DISINFO: EU made it difficult for people to get Sputnik V
SUMMARY
Europeans committed a terrible folly as they entrusted vaccination to the bureaucracy in Brussels. Brussels was unable to reach an agreement with the pharmaceutical companies. As a result, it is very difficult to get a (Sputnik V) vaccine, for example, in Germany today, and on this basis, there is a lot of anger and aggression.
RESPONSE
A disinformation message linked to the current EMA rolling review of Sputnik V.
The delay of rolling out the Russian vaccine in the EU cannot be laid over the shoulders of EMA alone as it is being painted in the claim.
Under EU rules, any vaccine or medicinal product must be authorised by the European Medicines Agency before it can be marketed in any state of the 27-nation bloc, EMA said.
Nonetheless, temporary import and distribution of unauthorised vaccines are allowed for emergency use in the EU “in response to the suspected or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation, any of which could cause harm,” the relevant EU law reads.
Thus the process of vaccine approval and distribution in the EU can be categorised as follows: a wholesale distribution, meaning an applicant can apply for the EMA approval after which if approved, the medicine is on the market in all EU MS. Or a 'piecemeal' distribution, meaning an applicant applies with the national medicines agency, and if approved, they are allowed to sell in that MS alone.
So far, Hungary and Slovakia have already bought the Russian shot, the Czech Republic is interested, and the EU official said Italy was considering using the country’s biggest vaccine-producing bioreactor at a ReiThera plant near Rome to make Sputnik V.
But on 15th March 2021, Kirill Dmitriev, head of RDIF, which is marketing Russia’s Sputnik V vaccine globally said that they are targeting getting approval by the EMA which “will allow starting supplying Sputnik V to the European single market”.
On that note, interim results from a phase 3 trial of the Sputnik V COVID-19 vaccine were only published in The Lancet on February 2, 2021.
And up until mid-February 2021, the producer of the Sputnik V vaccine has not submitted a market authorisation to EMA.
On March 4, the EMA launched a rolling review of Sputnik V, the first step in a process that could lead to its EU-wide approval, this will allow the EMA to assess data on a vaccine as they become available, while the development is still ongoing. EMA does not discriminate but follow the usual, fast procedures.
Read similar cases in our database that claim that a senior EMA official said getting Sputnik V is like playing Russian roulette; or that EMA's delay in approving Sputnik V is political; or that Sputnik V is a target of the corporate cold war; that the West wants to discredit the Sputni -V; or that Finns are choosing Sputnik V for vaccination.