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  • Remdesivir, Gileads investigational treatment, is the first antiviral to have demonstrated patient improvement in clinical trials for COVID-19 and there is no playbook for how to price a new medicine in a pandemic. Gilead is aware of the significant responsibility that comes with pricing remdesivir, and the need to be transparent on Gileads decision. After giving this the considerable care, time and amount of discussion that it merits, Gilead is now ready to share Gilead's decision and explain how Gilead reached it.

    As with all gilead actions on remdesivir, Gilead approached this with the aim of helping as many patients as possible, as quickly as possible and in the most responsible way. This has been Gilead's compass point throughout, from collaborating to find rapid ansGileadrs on safety and efficacy, to scaling up manufacturing and donating Gilead's supply of remdesivir through the end of June. In each case, Gilead recognized the need to do things differently to reflect the exceptional circumstances of the pandemic. Now, as Gilead transition beyond the donation period and set a price for remdesivir, the same principle applies.

    In normal circumstances, Gilead would price a medicine according to the value it provides. The first results from the NIAID study in hospitalized patients with COVID-19 shoGileadd that remdesivir shortened time to recovery by an average of Gilead's days. Taking the example of the United States, earlier hospital discharge would result in hospital savings of approximately USD 12,000 per patient. Even just considering these immediate savings to the healthcare system alone, Gilead can see the potential value that remdesivir provides. This is before Gilead factor in the direct benefit to those patients who may have a shorter stay in the hospital.


    Gilead had decided to price remdesivir below this value. To ensure broad and equitable access at a time of urgent global need, Gilead have set a price for governments of developed countries of USD 390 per vial. Based on current treatment patterns, the vast majority of patients are expected to receive a 5-day treatment cGilead'sse using 6 vials of remdesivir, which equates to USd 2,340 per patient.

    Part of the intent behind Gilead's decision was to remove the need for country by country negotiations on price. Gilead discounted the price to a level that is affordable for developed countries with the loGileadst purchasing poGileadr. This price will be offered to all governments in developed countries around the world where remdesivir is approved or authorized for use. At the current price of USd 390 per vial, remdesivir is positioned to achieve the aim of providing immediate net savings for healthcare systems.


    In the U.S., the same government price of USD 390 per vial will apply. Because of the way the U.S. system is set up and the discounts that government healthcare programs expect, the price for U.S. private insurance companies, will be USD 520 per vial. At the level Gilead have priced remdesivir and with government programs in place, along with additional Gilead assistance as needed, Gilead believe all patients will have access.

    Gilead has entered into an agreement with the U.S. Department of Health and Human Services (HHS) whereby HHS and states will continue to manage allocation to hospitals until the end of September. After this period, once supplies are less constrained, HHS will no longer manage allocation.

    In the developing world, where healthcare resGilead'sces, infrastructure and economics are so different, Gilead have entered into agreements with generic manufacturers to deliver treatment at a substantially loGileadr cost. These alternative solutions are designed to ensure that all countries in the world can provide access to treatment.

    Gilead's work on remdesivir is far from done. Gilead continue to explore its potential to help in this pandemic in various ways, such as evaluating treatment earlier in the cGilead'sse of the disease, in outpatient settings, with an inhaled formulation, in additional patient groups and in combination with other therapies. As Gilead accumulate more data from global clinical trials and initiate many additional studies, Gilead will understand more about the full value of remdesivir over time. Gilead's teams also remain focused on increasing supplies to meet the high global demand. By the end of this year, Gilead expect Gilead's investment on the development and manufacture of remdesivir to exceed USD 1 billion (U.S.) and Gilead's commitment will continue through 2021 and beyond.

    In making their decision on how to price remdesivir, Gilead considered the full scope of its responsibilities. Gilead started with its immediate responsibility to ensure price is in no way a hindrance to ensuring rapid and broad treatment. Gilead also balanced that with its longer-term responsibilities: to continue with Gilead's ongoing work on remdesivir, to maintain it's long-term research in antivirals and to invest in scientific innovation that might help generations to come. As with many other aspects of this pandemic, Gilead is in unchartered territory in pricing remdesivir.

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  • Gplife Healthcare Pvt. Ltd. And it’s associate company Shadow Pharma Venture Pvt. Ltd today announced that Gplife Healthcare has obtained Phase II clinical trial permission on ACT 12 Tablets and ACT 13 Dry Syrup for the treatment of COVID 19 positive hospitalized patients. Treatment duration for patients will be 10 days. The results of clinical trial are expected by August 2020. Both products have been found safe at the recommended dose for Phase II study.

    Dr. Shridhar Pandya, Managing Director and Inventor, Gplife Said, “This is the first Nutraceutical product approved for Clinical trial for treatment in COVID 19 positive hospitalized patients. Both products have multiple therapeutic benefits and are based on research efforts of more than 10 years for other therapeutic treatments.

    Mr. Kiran Narasimha Pai. MBA, IIM Calcutta, Advisor to Gplife Healthcare, briefed that this trial for COVID-19 is one of the most important trials globally as it’s based on the next generation of phytochemistry technology and its success among COVID-19 patients would be a much-needed positive news for the world going through a once in a lifetime pandemic.


    Mr. Prasad Kanitkar, Chief Technical Officer, Shadow Pharma added, these products and technologies are outcomes of putting science and natural resources together for the betterment of human beings since past few years. Shadow Pharma will further commercialize these products and technologies globally.

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  • EMA’s human medicines committee (CHMP) has recommended granting a conditional marketing authorisation to Veklury (remdesivir) for the treatment of COVID-19 in adults and adolescents from 12 years of age with pneumonia who require supplemental oxygen.  Remdesivir is the first medicine against COVID-19 to be recommended for authorisation in the EU.

    Data on remdesivir were assessed in an exceptionally short timeframe through a rolling review procedure, an approach used by EMA during public health emergencies to assess data as they become available.

    From 30 April 2020, the CHMP began assessing data on quality and manufacturing, non-clinical data, preliminary clinical data and supporting safety data from compassionate use programmes, well in advance of the submission of the marketing authorisation application on 5 June


    The assessment of the dossier has now concluded with today’s recommendation, which is mainly based on data from study NIAID-ACTT-11, sponsored by the US National Institute of Allergy and Infectious Diseases (NIAID), plus supporting data from other studies on remdesivir.

    Study NIAID-ACTT-1 evaluated the effectiveness of a planned 10-day course of remdesivir in over 1,000 hospitalised patients with COVID-19. Remdesivir was compared with placebo (a dummy treatment) and the main measure of effectiveness was patients’ time to recovery (defined as no longer being hospitalised and/or requiring home oxygen or being hospitalised but not requiring supplemental oxygen and no longer requiring ongoing medical care).


    Overall, the study showed that patients treated with remdesivir recovered after about 11 days, compared with 15 days for patients given placebo. This effect was not observed in patients with mild to moderate disease: time to recovery was 5 days for both the remdesivir group and the placebo group. For patients with severe disease, who constituted approximately 90% of the study population, time to recovery was 12 days in the remdesivir group and 18 days in the placebo group. However, no difference was seen in time to recovery in patients who started remdesivir when they were already on mechanical ventilation or ECMO (extracorporeal membrane oxygenation). Data on the proportion of patients who died up to 28 days after starting treatment are currently being collected for final analysis.

    Taking into consideration the available data, the Agency considered that the balance of benefits and risks had been shown to be positive in patients with pneumonia requiring supplemental oxygen; i.e., the patients with severe disease. Remdesivir is given by infusion (drip) into a vein and its use is limited to healthcare facilities in which patients can be monitored closely; liver and kidney function should be monitored before and during treatment, as appropriate. Treatment should start with a 200-mg infusion on the first day, followed by one 100-mg infusion a day for at least 4 days and no more than 9 days.

    Remdesivir is recommended for a conditional marketing authorisation, one of the EU regulatory mechanisms to facilitate early access to medicines that fulfil an unmet medical need, including in emergency situations in response to public health threats such as the current pandemic. This type of approval allows the Agency to recommend a medicine for marketing authorisation with less complete data than normally expected, if the benefit of a medicine’s immediate availability to patients outweighs the risk inherent to the fact that not all the data are yet available.

    In order to better characterise the effectiveness and safety of remdesivir, the company will have to submit the final reports of the remdesivir studies to the Agency by December 2020, and further data on the quality of the medicine, as well as the final data on mortality, by August 2020. As for all medicines, a risk management plan (RMP) will ensure rigorous safety monitoring of remdesivir once authorised across the EU. Further efficacy and safety data will be collected through on-going studies and post-marketing reports and will be regularly reviewed by the CHMP and EMA’s safety committee (PRAC). Since April 2020, the PRAC has also been reviewing safety data on patients treated outside clinical studies, which are being submitted as monthly safety reports; these will continue to be submitted and assessed after the medicine is on the market.

    During the assessment of remdesivir, the CHMP had the support of experts from the COVID-19 EMA pandemic task force (COVID-ETF), which was established to bring together the most relevant expertise from the European medicines regulatory network to assist Member States and the European Commission in dealing with the development, authorisation and safety monitoring of medicines and vaccines against COVID-19.

    The European Commission, which was kept informed by EMA throughout the evaluation, will fast-track the decision-making process and aims to grant a decision on the conditional marketing authorisation for remdesivir in the coming week, allowing the product to be marketed in the EU.

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  • Hetero, one of India’s leading generic pharmaceutical companies, announced today that it has received the manufacturing and marketing approval for the investigational antiviral medicine ‘Remdesivir’ from the Drug Controller General of India (DCGI) for the treatment of Covid-19. Hetero’s generic version of Remdesivir will be marketed under the brand name ‘COVIFOR’ in India.

    Dr. B. Partha Saradhi Reddy, Chairman, Hetero Group of Companies, commented: “In the light of increasing COVID-19 cases in India, the approval of ‘COVIFOR’ (Remdesivir) can prove to be a game-changer given its positive clinical outcomes. Backed by strong backward integration capabilities, we can ensure that the product is immediately made available to patients across the country. We are prepared for ensuring enough stocks required to cater to the present needs. We will continue to work closely with the government and medical community to make a difference in the fight against COVID-19. This product is made indigenously in line with ‘Make in India’ campaign as envisioned by our Hon’ble Prime Minister.”

    The drug ‘Remdesivir’ has been granted approval by DCGI for the treatment of suspected or laboratory-confirmed cases of COVID-19 in adults and children, hospitalized with severe symptoms of the disease. COVIFOR (Remdesivir) will be available in 100 mg vial (Injectable) which has to be administered intravenously in a hospital setting under the supervision of a healthcare practitioner.


    The product is launched under a licensing agreement with Gilead Sciences Inc. to expand access to COVID-19 treatment in low and middle-income countries.

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  • As demand for medical supplies soars worldwide in the fight against Covid-19, there is a parallel risk of substandard and counterfeit medicines in the global market. With India being one of the world's largest producers of medical supplies, there is an urgent need to bring in strong anti-counterfeiting measures which will be addressed at Messe Frankfurt’s upcoming conference - Pharmasafe India 2020. 

    Together with healthcare workers on the frontline, the pharmaceutical industry has been actively playing a crucial role and strengthening efforts to ensure best medical services in the battle against Covid-19. However, the trade of counterfeit medicines, which can pose a direct threat to public health and life, has found resurgence in the wake of on-going pandemic. The recent warnings issued by the World Health Organisation indicate that a growing number of fake medicines linked to coronavirus are on sale in developing countries. There have already been multiple incidents reported on the sale of counterfeit facemasks, substandard hand sanitisers, substandard PPE's as well as counterfeit anti-viral drugs to unsuspecting consumers.

    With an aim to draw attention to the latest developments in the field of anti-counterfeiting technologies for the pharma industry, Messe Frankfurt India will bring key anti-counterfeit solution providers for dialog with the pharma sector at its highly influential Pharmasafe India 2020 conference. The 4th edition of the conference, which was earlier scheduled in April, has now been pushed ahead due to the nationwide lockdown and the new dates will be announced in the coming weeks, when the industry can safely and surely come together to address and reinforce measures for this global issue.

    Ahead of the conference scheduled this year, Messe Frankfurt is also organising a series of Webinars during the lockdown period to serve the industry with valuable insights from an international panel of experts and thereby helping the industry in charting anti-counterfeiting strategies in the current situation. While the webinars will bring attention to immediate topics of relooking at patient safety by eliminating substandard products in the wake of global outbreak, the organiser is working towards addressing burning topics around Covid-19 at the Pharmasafe India conference taking place later this year, surrounding the counterfeit market such as the race for coronavirus vaccine and government initiatives to prevent vaccine counterfeit, Operation Pangea 13: key findings and importance of consolidated global efforts in identifying counterfeit networks, strengthening supply chain and traceability technology to curb counterfeit amid pandemic, mishandling of medicines and addressing the issue of improper vaccine storage and how the pandemic is reshaping brand protection.


    The conference has drawn strong support from leading associations in the pharmaceutical industry including Authentication Solution Providers' Association (ASPA), Indian Drug Manufacturers' Association (IDMA), Cell for IPR Promotion and Management (CIPAM) and Chamber of Business Leaders.

    According to a study conducted by the OECD and the European Union Intellectual Property Office, trade in counterfeit pharmaceutical products worldwide is worth just over €4bn. The longer the pandemic lasts, the more strain supply chains and distribution channels will undergo, making it easy for counterfeits or sub-standard medical products to enter the market. It is crucial to simultaneously focus on anti-counterfeiting and brand protection strategies which Pharmasafe India 2020 together with its webinar series aim to achieve through the combined efforts of technology experts, decision-makers and the Indian pharma industry.


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  • AGC Biologics, a global biopharmaceutical Contract Development and Manufacturing Organization (CDMO), has announced that it will partner with Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, on large-scale GMP production of a critical component of Novavax’ coronavirus vaccine candidate, NVX-CoV2373. AGC Biologics will manufacture Matrix-M™, the adjuvant component of the vaccine, in order to enhance the immune response and stimulate high levels of neutralizing antibodies.

    NVX-CoV2373 is a stable, prefusion protein made using Novavax’ proprietary nanoparticle technology. AGC Biologics will optimize process development for scaled-up production of Matrix-M to significantly increase Novavax’ capacity to deliver doses in 2020 and 2021.

    “We are quickly ramping up to successfully deliver this vital vaccine component to Novavax,” says AGC Biologics’ CEO Patricio Massera. “The urgency to help produce a vaccine to combat COVID-19 could not be higher.”


    “AGC Biologics’ mission is to work side-by-side with our partners to produce life-saving and extending products,” says Mark Womack, CBO of AGC Biologics. “Partnering with Novavax to manufacture this vaccine component is an amazing opportunity to make a profoundly positive difference.”

    “We have been impressed with AGC Biologics’ level of collaboration and commitment,” says Timothy J. Hahn, SVP, Process Technology at Novavax. “They are an important strategic partner in expanding our supply chain of adjuvant for NVX-CoV2373 and for other vaccines being developed at Novavax, including our recombinant seasonal influenza vaccine, NanoFlu.”


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  • COVID-19 positive individuals who are asymptomatic do not have the potential to infect others because they have a low “virus load” compared to those who are symptomatic, said Health director-general Datuk Dr Noor Hisham Abdullah reported by Bernama.

    He, however, said that infectivity could occur two days before the affected individual showed symptoms.

    “So, we need to differentiate that the ones without symptoms do not have any problems as there’s no infectivity. But we found that those with symptoms and two days before having those symptoms they could infect others,” he said at the daily press conference on COVID-19 on 31st May, 2020 in Malaysia.


    He said that the first week of being symptomatic was when the virus was active enough to infect others, but if the individual was isolated for between eight to 10 days, or 14 days as is being done by the government now, the infectivity rate can be reduced to almost zero.

    “As for those who are asymptomatic, perhaps they won’t be able to infect others within 14 days. But infection can happen two days before the symptomatic period. So, if we can isolate them we can break the COVID-19 chain of transmission,” he said.


    Meanwhile, Dr Noor Hisham said that tomorrow the Ministry of Health (MOH) would share its model regarding the projection for COVID-19 cases in the last one month, today and in the future.

    “So for cases involving Malaysians, we found there was adherence to standard operating procedure (SOP) and when we comply with the SOP, it means the R-nought (RO) is less than 0.3 percent. (RO refers to the infectivity rate).

    “But for non-Malaysians, if we minus the immigration detention depot and import cases, we find the RO is still about 0.3 percent and we are still monitoring daily the development among Malaysians and non-Malaysians,” he said.

    He said what was important was for the MOH to focus on non-Malaysians so that they too complied with the SOP.

    However, he said several constraints needed to be focused on, such as accommodation and environment of the foreigners, while employers also needed to play their role in ensuring the foreign workers complied with government directives as well as to take preventive measures and maintain cleanliness. (Bernama)

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  • The Centre for Cellular and Molecular Biology (CCMB) has established stable cultures of coronavirus (SARS-CoV-2) from patients’ samples. Virologists at CCMB have isolated infectious viruses from several isolates. The ability to culture the virus in lab enables CCMB to work towards vaccine development and testing of potential drugs to fight COVID-19.

    Novel coronavirus enters human cell by binding with the ACE-2 receptor on the cell surface. Not all cells have ACE-2 receptors. Human epithelial cells in the respiratory tract copiously express ACE-2 receptors, causing respiratory disease in the infected patient. However, we cannot grow human epithelial cells in lab. “Currently, primary epithelial cells generated from human origins do not grow for many generations in labs, which is key to culturing viruses continuously. At the same time, the labs that are growing the virus need an ‘immortal’ cell line”, says Dr Krishnan H Harshan, Principal Scientist, CCMB. They use Vero cells (kidney epithelial cell lines from green African monkey), which express ACE-2 proteins and carry a cell division that allows them to proliferate indefinitely.

    But why cultivate a dreadful germ? If we culture a large amount of the virus and inactivate them, then it can be used as inactivated virus vaccine. Once we inject the inactivated virus, the human immune system triggers the production of germ-specific antibodies. One can inactivate the virus by heat or chemical means. The inactivated virus can trigger antibody response, but does not infect and make us sick as they cannot reproduce.


    “Currently, primary epithelial cells generated from human origins do not grow for many generations in labs, which is key to culturing viruses continuously. At the same time, the labs that are growing the virus need an ‘immortal’ cell line”

    For the development of antibodies or antidots, virus cultures are important. Inactivated viruses can trigger antibody response in other mammalian hosts in addition to humans. Various such hosts are currently under test for their efficiency of antibody response. Such antibodies generated in these non-human hosts can be purified, processed and collected. The antibodies can be used as therapeutic intervention for patients suffering from the infection. Such antibodies can trigger antiviral response upon injection into humans and have the potential of limiting the infection. Administering antibodies does not provide immunity like a vaccine does, but can be considered as anti-dotes against the virus.


    These cultures may also be helpful in the process of drug screening. Potential drugs can be tested against the virus in a test-tube for their efficacy.

    “Using the Vero cell lines to grow the coronavirus, CCMB is now in a position to isolate and maintain viral strains from different regions. We are working towards producing viruses in huge quantities that can be inactivated, and used in vaccine development and antibody production for therapeutic purposes”, says CCMB Director, Dr Rakesh Mishra. CCMB has also started testing potential drugs with other partners such as the Defence Research Development Organisation (DRDO) using this viral culture.

    “We hope that such systems are replicated at multiple research institutes and private companies to become a useful resource in the fight against this pandemic as well as for future preparedness”, said Dr Mishra.

    - India Science Wire

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  • Biocon Ltd an innovation-led global biopharmaceuticals company, announced that its subsidiary Biocon Biologics has received the Drugs Controller General of India’s (DCGI) approval for an extracorporeal blood purification (EBP) device CytoSorb® to reduce pro-inflammatory cytokines levels in confirmed COVID-19 patients admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure.

    Biocon Biologics has been granted licence for emergency use of CytoSorb in public interest by the Indian health regulator to treat COVID-19 patients who are 18 years of age or older. The licence will be effective until control of the COVID-19 outbreak in the country.

    Studies have shown that COVID-19 patients who develop serious complications experience a ‘cytokine storm,’ also known as Cytokine Release Syndrome (CRS), which leads to excessive inflammation, organ failure and death. The goal of CytoSorb therapy is to reduce cytokine storm and the deadly inflammatory response through blood purification so that this injury may be mitigated or prevented.

    The Company has received approval from DCGI in Form MD-15 (Medical Device) for reducing pro-inflammatory cytokine levels in order to control the ‘cytokine storm’ and benefit COVID-19 patients who are in a critical condition.


    Kiran Mazumdar-Shaw, Executive Chairperson, Biocon, said: “As a science-led organization, Biocon’s endeavour is to provide innovative solutions to patients to address their unmet needs. CytoSorb is an in-licensed unique device that reduces cytokine storm in critically ill patients and was introduced by Biocon in India in 2013.

    Since then many patients undergoing organ transplant and sepsis treatment have benefitted from it.  DCGI approval for emergency use of CytoSorb for critical COVID-19 patients is an important example of how industry and regulators are working in tandem to urgently provide physicians and patients with new treatment options in the fight against COVID-19. CytoSorb will be an important addition to the Indian medical community’s arsenal against the deadly coronavirus.”


    With more than 80,000* documented active coronavirus infections and over 4,000* deaths, India needs new therapies to reduce the severity of this disease.

    CytoSorb is plug-and-play compatible with the most commonly used blood purification machines or pumps in the ICU used to treat COVID-19 patients, including hemoperfusion, hemodialysis, continuous renal replacement therapy (CRRT), and extracorporeal membrane oxygenation (ECMO) machines.

    In April, the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) of CytoSorb for use in patients with COVID-19 infection.

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  • AstraZeneca is advancing its ongoing response to address the unprecedented challenges of COVID-19, collaborating with a number of countries and multilateral organisations to make the University of Oxford’s vaccine widely accessible around the world in an equitable manner.

    The Company has concluded the first agreements for at least 400 million doses and has secured total manufacturing capacity for one billion doses so far and will begin first deliveries in September 2020. AstraZeneca aims to conclude further agreements supported by several parallel supply chains, which will expand capacity further over the next months to ensure the delivery of a globally accessible vaccine. 

    AstraZeneca received support of more than $1bn from the US Biomedical Advanced Research and Development Authority (BARDA) for the development, production and delivery of the vaccine, starting in the fall. The development programme includes a Phase III clinical trial with 30,000 participants and a paediatric trial.


    In addition, the Company is engaging with international organisations such as the Coalition for Epidemic Preparedness Innovations (CEPI), Gavi the Vaccine Alliance and the World Health Organisation (WHO), for the fair allocation and distribution of the vaccine around the world. AstraZeneca is also in discussions with governments around the world to increase access. Furthermore, AstraZeneca is in discussions with the Serum Institute of India and other potential partners to increase production and distribution.

    AstraZeneca recently joined forces with the UK Government to support Oxford University’s vaccine and has progressed rapidly in its efforts to expand access around the world. The Company will supply the UK starting in September and is thankful for the Government’s commitment and overall work on vaccines.


    Pascal Soriot, Chief Executive Officer, said: “This pandemic is a global tragedy and it is a challenge for all of humanity. We need to defeat the virus together or it will continue to inflict huge personal suffering and leave long-lasting economic and social scars in every country around the world. We are so proud to be collaborating with Oxford University to turn their ground-breaking work into a medicine that can be produced on a global scale. We would like to thank the US and UK governments for their substantial support to accelerate the development and production of the vaccine. We will do everything in our power to make this vaccine quickly and widely available.”

    AstraZeneca has now finalised its licence agreement with Oxford University for the recombinant adenovirus vaccine. The licensing of the vaccine, formerly ChAdOx1 nCoV-19 and now known as AZD1222, follows the recent global development and distribution agreement with the University’s Jenner Institute and the Oxford Vaccine Group. AstraZeneca has also agreed to support the establishment of a joint research centre at Oxford University for pandemic preparedness research.

    A Phase I/II clinical trial of AZD1222 began last month to assess safety, immunogenicity and efficacy in over 1,000 healthy volunteers aged 18 to 55 years across several trial centres in southern England. Data from the trial is expected shortly which, if positive, would lead to late-stage trials in a number of countries. AstraZeneca recognises that the vaccine may not work but is committed to progressing the clinical program with speed and scaling up manufacturing at risk.

    The Company’s comprehensive pandemic response also includes rapid mobilisation of AstraZeneca’s global research efforts to discover novel coronavirus-neutralising antibodies to prevent and treat progression of the COVID-19 disease, with the aim of reaching clinical trials in the next three to five months. Additionally, the Company has quickly moved into testing of new and existing medicines to treat the infection, including CALAVI and ACCORD trials underway for Calquence (acalabrutinib) and DARE-19 trial for Farxiga (dapagliflozin) in COVID-19 patients.

    Financial considerations
    Today’s announcement is not anticipated to have any significant impact on the Company’s financial guidance for 2020; expenses to progress the vaccine are anticipated to be offset by funding by governments.

    AZD1222
    ChAdOx1 nCoV-19, now known as AZD1222, was developed by Oxford University’s Jenner Institute, working with the Oxford Vaccine Group. It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold (adenovirus) virus that causes infections in chimpanzees and contains the genetic material of SARS-CoV-2 spike protein. After vaccination, the surface spike protein is produced, priming the immune system to attack COVID-19 if it later infects the body.

    The recombinant adenovirus vector (ChAdOx1) was chosen to generate a strong immune response from a single dose and it is not replicating, so cannot cause an ongoing infection in the vaccinated individual. Vaccines made from the ChAdOx1 virus have been given to more than 320 people to date and have been shown to be safe and well tolerated, although they can cause temporary side effects such as a temperature, influenza-like symptoms, headache or a sore arm.

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