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Спутник V
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Изображение флаконов с гам-COVID-Vac от Минздрава России
Описание вакцины
ЦельSARS-CoV-2
Тип вакциныВирусный вектор
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  • Спутник V [1]
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  • Зарегистрировано в России 11 августа 2020 г.
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Спутник V ( русский : Спутник V ) представляет собой вирусный вектор вакцина для COVID-19 , разработанной научно - исследовательского институт Гамалеи эпидемиологии и микробиологии им . Дата регистрации 11 августа 2020 года в МЗ РФ как Gam-COVID-Vac ( русском : гам-КОВИД-ВАК , латинизируется :  гам-Kovid-Вак ), [2] [3] Спутник V представляет собой аденовирус вирусный вектор вакцины. «V» обозначает букву английского алфавита, а не римскую цифру пять. [4]

Изначально Gam-COVID-Vac был одобрен для распространения в России, а затем в 59 других странах (по состоянию на апрель 2021 г.) по предварительным результатам исследований фазы I - II, опубликованным 4 сентября 2020 г. [5] Утверждение в начале августа 2020 г. Gam-COVID-Vac был встречен критикой в ​​средствах массовой информации и дискуссиями в научном сообществе по поводу того, было ли одобрение оправданным в отсутствие надежных научных исследований, подтверждающих безопасность и эффективность. [2] [3] [6] [7] [8] 2 февраля 2021 года в журнале «Ланцет» был опубликован промежуточный анализ исследования, который показал эффективность 91,6% без необычных побочных эффектов .[9]

Экстренное массовое распространение вакцины началось в декабре 2020 года в таких странах, как Россия, Аргентина, Беларусь, Венгрия, Сербия и Объединенные Арабские Эмираты. К февралю 2021 года было заказано более миллиарда доз вакцины для немедленного распространения по всему миру. [10]

Технология [ править ]

Встреча президента Путина с членами правительства 11 августа 2020 года в режиме видеоконференции, на которой он объявил об условно зарегистрированной вакцине против COVID-19 . [2] [3]
Медицинский работник в Москве с вакциной
См. Также: вакцина против COVID-19

Gam-COVID-Vac is a viral two-vector vaccine based on two human adenoviruses – a common cold virus – containing the gene that encodes the full-length spike protein (S) of SARS-CoV-2 to stimulate an immune response.[5][11][12] The Gam-COVID-Vac vaccine was developed by a cellular microbiologists team of the government-backed Gamaleya Research Institute of Epidemiology and Microbiology. The group was led by MD and RAS associate member Denis Logunov, who also worked on vaccines for the Ebolavirus and the MERS-coronavirus.[13]

The recombinant adenovirus types 26 and 5 are both used as vectors in the vaccine. They were biotechnology-derived and contain the SARS-CoV-2 S protein cDNA. Both of them are administered into the deltoid muscle: the Ad26-based vaccine is used on the first day and the Ad5 vaccine is used on the 21st day to boost immune response.[11][14][15]

Both Ad26 and Ad5 were modified to remove the E1 gene to prevent replication. Large quantities of both adenoviruses are then produced by HEK 293 cells that have the E1 gene necessary for viral replication. Rarely, Ad5 can acquire the E1 gene from the HEK 293 cells, restoring its ability to replicate. Gamaleya has set an acceptable limit of 5,000 replicating virus particles per vaccine dose, and quality control documents state that tested batches contain less than 100 replicating virus particles per dose.[16]

The vaccine can be formulated in two ways: as a ready-to-use solution in water that is frozen at the common home-freezer storage temperature of −18 °C or 0 °F or lower; and as a freeze-dried powder, "Gam-COVID-Vac-Lyo", whose storage temperature is above freezing, 2–8 °C or 36–46 °F, at the common home-refrigerator temperature. The freeze-dried powder must be reconstituted with water before use.[17]

The production of the frozen liquid formulation was developed for large-scale use, it is cheaper and easier to manufacture.

The production of the freeze-dried formulation takes much more time and resources, although it is more convenient for storage and transportation. It was developed with vaccine delivery to hard-to-reach regions of Russia in mind.[18]

The head of the Gamaleya Research Institute Alexander Ginzburg estimates that it will take 9–12 months to vaccinate the vast majority of the Russian population, assuming in-country resources are adequate.[19][20]

A single-dose version is also being developed to speed up vaccination outside Russia. It will offer less protection than the two-dose versions, but it is still expected to reach an efficacy of 85%.[21][22]

Clinical research[edit]

Phase I–II[edit]

A phase I safety trial began on 18 June 2020.[2] On 4 September 2020, data on 76 participants in a phase I–II trial were published, indicating preliminary evidence of safety and an immune response.[5] The results were challenged by international vaccine scientists as being incomplete, suspicious, and unreliable when identical data were reported for many of the trial participants,[23] but the authors responded that there was a small sample size of nine, and the measured results of titration could only take discrete values (800, 1600, 3200, 6400). Coupled with the observation that values tended to reach a plateau after three to four weeks, they contend that it is not unlikely that several participants would show identical results for days 21 to 28.[24]

Phase III[edit]

Sputnik V, efficacy for different conditions. The error bars indicate the confidence interval containing the efficacy with 95% probability

In early November 2020, Israel Hadassah Medical Center director-general Prof. Zeev Rotstein stated that Hadassah's branch in Moscow's Skolkovo Innovation Center was collaborating on a phase III clinical trial.[25]

The ongoing phase III study is a randomised, double-blind, placebo-controlled, multi-centre clinical trial involving 40,000 volunteers in Moscow, and is scheduled to run until May 2021.[26] In 2020–2021, phase III clinical studies were also being conducted in Belarus,[27] UAE,[28] India[29] and Venezuela.[30]

On 2 February 2021, an interim analysis from the Moscow trial was published in The Lancet, indicating 91.6% efficacy (95% CI 85.6–95.2) after the second vaccination, without unusual side effects.[31] The trial started on 7 September 2020 using the frozen liquid form of the vaccine, and data was analysed up to the second database lock on 24 November 2020. The over-60-years-old group in the trial (oldest participant was 87) had essentially the same efficacy (91.8%) as for all ages. The lowest age participants were 18 years old.[9][32]

On April 13, 2021 India's health ministry said its drug regulator had found that safety and immunogenicity data from a local trial of Sputnik V coronavirus vaccine was comparable to that of a late-stage trial done in Russia.[33]

Sputnik V – AstraZeneca COVID-19 vaccine trials[edit]

On 21 December 2020 the Russian Direct Investment Fund (RDIF), the Gamaleya National Center, AstraZeneca and R-Pharm signed an agreement aimed at the development and implementation of a clinical research program to assess the immunogenicity and safety of the combined use of one of the components of the Sputnik V vaccine developed by the Gamaleya Center, and one of the components of the AZD1222 vaccine, developed by AstraZeneca and the University of Oxford.[34] The study program will last 6 months in several countries, and it is planned to involve 100 volunteers in each study program. On 9 February 2021, the Ministry of Health of the Republic of Azerbaijan allowed clinical studies in the country for the combined use of the Sputnik V vaccine and the vaccine developed by AstraZeneca, stating that the trials would begin before the end of February 2021.[35][36] On February 20, 2021 in the official Sputnik V Twitter account it was stated that clinical trials have already started.[37]

Composition[edit]

The Gam-COVID-Vac is a two-vector vaccine.[1] The active component for both vectors is a modified (recombinant) replication-defective adenovirus of a different serotype (Serotype 26 containing (1.0 ± 0.5) × 1011 particles of gene for the first vaccination and serotype 5 containing (1.0 ± 0.5) × 1011 particles of gene for the second vaccination), which has been modified to include the spike protein-expressing gene of SARS-CoV-2.[1]

The other ingredients (excipients) are the same, both quantitatively and qualitatively, in the two components.[38]

  • Tris(hydroxymethyl)aminomethane
  • Sodium chloride (salt)
  • Sucrose (sugar)
  • Magnesium chloride hexahydrate
  • Disodium EDTA dihydrate (buffer)
  • Polysorbate 80
  • Ethanol 95%
  • Water

As per the official datasheet, no further components or ingredients, including other adjuvants, should be included in the vaccine.[1]

History[edit]

In May 2020, the Gamaleya Research Institute of Epidemiology and Microbiology announced that it had developed the vaccine without serious side effects. By August 2020, phases I and II of two clinical trials (involving 38 patients each) were completed. Only one of them used the formulation which later obtained marketing authorization under limited conditions.[39][40] This vaccine was given the trade name "Sputnik V", after the world's first artificial satellite.[3][7][41]

During preclinical and clinical trials, 38 participants who received one or two doses of the Gam-COVID-Vac vaccine had produced antibodies against SARS-CoV-2's spike protein, including potent neutralizing antibodies that inactivate viral particles.[2] On 11 August 2020, the Russian minister of Health Mikhail Murashko announced at a government briefing with the participation of President Vladimir Putin regulatory approval of the vaccine for widespread use. The state registration of the vaccine was carried out "conditionally" with post-marketing measures according to the decree of the Government of the Russian Federation. The registration certificate for the vaccine stated that it could not be used widely in Russia until 1 January 2021, and before that, it may be provided to "a small number of citizens from vulnerable groups", such as medical staff and the elderly, according to a Ministry of Health spokesperson.[3] The license under register number No. ЛП-006395 (LP-006395) was issued on 11 August by the Russian Ministry of Health. Although the announcement was made even before the vaccine candidate had been entered into Phase III trials, the practice of marketing authorization "on conditions" also exists in other countries.[42][43] On 26 August, certificate No. ЛП-006423 (LP-006423) was issued for the lyophilized formulation "Gam-COVID-Vac-Lyo".[2][3][7][44][5]

The commercial release of the Gam-COVID-Vac was first scheduled for September 2020. In October, Mikhail Murashko said that the Gam-COVID-Vac will be free for all Russian citizens after the launching of mass production.[45][46] Later on, Russian Ministry of Health registered maximum ex-factory price equal to 1,942 rubles for two components and included them into The National List of Essential medicines.[47] There were also suggestions to include the vaccine in the National Immunisation Calendar of Russia.[47]

According to Russian media, the mass production of the Gam-COVID-Vac was launched by 15 August. By that moment, the Russian Federation has already received applications from 20 countries for the supply of 1 billion doses of vaccine. Three facilities were able to produce about a million doses per month at each with a potential doubling of capacity by winter. By the end of 2020, Gamaleya Research Institute's production, according to an interview with the organization's spokesperson, was planned to produce 3–5 million doses.[48][49]

On 9 March 2021, an agreement was signed by the RDIF sovereign wealth fund and Swiss-based pharmaceutical company Adienne to produce the vaccine in Italy. Kirill Dmitriev, RDIF's head, told Russian state TV his fund had also struck deals with production facilities in Spain, France and Germany for local manufacturing of the vaccine.[50] However, a few days later, the Spanish company RDIF had contacted declared that no deal had been signed yet and that negotiations were still ongoing.[51]

Scientific assessment[edit]

Balram Bhargava, director of the Indian Council of Medical Research, said that Russia had managed to fast-track a COVID-19 vaccine candidate through its early phases.[52]

On 11 August 2020, a World Health Organization (WHO) spokesperson said, "... prequalification of any vaccine includes the rigorous review and assessment of all required safety and efficacy data".[8]

  • A WHO assistant director said, "You cannot use a vaccine or drugs or medicines without following through all of these stages, having complied with all of these stages".[53]
  • Francois Balloux, a geneticist at University College London, called the Russian government's approval of Gam-COVID-Vac a "reckless and foolish decision".[2] Professor Paul Offit, the director of the Vaccine Education Center at Children's Hospital of Philadelphia, characterized the announcement was a "political stunt", and stated that the untested vaccine could be very harmful.[8]

Stephen Griffin, Associate Professor in the School of Medicine, University of Leeds, said "that we can be cautiously optimistic that SARS-CoV2 vaccines targeting the spike protein are effective." Moreover, as the Sputnik antigen is delivered via a different modality, namely using a disabled Adenovirus rather than formulated RNA, this provides flexibility in terms of perhaps one or other method providing better responses in certain age-groups, ethnicities, etc., plus the storage of this vaccine ought to be more straightforward.[54]

Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, said "the data [is] compatible with the vaccine being reasonably effective ... These results are consistent with what we see with other vaccines, because the really big message for global health scientists is that this disease [COVID-19] is able to be addressed by vaccines."[55]

Julian Tang, clinical virologist at the University of Leicester, said: "Despite the earlier misgivings about the way this Russian Sputnik V vaccine was rolled out more widely – ahead of sufficient Phase 3 trial data – this approach has been justified to some extent now."[56]

Ian Jones, a professor of virology at the University of Reading, and Polly Roy, professor and Chair of Virology at The London School of Hygiene and Tropical Medicine, commenting on phase III results published in the Lancet in February 2021, said "The development of the Sputnik V vaccine has been criticised for unseemly haste, corner cutting, and an absence of transparency. But the outcome reported here is clear and the scientific principle of vaccination is demonstrated, which means another vaccine can now join the fight to reduce the incidence of COVID-19."[57]

Hildegund C. J. Ertl, a vaccine scientist at the Wistar Institute, called the phase-III results published on 2 February 2021 "great": "Good safety profile, more than 90% efficacy across all age groups, 100% efficacy against severe disease or death, can be stored in the fridge and low cost. What more would we want?"[58]

According to preliminary review by experts,[who?] the lyophilized formulation of Gam-COVID-Vac is similar to the smallpox vaccine, circumventing the need for continuous "colder chain" or cold-chain storage – as required for the Pfizer–BioNTech and Moderna vaccines respectively – and allowing transportation to remote locations with reduced risk of vaccine spoilage.[59][60]

Distribution, vaccination and public perception[edit]

Early perception[edit]

An opinion poll of Canadians conducted by Léger in August 2020 found that a majority (68%) would not take the Russian vaccine if offered a free dose, compared to 14% who said they would take it. When Americans were asked the same question, 59% would not take the Russian vaccine if offered a free dose, compared to 24% who said they would take it.[61][62]

  • At that time, British and American officials stated that the Gam-COVID-Vac vaccine would likely be rejected due to concerns that the normally rigorous process of vaccine clinical testing was not followed.[63] One public health expert said the quick approval of Gam-COVID-Vac by the Russian government was "cutting corners", and may harm public confidence if the vaccine proves to be unsafe or ineffective.[7] "There is a huge risk that confidence in vaccines would be damaged by a vaccine that received approval and was then shown to be harmful", said immunologist Peter Openshaw.[7]

As for early September 2020, according to public opinion polls, only half of the Russian population would take the vaccine voluntarily.[64]

In Russia[edit]

Vaccination of military personnel and civilian specialists of the Northern Fleet with the second component of the drug "Gam-COVID-Vac" ("Sputnik V")

In the beginning of December 2020, Russian authorities announced the start of a large-scale free of charge vaccination with Gam-COVID-Vac for Russian citizens: the "immunization" program was launched on 5 December 2020 (with 70 medical centers in Moscow providing vaccinations).[65]

Doctors and other medical workers, teachers, and social workers were given priority due to their highest risk of exposure to the disease.[66] The age for those receiving shots was initially capped at 60, later this restriction was lifted.[67]

Potential recipients were notified via text messaging, which says "You are working at an educational institution and have top-priority for the COVID-19 vaccine, free of charge". Patients are asked a few general health questions before getting the vaccine. Program's leaflet is handed to the patient, which warns of possible side effects, suggesting those are most likely to be mild and last a couple of days at most.[68][69][70] People with certain underlying health conditions, pregnant women, and those who have had a respiratory illness for the past two weeks are barred from vaccination.[66] Vaccine vial is removed from medical centre's freezer about 15 minutes before use.

In early December 2020, the Minister of Health, Mikhail Murashko, said that Russia had already vaccinated more than 100,000 high-risk people.[71] Forty thousand of those are volunteers in Sputnik V's Phase 3 trials, another 60,000 medics and doctors have also taken the vaccine.[72] The head of the Russian Direct Investment Fund, Kirill Dmitriev, said in an interview with the BBC that Russian medics expect to give about 2 million people coronavirus vaccinations in December.[73]

Up to the beginning of December 2020, Generium (which is supervised by Pharmstandard) and Binnopharm (which is supervised by AFK Sistema) companies produced Gam-COVID-Vac on a large scale.

On 10 December, Deputy Prime Minister Tatyana Golikova announced that approximately 6.9 million doses of the Sputnik V vaccine will enter civilian circulation in Russia before the end of February 2021.[74] Moscow Mayor Sergei Sobyanin announced that the newly opened Moscow-based "R-Pharm" will become a leading manufacturer of Russia's Sputnik V coronavirus vaccine. Working at full capacity, the factory will produce up to 10 million doses a month.[75]

Outside Russia[edit]

According to the Russian Direct Investment Fund, they had received orders for more than 1.2 billion doses of the vaccine as of December 2020. Over 50 countries had made requests for doses, with supplies for the global market being produced by partners in India, Brazil, China, South Korea, Hungary, and other countries.[76][77] In August 2020, according to the Russian authorities, there were at least 20 countries that wanted to obtain the vaccine.[78]

The vaccine is free of charge to users in Russia. The cost per dose would be less than US$10 (US$20 for the required two doses) on international markets, much less than the cost of mRNA vaccines from other manufacturers. Kirill Dmitriev, head of the fund, told reporters that over 1 billion doses of the vaccine are expected to be produced in 2021 outside of Russia.[79][80]

The Israeli Hadassah Medical Center signed a commercial memorandum of understanding to obtain 1.5–3 million doses.[81]

  • According to The New York Times' sources,[82] to secure the release of an Israeli civilian held in Syria, Israel agreed to finance a supply of Russian-made COVID-19 vaccines for Damascus.

Argentina agreed to buy 25 million doses of Russia's COVID-19 vaccine, subject to its clearing clinical trials;[83] the vaccine was registered and approved in Argentina in late December 2020.[84] The Brazilian state of Bahia signed an agreement to conduct Phase III clinical trials of the Sputnik V vaccine and planned to buy 50 million doses to market in northeastern Brazil.[85]

On 21 January 2021, Argentine president Alberto Fernández became the first Latin American leader to be inoculated with Sputnik V, shortly after it was approved for use in the country.[86][87] Two months after being vaccinated he suffered fever and headache, and tested positive for COVID-19.[88] He was asymptomatic ten days later, was discharged from medical treatment subject to medical follow-up as usual for former COVID-19 patients, and resumed his normal activities.[89]

Due to the delay in shipping of doses from Italy and the European Union, San Marino imported doses of the Sputnik V vaccine (not approved by the EMA) and started a mass vaccination on 28 February of its healthcare workers.[90]

EMA's human medicines committee (CHMP) has started a rolling review of Sputnik V (Gam-COVID-Vac), a COVID-19 vaccine developed by Russia's Gamaleya National Centre of Epidemiology and Microbiology.[91]

When asked about the prospect of Austria giving Sputnik V the approval (as some other European countries chose to do), EMA management board chair Christa Wirthumer-Hoche told Austria's ORF broadcaster: "It's somewhat comparable to Russian roulette. I would strongly advise against a national emergency authorisation," she said, pointing to the fact that there was not yet sufficient safety data about those who had already been given the vaccine. "We could have Sputnik V on the market in future, when we've examined the necessary data," she said, adding that the vaccine needed to match up to European criteria on quality control and efficacy.[92]

Vaccination rates in Russia are below those of other developed nations (as of March 2021).[93] Russia is pursuing deals to supply its vaccine abroad.[94]

Emergency use authorization[edit]

  Full authorization   Emergency authorization   Eligible COVAX recipient (ongoing assessment)[95]   EMA review in progress[96]
See also: List of COVID-19 vaccine authorizations § Sputnik V

As of December 2020, Belarus and Argentina granted emergency use authorization for the vector-based vaccine.[97] On 21 January 2021, Hungary became the first European Union country to register the shot for emergency use, as well as the United Arab Emirates in the Gulf region.[98][99][100][101][102]

On 19 January 2021, the Russian authorities applied for the registration of Sputnik V in the European Union, according to the RDIF.[103] On 10 February, the European Medicines Agency (EMA) said that they had "not received an application for a rolling review or a marketing authorisation for the vaccine". The developers have only expressed their interest that the vaccine be considered for a rolling review, but EMA's Human Medicines Committee (CHMP) and the COVID-19 EMA pandemic Task Force (COVID-ETF) need to give their agreement first before developers can submit their application for initiation of the rolling review process.[104] On 4 March 2021, the Committee for Medicinal Products for Human Use (CHMP) of the EMA started a rolling review of Sputnik V.[105] The EU applicant is R-Pharm Germany GmbH.[105]

Emergency use has also been authorized in Algeria, Bolivia, Serbia, the Palestinian territories,[106] and Mexico.[107]

On 25 January 2021, Iran approved the vaccine, with Foreign Minister Mohammad Javad Zarif saying the country hopes to begin purchases and start joint production of the shot "in the near future", after Supreme Leader Ayatollah Ali Khamenei banned the government from importing vaccines from the United States and United Kingdom.[108][109]

The Czech Republic is also considering buying Sputnik V, and Prime Minister Andrej Babis dismissed the minister of health, Jan Blatný, who was a loud opponent to the use of Sputnik V.[110][111][112]

On 18 March 2021, German regional leaders including State Premiers and the mayor of Berlin called for the swift approval of the Russian vaccine by the European Medicines Agency to counteract the acute shortages of effective vaccines in Europe. German medical experts have recommended its approval also, and consider the Sputnik Vaccine "clever" and "highly safe".[113]

On 19 March 2021, the Philippine Food and Drug Administration granted emergency use authorization for Sputnik V, the fourth COVID-19 vaccine to be given authorization. The Philippine government planned to buy 20 million doses of the vaccine.[114][115]

On 12 April 2021, India approved the use of Sputnik V vaccine for emergency use against COVID-19 based on strong immunogenicity data.[116][117]

As of 12 April 2021, 62 countries had granted Sputnik V emergency use authorization.[118]

On 27 April 2021, Bangladesh approved the use of Sputnik V vaccine for emergency use.[119]

On 30 April 2021, Turkey and Albania approved the use of Sputnik V vaccine for emergency use.[120][121]

Slovakia[edit]

On 1 March 2021, Slovakia bought 2 million Sputnik V vaccines. Slovakia received the first batch of 200,000 vaccines, and expected to receive another 800,000 doses in March and April. Another 1 million vaccines were set to arrive in May and June.[122]

On 8 April, Slovakia's drug regulator said that the Sputnik V vaccines it received did "not have the same characteristics and properties" as the version endorsed by The Lancet.[123] The Slovak State Institute for Drug Control stated that Sputnik V has not yet been approved for use, as the first 200,000 doses received on the 31st of March were different from the product currently being reviewed by EMA as well as from the vaccine used in studies published in The Lancet. The producers have failed to reply to requests for documentation, approximately 80% of the data was not supplied even after repeated requests. Due to the inconsistencies, it was not possible to review the safety and efficacy of the vaccine.[124][125]

Slovak Prime Minister Igor Matovič resigned on March 30, due to political crisis started by the order of Sputnik V vaccines.[126] On 6 April 2021 RDIF asked to return the delivered first batch of vaccines due to "multiple contract violations".[124][127]

Brazil[edit]

On 26 April 2021, the Brazilian health regulator Anvisa rejected the use of Sputnik V, alleging a lack of consistent and reliable data and the presence of replicating adenovirus in the vaccine. RDIF and Sputnik V's official Twitter account said the decision may be politically motivated, pointing to a recent report by the United States government that tried to persuade Brazil to reject the vaccine. Several Brazilian states in the North and Northeast regions had already signed contracts for the acquisition of more than 30 million doses.[128][129][130] Anvisa attributed its decision to a number of issues with the samples provided by Gamaleya for accreditation:[131][132][133]

  • the adenovirus carrier in all samples was actually able to replicate in spite of manufacturer's declaration it was incapacitated
  • the methodology used by Gamaleya to check immune system response was unreliable and documentation provided made its verification impossible
  • the procedure of registering adverse effects was insufficient
  • Anvisa delegation was also not allowed into the Gamaleya laboratory for inspection
  • all presented studies were performed on vaccine doses produced in laboratory, rather than in the manufacturing facility supplying vaccine for the mass market, which makes the results not representative
  • Anvisa found issues in one of the factories in Russia that could impact sterility of the doses.[132]

On April 29, 2021, the developers of Sputnik V said that Anvisa admitted not testing Sputnik V and that they would sue Anvisa in Brazil for defamation. At a press conference, Anvisa officials said that Gamaleya's own documents indicated multiple times the presence of replication-competent adenoviruses (RCAs) in ready vaccine batches and that the specifications accepted a level of RCAs 300 times greater than any other regulatory threshold. Anvisa presented the video of a meeting with representatives from Russia and Brazil where, when asked about the presence of RCAs, a representative from Russia reported problems with the cells and said that the vaccine could have been redeveloped, but it would take too long, so the developers instead chose to continue the research imposing an acceptable level of RCAs.[134][135] Virologist Angela Rasmussen described this problem as a quality control issue that is not important for healthy people because adenoviruses are not important pathogens, but added that it could produce serious adverse effects in immunocompromised individuals.[136] Medicinal chemist Derek Lowe commented that the presence of replicating adenoviruses is unlikely to cause any major problems, but it is a completely unnecessary risk, that it certainly will harm some people, and that providing a product different from the one described in studies undermines the credibility of all manufacturing and quality control processes,[137] adding that some posts on the official Sputnik V Twitter account constitute aggressive political marketing and some make invalid claims regarding the performance of competing vaccines, such as the Pfizer-BioNTech vaccine.[138] Anvisa said that the import ban can be reversed if Gamaleya clarifies the issues. Adenovirus infections cause only mild colds in healthy individuals, but they can cause life-threatening illnesses in immunodeficient individuals.[16] The director of the Public Health Institute of Chile (ISP), Heriberto Garcia, said that the ISP would not necessarily reject the vaccine, even if it had replicating adenoviruses, because the risk of getting a common cold from the vaccine must be seen in light of the risk of contracting Covid-19 when not vaccinated. He also said that real-world data from Argentina and Mexico showed no adverse effects greater than those seen in people vaccinated with the Pfizer-BioNTech vaccine or CoronaVac.[139]

Production[edit]

Pharmaceutical company União Quimica started production of Sputnik V in Brazil in January 2021[citation needed]

As of March 2021, the Russian Direct Investment Fund (RDIF) has licensed production in India, China, South Korea and Brazil. In the EU, RDIF has signed production agreements, subject to European Medicines Agency approval, with companies in Germany and France, and is in negotiations with a Spanish and a Swiss/Italian company. By the end of March 2021 RDIF anticipates 33 million doses will have been manufactured in Russia, less than 5% of which will have been exported.[140]

An agreement for the production of over 100 million doses of vaccine in India was made with Dr. Reddy's Laboratories, which on 11 January 2021 submitted mid-stage trial data to the Indian regulator and recommended moving onto late-stage trials.[106] The RDIF announced plans to sell 100 million doses to India, 35 million to Uzbekistan, and 32 million to Mexico, as well as 25 million each to Nepal and Egypt.[141]

In March 2021, the Italian-Russian Chamber of Commerce announced that Italy would be the first EU country to manufacture the two-dose COVID-19 vaccine under license. From July to the end of 2021, the Italian-Swiss pharmaceutical company Adienne in Caponago, Italy will manufacture 10 million doses. The announcement came in a time of vaccine shortages in Europe while the Sputnik V vaccine was still under rolling review by the European Medicines Agency. Russian authorities said they would be able to provide a total of 50 million doses to European countries beginning in June 2021.[142]

The Sputnik V doses to be manufactured in South Korea are not for domestic use. The vaccine is to be exported to Russia, Algeria, Argentina, Hungary, Iran and the United Arab Emirates.[143]

Argentina will be the first Latin America country to produce it.[144] Large-scale production is expected to start in June 2021.[145]

Turkey will begin producing Sputnik V in 2021.[146]

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External links[edit]

  • Official website