A study by the Buenos Aires Ministry of Health to monitor the safety of the Sputnik V vaccine against Covid-19 confirmed on Thursday that it is the safest among the vaccines.
“SputnikV shows the safest profile among #COVID vaccines used in the Buenos Aires province in Argentina, no deaths related to vaccination recorded – the province Health Ministry,” tweeted Sputnik V. There were no deaths related to the Russian vaccine, and most post-vaccination events were mild, such as fever, headaches, and pain at the site of application.
The study showed that the Events Supposedly Attributable to Vaccination or Immunization (ESAVI) were mostly mild. Among the most frequent are fever (47%), headaches (45%), myalgias and arthralgias (39.5%) and pain (46.5%) and swelling (7.4%) in the area of the injection, said the Buenos Aires province Health Ministry in a statement.
The objective of the Buenos Aires investigation was to describe the occurrence of ESAVI notified to the Integrated Argentine Health Information System (SIISA) after the application of the Russian vaccine against Covid-19 in the province of Buenos Aires since December 29, 2020, campaign start day was June 3, 2021.
In that period, 2.8 million doses of Sputnik V vaccine were applied; 1.3 million from Sinopharm and 0.9 million from Covishield/AstraZeneca with a severe ESAVI rate (product-related) per million applied doses of 0.7; 0.8 and 3.2 respectively, said the statement.
The investigation of each ESAVI involves classifying it according to a series of categories established by the World Health Organisation (WHO) and Pan American Health Organisation (PAHO).
Meanwhile, on WHO concern over Sputnik V coronavirus vaccine issues with the filling of vials at one plant, the Pharmastanfar – UfaVITA said that the issues did not relate to the safety or efficacy of the vaccine itself, the plant is responsible only for pouring into vials doses of Sputnik V vaccine produced elsewhere.
WHO did not raise any questions about the safety and efficacy of the produced and finished vaccine as the “Sputnik V” vaccine undergoes strictest double quality output control of the Gamaleya Institute and the Russian health regulator (Federal Healthcare Service – Roszdravnadzor), said OJSC Pharmstandard-UfaVITA statement.
Moreover, WHO interim inspection did not identify any critical issues with the actual vaccine’s production, quality, clinical studies, possible side effects, nor with the double quality output control by both the Gamaleya Institute and the Russian health regulator. Instead, WHO inspectors’ attention was focused on only 4 technical issues mostly related to one of the filling lines that have all been subsequently fully addressed, said the statement.
Further, OJSC Pharmstandard-UfaVITA invited WHO for another inspection.
