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Making Sinovac an available option without compromising on standards

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WHO on 1 June validated the Sinovac-CoronaVac COVID-19 vaccine for emergency use.

Following this, the MOH said the Sinovac-CoronaVac COVID-19 vaccine can be administered in Singapore under the special access route where private healthcare institutions can apply to be licensed providers for the vaccine under this special route. Questions have been asked including why the vaccine is not approved by HSA.

Here are a few things we know about the Sinovac-CoronaVac COVID-19 vaccine.

Its inclusion on WHO’s Emergency Use Listing (EUL)

WHO’s emergency use listing (EUL) procedure assesses the suitability of novel health products including vaccines during this pandemic.

The list focuses on the needs of low-and middle-income countries with limited access to Covid-19 vaccines. Its objective is to make vaccines available as rapidly as possible to address the pandemic. It is a risk-based process that expedites the assessment of vaccines for use especially in these countries, where the benefits are deemed to outweigh the risks.

Speaking to the Wall Street Journal, University of Hong Kong molecular virologist and professor Dongyan Jin said WHO’s approval of Sinovac’s jab would speak more to the need for additional vaccines rather than represent a vote of confidence. Questions remain due to a lack of data.

As Dr Mariângela Simão, WHO Assistant-Director General for Access to Health Products said, “The world desperately needs multiple COVID-19 vaccines to address the huge access inequity across the globe.”

“For a start, countries with no access to vaccines to date will finally be able to start vaccinating their health workers and populations at risk, contributing to the COVAX Facility’s goal of equitable vaccine distribution.”

Sinovac-CoronaVac COVID-19 vaccine

The Sinovac-CoronaVac COVID-19 vaccine is produced by the Beijing-based pharmaceutical company Sinovac.

It is an inactivated vaccine. Its easy storage requirements make it very manageable and particularly suitable for poorer countries with low resources.

The vaccine is recommended for use in adults 18 years and older, in a two-dose schedule with a spacing of two to four weeks.

A large phase 3 trial in Brazil showed that two doses, administered at an interval of 14 days, had an efficacy of 51% against symptomatic infection, 100% against severe COVID-19, and 100% against hospitalization starting 14 days after receiving the second dose.

A Chilean study found the vaccine to be 67 per cent effective in preventing symptomatic infection. It was 85 per cent effective in preventing hospitalisations and 80 per cent effective in preventing deaths according to a report prepared by the Chilean health ministry.

Indonesia which also uses the Sinovac vaccine reported an efficacy rate of 94% at preventing symptomatic disease in its study of 120,000 vaccinated healthcare workers.

Singapore

While Singapore takes reference from WHO, Singapore’s Health Sciences Authority (HSA) does it own independent and rigorous assessment of vaccines before approving them for use in Singapore. This is necessary to maintain high standards.

Out of a list of 6 vaccines ( Moderna, Pfizer-BioNTech, Johnson & Johnson, AstraZeneca, Sinopharm and Sinovac) approved by WHO, only 2 are approved by the HSA to date for our national vaccination programme. They are the Pfizer-BioNTech and Moderna vaccines. Both vaccines are based on the mRNA technology.

Although Singapore has received supplies of the Sinovac doses, the vaccine has not been approved for use by the Health Sciences Authority (HSA) which is still evaluating it. In March this year, HSA had asked Sinovac for more detailed data so it could make an “adequate, full assessment” of its vaccine.

According to WHO, few older adults (over 60 years) were enrolled in clinical trials for the Sinovac vaccine. Hence efficacy could not be estimated in this age group although WHO also said that data collected from subsequent use of the vaccine in multiple countries suggests that the vaccine is likely to have a protective effect in older persons.

We do not know if in the future, HSA will approve the use of Sinovac as part of our national vaccination programme. But as of now, it is not. It is still under evaluation.

Expert panel clears mRNA vaccines for people with allergies

On Friday (4 June), Singapore expert panel said individuals with a history of anaphylaxis and allergic reactions to other drugs, food, insect stings or unknown triggers can now be vaccinated with mRNA vaccines.

A large majority of the 32,000 people here who have not been able to take the Pfizer-BioNTech and Moderna mRNA vaccines previously because of medical reasons will now be able to do so under the national programme.

A choice without compromising standards set by Singapore

Still, there are people who prefer the vaccine from Sinovac, some because it uses the traditional method of an inactivated virus.

Allowing the administration of the Sinovac vaccine through the private healthcare sector gives people the option to get it without compromising on standards set by Singapore.

As Professor Teo Yik Ying, dean of the National University of Singapore’s Saw Swee Hock School of Public Health noted, “We want to ensure not just safety but maximum effectiveness when our people are vaccinated. That means we want to be very clear about the efficacy data for the vaccines that we roll out nationally.”

People rejected from the mRNA vaccines will be reimbursed for Sinovac vaccine

Individuals who had been rejected from taking the Pfizer-BioNTech or Moderna vaccines previously, or who are allergic to the mRNA vaccines will be reimbursed for the vaccine when they take the Sinovac jab at a private clinic.

MOH will release its stock of 200,000 doses of the Sinovac vaccine for free to 20 selected private clinics across Singapore. However, private clinics are allowed to charge a fee to recover their costs.

All Singapore citizens, permanent residents and individuals holding long-term visit passes may obtain the Sinovac vaccine at private clinics should they wish to, said MOH.

As Sinovac is not part of the national vaccine programme, it will therefore not be covered under the Vaccine Injury Financial Assistance Programme for COVID-19 vaccination.

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