WHO awaits Serum Institute data to recommend Covid-19 vaccine for international use

The World Health Organization is awaiting data from Serum Institute of India (SII) on the AstraZeneca-OxfordUniversity Covid-19 vaccine, so it can be evaluated and recommended for international use.

AstraZeneca (AZ) had earlier indicated it would approach the WHO for an Emergency Use Listing (EUL), an endorsement of sorts that would enable speedy pick-up of the vaccine by countries that did not have an elaborate regulatory set-up. Pfizer’s mRNA vaccine was the first to receive such an approval and discussions are underway on its roll-out, given its challenging storage and distribution requirement of –(minus) 70 degress Celsius.

WHO Director General Tedros Adhanom Ghebreyesus said recently that they looked forward to Serum Institute “submitting full data sets for rapid assessment so WHO can determine whether we can recommend their AstraZeneca vaccine for international use.”

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“WHO continues to ask vaccine manufacturers from around the world to move swiftly to provide the necessary data that will allow us to consider them for emergency use listings,” he added.

AZ-Oxford vaccine

SII has a production and distribution alliance on the AZ-Oxford vaccine, allowing it to ship the product to low and middle income countries. A vaccine expert told BusinessLine , the company would be expected to submit details including its local manufacturing and clinical trial data for the WHO evaluation. SII did not want to comment on the development.

Currently, Serum Institute and Bharat Biotech are in the process of shipping their vaccines to depots across India, as the country readies itself to start vaccination on Saturday.

Meanwhile, the WHO chief said, its team in China was also working with producers of the Sinovac and Sinopharm vaccines “to assess compliance with international quality manufacturing practices ahead of potential emergency use listing by WHO.”

A separate team is going to China to trace the origins of SARS-CoV-2, the virus that cause Covid-19. It was a year ago, the first death from Covid-19 was reported and WHO issued its first tranche of technical guidance, the multilateral agency recalled.

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“A year on, there have been almost 2 million deaths from the Covid-19 virus and while we are hopeful about the safe and effective vaccines that are being rolled out, we want to see this sped up and vaccines allocated equitably in the coming weeks,” he added. The WHO Executive Board meets next week, where Dr Tedros will urge countries to stick to their commitment to Covax, a WHO-supported facility working towards equitable access. Saving lives, livelihoods and economies depends on a global agreement, he said, not vaccine nationalism.

New strains

Over the weekend, WHO was notified by Japan about a new variant of the virus. About 1,750 scientists met recently at a WHO-convened event to discuss research gaps on mapping the variants. Genomic sequencing has been critical in identifying and responding to new variants, the WHO said. “So far an astounding 350,000 sequences have been publicly shared, but most come from just a handful of countries. Improving the geographic coverage of sequencing is critical for the world to have eyes and ears on changes to the virus,” said Maria Van Kerkhove, WHO Technical Lead on Covid-19.

“The more the virus spreads the higher the chance of new changes to the virus,” said Tedros, adding that transmissibility of some variants of the virus appeared to be increasing. “This can drive a surge of cases and hospitalisations, which is highly problematic for health workers and hospitals already close to breaking point,” he cautioned.

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