WHO 15th Feburary listed two versions of the AstraZeneca/Oxford COVID-19 vaccine for emergency use, giving the green light for these vaccines to be rolled out globally through COVAX. The vaccines are produced by AstraZeneca-SKBio (Republic of Korea) and the Serum Institute of India.
WHO’s Emergency Use Listing assesses the quality, safety and efficacy of COVID-19 vaccines and is a prerequisite for COVAX Facility vaccine supply. It also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines.
The WHO EUL process can be carried out quickly when vaccine developers submit the full data required by WHO in a timely manner. Once those data are submitted, WHO can rapidly assemble its evaluation team and regulators from around the world to assess the information and, when necessary, carry out inspections of manufacturing sites.
In the case of the two AstraZeneca/Oxford vaccines, WHO assessed the quality, safety and efficacy data, risk management plans and programmatic suitability, such as cold chain requirements. The process took under four weeks.
The vaccine was reviewed on 8 February by WHO’s Strategic Advisory Group of Experts on Immunization, which makes recommendations for vaccines’ use in populations (i.e. recommended age groups, intervals between shots, advice for specific groups such as pregnant and lactating women). The SAGE recommended the vaccine for all age groups 18 and above.
The AstraZeneca/Oxford product is a viral vectored vaccine called ChAdOx1-S [recombinant]. It is being produced at several manufacturing sites, as well as in the Republic of Korea and India. ChAdOx1-S has been found to have 63.09% efficacy and is suitable for low- and middle-income countries due to easy storage requirements.
Deusdedit Mubangizi, Head of WHO’s Prequalification Unit told reporters, “today is a great day, especially for the COVAX.”
He continued, “we started assessing these two vaccines hardly four weeks ago. But when you look at the map that has been shown in this various fora where you have continents that have access to vaccines and then other countries that don't have, I think,any movement that increases capacity on the manufacturing and supply of vaccine is a great milestone for this world.”
The emergency use listing 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.
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.
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.
WHO also listed the Pfizer/BioNTech vaccine for emergency use on 31 December 2020.
WHO’s Dr Mike Ryan also briefed the reporters. He said, "this mission was envisaged as a collaborative effort under the under the World Health Assembly resolution, where obviously working with China, a sovereign state, a member state of WHO, to better understand the origins of the virus so as to learn lessons for the future.”
He continued, “it was not as such an investigation of supposed wrongdoing or referring to any nonexistent investigatory powers that WHO might have. WHO does not possess the mandate to enter uninvited to any nation state."
Dr Tedros also said, "many times I hear that this is a WHO study or investigation. It's not. It's an independent study, a study which is composed of independent individuals from 10 institutions. And WHO's role here is coordination and that's what we should take into consideration too."
On Ebola, Dr Tedros said, on Sunday, “authorities in Guinea declared a separate outbreak of Ebola in the town of Gouecke, in the southeast of the country.”
Dr Tedros continued, “as you remember, Guinea was one of the three countries affected by the West Africa Ebola outbreak of 2014 to 2016, the largest Ebola outbreak on record. The outbreaks in Guinea and DRC are completely unrelated, but we face similar challenges in both."