergency use by the World Health Organisation (WHO).
It means it could now become available for some of the world's poorer nations.
Over a million doses have been issued worldwide - including more than 1,800 in Ireland.
It means the Pfizer/BioNTech vaccine is the first to receive emergency validation from WHO since the outbreak began a year ago.
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 UNICEF and the Pan-American Health Organization to procure the vaccine for distribution to countries in need.
Speaking about the news, Dr Mariângela Simão, WHO assistant-director general for Access to Medicines and Health Products said:
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.
“WHO and our partners are working night and day to evaluate other vaccines that have reached safety and efficacy standards."
She said that we encourage even more developers to come forward for review and assessment and that it is vitally important to secure the critical supply needed to serve all countries around the world and stem the pandemic.
Risk-versus-benefit analysis
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’s Strategic Advisory Group of Experts on Immunization (SAGE) will convene on January 5th, 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.
The vaccine requires storage using an ultra-cold chain; it needs to be stored at -60°C to -90°C degrees.
They said this requirement makes the vaccine more challenging to deploy in settings where ultra-cold chain equipment may not be available or reliably accessible. For that reason, WHO is working to support countries in assessing their delivery plans and preparing for use where possible.
The emergency use listing (EUL) procedure assesses the suitability of novel health products during public health emergencies.
Potential risks
The objective is to make medicines, vaccines and diagnostics available as rapidly as possible to address the emergency while adhering to stringent criteria of safety, efficacy and quality.
The assessment weighs the threat posed by the emergency as well as the benefit that would accrue from the use of the product against any potential risks.
The EUL pathway involves a rigorous assessment of late phase II and phase III clinical trial data as well as substantial additional data on safety, efficacy, quality and a risk management plan.
Experts from individual national authorities are invited to participate in the EUL review.
They said once a vaccine has been listed for WHO emergency use, they engage 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 prioritization specified for the earliest use.
