A senior aide to Hungarian Prime Minister Viktor Orban has said the country will not use Russia’s Sputnik-V vaccine, and will focus on the EU procurement mechanism or on China, instead.
Orban’s chief of staff, Gergely Gulyas said Hungary will continue scientific cooperation with Russia over its Coronavirus vaccine, however Sputnik-V will not top the country’s vaccination program at this stage, due to Moscow’s “inadequate” manufacturing capacity.
“Russia has inadequate manufacturing capacity,” Gulyas told ATV in an interview, adding that: “We are happy to partake in the testing, but vaccines en masse may come as part of the EU procurements or from China.”
Hungary has agreed to participate in trials for the Sputnik V vaccine, sent experts to Russia to observe its manufacture and floated the idea of producing it in Hungary, Reuters reported.
While the country has not committed to submitting vaccines it clears for use in Hungary to the European Medicines Agency (EMA) for approval, Brussels have warned Budapest against damaging the trust on the safety and efficacy of vaccines endorsed by the block, after Hungary announced its plans to import the Russian jab in November.
Russia’s vaccine is not included in the EU’s vaccine portfolio, as it has faced acute criticism over its fast-track approval that skipped the third phase of trials. Under EU rules, any vaccine must be authorised by the European Medicines Agency (EMA) before it can be marketed in any state of the 27-nation bloc. So far, EMA has received no data from Russia or Hungary on Sputnik V or any other COVID-19 vaccine.
According to the Union’s legislation, and in particular the Regulation on the conduct of clinical trials with and supply of medicinal products for human use containing or consisting of genetically modified organisms intended to treat or prevent coronavirus disease (COVID-19), “no medicinal product may be placed on the market in the Union or in a Member State unless a marketing authorisation has been granted by the competent authorities” under the relevant directives or regulations.
However, some exceptions are foreseen, “in situations characterised by an urgent need to administer a medicinal product to address the specific needs of a patient, for compassionate use or in response to the suspected or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation that could cause harm.”
So far, Europe’s drug regulators have greenlighted only the vaccine shot developed by US drugmaker Pfizer and its German partner, BioNTech, while a decision on Moderna’s COVID-19 vaccine candidate is awaited.