THE HAGUE, Feb 20, 2021 (BSS/AFP) – Russia’s Sputnik V vaccine is still
waiting for the European Medicines Agency (EMA) to start the countdown to its
launch across the 27-nation bloc.
With Moscow and Brussels trading barbs over the length of time the
Amsterdam-based regulator is taking, here is what we know so far:
– What’s the process? –
The EMA says Sputnik faces the same process as all other coronavirus
vaccines.
This first stage is a “rolling review” of data and trials, which the EMA
says Sputnik has not started.
That would be followed by a formal application for a one-year conditional
marketing authorisation.
“They have to submit the whole set of data, indeed go through the whole
scrutiny process, like any other vaccine,” European Commission chief Ursula
von der Leyen said on February 17 about Sputnik.
Three vaccines are authorised for the EU: Pfizer-BioNTech, Moderna and
AstraZeneca. One other, Johnson & Johnson, has applied for authorisation. Two
others, Novavax and CureVac, have started rolling reviews.
– What does the EMA say? –
The EMA insisted in a “clarification” on February 10 that it had “to date
not received an application for a rolling review or a marketing authorisation
for… the Sputnik V vaccine, despite reports stating the opposite.”
The regulator confirmed to AFP that was still the case on February 18.
It also said that EMA’s experts themselves “need to give their agreement
first before developers can submit their application for initiation of the
rolling review process.”
The EMA has however said that Sputnik V’s backers submitted a request for
“scientific advice” to prepare for a possible application for market
authorisation, and confirmed a meeting took place on January 19 to discuss
“further engagement”.
– What do the Russians say? –
Russian authorities tout the vaccine’s take-up by around 30 countries and
a Lancet study showing it was 91.6 percent effective against symptomatic
Covid-19 cases.
The developers and backers of Sputnik insist that a rolling review
application has been made.
The Russian sovereign wealth fund, which backed the vaccine, said Russian
authorities “filed a registration request” on January 19 — further than the
step the EMA said was taken on that date.
The fund also rejected “misdirected” reports that, after Sputnik’s Twitter
account posted a supposed filing of the registration, it turned out it had
been sent to the wrong agency.
The fund insisted it was “working with the EMA to start a rolling review”
and said the agency had a few days ago “appointed rapporteurs for the Sputnik
V dossier”.
– Is Sputnik being treated the same as other vaccines? –
As it would be the first non-Western developed vaccine deployed in the EU,
officials have said that Sputnik production sites outside the bloc would need
to be inspected.
“They are not producing in Europe, so of course there should be an
inspection process on the production sites,” von der Leyen said on February
17.
Brussels has been wary of Russian and Chinese vaccines, concerned that
Moscow and Beijing would use them as soft power tools.
Von der Leyen herself raised questions about why Moscow was so keen to
push the vaccine on the EU.
“Overall I must say, we still wonder why Russia is offering theoretically
millions and millions of doses while not sufficiently progressing in
vaccinating their own people,” she said.