WHO gives emergency approval to China’s Sinopharm vaccine
We are not an agent or recuirter, but a headhunter !
这是4月3日拍摄的运抵格鲁吉亚第比利斯国际机场的中国新冠疫苗。新华社发(格鲁吉亚卫生部供图)
The
World Health Organization (WHO) validated on Friday the BBIBP-CorV
COVID-19 vaccine developed by China's Sinopharm for emergency use.
WHO on 7th, May, 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).
Video: https://v.qq.com/x/page/t3244xad1k1.html
“The addition of this vaccine has the potential to rapidly accelerate COVID-19 vaccine access for countries seeking to protect health workers and populations at risk,” said Dr Mariângela Simão, WHO Assistant-Director General for Access to Health Products. “We urge the manufacturer to participate in the COVAX Facility and contribute to the goal of more equitable vaccine distribution.”
"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.
“The addition of this vaccine has the potential to rapidly accelerate COVID-19 vaccine access for countries seeking to protect health workers and populations at risk,” said Dr Mariângela Simão, WHO Assistant-Director General for Access to Health Products.
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
also the 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 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.
The
EUL assesses the quality, safety and efficacy of COVID-19 vaccines, as
well as risk management plans and programmatic suitability, such as cold
chain requirements. The assessment is performed by the product
evaluation group, composed by regulatory
experts from around the world and a Technical Advisory Group (TAG),
in charge of performing the risk-benefit assessment for an independent
recommendation on whether a vaccine can be listed for emergency use
and, if so, under which conditions.
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
hospitalized 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.
WHO emergency use listing
The emergency use
listing (EUL) procedure assesses the suitability of novel health
products during public health emergencies. The objective is to make
medicines, vaccines and diagnostics available as rapidly as possible to
address the emergency, while
adhering to stringent criteria of safety, efficacy and quality. The
assessment weighs the threat posed by the emergency as well as the
benefit that would accrue from the use of the product against any
potential risks.
The EUL pathway involves a rigorous assessment of
late phase II and phase III clinical trial data as well as substantial
additional data on safety, efficacy, quality and a risk management
plan. These data are reviewed by independent experts and WHO
teams who consider the current body of evidence on the vaccine under
consideration, the plans for monitoring its use, and plans for further
studies.
As part of the EUL process, the company producing the
vaccine must commit to continue to generate data to enable full
licensure and WHO prequalification of the vaccine. The WHO
prequalification process will assess additional clinical data generated
from
vaccine trials and deployment on a rolling basis to ensure the
vaccine meets the necessary standards of quality, safety and efficacy
for broader availability.
WHO also listed the Pfizer/BioNTech vaccine
for emergency use on 31 December 2020; two AstraZeneca/Oxford COVID-19
vaccines on 15 February 2021, produced by AstraZeneca-SKBio (Republic of
Korea) and the Serum Institute of India; and COVID-19 vaccine
Ad26.COV2.S
developed by Janssen (Johnson & Johnson) on 12 March 2021.
WHO has also listed the Pfizer/BioNTech, Astrazeneca-SK Bio, Serum Institute of India, Janssen and Moderna vaccines for emergency use.
Source:Chinadaily; Xinhua
https://www.who.int/news/item/07-05-2021-who-lists-additional-covid-19-vaccine-for-emergency-uses;
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