WHO validates China’s Sinovac COVID vaccine for emergency use
Marje Pelayo • June 2, 2021 • 252
The World Health Organization (WHO) on Tuesday, June 1, validated CoronaVac COVID vaccine produced by China-based pharmaceutical firm Sinovac for emergency use.
This gives the assurance that the vaccine meets international standards for safety, efficacy, and manufacturing.
“The world desperately needs multiple COVID-19 vaccines to address the huge access inequity across the globe,” said Dr. Mariângela Simão, WHO Assistant Director General for Access to Health Products.
“We urge manufacturers to participate in the COVAX Facility, share their know-how and data, and contribute to bringing the pandemic under control,” she added.
WHO’s Emergency Use Listing (EUL) is a prerequisite for COVAX Facility vaccine supply and international procurement.
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 through the product evaluation group composed of regulatory experts from around the world.
In the case of the Sinovac-CoronaVac vaccine, the WHO assessment included on-site inspections of the production facility.
Given Sinovac-CoronaVac’s easy storage requirements, it is very manageable and particularly suitable for low-resource settings.
Based on available evidence, WHO recommends the vaccine for use in adults 18 years and older, in a two-dose schedule with a spacing of two to four weeks.
Vaccine efficacy results showed that the vaccine prevented symptomatic disease in 51 percent of those vaccinated and prevented severe Covid-19 and hospitalization in 100 percent of the studied population.
Few older adults (more than 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 data collected during subsequent use in multiple countries and supportive immunogenicity data suggest the vaccine is likely to have a protective effect in older persons.
WHO recommends that countries using the vaccine in older age groups conduct safety and effectiveness monitoring to verify the expected impact and contribute to making the recommendation more robust for all countries.
MANILA, Philippines — The Philippines will receive on Thursday, June 17, some 1.5 million more doses of COVID-19 vaccine from Chinese drug firm Sinovac Biotech, the National Task Force (NTF) against COVID-19 said.
In a media advisory, the NTF said the shipment will be carried by a Cebu Pacific flight, which is expected to arrive at the Ninoy Aquino International Airport (NAIA) Terminal 2 at 7:30 a.m.
The incoming vaccine doses will be the third batch of Sinovac shots to be delivered to the Philippines in June.
The vaccines will then be transported to the cold storage facility of Pharmaserv Express, Inc. in Marikina City where they will be preserved prior to distribution to local government units.
Once delivered, the country’s vaccine supply will increase to more than 14 million doses.
Vaccine czar Carlito Galvez Jr. earlier said that around six million more vaccine doses are expected to arrive in the remaining days of June.
MANILA, Philippines — A total of one million doses of Sinovac vaccine from China arrived in the Philippines around 7:00 a.m. Thursday (June 10).
On board Cebu Pacific Flight 57671, the vaccines were welcomed by members of the government’s vaccine team led by Secretary Carlito Galvez Jr at the Ninoy Aquino International Airport Terminal 2.
Later tonight, an additional 2.28 million doses of Pfizer-BioNtech COVID-19 vaccine from the World Health Organization’s (WHO) COVAX facility are also set to arrive, marking the biggest single-day delivery of COVID-19 vaccine supply in the Philippines.
MANILA, Philippines – The Department of Health (DOH) is open to using Sinovac Biotech’s COVID-19 vaccine on children following China’s approval on the emergency use of the jab for those aged between three and 17, a health official said Monday.
Health Undersecretary Maria Rosario Vergeire said this is good news for the Philippines and other countries that are looking to expand their COVID-19 vaccination coverage.
“Magandang balita ‘yan, kung talagang makikita natin na ‘yun talagang pag-aaral ay may accuracy at saka makikita natin na ‘yung basis nila at ‘yung ebidensya nila ay maganda. Maganda itong balita hindi lang para sa Pilipinas kung hindi para sa buong mundo,” Vergeire said in a virtual press briefing.
“Tayo ay laging bukas sa ganitong makabago saka innovative na ginagawa para ma-expand natin ang coverage ng ating pagbabakuna,” she added.
Vergeire said Philippine health experts will study this once the drug firm submits a revision of its vaccine’s emergency use authority (EUA).
“’Pagka nabuo na nila ang mga ebidensya at nakumpleto na nila ‘yung mga trial at nagsumite sila dito sa Pilipinas ng revision ng kanilang emergency use authority, pag-aaralan po ‘yan ng ating mga eksperto,” she said.
“At kung mapatunayan natin na ito ay magiging ligtas din, it’s going to protect our children, then of course, we will be open to this,” she added.
The Department of Science and Technology earlier said that pharmaceutical firms Pfizer and Moderna are preparing to seek EUA for their COVID-19 vaccines to be used on minors.
Vaccine czar Secretary Carlito Galvez Jr. also said that the national government is looking to include minors aged 12 to 17 in the government’s vaccination program.
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