As India is yet to announce emergency use authorisation for its Covid-19 vaccine candidates, the World Health Organisation has listed Comirnaty COVID-19 mRNA vaccine for emergency use. This would mean that the Pfizer/BioNTech vaccine would be the first to receive emergency validation from the international health agency, and it would lead to clearing roadblocks for the pharmaceutical company.
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 agency’s listing would help countries, including India, to expedite regulatory approvals to import and administer the vaccine.
“This is a very positive step towards ensuring global access to Covid-19 vaccines. However, 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,” said Dr Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products.
In December 2020, the United Kingdom had given its emergency-use authorisation to the Pfizer/BioNTech vaccine, with the USA, Canada and other countries following suit. However, there were many reports of an allergic reaction to the vaccine, and top medical agencies in the countries had issued a warning in regards to it.
Dr Simão added that WHO and their 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 claimed.
The Comirnaty vaccine requires storage using an ultra-cold chain; 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. For that reason, the 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. 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.