Аннотация
Вакцина Gam-COVID-Vac (Спутник V) против COVID-19 — одна из одобренных вакцин, которая использовалась в Иране.
Цели
В настоящем ретроспективном исследовании мы оценили краткосрочную эффективность и побочные эффекты вакцины Спутник V против COVID-19 у медицинских работников в Иране.
Методы
Медицинские работники, обратившиеся в больницу Фирозгар при Иранском университете медицинских наук в Тегеране, Иран, между мартом 2021 и декабрем 2021 года, были оценены. Гуморальный иммунитет был оценен по S-RBD IgG SARS-CoV2 после вакцинации Спутник V на трех этапах: на 60-й день (фаза I), на 120-й день (фаза II) и на 210-й день (фаза III) с помощью набора для ELISA анти-S RBD IgG. Полученная вакцина была разделена на две группы на основе истории заражения SARS-CoV2. Побочные эффекты от вакцины были получены от каждого участника после первой и второй доз.
Результаты
Всего было включено 65 получателей вакцины (41,5% мужчин (27/65)) среднего возраста 35 ± 8,5 лет, из которых 41,5% имели историю заражения COVID-19. Уровень SARS-CoV-2 IgG значительно выше у получателей вакцины по сравнению с теми, у кого не было истории заражения COVID-19, через месяц (4 против 6,6), через три месяца (4,5 против 7,2) и через шесть месяцев (3,8 против 5,9) после вакцинации (P = 0,001). В нашем исследовании было выявлено 18 пациентов (27,7%) с прорывом вакцинации.
Выводы
Спутник V, по видимому, вызывает высокие уровни антител после второй дозы; однако защитные антитела снижаются через шесть месяцев после второй дозы. Для лиц со специфическими рисками настоятельно рекомендуется дополнительная доза.
Ключевые слова
Вакцина COVID-19 Sputnik V Иран
Фон
Текущая пандемия коронавируса 2-го типа (SARS-CoV-2) привела к значительной смертности по всему миру за последние годы. Согласно статистике Всемирной организации здравоохранения, к текущей дате (3 мая 2023 года) зарегистрировано более 765 миллионов подтвержденных случаев и 6,9 миллионов смертей от болезни 2019 года. По официальной статистике Ирана на эту дату было зафиксировано 7 607 744 подтвержденных случаев и 146 058 смертей (1). С всплеском дельта-вариантов SARS-CoV-2 статистика COVID-19 значительно возросла как по всему миру, так и в Иране (2). Эффективность разных платформ вакцин в борьбе с различными вариантами вируса и механизмы избегания вируса от нейтрализующих антител в настоящее время представляют собой значительные проблемы (3, 4).
Между тем, множество случаев вакцинации в разных странах снизили смертность от COVID-19, и разные страны используют разные вакцины для своего населения (5). В настоящее время существует несколько одобренных и экстренно одобренных вакцин ВОЗ (6). Одной из перспективных и доступных вакцин в Иране из этого списка является вакцина Sputnik V (Gam-COVID-Vac).
<strong>Гам-КОВИД-Вак: Обзор</strong>
<strong>Эффективность и побочные эффекты в исследовании в Иране</strong>
<strong>Оценка гуморального иммунитета</strong>
<strong>Статистический анализ</strong>
Оценка уровня антител и побочных эффектов вакцины Спутник V
<thead>
<tr>
<th>Симптом</th>
<th>Количество пациентов (%)</th>
<th>P-значение</th>
</tr>
</thead>
<tbody>
<tr>
<td>Диарея</td>
<td>2 (3,1)</td>
<td>0,56</td>
</tr>
<tr>
<td>Настиганье</td>
<td>18 (27)</td>
<td>0,43</td>
</tr>
<tr>
<td>Рвота</td>
<td>1 (1,5)</td>
<td>0,34</td>
</tr>
<tr>
<td>Головная боль</td>
<td>4 (6,2)</td>
<td>0,03</td>
</tr>
<tr>
<td>Жар</td>
<td>9 (13,8)</td>
<td>0,22</td>
</tr>
<tr>
<td>Миалгия</td>
<td>18 (27,7)</td>
<td>0,71</td>
</tr>
<tr>
<td>Боль в месте инъекции</td>
<td>1 (1,5)</td>
<td>0,49</td>
</tr>
</tbody>
The differences between the reported side effects of this vaccine seem to be due to the small number of evaluated samples in our study, which is our major limitation. As another limitation of the current study, we could not use other validated methods, like immunofluorescence or western blot, to support and approve antibody production or quantity.
After 6 months, we found that 18 vaccinated participants (27.7%) contracted SARS-CoV2. None of these individuals had a history of COVID-19 before vaccination. Several studies have reported the vaccination breakthrough in different countries and vaccine platforms (20-23). Meanwhile, there is no report of particular age or gender differences in the population with vaccination breakthroughs (20). Bergwerk et al. demonstrated the importance of antibody levels after vaccination and vaccine breakthroughs (24). It seems that the results of our study are in consensus with those of the previous studies using other vaccine platforms.
In conclusion, the present study presents Sputnik V as an acceptable vaccine based on the induced antibody levels after the second dose in both patients with and without a history of COVID-19. However, high levels of antibody secretion were obtained three months after the second dose of vaccination, and the decrease in antibody levels after six months indicated the relatively short duration of its immunogenicity after two doses of vaccination and the possible need for a booster; nonetheless, further investigations are needed.
Acknowledgements
"Sputnik V" redirects here. For the Soviet satellite known as Sputnik 5, see Korabl-Sputnik 2.
Russian Ministry of Health image of Gam-COVID-Vac vials
Vaccine typeViral vector
Doses Severity of illness Delta Alpha
1 Symptomatic Not reported Not reported
Vaccine Incidental infection effectiveness Hospitalization effectiveness Mortality effectiveness
Sputnik V vaccination certificate issued in Moscow Gostiny Dvor vaccination point.
Polysorbate 80
Ethanol 95%
Package and Vial for the first dose
Sputnik V, efficacy for different conditions. The error bars indicate the confidence interval containing the efficacy with 95% probability
Allowed for travel
Heterologous prime-boost vaccination
Medical worker in Moscow with the vaccine
Vaccination of military personnel and civilian specialists of the Northern Fleet with the second component of the drug "Gam-COVID-Vac" ("Sputnik V")
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.
Outside of Russia
In dark green are the countries that approved Sputnik V vaccine against COVID-19 (w/disputed Crimea). In light green are the countries that have shown interest in obtaining the vaccine. Light blue indicates current or future producers and dark blue the country origin of vaccine design (Russia).
Public opinion polls
Wikimedia Commons has media related to .
2023 Nov; 9(11): e21877.
There are few comparative studies on efficiency of broad range COVID19 vaccination strategy. This pilot aims to describe the effect of mixed COVID19 vaccination on vaccination adoption and subsequent total immunity, Conducted in Republic of Belarus, this pilot clinical study shows varying immunogenic responses to Sputnik V (Gam-COVID-Vac), Russian Federation (RF) and Sinopharm (BBIBP-CorV), People’s Republic of China (PRC) vaccines.
To compare the immunogenicity and reactogenicity of Sputnik V (Gam-COVID-Vac) and Sinopharm (BBIBP-CorV) vaccines in vaccinated individuals.
Materials and MethodsA total of 60 adults participated in the present study. The immune response after vaccination was assessed using enzyme immunoassay. IgG levels were measured in all participants at three time points: before vaccination, on the 42nd day after the first vaccine dose, and in 6 months after the first vaccine dose. Age, sex of participants, vaccine type, history of COVID-19/IgG seropositivity were included in the multivariate analysis. The results of the SARS-CoV-2 infection antibody test were quantified according to the WHO First International Standard (NIBSC code:20/136) and measured in international units (BAU/ml).
The study participants (n = 60) were divided into two groups where 50 % (n = 30) were vaccinated with Sputnik V (Gam-COVID-Vac), and 50 % (n = 30) were vaccinated with Sinopharm (BBIBP-CorV). Women represented 63 % and 77 % of Sputnik V and Sinopharm groups, respectively. The IgG levels on day 42 after the first vaccine dose were: Sputnik V (Gam-COVID-Vac): Me = 650.4 (642.2–669.4); Sinopharm (BBIBP-CorV: Me = 376.5 (290.9–526.4) (UMann–Whitney = 164, p = 0.000024). The IgG levels in 6 months after the first vaccine dose were: Sputnik V (Gam-COVID-Vac)Me = 608.7 (574.6–647.1); Sinopharm (BBIBP-CorV) Me = 106.3 (78.21–332.4); (UMann–Whitney = 172.5, p-value = 0.000042)). In a multivariate model Sputnik V vaccine type and IgG seropositivity at the baseline were significantly associated with higher levels of IgG both at 42 days and 6 months post-vaccination. Reactions after vaccination appeared in 27 vaccinated people (45 %).
Keywords: SARS-CoV-2 infection, Vaccines, Humoral immune response, Enzyme-linked immunosorbent assay (ELISA), BAU/ml
Introduction
Comparative description of immunogenicity and reactogenicity of Sputnik V (Gam-COVID-Vac), RF and Sinopharm (BBIBP-CorV), PRC vaccines among vaccinated people.
Materials and methods
The quantification of the SARS-CoV-2 infection antibody assay is based on the WHO First International Standard (NIBSC code:20/136) and measured in international units (BAU/ml).
According to the manufacturer’s instructions, the diagnostic sensitivity to the detection of IgG to SARS-CoV-2 is 100 % (range 95.7%–100 %, 95 % confidence interval). The diagnostic specificity is 100 % (range 98.5%–100 %, 95 % confidence interval). The information letter accompanying the reagent kit SARS-CoV-2-IgG Quantitative ELISA-BEST, No. RZN 2021/14458. The kit reports that virus neutralizing activity with a neutralization titer of 1/160 or higher is observed in all samples with a specific IgG concentration of 150 BAU/ml or higher (ELISA titer ≥1/600; 95 % CI: 83.16–100 %) and only 50 % of samples showed a specific IgG concentration of 80–149 BAU/ml (ELISA titer ≥1/400 — 1/800; 95 % CI: 32.43–67.57 %), a specific IgG level of less than 10 BAU/ml should be considered as a negative result of the quantitative assay.
Statistics
This pilot study originally enrolled 89 participants; 29 dropped out due to external circumstances and the final cohort included 60 participants. ().
Table 1
The demographic and clinical characteristics of the study participants (N = 60).
Sinopharm (BBIBP-CorV), PRCSputnik V (Gam-COVID-Vac), RFTotal
female23 (76.7 %)19 (63.3 %)42 (70.0 %)
male7 (23.3 %)11 (36.7 %)18 (30.0 %)
Pre-vaccination COVID-19 history:
yes11 (36.7 %)18 (60.0 %)29 (48.3 %)
no19 (63.3 %)12 (40.0 %)31 (51.7 %)
Chronic diseases:8 (47.1 %)9 (52.9 %)17 (100.0 %)
Cardiovascular2 (25.0 %)4 (44.4 %)6 (35.3 %)
Gastrointestinal4 (50.0 %)3 (33.3 %)7 (41.2 %)
Musculoskeletal2 (25.0 %)1 (11.1 %)3 (17.6 %)
Respiratory0 (0 %)2 (22.2 %)2 (11.8 %)
Endocrine0 (0 %)1 (11.1 %)1 (5.9 %)
Female reproductive0 (0 %)1 (11.1 %)1 (5.9 %)
Immunogenicity is one of the proxy markers for a vaccine efficacy. In this study IgG levels to SARS-CoV-2 S-protein were tested in all participants at three stages: before vaccination, on 42 day after the first dose of vaccine and in 6 months after the first dose of vaccine. The unit of measurement for IgG levels is BAU/ml. (Note: BAU-binding antibody units). The study data is shown in , , .
Dynamics of Ig G production in response to Vaccine Sputnik V (Gam-COVID-Vac). (before vaccination — Ig G value (BAU/ml); on 42 day — Ig G value (BAU/ml); in 6 months after the first vaccine dose — Ig G value (BAU/ml). Individually matched data is shown in Suppl., SF_2.
Dynamics of IgG appearance in response to Sinopharm (BBIBP-CorV) vaccine (before vaccination — IgG value (BAU/ml); on 42 day after the first dose — IgG value (BAU/ml); in 6 months after the first vaccine dose — IgG value (BAU/ml). Individually matched data is shown in Suppl., SF_3.
In , we demonstrate that quantitative IgG levels at three measurement stages have significant differences (Friedman chi-squared = 47.267, df = 2, p-value <0.001). IgG levels on the 42nd day were significantly higher compared to the before vaccination stage (TWilcoxon = 461, pBonferroni corr. < 0.001). Comparing 42nd day and 6 months post vaccination, IgG levels demonstrated a significant drop (TWilcoxon = 447, pBonferroni corr. < 0.001); nevertheless, IgG level remained significantly higher than at before vaccination stage. (TWilcoxon = 452, pBonferroni corr. < 0.001).
As shown in , the quantitative IgG values at the three study stages are significantly different (Friedman chi-squared = 44.891, df = 2, p-value <0.001). Levels of IgG on the 42nd day after the first dose of vaccine were significantly higher than prior to vaccination (TWilcoxon = 465, pBonferroni corr. < 0.001)). In 6 months after the first dose, there was a significant decrease in IgG values (TWilcoxon = 428, pBonferroni corr. < 0.001), but they remained at a higher level compared to the before vaccination stage (TWilcoxon = 385, pBonferroni corr. < 0.001)).
According to the questionnaire survey and the answers of study participants, 52 % of participants did not have COVID-19 before vaccination; 48 % had had the infection prior to vaccination. Having compared the groups’ characteristics on the basis of prior infection with SARS-CoV-2, no significant difference was found (p = 0.071).
As the factor of previous SARS-CoV-2 infection influences the outcome of the study, it was also included in the statistical analysis.
shows that in the Sputnik V (Gam-COVID-Vac) vaccine group, the largest group of participants at the 42nd day stage had IgG levels above 500 BAU/ml, while most Sinopharm (BBIBP-CorV)-vaccinated patients had levels ≤500 BAU/ml (χ2 = 19.644; df = 2; p < 0.001). At the 6-months stage this trend continued: in the Sputnik V (Gam-COVID-Vac) vaccine group most participants had IgG levels above 500 BAU/ml, while most patients vaccinated with Sinopharm vaccine had IgG level below 150 BAU/ml (χ2 = 20.747; df = 2; p < 0.001). The groups were also compared taking into account the serological status of the study participants.
Comparison of the groups (vaccinated with Sputnik V (Gam-COVID-Vac) and Sinopharm (BBIBP-CorV)) by IgG levels (BAU/ml) – on day 42 and in 6 months after the first vaccine dose.
compares IgG levels to the SARS-CoV-2 between those with prior COVID-19 infection and COVID-19 naïve participants in both Sputnik V and Sinopharm groups. The highest antibody levels were observed on the 42nd day after vaccination in both the COVID-19 – immune-naive participants (UMann–Whitney = 47, p = 0.006) and previous COVID-19 groups (UMann–Whitney = 15, p < 0.001), in 6 months after vaccination the IgG value declined in those who had not previously been ill (UMann–Whitney = 42, p = 0.003) and in those who had had COVID-19 before vaccination (UMann–Whitney = 1, p < 0.001). However, the combination of antibodies generated by previous COVID-19 and the Sputnik V vaccine has higher titers and duration (UMann–Whitney = 1, p < 0.001).
The rate of adverse events of Sputnik V (Gam-COVID-Vac) and Sinopharm (BBIBP-CorV) vaccines is worth considering separately, as this is a frequent topic of discussion. The incidence of post-vaccine reactions in this study was 45 %. All of the observed reactions were mild to moderate in severity. The most frequent ones were: injection site soreness (33.33 %), redness around the site of injection (5 %), fever (11.67 %) and a combination of these reactions (). Participants also reported weakness (1.67 %), headache (1.67 %), and swelling at the injection site (1.67 %).
The main post-vaccination adverse event rate (and their combination) noted in the study participants: soreness and redness at the injection site, increased body temperature.
Post-vaccination reactions were observed in both vaccinated groups (p = 0.119). However, significant statistical differences were found only regarding to the increase in body temperature; although in the group vaccinated with Sputnik V (Gam-COVID-Vac) this reaction was more frequent (p = 0.006).
Discussion
Obtained study results may be generalized towards regions, where both vector vaccines and inactivated vaccines are widely used, especially in a condition of average vaccination coverage.
Results of multivariate analysis
Age, sex, vaccine type and history of COVID-19/IgG positivity were included as variables in a multiple linear regression model. This analysis was performed for each endpoint in the study (42 days, 6 months).
For the endpoint at 42 days: age was not associated with IgG levels (p = 0.441); sex was not associated with IgG levels (p = 0.66); type of vaccine had a significant association with IgG levels (p < 0.001). For Sputnik V (Gam-COVID-Vac) IgG levels were significantly higher than for Sinopharm (BBIBP-CorV) with an Estimate = 243.09. IgG seropositivity at the baseline (SP) was also significantly associated with higher IgG levels (p < 0.001), with a strong influence observed in the regression model (Estimate = 256.56). For the endpoint at 6 months: age was not associated with IgG levels (p = 0.887); sex was not associated with IgG levels (p = 0.551); type of vaccine had a significant association with IgG levels (p < 0.001). For Sputnik V (Gam-COVID-Vac) IgG levels were significantly higher than for Sinopharm (BBIBP-CorV); Estimate = 258.72. IgG seropositivity at the baseline (SP) was significantly associated with higher IgG levels (p < 0.001), with a strong influence in the regression model (Estimate = 286.81).
The level of the variance explained by the model (adjusted R-squared) was 0.5343 (42 days) and 0.5381 (6 months). These values were not high, probably due to some potential outliers in IgG levels.
Meaning of the study/understanding possible mechanism
The sample sizes of available international publications directly comparing the immunological efficacy and reactogenicity of Sputnik V (Gam-COVID-Vac) and Sinopharm (BBIBP-CorV) vaccines still leave a knowledge gap.
Findings of the present study in light of what was published before
Several limitations should be considered while interpreting our manuscript: sample size, limited age of participants (from 29 to 73 years), lack of an orthogonal immunoassay to confirm the results obtained from the utilized kit, lack of neutralizing antibodies and T-cell response assessments. It’s necessary to emphasize that this study is still underpowered to detect rare side effects, what may be done only in larger multicenter post-registration studies. Nevertheless, the strength and clinical importance of our study is in the direct comparison of Sputnik V and Sinopharm in real-life settings. Among the strong points of this study are simultaneous comparison of 2 different vaccines in the same epidemiological conditions (the same circulating SARS-CoV-2 strains) and the double-controlled system of data collection, which helped to avoid the missing data in the analysis.
In conclusion, the Sputnik V (Gam-COVID-Vac) vaccine has higher immunogenicity rates on the 42nd day and in 6 months after the first dose compared to Sinopharm (BBIBP-CorV). This trend was seen among both groups previously infected with SARS-CoV-2 and those without a history of COVID-19. This study also confirmed that a combination of post-vaccination antibodies and those developed as a result of prior SARS-CoV-2 infection creates a higher levels of antibodies, which persist for a longer time both in Sputnik V and Sinopharm study groups. In a multivariate analysis, IgG seropositivity at a baseline and Sputnik V vaccine type were shown to be significantly associated with higher IgG levels both at 42 days and at 6 months post-vaccination.
The main reactions after vaccination were fever, redness and soreness in the injection site. The reactogenicity of both vaccines was relatively similar, while a fever after vaccination was more common among those vaccinated with Sputnik V (Gam-COVID-Vac) compared to vaccinated with Sinopharm (BBIBP-CorV) vaccine.
Authors have reported no relevant conflict of interest regarding to this study exist.
Declaration of competing interest
The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
Footnotes
Articles from are provided here courtesy of Elsevier
Sputnik V (Gam-COVID-Vac) is the first adenoviral-based vaccine registered against the SARS-CoV-2 betacoronavirus that causes COVID-19. Initially produced in Russia in 2020, Sputnik V uses a weakened virus to deliver small pathogen parts and stimulate an immune response. The Sputnik V vaccine reduces the time taken for the actual development of immunity to SARS-CoV-2. Sputnik V is a two-component vaccine used by adenovirus serotypes 5 and 26. A fragment of tissue-type plasminogen activator is not used, and the antigen insert is an unmodified full-length S-protein. Sputnik V is produced with the HEK293 cell line and is based on adenovirus DNA, in which the SARS-CoV-2 coronavirus gene is integrated. Adenovirus is a "container" that delivers the coronavirus gene to cells and synthesizes the SARS-CoV-2’s envelope proteins, "introducing" the immune system to a potential enemy. The cells then use the gene to produce the spike protein. A person’s immune system treats this spike protein as foreign and produces natural defenses, antibodies, and T cells against this protein.
Enhanced Sputnik Vaccine 2024
TASS reported on October 23, 2023, that a new Sputnik V vaccine is expected to enter public circulation by March 2024. According to Professor Vladimir Chulanov, MD, PhD, DSc, diseases specialist, the updated Sputnik V vaccine may be made available to the public as soon as safety testing of the drug is successfully completed.
Original Sputnik Vaccine
On March 22, 2021, the Ulema Council confirmed that ‘faith does not forbid Russian Muslims from getting vaccinated with Sputnik V after considering two components of the Covid-19 vaccine for Sharia compliance (for medicine). Interfax reported on February 12, 2021, that the Sputnik V coronavirus vaccine contains no components prohibited by Islam.
The Gamaleya National Research Center of Epidemiology and Microbiology announced on August 23, 2022, that a new version of Sputnik V has been Delta- and Omicron-adapted. This new version addresses the L-452-R mutation in the Omicron BA5 variant, which was not present in the BA1 variant.
The Sputnik V vaccine was Authorized in August 2020 and Approved in Russia on February 4, 2020. The Sputnik V vaccine (Спутник V) Accession Number: DB15848. Registered on August 11, 2020: ЛП-006395. As of Agust 2023, the WHO indicated it had restarted the authorization process.
Sputnik V History
The Sputnik V vaccine was created at the N.F. Gamaleya Research Center for Epidemiology and Microbiology Ministry of Health of Russia. On August 1, 2020, the Russian Health Minister Mikhail Murashko told reporters the ‘clinical trial had been declared completed’ and was then registered to ‘FSBI "NF Gamaleya NITsEM" of the Ministry of Health of Russia ("Medgamal" branch of NF Gamaleya NITsEM "of the Ministry of Health of Russia)’ on August 8, 2020. he Gamaleya Center used the same human adenoviral platform for their earlier research, including but not limited to vaccines against Ebola in 2017 and MERS in 2019.
The Russian Direct Investment Fund announced on August 20, 2020, that the Sputnik V vaccine candidate would be tested on 40,000 volunteers in more than 45 medical centers to confirm clinical efficacy post-approval studies. On October 27, 2020, RDIF announced it had submitted applications to the World Health Organization for an Emergency Use Listing and prequalification of the Sputnik V vaccine candidate. the RDIF was established in 2011 and provided support to facilitate partnerships, including the Gamaleya National Research Institute of Epidemiology and Microbiology and the Central Research Institute of the Radiation, Chemical, and Biological Defense Troops.
Sputnik V Dosage
The Sputnik V vaccine is manufactured as a liquid formulation containing 10¹¹ vp per 0·5 mL/dose. or intramuscular injection composition for one dose (0.5 ml): Active substance: recombinant serotype 26 adenoviral particles containing the SARS-CoV-2 S protein gene, in the amount of (1.0±0.5) x 10*11 particles per dose.
Sputnik Light Vaccine
The Sputnik Light vaccine is the first component (recombinant human adenovirus 26 serotype (rAd26) of the Sputnik V vaccine.
Sputnik V Booster
Bahrain’s National Medical Taskforce for Combatting the Coronavirus (COVID-19) announced on September 4, 2021, the formal authorization of Sputnik V as a booster shot for those 18 and above who received their second dose of the Sputnik V vaccine at least six months ago. He authorized the Sputnik V booster shot. Gintsburg, Gamaleya Center head: "Sputnik nasal vaccine, world’s 1st registered СOVID vaccine in nasal form, is especially effective vs. highly transmissible #Omicron & other emerging variants not only in terms of protection from infection but also at preventing transmission" t was the first of its kind.
India’s central government approved using the Sputnik V vaccine as a booster, as reported by the Hindustan Times on May 7, 2022.
Sputnik V Nasal Spray
On August 31, 2022, the Gamaleya National Research Center of Epidemiology and Microbiology announced a publication in Emerging Microbes & Infections, a peer-reviewed medical journal, sharing the results of a study on the intranasally delivered Sputnik V coronavirus vaccine. The study shows this vaccine induces a strong and durable immune response in animals.
Sputnik V Indication
The Russian Sputnik V COVID-19 Vaccine (Gam-COVID-Vac) is indicated to build immunity to SARS-CoV-2, which causes COVID-19 disease. Sputnik V is available in the vaccine’s lyophilized (dry) form. It significantly facilitates the logistics of its distribution in international markets due to simplified requirements for its storage temperature (+ 2 — 8 degrees Celsius).
Sputnik V and HIV
Data presented in The Lancet eClinicalMedicine on March 23, 2022, are scientific results on the preventive efficacy of a COVID-19 vaccine to protect against infection in people living with HIV (PLWH). Based on data from more than 24,000 HIV+ patients in Moscow on antiretroviral therapy (ART), Sputnik V’s efficacy was 79%. The vaccine’s efficacy against hospitalization was more than 90%. putnik V is more than 97% effective against moderate or severe disease development among PLWH. The Gamaleya Center and Moscow City Center for AIDS Prevention and Control conducted the analysis.
Sputnik V Production
Sputnik V vaccine has built production partnerships with producers in 14 countries and intends to double its capacity in September 2021, stated the Sputnik V website on August 11, 2021. The quality and safety of the Russian Sputnik V vaccine are, among other things, assured by the fact that it uses a 4-stage purification technology that includes two stages of chromatography and two stages of tangential flow filtration. This purification technology helps obtain a highly purified product through mandatory quality control, including control for RCA or any additives presence. Furthermore, only E1- and E3-type non-replicating adenoviral vectors, which are harmless to the human body, are used in the Sputnik V vaccine production. Sputnik V cell lines: Design and Development: HEK293 cells; Production: HEK293 cells.
RDIF announced on May 24, 2021, that India-based Panacea Biotec started Sputnik V vaccine production at facilities in Buddy. Full-scale production of Sputnik V is expected to begin during the summer of 2021. On June 3, 2021, local media reported Bahrain Mumtalakat Holding Company announced a memorandum of understanding with the RDIF and Binnopharm Group, а subsidiary of Sistema PJSFC, to explore the establishment of a vaccine production facility in the Kingdom of Bahrain to manufacture and distribute the Sputnik V COVID-19 vaccine across the Gulf Cooperation Council and the Middle East region.
Argentina and Serbia confirmed on June 4, 2021, that they had begun industrial production of the Sputnik V vaccine. and India’s DCGI granted the Serum Institute of India permission on June 4, 2021, to manufacture the Sputnik V Covid-19 vaccine at its licensed Hadapsar facility. On June 16, 2021, TASS reported that the Swiss-Italian company Adienne Pharma & Biotech had launched the first Sputnik V vaccine test batch in Italy. Reuters reported on June 18, 2021. he Argentine laboratory Richmond produced almost half a million doses of the Sputnik V vaccine in the country.
The RDIF and Actoverco, one of Iran’s leading pharmaceutical companies, confirmed on June 26, 2021, the production of a Sputnik V vaccine test batch. These vaccines will be used in Iran.
On July 5, 2021, the RDIF and Mexican pharmaceutical company Laboratorios de Biológicos y Reactivos de México (BIRMEX) announced the production of a test batch of the Russian Sputnik V vaccine. Mexico became the first country in North America to register Sputnik V and launch its local production. On July 20, 2021, the Laboratorios de Biológicos y Reactivos de México SA de CV (Birmex) sent the pilot tests to the Gamaleya National Research Center for Epidemiology and Microbiology. The batches with the pilot tests of components 1 and 2 were kept in the National Institute of Virology of Birmex facilities in conditions of -20ºC.
South Korea-based GL Rapha was certified to produce Sputnik vaccines on October 26, 2021. L Rapha has agreed to produce over 150 million Sputnik V and Sputnik Light vaccine doses annually. On December 1, 2021, the RDIF, Binnopharm Group, and Vietnam’s T&T GROUP signed an agreement to create a full-cycle production of Sputnik V in Vietnam.
QazCovid-in Vaccine
The Karaganda Pharmaceutical Complex in Kazakhstan used the Sputnik V vaccine to produce the QazCovid-In Vaccine. The first batch of 50,000 vaccine doses was delivered on April 26, 2021.
Sputnik V Ingredients
The active components are a modified replication-defective adenovirus of a different serotype (Serotype 26 for the first component and Serotype 5 for the second), modified to include the protein S-expressing gene of the SARS-CoV-2 virus. The ingredients include Tris-(hydroxymethyl)-aminomethane, Sodium chloride, Sucrose, Magnesium chloride hexahydrate, Disodium EDTA dihydrate, Polysorbate 80, Ethanol, and Water.
Sputnik V Cost
The cost of one dose of the Sputnik V vaccine for international markets will be less than $10. Sputnik V is a 2-dose vaccine. Thus, it may cost less than $20 per person.