Times Of Swaziland: WHO GIVES ASTRAZENECA GREEN LIGHT

WHO GIVES ASTRAZENECA GREEN LIGHT
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Phumelele Mkhonta on 17/02/2021 08:33:00


MBABANE - The World Health Organisation (WHO) has finally given the Oxford
AstraZeneca COVID-19 vaccine the green light.
The long wait for the said COVID-19 vaccine to be listed is finally over as the
WHO officially listed it under the ‘WHO Emergency Use List’ on Monday
evening. The vaccine, which raised debate in the African region, after it was
discovered that it was less effective on the South African COVID-19 strain, is
now ready to be rolled out to countries that were waiting for it to be listed.
According to a press statement by the WHO Strategic Advisory Group of Experts
(SAGE), WHO listed two additional COVID-19 vaccines for emergency use and COVAX
rollout. The two vaccines are the two versions of the Oxford AstraZeneca.
Versions
“The WHO has 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
(EUL) 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,” read the statement.
WHO Assistant Director General for Access to Medicines and Health Products Dr
Mariângela Simão, said countries with no access to the vaccines, to date,
would finally be able to start vaccinating their healthcare workers and
populations at risk, contributing to the COVAX facility’s goal of equitable
vaccine distribution. “But we must keep up the pressure to meet the needs of
priority populations everywhere and facilitate global access. To do that, we
need two things, a scale-up of manufacturing capacity and developers’ early
submission of their vaccines for WHO review,” said Simão.
He said WHO EUL process could be carried out quickly when vaccine developers
submitted the full data required by WHO in a timely manner. “Once these 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,” read the
statement by the SAGE. They said the process took under four weeks.