Pfizer first off the block to get WHO nod for emergency use

The World Health Organisation (WHO) has given its stamp of approval to the Covid-19 mRNA vaccine from Pfizer-BioNTech, making it the first to receive emergency validation from the multilateral agency 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 Organisation to procure the vaccine for distribution to countries in need,” a WHO note on new-year’s eve said.

Others in the fray like the AstraZeneca-OxfordUniversity combine have also said they would seek emergency use listing from the WHO for their vaccine.

But the rapid pick-up of this vaccine faces a challenge from its steep requirements for storage and distribution. “The Comirnaty (Pfizer-BioNTech) 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, WHO is working to support countries in assessing their delivery plans and preparing for use where possible,” it added.

Calling the EUL a positive step towards global access to Covid-19 vaccines, Dr Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products, emphasised 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,” she said.

Currently, over 230 Covid-19 vaccines are in the works, 60 under clinical development and 172 in the pre-clinical stage, according to WHO. And the clutch of vaccines that have already received emergency use authorisations on home turf or other regions include those from Pfizer-BioNTech , Moderna, AstraZeneca-Oxford University, the Gamaleya Research Institute and Sinopharma.

Risk-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 WHO note explained.

The vaccine is also under policy review. WHO’s Strategic Advisory Group of Experts on Immunisation (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 prioritisation recommendations for Covid-19 vaccines in general, issued in September 2020, it added.

EUL procedure

Further explaining the emergency use listing procedure, the WHO said it 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 the 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. These data are reviewed by independent experts and WHO teams who consider the current body of evidence on the vaccine under consideration, the plans for monitoring its use, and plans for further studies.

Experts from individual national authorities are invited to participate in the EUL review. 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.

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, the WHO said.

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