The Gamaleya National Research Center of Epidemiology and Microbiology (Gamaleya Center) and the Russian Direct Investment Fund announce a publication in Emerging Microbes & Infections, a peer-reviewed medical journal, sharing the results of a study on intranasally delivered Sputnik V coronavirus vaccine. The study shows this type of the vaccine induces a strong and durable immune response in animals.
The article has been peer-reviewed and is available at:
The intranasal Sputnik V was studied in in mice and in non-human primates (common marmosets). High immunogenic properties of the vaccine were verified by marked IgG and neutralizing antibody (NtAb) production in blood serum, antigen-specific T-cell proliferation and formation of IgA antibodies in the nasal mucosa.
The vaccine induced a robust (no less than 180 days) systemic and local immune response. Study’s findings demonstrate that in the mouse model, intranasal and intramuscular administration of Sputnik V vaccine elicits comparable magnitude of central antigen-specific immunity, while only intranasal vaccination forms humoral and cell-mediated response in lungs.
Lungs are more vulnerable to infection by the novel strains of coronavirus, including BA4 and BA5 sub-strains of Omicron. The ability of intranasal vaccine to elicit protective immunity at the entry gates of infection provided by mucosal vaccination is key to block virus infection and transmission and may become a “silver bullet” that could bring the pandemic to an end.
Intranasal administration of Sputnik V is well-tolerated and effective for developing both local and systemic immune responses, as well as providing protection against lethal virus challenge, which is comparable to that of the initially developed intramuscular vaccine.
An earlier study conducted by a team of Russian scientists including representatives of the City Clinical Hospital No. 67 named after L.A. Vorokhobov and the Gamaleya Center has demonstrated Sputnik V’s efficacy against hospitalisation caused by Omicron for those vaccinated with 3 or 4 components (re-vaccination with Sputnik Light or Sputnik V after Sputnik V) was 97% and 99.4% against critical cases. These results have been published in June 2022 in the Vaccines leading peer-reviewed medical journal[i].
Sputnik V is one of the safest and most effective vaccines against coronavirus in the world and has become the most exported pharmaceutical product in the Russian history. The high safety and efficacy of Sputnik V and one-shot Sputnik Light have been confirmed by more than 50 clinical studies and data compiled during national vaccination programs in various parts of the world, including Europe, Asia, the Middle East and Latin America. Research on the Sputnik V vaccine has been published in leading international peer-reviewed medical journals, including The Lancet, Nature, Vaccines, Cell Reports Medicine and others.
The Russian Direct Investment Fund is among the world’s leading sovereign wealth funds with a diversified investment portfolio in key sectors. RDIF has played a leading role in development of a ‘triad’ against coronavirus including test-systems, a drug and the Sputnik V vaccine, which has helped to save millions of lives in more than 30 countries around the world.
RDIF invested in development and production of both Sputnik V and Sputnik Light, which have helped save millions of lives globally. Sputnik V has been authorized in 71 countries with total population of over 4 billion people. Sputnik Light has been approved in more than 30 countries. Sputnik V and Sputnik Light are based on a safe human adenoviral vector platform proven in more than 30 years and are not associated with serious adverse events such as myocarditis or pericarditis.
The Gamaleya National Research Center of Epidemiology and Microbiology (Gamaleya Center) today announced that Vaccines, the leading peer-reviewed medical journal, has published the results of a joint study conducted by team of scientists including representatives of Moscow’s City Clinical Hospital No. 67 named after L.A. Vorokhobov and the Gamaleya Center showing the two-dose Sputnik V vaccine is 97% effective against hospitalisation caused by the Omicron variant of coronavirus (B.1.1.529) among those vaccinated with 3 or 4 components (re-vaccination with Sputnik Light or Sputnik V after Sputnik V).The corresponding article has been peer-reviewed and is available at:
The study was conducted from 11 January to 21 February 2022 involving over 1,000 patients in Moscow. Sputnik V showed high efficacy against hospitalisation at 85.9% among patients vaccinated with at least one component. Efficacy among those vaccinated with 3 or 4 components (re-vaccination with Sputnik Light or Sputnik V after Sputnik V) rose to:
97% against any cases of hospitalisation;
97.7% against moderate-severe and more severe cases;
98.6% against severe and critical cases;
99.4% against critical cases.
As authors note, “the study shows that vaccination with Sputnik V and Sputnik Light has a high effectiveness for protection against hospitalisation. The reduction in the severity of COVID-19 regarding the Omicron variant was also observed. The greatest effectiveness was evident in protection against a critical course of the disease requiring patients to be admitted to the intensive care unit.”
To date, Sputnik V has been authorized in 71 countries with a total population of over 4 billion people, and Sputnik Light has been approved in more than 30 countries. The Russian Direct Investment Fund invested in development and production of both Sputnik V and Sputnik Light.
Mykare a tech-enabled full-stack asset-light and bootstrapped healthcare startup has registered a growth of more than 300% in its revenue since July 2020. Mykare was born in Covid period to offer affordable, personalized and standardized elective surgery and wellness space for patient travelling from domestic and international regions. Despite the pandemic and travel restrictions Mykare has touched this hike.
The startup delivers an affordable and standardized surgical care and wellness care for domestic & international patients, ensuring maximum utilization of small & medium hospital facilities. Mykare has served more than 1500+ national and international patients so far. Currently, MyKare operates with four facilities in Chennai and plans to expand its services in the whole South Indian region including Tamil Nadu, Karnataka, Kerala, Telangana, Andhra Pradesh, and Maharashtra. It has operating offices in Bangalore, Chennai, Kolkata, Assam, Tripura, Andhra, Kerala and one in Bangladesh. Due to high demand of affordable health care services Mykare will also expand its facilities in North and North East of India along with SAARC regions, by next year.
Mykare has witnessed the 204% YOY growth, 63% growth in the current financial.
Mykare was founded by Mr Senu Sam in 2020 with a vision of transforming the healthcare experience of every common man by providing the most affordable, personalised and standardised care. The Idea of building Mykare had came in Senu’s mind when his father was admitted at a local hospital in his home town for a surgery, he flew down to coordinate the entire process. Put in the shoes of a regular patient, he observed the entire process unfold in a new perspective. This made him wonder how his father was one among many countless patients across the country, waiting at the hospital without a clue of what they are going through. This is when he felt the need for an end-to-end tech platform experience with personalised and standardised care for patients who are looking for affordable surgical care.
Now, Mykare Health aims to build India’s largest asset-light healthcare chain for elective surgeries & preventive/wellness care. Mykare is an integrated platform solution including free second medical opinion, providing 24*7 in-app assistance for travel, logistics, stay & pre-insurance care. The brand also provides standardized care at Hospital and post- surgeries care as well.
Mykare has tied up with small & medium hospitals in India as well as abroad. It enables partner hospitals with technology, patient access, and branding. The brand utilises the under utilised facilities & their senior surgeons for the procedure.
People can utilize Mykare services by downloading its mobile application from the Google Play store and following a few easy steps. They can book their surgeries and medical checkups using one application.
Avifavir® is effective against various variants of coronavirus, including Delta and Omicron, as it affects the highly conservative and mutation-resistant replication systems of RNA virus (RdRp).
The virus is incapable of developing resistance to favipiravir even with long-term exposure on infected cells, as has been confirmed in clinical trials. This provides Avifavir® with a major advantage not only over highly specific biologics but also over many other similar nucleoside products.
ChemRar Group announces the Russian Avifavir® (INN: favipiravir) drug is effective against various variants of SARS-CoV-2 (coronavirus), including Delta and Omicron, as it affects the highly conservative and mutation-resistant replication systems of RNA virus (RdRp) via three complementary mechanisms, resulting in complete blockade of the viral infection.
In addition, the virus is incapable of developing resistance to favipiravir even with long-term exposure on infected cells, as has been confirmed in clinical trials. This provides Avifavir® with a major advantage not only over highly specific biologics but also over many other similar nucleoside products prone to inducing rapid evolution of resistant clinical variants.
The problem of rapid mutation is particularly typical of RNA viruses, such as SARS-CoV-2 (coronavirus). Most of the mutations are found in the spike protein structure, in particular in two of its key parts that are recognized by the human immune system.
A meta analysis of 23 COVID-19 treatment studies for favipiravir is demonstrating a 47% improvement when favipiravir is used in early treatment of coronavirus. This analysis is available at: https://c19favipiravir.com/meta.html
Figure. Mechanism of Antiviral Action of Avifavir® (INN: favipiravir)
In June 2020, with the support of the Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund), ChemRar Group specialists developed and were the first in the world to release Avifavir® (INN: favipiravir), a direct antiviral for COVID-19 treatment, to the Russian and international markets. The product’s efficacy has been confirmed in a full-scale clinical trial in Russia involving 460 COVID patients. Avifavir® has been supplied to more than 15 countries around the world.
Clinical trials of Avifavir® have demonstrated its anti-COVID properties, such as alleviating symptoms and cut the duration of the disease by half compared to standard therapy.
In particular:
Avifavir® is demonstrating the best results in COVID treatment when used in the first 3-5 days after first symptoms;
After the first 4 days of treatment, 65 % of patients on Avifavir® tested negative for coronavirus, twice the rate of the standard treatment group. By day 10, the number of negative patients had reached 90 %;
In 68 % of patients on Avifavir®, body temperature normalized earlier (on Day 3) compared to the control group (on Day 6).
Median time to clinical improvement with Avifavir® was 7 days vs. 10 days in the standard treatment group.
In addition, the results of Avifavir® in patients with COVID-19 are being closely monitored in real-world clinical practice. A retrospective review of favipiravir’s efficacy and safety is currently under way in 40,000 patients exposed to the product in an outpatient or inpatient setting.
In 2020–2021, potential of favipiravir against coronavirus infection was actively investigated in more than 50 clinical trials involving around 5,000 patients in Russia, Japan, China, India, Thailand, Turkey, Iran, Saudi Arabia, EU countries and Latin America. To date, the PubMed database of international medical and biological literature contains almost 900 peer-reviewed favipiravir-related papers. At least 700 of them were published in the last 1.5 years. These publications speak for the high efficacy and safety of favipiravir against COVID-19.
Elena Yakubova, Medical Director of ChemRar Group, commented:
“Having accumulated extensive experience with Avifavir® in patients infected with COVID both from clinical trials and real-world clinical practice, we see that taking Avifavir® in the first 3–5 days after infection leads to a milder disease in most cases and prevents hospitalization. Over the past 17 months, more than 4 million patients have been treated with favipiravir worldwide. The product was well tolerated with no new adverse events, which confirms the high safety of favipiravir”.
To date, vast body of information has been accumulated in the scientific literature on various aspects of the favipiravir pharmacology as the product has been well studied, including its mechanisms of action, activity in vitro and in vivo, clinical efficacy, safety, cost-effectiveness, potential for combination therapy, analytical control methods, etc. A series of clinical trials in 2020-2021 have provided objective evidence for the efficacy and safety of favipiravir as treatment for COVID-19.
If therapy begins in the first days after the onset of disease, the product significantly increases survival rate, reduces viral load, need for artificial ventilation, and length of hospital stay.
Robert Redfield, a renowned American virologist and former director of the U.S. Center for Disease Control and Prevention (2018–2021), notes: “Avifavir® has been shown to be effective against COVID-19 in clinical trials and medical practice. Recently additional direct acting antiviral have been developed. Studying the combination of Avifavir® with other antivirials such as Paklovid (Pfizer) could offer even better therapeutic options for those at higher risk of COVID-19 disease progression, reduce the likelihood of drug-resistant virus mutations, and increase the time after diagnosis when therapy can be effective”.
References to studies supporting the efficacy of favipiravir against COVID-19:
In a multicenter randomized phase II/III clinical trial in patients with moderate COVID-19 (NCT04434248), Avifavir provided effective clearance of SARS-CoV-2 virus in 62.5 % of patients within 4 days, was safe and well tolerated (Ivashchenko А.А. et al. Avifavir for Treatment of Patients With Moderate Coronavirus Disease 2019 (COVID-19): Interim Results of a Phase II/III Multicenter Randomized Clinical Trial. Clin Infect Dis. 2021 Aug 2;73(3):531-534. doi: 10.1093/cid/ciaa1176.). Now we can summarise and supplement both the ChemRar Group data on the use of the product and the findings of extensive scientific research with the product performed around the world.
A systematic meta-analysis of 11 clinical trials has demonstrated that favipiravir causes effective clearance of the SARS-CoV-2 virus by day 7 and promotes clinical improvement within 14 days (Manabe et al. Favipiravir for the treatment of patients with COVID-19: a systematic review and meta-analysis. BMC Infect Dis. 2021; 21(1):489.).
In a randomized, blind, placebo-controlled phase III study of favipiravir efficacy and safety in 156 COVID-19 patients with moderate-to-severe pneumonia (Japan), the median time to patient recovery was 11.9 days in the favipiravir group and 14.7 days in the placebo group, with a statistically significant difference (p = 0.0136) (Shinkai M. et al. Efficacy and Safety of Favipiravir in Moderate COVID-19 Pneumonia Patients without Oxygen Therapy: A Randomized, Phase III Clinical Trial. Infect Dis Ther. 2021 Aug 27; 1-21.).
Inclusion of favipiravir in the national COVID-19 treatment protocol in Turkey resulted in a pronounced, statistically significant decrease in ICU hospitalization rates from 24 % to 12 % (Guner et al. ICU admission rates in Istanbul following the addition of favipiravir to the national COVID-19 treatment protocol. North Clin Istanb. 2021; 8(2):119.).
In a retrospective study conducted in specialized public hospitals in Saudi Arabia, the median time to discharge for patients with COVID-19 was 10 days in the favipiravir group compared to 15 days in the maintenance therapy group, across all grades of COVID-19 severity (Alamer et al. Effectiveness and safety of favipiravir compared to supportive care in moderately to critically ill COVID-19 patients: a retrospective study with propensity score matching sensitivity analysis/ Curr Med Res Opin. 2021; 37(7):1085.).
In a randomized, open-label, parallel, multicenter phase III study of 150 patients with mild to moderate COVID-19 conducted in India, the median time to cessation of virus excretion was 5 days versus 7 days, and the median time to clinical recovery was 3 days versus 5 days for favipiravir and control, respectively (Udwadia et al. Efficacy and safety of favipiravir, an oral RNA-dependent RNA polymerase inhibitor, in mild-to-moderate COVID-19: A randomized, comparative, open-label, multicenter, phase 3 clinical trial. Int J Infect Dis. 2021; 103:62.).
Favipiravir has demonstrated efficacy and safety in treatment of mild to moderate COVID-19 in outpatients and hospitalized patients: the median time to clinical improvement was 6.0 days (IQR 4.0; 9.3) in the favipiravir group and 10.0 (IQR 5.0; 21.0) days in the SOC group. The rate of viral elimination on Day 5 in the favipiravir group was significantly higher than in SOC group: 81.2% vs. 67.9% (RR 1.22; 05% CI 1.00-1.48; P=0.022). (Phase 3 trial of coronavir (favipiravir) in patients with mild to moderate COVID-19. Am J Transl Res 2021;13(11):12575-12587)
