China's Sinopharm Receives WHO Validation for Safety, Efficacy & Quality
Date
5/7/2021 11:16:51 PM
(MENAFN- Wadsam) The World health Organization (WHO) validated on Friday the
BBIBP-CorV COVID-19 vaccine developed by China's Sinopharm for emergency use.
"This afternoon, WHO gave emergency use listing to
Sinopharm Beijing's COVID-19 vaccine, making it the sixth vaccine to receive
WHO validation for safety, efficacy and quality," said WHO
Director-General Dr. Tedros Adhanom Ghebreyesus at a press briefing.
"This expands the list of vaccines that COVAX can buy,
and gives countries confidence to expedite their own regulatory approval, and
to import and administer a vaccine," he said.
In an official press release, WHO Assistant-Director General
for Access to Health Products Dr. Mariangela Simao said that the addition of
the Sinopharm vaccine has "the potential to rapidly accelerate COVID-19
vaccine access for countries seeking to protect health workers and populations
at risk."
The vaccine produced by Beijing Bio-Institute of Biological
Products Co Ltd, a subsidiary of the China National Biotec Group, is an
inactivated vaccine with easy storage requirements, which makes it highly
suitable for low-resource settings.
It is also the first vaccine that will carry a vaccine vial
monitor, a small sticker on the vaccine vials that change color if the vaccine
is exposed to heat, letting health workers know whether the vaccine can be
safely used.
According to WHO's Strategic Advisory Group of Experts on
Immunization (SAGE), the Sinopharm vaccine is recommended for use in adults 18
years and older, in a two-dose schedule with a spacing of three to four weeks.
Though few older adults over 60 years were enrolled in
clinical trials and efficacy could not be estimated in this age group, WHO is
not recommending an upper age limit for the Sinopharm vaccine, because reviewed
data have suggested that the vaccine is likely to have a protective effect in
older persons, according to the WHO press release.
"There is no theoretical reason to believe that the
vaccine has a different safety profile in older and younger populations,"
said the WHO press release, which recommends that countries using the vaccine
in older age groups conduct safety and effectiveness monitoring.
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