WHO endorses Sinopharm vaccine
Print Edition
The World Health Organization has validated the COVID-19 vaccine developed by China’s Sinopharm for emergency use, a move set to boost global vaccine rollout, particularly in the developing world.
“This afternoon, the 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 on Friday.
“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.
The decision by a WHO technical advisory group is a first for a Chinese vaccine. COVAX is a global coalition that works to ensure fair and equitable access to COVID-19 vaccines around the world.
In addition to the Sinopharm’s BBIBP-CorV vaccine, the WHO had previously listed the COVID-19 vaccines developed by Pfizer-BioNTech, Johnson & Johnson, Moderna, AstraZeneca, and a version of the AstraZeneca vaccine made by the Serum Institute of India for emergency use.
A WHO decision is expected within days on Sinovac, a second Chinese-made vaccine already being used in 22 territories.
In an official press release, WHO Assistant Director General for Access to Health Products 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 jab produced by the 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 use in low-resource settings.
It is also the first vaccine that will carry a vial monitor, a small sticker on the vials that changes color if the vaccine is exposed to heat, letting health workers know whether the vaccine can be safely used.
“(We) came to the conclusion that there is enough evidence of safety and the capacity of the vaccine to prevent severe disease or symptomatic and hospitalized cases up to 79 percent,” said Alejandro Cravioto, who heads the WHO advisory group on immunizations.
According to the WHO’s Strategic Advisory Group of Experts on Immunization, 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 adults over 60 years were enrolled in clinical trials and efficacy could not be estimated in this age group, the 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,” read the WHO press release, which recommends that countries using the vaccine in older age groups conduct safety and effectiveness monitoring.
Assessment by SAGE has shown that the Sinopharm vaccine had been authorized by 45 countries or jurisdictions for use in adults 18 years or older, where more than 65 million doses had been administered. No safety concerns have been identified from pre-clinical or repro/tox (reproductive toxicity) studies, while most adverse events were mild to moderate, such as injection pain, headache and fatigue.
By last Wednesday, more than 1.1 billion COVID-19 vaccine doses had been administered globally, according to Tedros.
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