The Pandemic Commission advised the Government on Tuesday to start holding talks with the Russian producer of the Sputnik V vaccine and procure a sufficient amount of the vaccine, given the poor pandemic situation in Slovakia and the shortage of vaccines approved by the European Medicines Agency (EMA), Health Minister Marek Krajčí (OLaNO) reported on Tuesday. The Government is set to deal with the recommendation at its session due to be held on Thursday.
The Sputnik V vaccine has not been approved by the EMA, and even the request for its approval has not yet been sent.
On Wednesday, the Slovak State Medicines Agency (ŠÚKL) stated that it was invited to a meeting of the Pandemic Commission on Tuesday, where it learnt that it will be asked for an opinion on the safety, efficacy and quality of the Sputnik V vaccine. The Slovak Ministry of Health will subsequently decide on the authorization to use it as an unregistered vaccine. The agency as such cannot issue an individual registration decision for the Sputnik V vaccine in Slovakia.
ŠÚKL will request from the manufacturer the standard information necessary for the proper evaluation of any vaccine: data from pre-clinical trials, details about production (including data on vaccine stability, storage and expiration), data from clinical trials, including those on safety and efficiency.
As it is a vaccine from a non-EU producer, it is also necessary to carry out an inspection of good manufacturing practice. It can be done only by qualified inspectors, and ŠÚKL mentioned the option of creating an European inspection team in negotiations with the EMA and partner agencies. The inspection of the good manufacturing practice of the vaccine will be performed by an international team at the EU level and ŠÚKL has already applied to participate in this team.
"The actual length of the process will depend in particular on the speed, quality, transparency and scope of the data supplied by the manufacturer. The vaccine can only be scientifically assessed if the manufacturer makes available all the required data and documents, be it to ŠÚKL or the EMA," reads the statement of the Slovak State Medicines Agency.
