Sputnik V Manufacturer Didn’t Supply SUKL with Most of Needed Data

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the Russian Sputnik V vaccine (photo by TASR)

Bratislava, April 8 (TASR) – The manufacturer of the Russian Sputnik V vaccine didn’t provide the State Institute for Supervision of Medicines (SUKL) with approximately 80 percent of the data necessary for its evaluation, TASR has learnt from SUKL head Zuzana Batova, adding that the lack of and inconsistency of the data has made it impossible to adopt a conclusion on the benefit-risk balance.

SUKL further recommends that people in Slovakia should be inoculated with registered vaccines. At the same time, it pointed out that the missing documentation from the manufacturer is necessary for a clinical examination of Sputnik V. In addition, vaccines imported into Slovakia cannot be compared with those used abroad, as they are connected only by name.

“Despite repeated requests, the manufacturer of Sputnik V failed to provide data from pre-clinical testing, manufacturing (including data on drug manufacturing, final product, vaccine stability, storage and expiration) and clinical testing, which chiefly includes safety and efficacy data,” said Batova.

SUKL stated that the vaccine passed tests regarding its sterility, pyrogenicity, pH, clarity, colour, abnormal toxicity, specific activity, absence of visible mechanical impurities, extractable volume, determination of protein concentration and appearance. “However, it is impossible to conclude on efficacy and safety in humans based on laboratory tests alone, even after completing the remaining tests,” said Batova.

It stems from the data that the producer submitted to the European Medicine Agency (EMA) that the pharmaceutical form of the vaccine imported to Slovakia is not and will not be identical to the finished product, which is being assessed by EMA. “Vaccine batches used in pre-clinical tests and clinical studies published in the Lancet magazine don’t have the same characteristics and properties as the vaccine batches imported to Slovakia,” stressed Batova.

SUKL co-operated in the vaccine’s assessment with 30 official laboratories, as well as accredited laboratories of the Biomedicine Centre of the Slovak Academy of Sciences.

The unregistered vaccine could be used in Slovakia, for example, as part of the third stage of a clinical study. However, in order to approve a clinical testing, it is necessary to supply SUKL with the missing documentation from the Sputnik V producer and to apply adequate deadlines necessary for its assessment.