COVID-19

The Russian President Vladimir Putin has launched a coronavirus vaccine amid the global race to develop and distribute it. The world’s first vaccine comes even with the final stages of clinical trials to test efficiency and safety still going on.

The announcement came in the wake of the Covid-19 pandemic that has infected more than 20 million people and killed around 0.75 million people all over the world. It has also resulted in crippling world economies.

The Russian vaccine has been developed by the Gamaleya Institute in Moscow. The vaccine uses two strains of adenovirus that is known to cause mild cold in humans. Adenovirus vaccine is under trial in many other countries as well. The strains are genetically modified which can cause infected cells to create proteins from the spike of the coronavirus. This is a similar approach to a vaccine under development by AstraZeneca and Oxford University.

As per reports, Russia has dubbed the newly created vaccine “Sputnik V” after its Soviet satellite. Kirill Dmitriev, who is the head of the Russian Direct Investment Fund, an organization responsible for financing the vaccine project, announced that the Phase 3 trials would start by Wednesday. This means that mass production can be expected from September. He also mentioned that around 20 countries have already pre-ordered more than a billion doses.

Putin thanked everyone who has worked on the vaccine’s development and mentioned that this is a very important step for the world. He also hopes that the country’s research body should start the mass production of the vaccine very soon.

When talking about the vaccine, Putin mentions that it works effectively, helps build strong immunity, and has passed all the needed checks. He also added that one of his two daughters have received a shot of the vaccine and is doing well.

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The CEO & Chief Architect of Dokat, Inc, Ram Chella led a team to devise a fully Made in India Deep UV-C Air Sanitizer called as ‘Dokat Air’. This product has better germ-killing efficiency than any air purifier in the market because of its ‘Deep UV germicidal irradiation technology’ that helps to make indoors safer for people by killing disease-causing germs from the air.

It's a patent-pending novel product that can sanitize 1000-cubic feet of air within 15 minutes killing 99.99% germs. It's capable of killing various kinds of bacteria, viruses & molds like SARS, MERS, COVID-19, SARS-CoV-2 & Influenza Virus. The UV-C ray penetrates the cell of the micro-organisms and kills them by breaking their DNA. Having met international regulatory standards like ISO 9000:2015, FCC (US standard for electronic products) and European CE, this product helps in giving us an effective and efficient disinfecting solution to face the ongoing pandemic along with other numerous airborne diseases. This product is different from the regular air purifiers as it kills various kinds of disease-causing micro-organisms while filtering the air too. Regular air purifiers do not kill germs this well, instead, increases the germs’ spread. Here, comes the need for such a device that can sanitize the air while filtering pollutants along with.

Dokat-Air’s 100% UV leak proof ‘Germ Squash’ chamber uses the most effective broad-spectrum UV-C light and when the air passes through, it gives an optimal flow with maximum germicidal exposure, therefore making it better than the traditional  UV-C technology.

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New research conducted by scientists from various US based universities like Harvard University, University of Nebraska Medical Center, University of Illinois at Urbana-Champaign concluded that SARS-CoV-2 (novel coronavirus) RNA exists in respired aerosols less than 5 μm in diameter; that aerosols containing SARS-CoV-2 RNA exist in particle modes that are produced  during respiration, vocalization, and coughing.

This study sought to characterize the presence of SARS-CoV-2 in particles consistent with the potential to result in aerosol transmission between patients. Although not all particles measured by the Aerodynamic Particle Sizer Spectrometer (APS) may be attributable to patient extrusions, increases in particle count while measurements were being taken using the APS were anecdotally observed to occur when patients were talking and coughing.

The aerosol modes observed in this study were compared to those from previous observations of human aerosol production during respiratory activities. The small aerosol mode, with a mean diameter between 0.64 and 0.80, is consistent with particles found in exhaled breath in previous studies. This mode of aerosol was observed in all manner of human respiration including breathing, vocalization and coughing and has been attributed to particles produced deep in the bronchial region, referred to as the Bronchiolar Fluid Film Burst (BFFB) mechanisms. Particles in the larger modes observed in this study are more consistent with those produced in the larynx during vocalization and coughing.

As per this finding, observation of fine mode aerosol particles containing infectious SARS-CoV-2 particles leads to several general observations about the potential transmission of SARS-CoV-2. The results of this study, along with the evidence of the stability of SARS-CoV-2 in aerosol and that SARS-CoV-2 infects respiratory tissue provide indications that SARS-CoV-2 may be transmitted via the airborne route.

The results were published in medRxiv on 21st July, 2020.

This study supports the use of efficient respiratory protection and airborne isolation precautions  to protect from exposure to fine SARS-CoV-2 aerosol when interacting with infected  individuals, regardless of symptoms or medical procedure being performed.

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Mylan, a global pharmaceutical company announced the commercial launch of its Remdesivir under the brand name DESREM™ in India to address urgent, unmet needs amid the evolving coronavirus 2019 (COVID-19) pandemic. The drug is approved for the treatment of suspected or laboratory confirmed incidences of COVID-19 in adults and children hospitalized with severe presentations of the disease. The company also launched a 24/7 helpline where patients and healthcare practitioners can access information about Mylan’s Remdesivir and its availability.

Mylan released the first batch of its generic Remdesivir (DESREM™) and will continue to increase its supply across the country in the wake of the rising demand for the drug.

Mylan will manufacture DESREM™ in its state-of-the-art injectable facility in Bangalore, which will work to service the demand in India and other export markets where Mylan has received a license from Gilead for the commercialization of Remdesivir. The previously announced agreement between Mylan and Gilead is part of a long-standing history between the two organizations to tackle key public health issues in India and around the world, beginning with expanding access to high quality, affordable HIV/AIDS antiretrovirals and now extending its partnership to include COVID-19 treatments.

President, India and Emerging Markets, Rakesh Bamzai said: “In the wake of increasing cases of COVID-19 across India, Mylan remains committed to continue its efforts in the fight against the pandemic. With the launch of DESREM™ and our national 24/7 COVID-19 helpline, we aim to enhance access to this critical medicine, used for treating adults and children with severe presentations of Covid-19. At Mylan, we believe we have a responsibility to help make the world a better place and the entire team at Mylan has stepped up in this time of need to serve patients and deliver better health for a better world.”

Mylan is committed to continue doing its part in support of public health needs as the situation around COVID-19 continues to evolve. Mylan’s priorities remain protecting the health and safety of its workforce, continuing to produce critically needed medicines, deploying our resources and expertise in the fight against COVID-19 through potential prevention and treatment efforts, and supporting the communities in which we operate.

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Biocon Ltd an innovation-led global biopharmaceuticals company, announced that it has received the Drugs Controller General of India’s (DCGI) approval to market Itolizumab  (ALZUMAb®) Injection 25mg/5mL solution for emergency use in India for the treatment of cytokine release syndrome (CRS) in moderate to severe  ARDS (acute respiratory distress syndrome) patients due to COVID-19.

Itolizumab is the first novel biologic therapy to be approved anywhere in the world for treating patients with moderate to severe COVID-19 complications. Biocon has repurposed Itolizumab, an anti-CD6 IgG1 monoclonal antibody launched in India in 2013 as ALZUMAb® for treating chronic plaque psoriasis, for the treatment of CRS in moderate to severe ARDS patients due to COVID-19.

Itolizumab will be manufactured and formulated as an intravenous injection at Biocon’s bio-manufacturing facility at Biocon Park, Bengaluru.

The SARS-CoV-2 virus has been observed to induce an overreaction of the immune system, generating a large number of cytokines that can cause severe damage to the lungs and other organs, and, in the worst scenario, multi-organ failure and even death.

The approval of Itolizumab, from the DCGI is based on the results from the successful conclusion of a randomized, controlled clinical trial at multiple hospitals in Mumbai and New Delhi.  The study focussed on the safety and efficacy of Itolizumab in preventing CRS in moderate to severe ARDS patients due to COVID-19. The primary endpoints for reduction in mortality rate were met and other key secondary endpoints for efficacy and biomarkers were also achieved.

Kiran Mazumdar-Shaw, Executive Chairperson, Biocon, said: “As an innovation-led biopharmaceuticals company, I am proud of the successful outcome of the pivotal study we conducted with our novel immuno-modulating anti-CD6 monoclonal antibody, Itolizumab, which has proven to be an efficacious intervention in treating the serious hyper immune response seen with COVID-19. The data is compelling and I am confident that this ‘first-in-class’ biologic will save lives and help reduce the mortality rate in our country.

“This positions India amongst the leading global innovators in their effort to overcome the COVID-19 pandemic. The randomized control trial indicated that all the patients treated with Itolizumab (ALZUMAb®) responded positively and recovered. The control arm that did not receive Itolizumab unfortunately had deaths. Itolizumab is now approved for the treatment of CRS in patients with moderate to severe ARDS due to COVID-19. We plan to take this therapy to other parts of the world impacted by the pandemic.

“Itolizumab’s unique mechanism of action made it an ideal candidate for treating the ‘cytokine storm’, which is a leading cause of death in COVID-19 patients. I am pleased that our R&D and clinical teams delivered on this promising hypothesis in such a short period of time. It is a proud moment for all of us at Biocon and we would like more and more patients to benefit from this therapy. I also thank the investigators and the regulators for the sense of urgency that they displayed in this study.

“ALZUMAb®  has a seven-year proven track record of safety as doctors in India have been prescribing this biologic to treat acute psoriasis and ensure a better quality of life for patients and now we will be able to save many critically ill COVID-19 patients with our drug.”

Dr Suresh Kumar, Medical Director, Lok Nayak Hospital, Delhi said: “At the time of this COVID-19 pandemic, we do not have any specific treatment for patients who are losing the fight against the disease in spite of best supportive care. Lok Nayak Hospital was one of the sites of the Itolizumab study wherein we used Itolizumab to treat eight patients. These patients did extremely well even with a single dose of Itolizumab. Patients who were with initial oxygen saturation of less than 80% and would have  been put on ventilator support with little chance of survival, recovered completely when treated with Itolizumab and got discharged. I sincerely believe Itolizumab will not only help in reducing morbidity and mortality of COVID-19 patients but will also help us in judiciously managing healthcare resources like ICUs and ventilators for critically ill patients.

Dr Mohan Joshi, Dean, BYL Nair Hospital, Mumbai, said: “In our hospital, we have tried Itolizumab in many COVID-19 patients with moderate to severe ARDS and found significant improvement in clinical, radiological and inflammatory markers after administering Itolizumab. These outcomes were quite evident with one dose of Itolizumab when administered before the ‘cytokine storm’ set in. Most of the patients have well tolerated the drug. Given the growing surge of COVID-19 cases, I would recommend use of Itolizumab in moderate to severe complications in COVID-19.

Dr Sandeep Athalye, Chief Medical Officer, Biocon Biologics, said: “We are delighted with the results of the clinical trial for Itolizumab in India. Itolizumab demonstrated statistically significant advantage over the control arm, in one month mortality rate. Key efficacy parameters such as PaO2 and SpO2 (oxygen saturation) improvement without increasing FiO2 (oxygen flow) also showed statistically significant advantage for Itolizumab arm over the control arm. All the patients on Itolizumab arm were weaned off oxygen by Day 30, and none needed ventilator support unlike the control arm. Key secondary endpoints of clinical markers of inflammation such as IL-6, TNF-α, serum ferritin, d-dimer, LDH and CRP showed clinically significant suppression post dose and correlated well with clinical improvement in symptoms and chest x-ray images. Itolizumab was overall well tolerated and was found to be safe. Itolizumab when administered to patients with moderate to severe ARDS due to COVID-19, prevents morbidity and mortality due to cytokine storm.

India currently has more than 283,400* documented active coronavirus infections and over 22,100* deaths

Itolizumab’s unique mechanism of action of immunomodulation involves binding to the CD6 receptor and blocking the activation of T lymphocytes, which in turn suppresses the pro-inflammatory cytokines, thus reducing the cytokine storm and deadly inflammatory response.

Biocon launched ALZUMAb® (Itolizumab) in India in 2013 for the treatment of chronic plaque psoriasis. Many patients have benefitted from this novel therapy.

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