Why AZ’s vaccine was used as comparator for SKY Covione

MFDS disclose minutes of the Central Pharmaceutical Affairs Council’s meeting

“Global vaccine companies did not approve use as control vaccine…considered the approval status and availability of vaccines”

The minutes of the Central Pharmaceutical Affairs Council’s meeting that reviewed the first homegrown COVID-19 vaccine - SK Bioscience’s 'hasCovione multi inj.’ – have now been disclosed.

 

The minutes contained discussions on the reason why a vaccine from a different platform was selected as the control vaccine for SKY Covione, whether its safety is acceptable, and on the adequacy of post-approval safety assurance measures.

 

The CPAC meeting that was held on June 26th, whose minutes were disclosed by the MFDS recently, sought counsel on the safety and efficacy of the homegrown COVID-19 vaccine SKY Covione, which applied for manufacture, sale, and marketing authorization in Korea.

 

An employee from SK Biosience’s Andong L House is filling the Sky Covione formulation (Pic: SK Bioscience)

On why a vaccine from a different platform was selected as a control vaccine for SKY Covione, the MFDS explained, “Although it is best to use a comparator from the same platform, a recombinant vaccine using the same platform had only been approved in January this year in Korea, and at a similar period in Europe as well.” “The clinical trial for SKY Covione had been approved in August last year, and no approved vaccines were using the same platform at the time.

 

Therfore, the company had to find the most appropriate control vaccine among available vaccines, all of which were being supplied by the state.

 

The multinational pharmaceutical companies have not approved the use of their vaccines as control vaccines, therefore, AstraZeneca’s vaccine was used as control vaccine in consideration of the approval status and availability of vaccines.” The World Health Organization also states that although using vaccines from the same platformas a control vaccine is advisable if the company cannot secure a vaccine from the same platform, it may use other vaccines as control as long it can demonstrate clear immunogenicity compared to that control vaccine.

 

The MFDS said, “Unlike in the past, all of the vaccines for COVID-19 are being contracted and used by the state.

 

This was why it was difficult for latecomers to obtain a control vaccine, and only AZ’s vaccine was available for use as a control vaccine." Explaining how vaccines based on bridging immunogenicity data are approved under the condition that it submits efficacy evaluations, the MFDS added, “The Ministry will add a condition for the drug’s approval to follow-up for a certain period post-approval to evaluate how much infection is prevented after actual vaccination."