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Sinopharm now authorized for emergency use


Text by Henrylito D. Tacio

Photo from Wikipedia

Last May 3, President Rodrigo R. Duterte was vaccinated against the coronavirus disease 2019 (COVID-19). It was Health Secretary Francisco Duque III himself who administered the Sinopharm-developed vaccine. 

The Sinopharm vaccine is produced by Beijing Bio-Institute of Biological Products Co Ltd, a subsidiary of China National Biotec Group (CNBG).

Instead of being lauded, Duterte was criticized on social media as the vaccine he was inoculated “has yet to secure an emergency use authorization (EUA) from the Food and Drug Administration (FDA).”

During his nationally televised address, the president apologized. “Well, we are sorry that we committed the things that you are criticizing us for. We accept responsibility. I myself had been vaccinated. Well, it’s the decision of my doctor. Anyway, it’s my life.”

As a result of this faux pas, he ordered to return the remainder of the 1,000 doses donated by China. He told the Chinese ambassador to withdraw all Sinopharm vaccines. “Do not send Sinopharm here so that there would be no trouble,” he said.

On May 7, the Geneva-based World Health Organization issued a press statement that it listed Sinopharm for emergency use, paving the green light for the vaccine to be rolled out globally.

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.”

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 of 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 the 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, the 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,” the statement said. As such, the United Nations health agency recommends that countries using the vaccine in older age groups conduct safety and effectiveness monitoring to make the recommendation more robust.

Sinopharm vaccine is being used in vaccination campaigns by certain countries in Asia, Africa, South America, and Europe, Wikipedia reports. On March 26, Sinopharm said more than 80 million doses had been administered.

Sinopharm vaccine is an inactivated vaccine-like CoronaVac and BBV152. A more traditional technology that is similar to the inactivated polio vaccine has been used in producing Sinopharm.

“Initially, a sample of SARS-CoV-2 from China capable of rapid multiplication was used to grow large quantities of the virus using vero cells,” Wikipedia reports. “From then on, the viruses are soaked in beta-propiolactone, which deactivates them by binding to their genes, while leaving other viral particles intact. The resulting inactivated viruses are then mixed with an aluminum-based adjuvant.”

Before Sinopharm, WHO also listed the Pfizer/BioNTech vaccine for emergency use on December 31, 2020; two AstraZeneca/Oxford COVID-19 vaccines on February 15, 2021, produced by AstraZeneca-SKBio (Republic of Korea) and the Serum Institute of India; and COVID-19 vaccine Ad26.COV2.S was developed by Janssen (Johnson & Johnson) on March 12, 2021.

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