Sinovac approval only if new vaccine needed

  • Many vaccines already available in SL: Expert Committee 
  • Comm. seeks evidence on efficacy against new strains 

By Pamodi Waravita 

The Independent Vaccine Advisory Expert Committee will approve the Chinese Sinovac Covid-19 vaccine only if it deems Sri Lanka to be in need of this vaccine in addition to all other vaccines currently available, and scheduled to arrive, in Sri Lanka.

Sources told The Morning that since the country is already receiving stocks of a number of different vaccines, it is yet to be determined by the Committee as to whether there is a convincing need to administer the Sinovac vaccine to the Sri Lankan population.

The approval of the National Medicines Regulatory Authority (NMRA) Independent Vaccine Advisory Expert Committee is required for the emergency use of the Sinovac vaccine (CoronaVac), developed by Chinese drug maker Sinovac, in Sri Lanka.

It is further learnt that a period of approximately two weeks will be needed to collect convincing evidence about the efficacy of the vaccine, especially with regard to its efficacy against the new strains of the virus. This has already been communicated to Health Ministry Secretary Dr. S.H. Munasinghe.

Reportedly, the NMRA is to make inquiries from the expert panel about why approval has not yet been granted for the Sinovac vaccine.

The World Health Organisation (WHO) granted approval for emergency use of the Sinovac  vaccine on 1 June.

“On the basis of the available evidence, the WHO recommends the vaccine for use on adults who are 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% of those vaccinated, and prevented severe Covid-19 and hospitalisation in 100% of the studied population. 

“Since only a few older adults (over 60 years) were enrolled in clinical trials, efficacy could not be estimated in this age group. Nevertheless, the WHO is not recommending an upper age limit for the vaccine because the data collected during subsequent use in multiple countries and supportive immunogenicity data suggest that the vaccine is likely to have a protective effect in older persons,” the WHO noted, in granting the approval.

Foreign media reports continue to raise concerns about both the Sinovac and the Chinese Sinopharm vaccines, as countries such as the Seychelles, Chile, Bahrain, and Mongolia, which had mainly relied on these two vaccine types, had later seen outbreaks of the virus.

Just yesterday (12), Thailand changed its vaccine policy to mix Sinovac with the Oxford AstraZeneca vaccine in a bid to boost protection, after hundreds of medical workers caught Covid-19 despite being fully vaccinated with Sinovac. Now, instead of two Sinovac doses, people will receive the AstraZeneca vaccine after their first Sinovac shot. Health workers already fully vaccinated with Sinovac will also receive a third booster using a different vaccine.

However, the Sinovac vaccine proved highly effective in a large-scale Phase 3 trial in Chile, according to a new study published in the New England Journal of Medicine on Wednesday (7). Results of a nationwide mass-vaccination campaign in Chile from 2 February to 1 May showed that the inactivated vaccine is 65.9% effective against symptomatic Covid-19, 87.5% in the prevention of hospitalisation, 90.3% against ICU admission, and 86.3% against Covid-19 related deaths.

The research involved 10.2 million participants aged 16 years and above. The results suggested that it offers very similar protection to people over 60 years, as it does for other groups.