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Sinovac COVID-19 vaccine effective but some data lacking - WHO experts

Wed 5th May, 2021 4:07pm
GENEVA, May 5 (Reuters) - The COVID-19 vaccine produced by
China's Sinovac Biotech  SVA.O  is efficacious in preventing
COVID-19 in adults under 60, but some quality data on the risk
of serious adverse effects is lacking, World Health Organization
experts have found.
    The independent experts on the WHO's Strategic Advisory
Group of Experts (SAGE) reviewed Sinovac's CoronaVac jab from
phase 3 clinical trials in China, Brazil, Indonesia, Turkey and
Chile. 
    The assessment came shortly after WHO SAGE experts had
voiced "very low confidence" in data provided by Chinese
state-owned drugmaker Sinopharm on its COVID-19 vaccine
regarding the risk of serious side-effects in some patients, but
overall confidence in its ability to prevent the disease, a
document seen by Reuters showed.  urn:newsml:reuters.com:*:nL1N2MS0SU
    The Sinovac vaccine has been authorised in 32 countries and
jurisdictions, with 260 million doses distributed, the SAGE
experts said.
    "We are very confident that 2 doses of CoronaVac are
efficacious in preventing PCR confirmed COVID19 in adults (18-59
years)," SAGE said in an assessment posted on the WHO website.
    It cited evidence gaps in safety in pregnancy, and on safety
and clinical protection in older adults, those with underlying
disease, and evaluation of rare adverse events detected through
post-authorization safety monitoring.
    The experts said they had a "moderate level of confidence"
that the risk of serious adverse effects was low in people aged
59 and less, but had a "low level of confidence" in the quality
of evidence that such risk was also low for adults above 60.
    "We have low confidence in the quality of evidence that the
risk of serious adverse events in individuals with comorbidities
or health states that increase risk for severe COVID-19
following one or two doses of CoronaVac is low," they added.
    A separate group of WHO technical experts was reviewing
Sinovac's shot on Wednesday for possible WHO emergency use
listing - which would not only pave the way for its use in the
global COVAX vaccine sharing platform but also provide a crucial
international endorsement for a vaccine developed in China.
    
    

 (Reporting by Stephanie Nebehay; Additional reporting by
Miyoung Kim; Editing by Giles Elgood)
 ((Stephanie.Nebehay@thomsonreuters.com; +41 58 306 2161;
Reuters Messaging:
stephanie.nebehay.thomsonreuters.com@reuters.net; twitter
@StephNebehay))
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