The World Health Organisation (WHO) has approved the use of
Sinopharm, the COVID-19 vaccine produced in China, for emergency use.
Sinopharm is the sixth vaccine approved by the WHO against
COVID-19 — Pfizer/BioNTech, Astrazeneca-SK Bio, Serum Institute of India,
Janssen and Moderna vaccines are five others listed by the WHO for emergency
use.
Announcing the approval via a statement on Friday, the WHO
said the decision was part of efforts to improve access to vaccines to curb the
spread of the coronavirus.
According to the global health organisation, the emergency use listing (EUL) will also provide more options for countries interested in accessing vaccines via the United Nations-led COVAX facility — African countries are procuring vaccines via the COVAX facility.
Nigeria has also expressed interest in procuring COVID-19
vaccine from China — although the AstraZeneca vaccine is what is currently
being distributed in the country.
“WHO today listed the Sinopharm COVID-19 vaccine for
emergency use, giving the green light for this vaccine to be rolled out
globally. The Sinopharm vaccine is produced by Beijing Bio-Institute of
Biological Products Co Ltd, subsidiary of China National Biotec Group (CNBG),”
the statement read.
“WHO’s Emergency Use Listing (EUL) 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 Sinopharm vaccine, the WHO assessment
included on-site inspections of the production facility. The Sinopharm product
is an inactivated vaccine called SARS-CoV-2 Vaccine (Vero Cell). Its easy
storage requirements make it highly suitable for low-resource settings. It is
the also first vaccine that will carry a vaccine vial monitor, a small sticker
on the vaccine vials that change color as the vaccine is exposed to heat,
letting health workers know whether the vaccine can be safely used.
“WHO’s Strategic Advisory Group of Experts on Immunization
(SAGE) has also completed its review of the vaccine. On the basis of all
available evidence, WHO recommends the vaccine for adults 18 years and older,
in a two-dose schedule with a spacing of three to four weeks. Vaccine efficacy
for symptomatic and hospitalised disease was estimated to be 79%, all age
groups combined.
“Few older adults (over 60 years) were enrolled in clinical
trials, so efficacy could not be estimated in this age group. Nevertheless, WHO is not recommending an
upper age limit for the vaccine because preliminary data and supportive
immunogenicity data suggest the vaccine is likely to have a protective effect
in older persons.
“There is no theoretical reason to believe that the vaccine
has a different safety profile in older and younger populations. WHO therefore
recommends that countries using the vaccine in older age groups conduct safety
and effectiveness monitoring to make the recommendation more robust.”
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