Spanner in the works for Sputnik V as missing data reported
pharmafile | July 13, 2021 | News story | Manufacturing and Production | COVID-19, EMA, Russia, Vaccine
Developers of Russia’s Sputnik V COVID-19 vaccine have repeatedly failed to present data to regulators, Reuters has reported.
Five sources with knowledge of European efforts to assess the drug have informed Reuters that standard data required for the approval process has repeatedly been missed by the drug’s developers.
Reuters reported last month that the EMA’s review of the drug’s safety and efficacy was delayed because a June 10 deadline to submit data on the vaccine’s clinical trials was missed, however the issue of missed data goes further than this.
It is reported that the EMA has received “hardly any manufacturing data” with the clinical data it has received being incomplete. Furthermore, it was reported that an independent French assessment carried out in advance of the EMNA review found that the vaccine developers were unable to document that the master cell bank, the initial building block of the vaccine, complied with specific EU regulation on preventing disease contamination.
Reuter’s source has also stated that vital forms pertaining to the reporting of any adverse effects following inoculation in clinical trials were missing. It was also reported that scientists were unclear on how they tracked the outcomes of people given a placebo.
Sputnik V is marketed overseas by Russia’s sovereign wealth fund, called the Russian Direct Investment Fund (RDIF).
The RDIF said Reuters’ reporting contained “false and inaccurate statements” based on anonymous sources who are attempting to harm Sputnik V as part of a disinformation campaign. RDIF suggested the vaccine could be under attack by the “Western pharmaceutical lobby,” without offering evidence of such a campaign.
Globally the vaccine is now being used in over 60 countries, with Brazilian regulators having initially rejected imports of Sputnik V after technical staff highlighted “inherent risks,” citing a lack of data guaranteeing its safety, quality, and effectiveness. Slovakia’s drug agency said it had insufficient data from Moscow before the government ultimately gave a limited go-ahead for the vaccine. Hungary gave emergency approval for the jab despite what several people with knowledge of the process said were concerns raised by some specialists working on the review at Hungary’s drug regulator about insufficient documentation.
Another issue reported by Reuters is in the documentation of the source of the drug’s fetal bovine solution. Fetal bovine serum is commonly used around the world in vaccine development, but since the outbreak of mad cow disease in the 1980s, European and North American regulators have required that vaccine developers document it is from a safe source.
The RDIF told Reuters that the Gamaleya Institute “never used ‘non-traceable bovine serum’ for cell bank preparation.” It added that the Sputnik V cell bank has been independently verified not to contain prions – the proteins associated with conditions like mad cow disease. RDIF didn’t identify who conducted the independent verification.
The Brazilian regulator Anvisa’s rejection in April of Sputnik V imports led to the RDIF threatening to sue the Brazilian agency for defamation.
A crucial issue for Anvisa related to the adenovirus, the virus that causes the common cold and which is used in Sputnik V to carry into the body information that triggers an immune response. Anvisa publicly said there was a risk the adenovirus in Sputnik V could replicate, potentially causing a negative reaction in recipients. Anvisa’s manager for medicines and biological products called this possibility a “serious” defect. However, the Russians said there was no evidence of replication and Anvisa had misinterpreted the documentation.
Anvisa said studies and documents supplied by Gamaleya indicated the “occurrence of replicating adenoviruses” and lacked adequate assessment of the relationship between that and the vaccine’s safety. Anvisa added that the conditions it imposed included demonstrating the absence of replication in all batches sent to Brazil.
The RDIF, in its responses to Reuters, said Gamaleya “has confirmed that no replication-competent adenoviruses were ever found in any of the Sputnik V vaccine batches that have been produced.”
Kat Jenkins
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