Bumpy road to approval in Brazil and parts of Europe for Sputnik V Covid-19 vaccine
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Bumpy road to approval in Brazil and parts of Europe for Sputnik V Covid-19 vaccine

By GlobalData Healthcare 01 Jul 2021 (Last Updated July 1st, 2021 17:17)

Russia's Covid-19 vaccine, Sputnik V, is believed unlikely to receive central approval in highly regulated pharmaceutical markets such as North America and the EU.

Brazil’s pharmaceutical regulator, Agência Nacional de Vigilância Sanitária (ANVISA), has performed a U-turn and granted conditional approval to Russia’s Sputnik V Covid-19 vaccine, which it had previously rejected. At the same time, several European countries are internally disputing over whether to wait for a central verdict from the European Medicines Agency (EMA) or to independently approve the vaccine without Brussels’ involvement.

ANVISA rejected the Gamaleya Federal Research Centre of Epidemiology and Microbiology’s (Moscow, Russia) vaccine on 26 April, stating that documents submitted by Gamaleya suggested that one of its two doses contains adenoviruses capable of replication. This is potentially dangerous to recipients.

ANVISA’s conditional approval brings the number of countries that have approved Sputnik V to more than 60. While the vaccine is currently under review by the World Health Organisation (WHO) and EMA, it is believed unlikely that it will receive central approval in highly regulated pharmaceutical markets such as North America and the EU. Despite the lack of approval from Brussels, EU member states Hungary and Slovakia approved the vaccine on 21 January and 26 May respectively.

The roll-out in Slovakia has been bumpy amid political division. In March, then-Prime Minister Igor Matovic signed a secret deal without coalition support to purchase two million doses. This triggered a political crisis and Matovic’s resignation. The new government has approved the vaccine but has said it will wait for the EMA’s approval before ordering more doses.

Slovakia’s State Institute for Drug Control has claimed it is missing manufacturing data about Sputnik V and that the vaccines the country received are different from those shipped elsewhere, a national newspaper reported. In response, Gamaleya demanded the return of the doses, while Sputnik V’s official Twitter account accused the Slovakian regulator of an ‘act of sabotage’ and a ‘disinformation campaign’. The same Twitter account also threatened to sue ANVISA for defamation after its initial rejection. The Czech Republic is also torn on approval. In March, the country’s president condemned the health minister for not approving Sputnik V.

Russia has also developed CoviVac or KoviVac, marketed by the Federal Research Centre for Research and Development of Immunobiological Preparations (Moscow), and EpiVacCorona, marketed by The State Research Centre of Virology and Biotechnology VECTOR (Koltsovo). Belarus has separately announced that it has created its own Covid-19 inactivated vaccine, according to the Russian news agency.

In early June, ANVISA also approved Bharat Biotech’s (Hyderabad, India) Covaxin vaccine and granted good manufacturing practice (GMP) certification to the company’s manufacturing site in Hyderabad.

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