OREANDA-NEWS. July 04, 2014. The Federal Antimonopoly Service completed surveying product boundaries of the market of pneumococcal vaccines for children aged from 1.5 month to 5 years.

The analysis was initiated upon two mutually exclusive petitions from vaccine producers.

“GlaxoSmithKlain” asked to recognize substitutability of “Sinflorix” and “Prevenar 13” vaccines.

“Pfizer” insisted that “Prevenar 13” is unique because these vaccines have different formulas.

FAS analysis established limited substitutability of “Sinflorix” and “Prevenar 13” vaccines.

On 18th June 2014, FAS published the official position on vaccine substitutability to prevent pneumococcal infection, according to which “Sinflorix” and “Prevenar 13” vaccines can be similarly effective to prevent pneumococcal infection caused by ten serotypes included in the formulas of both vaccines. It means that for the purposes of vaccinating children from pneumococcus, serotypes 4, 6B, 9V, 14, 18C, 19F, 23F, 1, 5, 7F, “Sinflorix” and “Prevenar 13” vaccines are substitutes.

To prevent pneumococcal infection caused by 3, 6А and 19А strains, “Prevenar 13” vaccine should be used.

Analysis accounted for FAS comments to the draft national calendar of preventive vaccines (approved by No. 125n Order of the Ministry of Health Care of 21.03.2014) on administering vaccines that contain antigens of current concern for the Russian Federation, thanks to which different producers will be able to take part in public procurement of vaccines depending on an epidemical situation.

“A decision on procurement and administration of a particular vaccine must be made by government customers factored in epidemiological monitoring data, compliance of the antigen formulae of a vaccine to the serotypes dominating among the target groups of the population in a particular territory. The FAS position is submitted to the Ministry of Health Care of the Russian Federation”, pointed out the Head of FAS Department for Control over Social Sphere and Trade, Timophei Nizhegorodtsev.