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WHO lists AstraZeneca-Oxford vaccine for emergency use

PT Jyothi Datta Mumbai | Updated on February 16, 2021

Two sites, including Serum Institute, to produce it despite global concerns over age and virus variants

The World Health Organization (WHO) has listed listed two versions of the AstraZeneca/Oxford Covid-19 vaccine for emergency use, paving the way for their roll out globally through the COVAX facility.

The vaccines are produced by AstraZeneca-SKBio (Republic of Korea) and the Serum Institute of India, a WHO note said.

This adds to the WHO-recommended arsenal of Covid-19 vaccines that can be readily picked up by countries that don’t have an elaborate regulatory system to evaluate these vaccines. The Pfizer-BioNTech Covid-19 vaccine was the first to get a similar listing just ahead of the new year.

The EUL comes at a time when the AZ-Oxford vaccine is not being recommended for people above 55 years in some European countries. The WHO’s expert group, though, had earlier this month recommended the vaccine for all age groups, 18 and above.

SA variant

The listing also comes against the backdrop of South Africa opting for the Johnson and Johnson vaccine over the AZ one, following a local study that showed it offered minimal protection against the SA variant of the virus. Reports from Johannesburg quoted a heath official saying, they would look to share their vaccines procured from Serum Institute with other African countries. Serum Institute did not comment on the issue.

Assesses safety

WHO’s Emergency Use Listing (EUL) assesses the quality, safety and efficacy of Covid-19 vaccines and is a prerequisite for COVAX Facility vaccine supply.

Pascal Soriot, AZ Chief Executive Officer, however said, the approval “endorses that the vaccine can be used to help protect populations across the world, including adults over 65 years and in countries where different variants of the SARS-CoV-2 virus are in circulation.”

“The WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) recommended a dosing interval of eight to 12 weeks. In addition, they also recommended use of the vaccine in countries where new variants, including the South African B1.351 variant, are prevalent,” the company said.

Looking to supply low and middle income countries, AZ hoped to supply 300 million doses to 145 countries in the first half of 2021, through Covax, “pending supply and operational challenges”.

AstraZeneca said, the EUL allows for two doses of the vaccine to be administered at a four to 12-week interval. This regimen was shown in clinical trials to be safe and effective in preventing symptomatic Cövid-19, with no severe cases and no hospitalisations more than 14 days after the second dose.

The AstraZeneca/Oxford product is a viral vectored vaccine and has been found to have 63.09 percent efficacy. It is suitable for low- and middle-income countries due to easy storage requirements (temperatures of 2 to 8 degrees C) , the WHO said. (eom)

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Published on February 16, 2021
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