MOSCOW — Russia's boast in August that it was the first country to authorize a coronavirus vaccine led to skepticism at the time because of its insufficient testing. Six months later, as demand for the Sputnik V vaccine grows, experts are raising questions again — this time, over whether Moscow can keep up with all the orders from the countries that want it.
Slovakia got 200,000 doses on March 1, even though the European Medicines Agency, the European Union's pharmaceutical regulator, only began reviewing its use on Thursday in an expedited process. The president of the hard-hit Czech Republic said he wrote directly to Russian President Vladimir Putin to get a supply. Millions of doses are expected by countries in Latin America, Africa, the former Soviet Union and the Middle East in a wave of Russian vaccine diplomacy.
"Sputnik V continues to confidently conquer Europe," anchor Olga Skabeyeva declared on the Russia-1 state TV channel.
Dmitry Kiselev, the network's top pro-Kremlin anchor, heaped on the hyperbole last month, blustering: "The Russian coronavirus vaccine, Sputnik V, is the best in the world."
State TV channels have covered vaccine exports extensively, citing praise from abroad for Russia and running segments about the difficulties countries are having with Western vaccines.
The early criticism of Sputnik V has been blunted by a report in the prestigious British medical journal The Lancet that said large-scale testing showed it to be safe, with an efficacy rate of 91% against the virus.
That could help revamp Russia's image to one of a scientific, technological and benevolent power, especially as other countries encounter shortages of COVID-19 vaccines because richer nations are scooping up the Western-made versions or manufacturers struggle with limited production capacity.
"The fact that Russia is among five countries that were able to quickly develop a vaccine … allows Moscow to present itself as a high-tech power of knowledge rather than a petrol pump in decline," said foreign affairs analyst Vladimir Frolov.
Some experts say boosting the use of vaccines from China and Russia — which have not been as popular as those from the West — could offer a quicker way to increase the global supply. Others note that Russia wants to score geopolitical points.
"Putin is using (the vaccine) to bolster a very tarnished image of Russia's scientific and technological prowess," said Lawrence Gostin, a Georgetown University professor and director of the World Health Organization Collaborating Center on National and Global Health Law. "He's using it for geostrategic purposes in areas where Russia would like to have spheres of influence."
Whether Russia can deliver is another question. China has supplied millions of doses to other countries, but the output of Sputnik V appears for now to be far lower than the demand.
"They succeeded beyond their wildest dreams in terms of this vaccine actually being a viable, marketable product," said Judy Twigg, a political science professor specializing in global health at Virginia Commonwealth University. "They've made all of these explicit and implicit promises to people inside and outside Russia about access to this product that now is unexpectedly great. And now they're stuck trying, scrambling, trying to figure out how to deliver on all those promises."
Russia also must take care of its own. Authorities have announced plans to vaccinate 60% of adults, or roughly 68 million people, by the end of June.
The domestic rollout in Russia has been slow, compared with other nations, with about 4 million people, or less than 3% of the population, vaccinated as of late February. Some of that could also be due to widespread reluctance among Russians to trust vaccines.
The Russian Direct Investment Fund, which bankrolled and markets the vaccine abroad, has not responded to a request for comment on how many doses are going to other countries. It said earlier that it has received requests for 2.4 billion doses from over 50 nations.
Airfinity, a London-based science analytics company, estimates that Russia agreed to supply about 392 million doses abroad, and there are talks with countries for at least another 356 million.
Judging by production and exports so far, "Russia is very far from being able to deliver this," said Airfinity CEO and founder Rasmus Hansen.
Russia manufactured just over 2 million doses last year amid reports of local producers having problems with buying equipment and making the second component of the two-shot vaccine.
Russian Prime Minister Mikhail Mishustin said Feb. 20 that over 10 million doses of Sputnik V have been produced.
Sputnik V is a viral vector vaccine, which uses a harmless virus that carries genetic material to stimulate the immune system. Producing it is a complicated process, said Elena Subbotina, a consultant with the pharma consultancy CBPartners' Central and Eastern Europe Team. Producers can't guarantee stable output because working with biological ingredients involves a lot of variability in terms of the quality of the finished product.
Some countries that have been offered large batches of Sputnik V have yet to approve it for use.
In India, which has been pledged 125 million doses, the vaccine is undergoing studies to determine if it produces a comparable immune response. Brazil's health ministry said it is negotiating to purchase 10 million doses, but the nation's regulatory agency has yet to authorize its use. Nepal, which has been offered 25 million doses, also hasn't given its approval.
Other countries have had delays in receiving Sputnik V shipments.
Argentina got nearly 2.5 million doses by March 1, even though at one point the government was expecting 5 million in January and over 14 million more in February. Officials in Hungary, who agreed to buy 2 million doses over three months, said Jan. 22 they were expecting 600,000 doses in the first 30 days, but got only 325,600 by early March. Mexico signed a deal for 24 million doses and was hoping to receive 400,000 in February but got only 200,000.
The Russian Direct Investment Fund has agreements with manufacturers in countries including Brazil, South Korea and India to boost production, but there are few indications that manufacturers abroad have made any large amounts of the vaccine so far.
The Brazilian company Uniao Quimica is in the pilot testing phase, the results of which will be shared with Russia before the company can produce it for sale. Indian drugmaker Hetero Biopharma, with a deal to make 100 million doses, was to begin production at the start of 2021, but it isn't clear if it has actually started.
South Korean company GL Rapha, which expects to make 150 million doses this year, will be manufacturing finished products by sometime in March, said company official Kim Gi-young.
Russia so far hasn't faced any criticism for delaying supplies of Sputnik V to other countries, with foreign officials optimistic about the deals.
Hungary is still awaiting large shipments, but expressed optimism about receiving them.
"The Russian side, with minimal delay, will meet the 600,000 doses agreed to in the first phase, and then the additional 1.4 million doses," Hungary's State Secretary Tamas Menczer said last month. Prime Minister Viktor Orban added Friday: "The Russians are pretty much keeping their promises."
Promising more than can be delivered appears to be a universal problem with coronavirus vaccines, and it is a real risk for Russia as well, said Theresa Fallon, director of the Brussels-based Centre for Russia Europe Asia Studies.
"They have won the gold medal for creating this very effective vaccine," she said. "But the problem is, how are they going to implement it?"