[Vaccine-manufacturing] Russia Pushes Ahead With Open License Approach To Sputnik V - Despite WHO Concerns Over Manufacturing Practices - Health Policy Watch

James Love james.love at keionline.org
Sat Jul 3 08:53:53 PDT 2021



Earlier this year, Brazil’s medicines regulator rejected Sputnik V’s
request for approval, due to the contamination of some batches of the
adenovirus vector, among other issues.

Meanwhile, Slovakia’s regulator also has voiced concerns that the batches
of Sputnik V it received did “not have the same characteristics and
properties” as the version of Sputnik V reviewed in a Lancet study, which
published favourable Phase III trial results for the vaccine earlier in
February – with an efficacy of 91 % against symptomatic COVID-19 disease
and 100% against severe COVID.

And the European Medicines Agency (EMA) has delayed Sputnik V’s approval
following the RDIF’s failure to submit additional clinical trial data by a
deadline that was initially set for early June.

At the same time, low- and middle-income countries, desperate for vaccines,
have largely ignored such concerns. Since Russia’s own approval last
August, almost seventy, mostly low- and middle-income countries have
greenlighted the vaccine, which features a low price and easy storage
requirements – and is even more attractive after India’s Serum Institute
halted its AstraZeneca vaccine exports via the Global COVAX facility in

Even more significantly, a number of countries, including India, Serbia,
Argentina, and Iran, have already begun their own mass production of
Sputnik V vaccines. That includes half a dozen manufacturers in India,
which are set to produce 65%-70% of Sputnik V’s global supply, or about 850
million doses or more a year, according to RDIF projections.

Should those aims indeed be reached, the RDIF and its partners could
potentially produce nearly 10% of the world’s total vaccines for 2021.

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