Sputnik V Vaccine Developers Expand The Global Production Network; EU To Resolve Supply Dispute With AstraZeneca Medicines & Vaccines 19/03/2021 • Madeleine Hoecklin Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to print (Opens in new window) The Stelis Biopharma manufacturing site in Bangalore, India, where the Sputnik V vaccine will be produced. Developers of Russia’s Sputnik V vaccine have entered into a partnership with Stelis Biopharma, an India-based drugmaker, to produce 200 million doses of the COVID-19 vaccine. Stelis is now the latest addition to the global production network for Sputnik V. The Russian Direct Investment Fund (RDIF), the company responsible for marketing the Sputnik vaccine abroad, announced the partnership on Friday, making Stelis – the biopharmaceutical division of Strides, an Indian pharma company – the most recent in a series of manufacturers RDIF signed agreements with. “We are delighted to announce our agreement with Stelis Biopharma for a significant capacity of Sputnik V,” said Kirill Dmitriev, CEO of RDIF, in a press release. “The significant vaccine volumes, which will be produced jointly with Stelis, will help widen access to the vaccine on a global scale.” The vaccine has shown high efficacy results in a peer-reviewed study, with 91.6% efficacy in preventing symptomatic COVID-19 cases and full protection against severe infection. Sputnik V has been authorized for use in over 50 countries, with rollouts underway in several of those countries. Today we celebrate a major global milestone as 50 countries have now authorized Sputnik V! Let's win the fight against the #COVID19 pandemic together! pic.twitter.com/jOSs8qUGGo — Sputnik V (@sputnikvaccine) March 11, 2021 Global Production Contracts for Sputnik V The Gamaleya National Research Institute of Epidemiology and Microbiology, the developer of Sputnik V, and RDIF have signed contracts with over 15 manufacturers in ten countries to produce 1.4 billion jabs and expand the manufacturing capacity for the vaccine. Certain factories, including ones in Brazil and Serbia, will be producing vaccines for the domestic population and others – in China, South Korea, India, and Iran – will be exporting vaccines to meet global demand. “We have some players who are really big, and they will be producing for the whole world. And we have some who are smaller and they will be producing more for local demand,” Dmitriev told the Financial Times in February. “This is our approach: to solve the bigger production issue while also…providing local availability.” Kirill Dmitriev, CEO of the Russian Direct Investment Fund (RDIF). India was described as a “key partner” for the production of the vaccine. On Tuesday, an agreement with Gland Pharma, an India-based pharmaceutical company, was announced for 252 million doses, joining India’s Hetero pharma firm, which is set to produce over 100 million doses. “We are delighted to partner with RDIF to make a substantial contribution towards providing global supply of the Sputnik V vaccine which is one of the most efficacious approved vaccines commercially available,” said Arun Kumar, the founder of the Strides Group. Supplies from the partnership are expected to be ready for distribution from the third quarter, between July and September. Efforts to Expand Production in Europe Talks are reportedly underway with companies in Spain, France, Germany and Sweden to arrange vaccine production, pending Sputnik V’s authorization for emergency use by the European Medicines Agency (EMA). Italy became the first country in the EU to sign a deal to produce the Sputnik V vaccine last week, with plans for Adienne, an Italian-Swiss pharma company, to produce 10 million doses of the vaccine in Italy by the end of the year. Support for the Sputnik V vaccine’s approval in Europe seems to be growing, with Norwegian, Austrian and German politicians calling for its procurement. The vaccine could prove to be useful in speeding up the EU’s slow vaccination campaign across the bloc’s 27 member states. “Concerning Sputnik V and other vaccines, I strongly insist that the relevant EU bodies issue an authorization for all safe vaccines as soon as possible,” said Sebastian Kurz, the Austrian Chancellor, in an interview on OE24 TV on Wednesday. “The more vaccines we have, the better the situation is.” Sebastian Kurz, Austria’s Chancellor, in an interview on Wednesday. A couple of EU countries have already moved forward with the national approval and rollout processes ahead of the EMA’s decision, including Hungary, Slovakia, and Czech Republic. Germany is also interested in signing a national supply deal for Sputnik V, according to Jens Spahn, Germany’s Health Minister, adding that the country is in close contact with Russia about the vaccine. “I am actually very much in favor of us doing it nationally if the European Union does not do something,” said Spahn at a press conference on Friday. A requirement for the deal, however, would be specifics on the number of doses that could be delivered. Although RDIF has established a global, decentralized network of manufacturers – attempting to avoid the production shortfalls and delays faced by AstraZeneca, mass production in several of the sites has not yet begun and scaling up production may be an issue. According to Dmitriev, RDIF plans to announce the details of overseas production in March. EU to Send a Letter to AstraZeneca in Effort to Resolve Dispute In other vaccine news, the European Commission plans to send a letter to AstraZeneca in an attempt to resolve the dispute over vaccine supply and delays in deliveries. According to Ursula von der Leyen, President of the European Commission, the pharma company has “under-produced and under-delivered” vaccines to the region, with a reduction in projected deliveries for the first quarter from 90 million to 30 million doses. Ursula von der Leyen, President of the European Commission, at a press conference on Wednesday. AstraZeneca also will only manage to deliver 70 million doses for the second quarter instead of the 180 million stated in its contract with the EU. EU officials say the company is contractually obligated to deliver 300 million doses by the end of June, but is projecting having only 100 million doses available due to production issues. “We plan to send a letter to AstraZeneca that will allow us to begin a dialogue with the company as part of a process to resolve the dispute,” said a spokesperson for the European Commission at a press conference on Thursday. The letter will be discussed with EU governments before it is sent. In the EU’s Advance Purchase Agreement with AstraZeneca, the two parties are required to resolve any issues that arise through informal discussions, initiated by sending a written notice. If the dispute cannot be settled through negotiations, legal action can be pursued. “Today we are taking a specific step. We will see where that leads us,” said a Commission spokesperson, not ruling out the potential of the EU filing a legal case against AstraZeneca in the future. UK Vaccine Supply to be Hit in the Coming Weeks Meanwhile, a reduction in the United Kingdom’s vaccine supply is expected from 29 March, in part due to a delayed delivery from India of five million doses of the Oxford/AstraZeneca vaccine. India’s recent surge in cases has led the government to use the available vaccine supply to meet domestic needs. A large increase in cases has been recorded over the past week in India, where just 2.4% of the population have received one dose of a COVID-19 vaccine. The seven day average of new COVID-19 cases is 29,355. According to Adar Poonawalla, CEO of the Serum Institute, the pharma company was directed in February to prioritize the needs of India in its distribution of vaccines. The UK – a country where 37.9% of the population have received at least one jab – made a deal in early March with the Serum Institute of India, the world’s largest vaccine manufacturer and a key source of doses for COVAX to supply low- and middle-income countries, for 10 million doses. “Five million doses had been delivered a few weeks ago to the UK and we will try to supply more later, based on the current situation and the requirement for the government immunization programme in India,” said a spokesperson for the Serum Institute. The shipment of the next five million doses will be delayed by at least four weeks, slowing the vaccination campaign in the UK and making it somewhat dependent on the worsening situation in India. US Plans to Send Millions of Doses to Mexico and Canada A healthcare professional preparing to administer the Oxford/AstraZeneca COVID-19 vaccine. In contrast, the US has millions of doses of the Oxford/AstraZeneca vaccine that cannot be administered nationally because the vaccine has not yet received emergency use authorization from the US Food and Drug Administration (FDA). Some four million of these doses will be delivered to Mexico and Canada, the White House press secretary said on Thursday. Approximately 30 million doses have been sitting in a manufacturing site in Ohio, ready to be administered, awaiting data from the US clinical trial for the approval process to move forward. “Our first priority remains vaccinating the US population,” said Jen Psaki, the White House press secretary during a press briefing. “[But] ensuring our neighbors can contain the virus is…[a] mission critical to ending the pandemic.” In the US’ first export of COVID-19 vaccines, 2.5 million doses will be distributed to Mexico and 1.5 million to Canada as a loan. Some 3.3% of the Mexican population have received at least one dose of a COVID-19 vaccine, 7.8% of the Canadian population, and 22.6% of the US population. The share of the total population that has received at least one dose of the COVID-19 vaccine in Mexico, Canada, and the US, as of 18 March. Mexico has received 8.1 million doses of COVID-19 vaccines as of Thursday and has begun the rollout of the Pfizer/BioNTech, AstraZeneca, Sinovac and Sputnik V vaccines. Canada’s regulators have approved the Pfizer, Moderna, AstraZeneca and Johnson & Johnson vaccines and the country has received 4.7 million doses so far. Canada has struggled to acquire vaccines, turning to Europe, Asia and COVAX to increase its supply. “We believe they’re coming very shortly, that’s been the content of our discussions thus far, but I have to stress that we are still finalizing the details,” Anita Anand, Canada’s Vaccine Procurement Minister, said in an interview on CTV News. “We are working to expedite this process as quickly as possible, knowing that Canadians want vaccines.” The doses could be delivered as soon as the end of March. Image Credits: RDIF, Stelis BioSource, CNBC, OE24.TV, Twitter – Ursula von der Leyen, Flickr, Our World in Data. Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to print (Opens in new window) Combat the infodemic in health information and support health policy reporting from the global South. 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