SII gets WHO emergency approval for Oxford-AstraZeneca Covid vaccine

The World Health Organisation (WHO) gave its approval to AstraZeneca and Oxford University’s COVID-19 vaccine for emergency use.

A WHO statement said it had approved the vaccine as produced by South Korea’s AstraZeneca-SKBio and the Serum Institute of India.

The authorisation will allow SII, one of the world’s biggest vaccine maker, to begin supplies of the Oxford vaccine to WHO-backed COVAX initiative. Some 190 countries have joined the programme, which was established to ensure equal distribution of vaccines.

Earlier, Serum Institute CEO Adar Poonawalla had said it would sell each dose at $3 for low-income countries. Besides the Oxford vaccine, WHO listed Pfizer and BioNTech’s Covid-19 shot for emergency use on December 31.

WHO’s Emergency Use Listing

An EUL by WHO is an endorsement of sorts that will enable speedy pick-up of the vaccine by countries that lack an elaborate regulatory setup. According to WHO, it’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.

In the case of the AstraZeneca/Oxford vaccine, WHO assessed the quality, safety and efficacy data, risk management plans and programmatic suitability, such as cold chain requirements, the statement said. The process took four weeks.