WHO Has Approved Sinovac’s COVID-19 Vaccine for Emergency Use

It seems that another vaccine has been added to the Emergency Use List (EUL), which means there are now more alternative vaccines for private healthcare providers in Singapore to administer to those who can’t take the Pfizer-BioNTech and Moderna vaccines!

On Tuesday (1 Jun), the World Health Organisation (WHO) finally approved a COVID-19 vaccine made by Sinovac Biotech for emergency use, the second Chinese vaccine approved after Sinopharm’s.

According to Reuters and The Straits Times, the WHO emergency listing is a signal to national regulators on a product’s safety and efficacy.

WHO’s chief, Mr Tedros Adhanom Ghebreyesus, reassured that the vaccine was found to be “safe, effective and quality-assured”.

The listing allows countries to approve and import a vaccine for distribution quickly, especially states without an international-standard regulator of their own, reported CNA.

In addition, Sinovac’s addition to the EUL meant that it would be included in COVAX, the global vaccination programme which provides this essential resource to poorer countries that face major supply problems due to India’s suspension of vaccine exports.

Sinovac’s vaccine, the two-dose CoronaVac, relies on a traditional technology with cheaper, less stringent storage requirements as compared to vaccines developed by other firms. This makes it a better option for less-developed nations.

“We urge manufacturers to participate in the COVAX facility, share their know-how and data and contribute to bringing the pandemic under control,” said Mariangela Simao, the WHO’s Assistant Director-General for access to health products, citing the “huge access inequity” as an issue.

So far, other vaccines included in the EUL are those developed by Pfizer-BioNTech, Moderna, Johnson & Johnson, Sinopharm, Oxford-AstraZeneca—WHO counts the AstraZeneca jabs produced in India, South Korea, and the European Union (EU) separately.

Sinovac’s Efficacy

Sinovac differs from the two mRNA-based vaccines approved in Singapore—the ones developed by Pfizer-BioNTech and Moderna—as it contains an inactivated form of coronavirus that cannot cause the disease. It also has a substance that helps strengthen the immune response to the vaccine.

When given the shot, the immune system identifies the inactivated virus as foreign and makes antibodies against it, which will then recognise the active virus and defend the body against it.

As reported by the South China Morning Post, there has been much uncertainty over Sinovac’s reliability throughout its global roll-out as data from its final phase clinical trials have yet to be published in a peer-reviewed journal. Different study locations reported various efficacy results, ranging from a high 83.5% to just 50.7%.

To be included in the EUL, doses must be at least 50% effective in preventing COVID-19.

WHO has announced that vaccine efficacy trials showed that Sinovac prevented symptomatic disease in 51% of those vaccinated and prevented severe COVID-19 and hospitalisation in 100% of the studied population.

They also recommend administering the vaccine to adults aged 18 years or older, in a two-dose schedule with a spacing of two to four weeks.

Though there were few participants older than 60 years old in the clinical trial, WHO said that there was “no reason to believe it has a different safety profile” in older generations.

On the other hand, the organisation’s separate Strategic Advisory Group of Experts (SAGE) found that some quality data on the risk of serious adverse effects was lacking in their preliminary evaluation.

More specifically, there were gaps in safety in pregnancy, and in safety and clinical protection in older adults, those with underlying disease and evaluation of rare adverse events detected through post-authorisation safety monitoring.

Sinovac has since supplied more than 600 million doses of its vaccine worldwide and has administered over 430 million doses.

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