Sputnik V demonstrates 94.8% efficacy against COVID during the vaccination in San Marino
The Russian Direct Investment Fund (RDIF) announces the real world data of the Ministry of Health of San Marino on the Russian Sputnik V coronavirus vaccine confirming its high efficacy during the vaccination campaign in the country including against new variants of COVID.
The efficacy of Sputnik V was measured based on the monitoring of COVID cases between 25 February and 23 August, 2021. Overall efficacy over 21 days after administering the first dose was estimated at 94.8% while efficacy against hospitalizations estimated at 95.9%. Sputnik V is the most efficient vaccine against hospitalizations with COVID-19 in the country.
San Marino was the first country in Europe to defeat COVID and lift restrictions thanks to inclusion of Sputnik V in the national portfolio. Over 70% of the adult population has been vaccinated with Sputnik V.
The Russian vaccine is demonstrating high safety profile with data published in EClinicalMedicine (an open access clinical journal published by The Lancet, one of the world’s most respected medical journals). In particular, Sputnik V shows high tolerability profile in ≥60 age group with nearly all reported adverse events following immunization being mild or moderate and lasting less than 2 days.
Sputnik V has a number of key advantages:
Efficacy of Sputnik V is 97.6% based on the analysis of data on the coronavirus infection rate among those in Russia vaccinated with both components of Sputnik V from December 5, 2020 to March 31, 2021;
The Sputnik V vaccine is based on a proven and well-studied platform of human adenoviral vectors, which cause the common cold and have been around for thousands of years.
Sputnik V has pioneered the use of heterogeneous boosting (two different vectors for the two shots in a course of vaccination among COVID vaccines). This approach provides for immunity with a longer duration than vaccines using the same delivery mechanism for both shots.
The safety, efficacy and lack of negative long-term effects of adenoviral vaccines have been proven by more than 250 clinical studies over two decades.
There are no strong allergies caused by Sputnik V.
In October 2020, the Federal Service for Veterinary and Phytosanitary Surveillance (Rosselkhoznadzor) announced that from January 1, 2021, the Rules of Good Manufacturing Practice of the Eurasian Economic Union, approved by the Resolution of the Council of the Eurasian Economic Commission of November 3, 2016 No. 77, will come into force, in relation to medicinal products for veterinary use. Compliance with these Rules will be taken into account when issuing permits (licenses) to manufacturers of medicinal products for animals for these activities, as well as when inspecting them . In this short overview, we’ll look at some of the articles, presentations and documents that veterinary manufacturers may find useful. EAEU GMP rules The text of the Rules of Good Manufacturing Practice of the Eurasian Economic Union (the EAEU GMP Rules) is published on the website of the Eurasian Economic Commission (EEC) in the section “Resolutions of the Council of the Eurasian Economic Commission” . The EAEU GMP rules were approved in 2016. They entered into force in 2017, with the exception of the provisions of these Rules concerning the requirements for the production of veterinary medicinal products. The requirements of the EAEU GMP Rules for the manufacture of veterinary medicinal […]
AstraZeneca has entered into a collaboration with Regeneron to research, develop and commercialise small molecule compounds directed against the GPR75 target with the potential to treat obesity and related co-morbidities. The companies will evenly split research and development costs and share equally in any future potential profits. As published in Science, the new target was found by sequencing nearly 650,000 people and identifying individuals with rare protective mutations. Individuals with at least one inactive copy of the GPR75 gene had lower body mass index (BMI) and, on average, tended to weigh about 12 pounds less and faced a 54% lower risk of obesity than those without the mutation.1 Strong associations were also seen with improvements in diabetes parameters, including glucose lowering.1 Obesity and insulin resistance are key drivers in the development of type-2 diabetes and often lead to cardiorenal complications, as well as liver disease. Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: We are pleased to announce this important collaboration with Regeneron to identify small molecule modulators against GPR75, a newly identified target with genetic validation in metabolic disorders. Obesity and insulin resistance remain key drivers in the development of type-2 diabetes and areas of significant unmet medical […]
This article provides information on French manufacturers of veterinary medicines and the French Agency for Veterinary Medicinal Products (ANMV). In addition, the article summarizes the results of an inspection of French manufacturers for compliance with the requirements of the Good Manufacturing Practice (GMP), which were conducted in 2017-2020 by specialists of the Federal State Budgetary Institution “The All-Russian State Center for Quality and Standardization of Veterinary Drugs and Feed” (FSBI “VGNKI”) subordinated to Rosselkhoznadzor. French manufacturers of medicines for animals According to the French Association for Animal Health Industry (SIMV), France is the European leader in research and manufacture of veterinary medicines and reagents, with over 6,700 employees, and the largest therapeutic arsenal in Europe (2,700 marketing authorizations). Furthermore, two in every three medicines produced in France are exported . France offers products and services for the prevention and treatment of diseases affecting farm animals (cattle, pigs, sheep, poultry), pets (dogs, cats, horses), and wildlife (foxes, raccoons). In addition, veterinary autogenous vaccines are produced in France. Autogenous vaccine is a vaccine prepared using microorganisms which have been isolated from the same infected animal to which it is then administered. Autogenous vaccines regulation is defined in the Public Health Code and […]
Crohn’s disease and ulcerative colitis are severe chronic bowel diseases for which there are no effective drugs yet. The main approach in their therapy is to take drugs that reduce inflammation and restore the intestinal mucosa. At the same time, there are still no funds on the market that can gradually release an active substance inside the body, which could significantly increase the effectiveness of therapy. Under the leadership of the Federal State Budgetary Institution “CSP” of the FMBA of Russia, scientists from the N.N. DI Mendeleev developed a technology for obtaining such a dosage form: they created enteric capsules containing a biopolymer complex that releases an active substance at a controlled rate, which ensures a prolonged action and high bioavailability of the drug. Crohn’s disease and ulcerative colitis are severe chronic inflammatory bowel diseases of a non-infectious nature. According to statistics, they affect more than 23 million people around the world, while the frequency of detection of these diseases is increasing every year, and most often they are sick in developed countries and regions with a high level of urbanization. The exact figures for Russia are unknown, but according to various estimates, the prevalence of ulcerative colitis and Crohn’s […]
ISPE announced the release of its latest Guide, ISPE Good Practice Guide: Knowledge Management in the Pharmaceutical Industry. The Guide focuses on how Knowledge Management (KM) can enable a more effective Pharmaceutical Quality System (PQS).
The R&D centre is tasked to optimise its substance manufacturing process and develop new unique molecules. The complex has modern and high-precision equipment that allows to: optimise technologies for synthesising generic drugs, develop synthesis methods and produce substance samples for clinical and preclinical studies, validate analytical procedures to control the quality of active pharmaceutical ingredients. The laboratory is also unique since it is in touch with production, which allows transferring laboratory scale developments faster to the industrial level. It is also possible to carry out advanced multi-stage syntheses, which helps reduce substance prices and import dependence. More than 20 synthetic chemists, analytical chemists and operators work in the laboratory that is in active search for personnel and recruitment.
The European Investment Bank (EIB) and Univercells S.A (Univercells) have signed a €30 million loan agreement to enable the production of large volumes of prophylactic COVID-19 vaccines in a new facility and to co-develop a pipeline of COVID-19 vaccines. This facility will address the unprecedented global demand for vaccines brought on by the COVID-19 pandemic. The partnership backs Univercells’s Belgian hub, strengthening pandemic resilience in Europe and supporting global manufacturing autonomy through Univercells’ efforts to launching new production sites around the world based on the company’s innovative biomanufacturing technology. In collaboration with the European Commission, the EIB Group is on its way to mobilising billions for the COVID-19 response, which it kicked off as soon as the crisis hit to tackle the global health emergency and the economic consequences of the COVID-19 pandemic. The InnovFin Infectious Diseases Finance Facility (IDFF) was scaled up at the beginning of the outbreak to directly support highly innovative projects that work towards halting the spread of the virus. The programme helps biotech and medtech companies across Europe find solutions for vaccines, cures and diagnostics. The new venture debt to Univercells backed by the IDFF adds to a previous €20 million operation under the programme […]
An efficacy study was conducted in Bahrain in accordance with WHO guidelines involving more than 5,000 subjects. Overall efficacy beyond 14 days after administering the second dose was estimated at 94.3%.
The Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund) and Panacea Biotec, one of the leading vaccine and pharmaceutical producers in India, today announced the launch of production of the Russian Sputnik V vaccine against coronavirus. The first batch produced at Panacea Biotec’s facilities at Baddi will be shipped to the Gamaleya Center for quality control. Full-scale production of the vaccine is due to start this summer. Company’s facilities comply with GMP standards and are prequalified by WHO. Sputnik V was registered in India under the emergency use authorization procedure on April 12, 2021 and vaccination against coronavirus with the Russian vaccine started on May 14. As announced in April, RDIF and Panacea have agreed to produce 100 million doses per year of Sputnik V. To date Sputnik V has been registered in 66 countries globally with total population of over 3.2 billion people. Efficacy of Sputnik V is 97.6% based on the analysis of data on coronavirus infection rate among those in Russia vaccinated with both components of Sputnik V from December 5, 2020 to March 31, 2021. The vaccine is based on a proven and well-studied platform of human adenoviral vectors and uses two different vectors for […]
The Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund) today announced the Russian single-component Sputnik Light vaccine against coronavirus has been approved by the Ministry of Health of the Republic of Armenia. Sputnik Light vaccine based on human adenovirus serotype 26 is the first component of the Sputnik V vaccine. Immunization with Sputnik Light will help Armenia to significantly reduce the infection rate in the country and create herd immunity in a short time frame. In February 2021 the two-dose Sputnik V vaccine was also approved in Armenia. Sputnik Light is safe and highly effective as demonstrated by the real-world vaccination data in a number countries. In particular, the data from the Ministry of Health of the Buenos Aires province (Argentina) shows 78.6-83.7% efficacy among the elderly. In Paraguay Sputnik Light is 93.5% effective during the ongoing vaccination campaign according to the country’s Ministry of Health. Thanks to its safety and efficacy, single-component Sputnik Light vaccine is now both used on standalone basis and also studied in combination with vaccines from other producers in a number of countries. The heterogeneous boosting approach (“vaccine cocktail” using human adenovirus serotype 26 as the first component and human adenovirus serotype 5 as […]
Production of Moderna COVID-19 vaccines at a plant in Spain can continue, the European Union drugs regulator said on Friday, while it carries out its investigation of a suspected metallic contamination incident.
The 67,000-square-foot facility, located on Thermo Fisher’s Carlsbad campus, is part of an investment strategy to ensure customers can reliably meet growing global demand for cell and gene therapies and vaccines.
Interleukin-6 blocking drugs – tocilizumab and sarilumab – act to suppress this overreaction. WHO has launched an expression of interest for prequalification of manufacturers of interleukin-6 receptor blockers.
A Wuhan-based affiliate of China National Pharmaceutical Group (Sinopharm) said the start of operations at a new factory will raise the annual production capacity of its COVID-19 vaccine to at least 1 billion doses.
Vladimir Rusinov, the Head of the Laboratory of Organic Synthesis of Ural Federal University, Corresponding Member of RAS, one of the creators of Triazavirin, told Rossiyskaya Gazeta why scientists have not yet invented a pill against coronavirus, how scientists managed to create vaccines against Covid pretty quickly and in what direction scientists are working now. The virus is mutating rapidly, right before our eyes: more than a dozen strains have already appeared since the pandemic began. It is incredibly difficult to catch up with it. Scientists can for a long time select a compound that will bind to the viral protein of a certain structure, but during mutation its structure may change, and the virus will become resistant to the drug, Vladimir Rusinov explained why scientists have not yet invented a cure for coronavirus. Moreover, the virus is not a cell, but an RNA particle covered with a protein shell, the chemist explains. The purpose of the virus is to penetrate into our cell at all costs, use it as an incubator for its own reproduction, and eventually kill the cell itself. Then break out and continue destroying other cells. Today, there are no drugs that specifically and invasively attack […]
The Heads of the World Bank Group, International Monetary Fund, World Health Organization, and World Trade Organization today convened for the first meeting of the Task Force on COVID-19 Vaccines, Therapeutics and Diagnostics for Developing Countries. They issued the following joint statement: “As many countries are struggling with new variants and a third wave of COVID-19 infections, accelerating access to vaccines becomes even more critical to ending the pandemic everywhere and achieving broad-based growth. We are deeply concerned about the limited vaccines, therapeutics, diagnostics, and support for deliveries available to developing countries. Urgent action is needed now to arrest the rising human toll due to the pandemic, and to halt further divergence in the economic recovery between advanced economies and the rest. We have formed a Task Force, as a “war room” to help track, coordinate and advance delivery of COVID-19 health tools to developing countries and to mobilize relevant stakeholders and national leaders to remove critical roadblocks—in support of the priorities set out by World Bank Group, IMF, WHO, and WTO including in the joint statements of June 1 and June 3, and in the IMF staff’s $50 billion proposal. At today’s first meeting, we discussed the urgency of increasing supplies of vaccines, […]
Johnson & Johnson has shaken off another lingering liability claim in the US, agreeing a $263 million settlement with New York to resolve lawsuits focused on its role in the US opioid crisis. The last-ditch agreement over the weekend means that a jury trial due to start today will now go ahead without J&J, although other defendants will still be in the spotlight. J&J also said in a statement that it committed to exiting its opioid painkiller business altogether last year. While the company didn’t provide finished opioid drugs, J&J supplied raw materials used to make them, and has been accused by various US states of using deceptive marketing to say the drugs were effective for treating pain and were unlikely to cause addiction. The settlement relates to its marketing and promotion of Duragesic (fentanyl), Nucynta (tapentadol) and Nucynta ER products, which are no lomger on sale in the US. The opioid epidemic has wreaked havoc on countless communities across New York state and the rest of the nation, leaving millions still addicted to dangerous and deadly opioids, – said NY attorney general Letitia James, – Johnson & Johnson helped fuel this fire, but today they’re committing to leaving the opioid business […]
The U.S. Food and Drug Administration has approved Pfizer Inc.’s (PFE) PREVNAR 20 or Pneumococcal 20-valent Conjugate Vaccine for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae or pneumococcus serotypes in the vaccine in adults ages 18 years and older.
China has provided more than 480 million doses of COVID-19 vaccines to the world, a Chinese Foreign Ministry spokesperson said here Friday. Wang Wenbin said China is a firm believer in making COVID-19 vaccines a public good, and has provided the most vaccines to the world. He said China so far has provided vaccines to nearly 100 countries, and announced that it has pledged to provide the first batch of 10 million doses of vaccines to COVAX. Chinese vaccines are the first batch of vaccines obtained by many developing countries. China has carried out joint research and development and cooperative production with many developing countries, and supported relevant companies to cooperate with foreign parties in conducting the phase III clinical trials, Wang said. He said the Chinese vaccines have gained a good reputation in the international community, adding that the safety and effectiveness of Chinese vaccines have been widely recognized. “At present, more than 100 countries have approved the use of Chinese vaccines. The WHO has included China’s Sinopharm and Sinovac vaccines in the emergency use list,” Wang said, adding that more than 30 foreign leaders took the lead in taking Chinese vaccines. Pledging that China will continue to contribute […]
Today, the domestic COVID-19 vaccine QazVac has been officially registered in the Kyrgyz Republic! The Ministry of Health and Social Development of the Kyrgyz Republic issued a registration certificate (KG.1.11159.08560-2021) on the state registration of the COVID-19 vaccine QazVac.
Isotope JSC (a part of Rusatom Healthcare JSC, Rosatom’s radiation technologies integrator) has signed a five-year contract with Brazil’s Nuclear and Energy Research Institute (IPEN; linked to the National Nuclear Energy Commission or CNEN) to supply lutetium-177 and actinium-225, the most promising medical isotopes in radiopharma. A long-term contract for monthly supplies of 177Lu-trichloride carrier-added became possible following a successful registration of lutetium-177 manufactured by INM JSC and approval of the Russian-made radioisotope for further registration of radiopharmaceutical DOT-IPEN-177 produced by IPEN/CNEN by the Brazilian National Health Surveillance Agency (Anvisa). The contract strengthens ROSATOM’s standing as the leading supplier of radioisotopes to the Latin American markets. This contract is the result of many years of meticulous work on both sides. It is of great social importance as it opens up new possibilities for the treatment of thousands of patients. With its unique technological base of research reactors, ROSATOM State Corporation produces the widest range of medical isotopes. One of the key tasks of Rusatom Healthcare and Isotope JSC is to increase the availability of radionuclide products which are the foundation of Nuclear Medicine. Collaboration with IPEN-CNEN is an example of international cooperation aimed to introduce high technologies to cancer treatment […]
German biotechnology company BioNTech SE, based in Mainz, and Siemens intend to expand their strategic cooperation. The companies plan to intensify their collaboration for the rapid expansion and creation of production capacity for the Covid-19 vaccine. BioNTech has expressed its aim of establishing new production sites for Covid-19 vaccine production worldwide based on the Marburg plant and its technology, starting with a production facility in Singapore. In Marburg, BioNTech has converted an existing plant into a vaccine production facility with support from Siemens in just five months. Within this cooperation, Siemens will provide the latest automation and digitalization technologies for BioNTech production sites, such as design, simulation, and engineering software as well as process control technology.
Sanofi and GSK started enrollment in their Phase 3 clinical study to assess the safety, efficacy, and immunogenicity of their adjuvanted recombinant-protein COVID-19 vaccine candidate. The global, randomized, double-blind placebo-controlled Phase 3 study will include more than 35,000 volunteers aged 18 and older from several countries, including sites in the US, Asia, Africa, and Latin America. The primary endpoint of the study is the prevention of symptomatic COVID-19 in SARS-CoV-2 naïve adults, with secondary endpoints being the prevention of severe COVID-19 disease and prevention of asymptomatic infection. In a two-stage approach, the study will initially investigate the efficacy of a vaccine formulation targeting the original D.614 virus (Wuhan), while a second stage will evaluate a second formulation targeting the B.1.351 (South African) variant. Recent scientific evidence1 shows that antibodies created against the B.1.351 variant may provide broad cross-protection against other more transmissible variants. The design of the Phase 3, conducted across a broad diversity of geographies, also allows evaluation of the efficacy of the candidate against a variety of circulating variants. Following encouraging interim results from the recent Phase 2 study, the companies will also begin clinical studies in the coming weeks to assess the ability of the adjuvanted recombinant-protein […]
Human Vaccine LLC, a wholly owned subsidiary of the Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund) announces the signing of an agreement for the supply of 220 million doses of two-dose Sputnik V Russian COVID-19 vaccine with the United Nations International Children’s Emergency Fund (UNICEF). This amount is sufficient to vaccinate 110 million people. The supply agreement with UNICEF for Sputnik V vaccine will broaden access to help meet vaccine demand around the world. Procurement and delivery of the vaccine by UNICEF is subject to the vaccine receiving WHO Emergency Use Listing. The decision is expected soon on the Sputnik V application for WHO Emergency Use Listing that was submitted in October 2020. Concurrently, RDIF will be holding a separate discussion with Gavi, the Vaccine Alliance to see the Sputnik V vaccine considered for inclusion in the COVAX Facility’s Portfolio of COVID-19 vaccines. The COVAX Facility (co-led by Gavi, the Coalition for Epidemic Preparedness Innovations (CEPI) and WHO) together with UNICEF aims to help end the acute phase of the global pandemic by the end of 2021 by providing rapid, fair and equitable access to safe and effective vaccines to all participating countries and territories regardless of income level, thus enabling […]
An application for the registration of the anti-COVID vaccine EpiVacCorona-N has been submitted to the Russian Health Ministry for registration, as follows from a post uploaded to the state register of medicines. Earlier, the CEO of the State Research Center of Virology and Biotechnology Vector, Rinat Maksyutov, said there were no fundamental distinctions between EpiVacCorona-N and the previous version EpiVacCorona. EpiVacCorona, developed at the State Research Center of Virology and Biotechnology Vector, was a second vaccine to have been registered in Russia. The registration certificate was issued on October 14, 2020. About a month later the vaccine’s developers were given permission to conduct post-registration research in different groups of patients, including elderly people.
Russia should minimize its dependence on imports of ready-made medicines and pharmaceutical substances, Russian Deputy Prime Minister Tatyana Golikova said on Thursday. /TASS/ “In 2020, we updated the list of drugs strategically important for the country, the production of which should be in a full cycle [created within Russia — TASS]<…> The pace [of production] is important here. Of course, the production of cardiovascular and oncological drugs means long cycles of preclinical and clinical trials, but our work with vaccines has shown that we know how we can, and so we must. We must minimize our country’s dependence on imports <…> both on foreign pharmaceutical substances and on ready-made medicines,” she said at the final board of the Industry and Trade Ministry. Golikova recalled that in 2020, the government updated the list of 215 strategically important drugs, the production of which should be fully located in the country. By 2024-2025, a full production cycle in Russia should be provided for 65% of such drugs, by 2030 — for 80%, the Deputy Prime Minister emphasized. “These are mainly painkillers, cardiovascular and oncological drugs <…>”, Golikova specified.
Presidential Decree UP-No. 6221 of 5 May 2021 has introduced a registration recognition procedure for medical devices from June 1, 2021. Medical devices that have been registered with the following foreign organizations shall be subject to the recognition procedure: Food and Drug Administration (FDA), USA. Bodies authorized to issue the European Certificate of Conformity (CE), European Union. European Medicines Agency (EMA), European Union. Pharmaceuticals and Medical Devices Agency (PMDA), Japan. Ministry of Food and Drug Safety (MFDS), Republic of Korea. Medicine and Healthcare Products Regulatory Agency (MHRA), United Kingdom. Medical devices certified under the requirements of the above organizations during the state registration in the Republic of Uzbekistan, shall not be tested in vitro and shall be duly registered no later than fifteen working days. Also, the State Customs Committee (Azimov M. B.), together with the Pharmaceutics Development Agency, the Uzstandard Agency, the Commissioner for the Protection of the Rights and Legitimate Interests of Business Entities and the Chamber of Commerce and Industry, shall establish permanent control over the import of medical devices and their components provided for in this paragraph, without allowing unnecessary barriers.
Philip Morris International Inc. announced it has entered into an agreement to acquire Fertin Pharma A/S (Fertin Pharma), a leading developer and manufacturer of innovative pharmaceutical and well-being products based on oral and intra-oral delivery systems, for an enterprise value of DKK 5.1 billion (approximately USD 820 million). “The acquisition of Fertin Pharma will be a significant step forward on our journey toward delivering a smoke-free future—enhancing our smoke-free portfolio, notably in modern oral, and accelerating our progress in beyond nicotine,” stated Jacek Olczak, Chief Executive Officer. “Both PMI and Fertin share a commitment to science and consumer-centric innovations for better living, and I am delighted we have reached this agreement. Fertin’s diverse portfolio of technologies, evolving business mix, and world-class expertise will enrich our innovation pipeline and capabilities, providing speed and scale in oral delivery to support our 2025 goals of generating more than 50% of our net revenues from smoke-free products and at least USD 1 billion from products beyond nicotine.” Fertin Pharma is a privately held company with more than 850 employees and operations in Denmark, Canada, and India. It is a leading contract development and manufacturing organization (CDMO), specializing in the research, development and production of […]
When an epidemic of smallpox came to the English village of Yetminster in 1774, Benjamin Jesty vaccinated his family with cowpox, and later Peter Plett repeated this experiment. The first known vaccines were developed in 1796, when Edward Jenner after finding a case of cowpox in a dairy maid collected matter from her pustules and inoculated an 8-year-old boy. In the 1870-80s, Louis Pasteur developed the first vaccines for anthrax and rabies. Autogenous vaccine (prepared from the bacteria harbored by the patient) was first introduced by Sir Almroth Edward Wright in 1903. In the following years, several case reports were published regarding the preparation and indications of autogenous vaccines. This article is dedicated to veterinary autogenous vaccines used to treat various animal infections. Important role of veterinary autogenous vaccines Today, autogenous vaccines play a much more important role than simply “filling the gap” where there are no commercial products currently available. They play a vital role in preventative health management programs, allowing veterinarians to stay close to the farm, better understand the existing disease status and as a result reduce the need for emergency treatments. This is particularly vital to ensure that antibiotics remain effective and available for use when […]
EMA’s safety committee (PRAC) has concluded that people who have previously had capillary leak syndrome must not be vaccinated with Vaxzevria (formerly COVID-19 Vaccine AstraZeneca). The Committee also concluded that capillary leak syndrome should be added to the product information as a new side effect of the vaccine, together with a warning to raise awareness among healthcare professionals and patients of this risk. The Committee carried out an in-depth review of 6 cases of capillary leak syndrome in people who had received Vaxzevria.1 Most of the cases occurred in women and within 4 days of vaccination. Three of those affected had a history of capillary leak syndrome and one of them subsequently died. As of 27 May 2021, more than 78 million doses of Vaxzevria had been administered in the EU/EEA and the UK.2 Healthcare professionals should be aware of the signs and symptoms of capillary leak syndrome and of its risk of recurrence in people who have previously been diagnosed with the condition. People who have been vaccinated with Vaxzevria should seek immediate medical assistance if they experience rapid swelling of the arms and legs or sudden weight gain in the days following vaccination. These symptoms are often associated […]
Parliament wants to strengthen the transparency of both the Agency and all actors in the supply chain, and give a more active role to healthcare professionals, as well as encouraging synergies between EU agencies.
Young scientists from NUST MISIS have presented multilayer antibacterial coatings with a prolonged effect and a universal spectrum of action. The coating is based on modified titanium oxide and several antiseptic components. The coatings can be used in modern implantology as a protective layer for the prevention of concomitant complications – inflammation or implant rejection. The results of the work have been published in the international scientific journal Applied Surface Science. Antibacterial coatings are currently being actively researched, as the search for alternatives to traditional antibiotics is growing. They can be applied to implants, thereby preventing inflammation caused by nosocomial infections. Nevertheless, the creation of antibacterial, but at the same time biocompatible and bioactive surfaces is a problem that the scientific community has been solving for many years, and the “dream materials” have not been developed. Young scientists from the NUST MISIS Laboratory of Inorganic Nanomaterials have created an innovative multilayer coating that synthesizes the protective properties of nanoparticles, biopolymers, anticoagulants and antibiotics. The antibiotic and silver nanoparticles provide an antibacterial effect, while heparin prevents bacterial cells from sticking to the tissue surface, which reduces the amount of antibacterial agent required. The method of obtaining a multilayer coating is a […]
A COVID-19 vaccine developed by a unit of China’s Chongqing Zhifei Biological Products (Zhifei) showed an 81.76% efficacy rate against COVID-19 cases of any degree of severity in a large, late-stage trial, Zhifei said on Friday.
Sai Life Sciences, a leading global Contract Research, Development & Manufacturing Organization (CRO-CDMO), announced the opening of a new biology facility at its integrated R&D campus in Hyderabad, India. The facility marks an important milestone in the journey of positioning itself as a differentiated player in Discovery Biology. Making the announcement, CEO & Managing Director of Sai Life Sciences, Krishna Kanumuri said, The new facility marks the culmination of a journey we began two years ago, of creating differentiated value for our discovery clients through an integrated delivery model across Boston and Hyderabad. Continuing with the company’s aggressive growth in its biology services, the new state-of-the-art facility houses expanded in vitro and in vivo biology services, DMPK, toxicology and a vivarium. In this new facility Sai Life Sciences is augmenting both, its capabilities and capacity, to deploy cutting-edge platforms and technologies for accelerating integrated drug discovery programs. Boston-Hyderabad integrated delivery model Sai Life Sciences has been steadily growing its biology capabilities to complement its strong foundation in medicinal chemistry, DMPK and toxicology for supporting its customers across the entire drug discovery journey from target ID and validation to IND. In 2019, the company opened its first international R&D facility with […]
The factory, which will be located on a 42 hectare greenfield site is planned to be operational by 2023, will be run by Recipharm and will mirror the company’s new fill finish line at its facility in Monts, France on a larger scale.
Novavax, Inc., a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced enrollment of the first participants in a Phase 1/2 study to evaluate the safety and immunogenicity of a combination vaccine using Novavax’ seasonal influenza and COVID-19 vaccines. The clinical trial combines Novavax’ recombinant protein-based NVX-CoV2373 and NanoFlu™ vaccine candidates and patented saponin-based Matrix-M™ adjuvant in a single formulation (COVID-NanoFlu Combination Vaccine). Both NVX-CoV2373 and NanoFlu have previously demonstrated strong results as standalone vaccines in Phase 3 clinical trials. “This study is the first-of-its-kind to evaluate the vaccine’s potential to induce a robust immune response, augmented by our Matrix-M adjuvant, against two life-threatening diseases simultaneously,” said Gregory M. Glenn, M.D., President of Research and Development, Novavax. “The combination of these two vaccines, which have individually delivered outstanding results with favorable safety and tolerability profiles, may lead to greater efficiencies for the healthcare system and achieve high levels of protection against COVID-19 and influenza with a single regimen.” The trial will evaluate the safety, tolerability and immune response to NanoFlu formulated together with NVX-CoV2373 and Matrix-M adjuvant in 640 healthy adults 50 to 70 years of age. Participants will have been either previously infected with the […]
Cuba will supply large quantities of its home-grown COVID-19 vaccine, Abdala, to Vietnam and also transfer the production technology to the Southeast Asian country by the end of the year, the Vietnamese health ministry said on Tuesday.
The Chumakov Center plans to double the production of the CoviVac whole-virion vaccine against the coronavirus to 2.5 mln doses per month in October 2021, Director General Aidar Ishmukhametov said in an interview aired by the Rossiya-24 TV news channel on Tuesday, TASS reports. We spoke for three months about the technical upgrade we expected, and finally, we received reactors two weeks ago. Two reactors mean a breakthrough for us, a principal modernization. We managed to install them properly. Basically, we will use them for the first time since the creation of the vaccine as early as the end of this week. We suggest that we will be able to plan at least a doubling of the production to 2.5 mln [doses of CoviVac vaccine] per month starting October. It will be clear at the end of September. The inactivated whole-virion CoviVac vaccine was developed by the Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences (known as the Chumakov Center) was registered with the Russian Health Ministry on February 19. Whole-virion vaccines are based either on artificially weakened viruses incapable of causing a disease or killed (inactivated) viruses. Four coronavirus vaccines have […]
European Union approval of Russia’s Sputnik V coronavirus vaccine will be delayed because a June 10 deadline to submit data was missed, two people familiar with the matter told Reuters, diminishing the shot’s prospects in the EU’s pandemic response, – reports Reuters One of the sources, a German government official, said the failure to provide the necessary clinical trial data to the EU medicines watchdog would postpone any go-ahead in the bloc until at least September. “Approval of Sputnik will be delayed probably until September, maybe until the end of the year,” the official said, speaking on condition of anonymity. The European Medicines Agency (EMA) had previously been expected to conclude its review of the Russian vaccine and issue a decision in May or June. A second source said the June 10 cut-off date not been met and that EMA had given the vaccine’s developer, Russia’s Gamaleya Institute, another week to file the required data. The Russian Direct Investment Fund (RDIF), which markets the vaccine, said the EMA review was on track. “All of the information on the Sputnik V vaccine clinical trials has been provided and GCP (General Clinical Practice) review has been completed with positive feedback from the […]
This Combination Vaccine May Simplify Execution and Reduce Shots Needed to Complete CDC’s Recommended Child and Adolescent Immunization Schedule VAXELIS™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine), developed as part of a U.S.-based partnership between Merck, known as MSD outside the United States and Canada, and Sanofi Pasteur, the global vaccines business unit of Sanofi, is now available in the U.S. VAXELIS is the first and only hexavalent (six-in-one) combination vaccine available in the U.S. indicated for active immunization to help prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type b. VAXELIS is approved for use as a 3-dose series in children 6 weeks through 4 years of age (prior to the 5th birthday). Given the potential to reduce the number of shots by as many as three in the first six months of life, as compared to pentavalent vaccines plus hepatitis B or Haemophilus influenzae type b vaccines, VAXELIS represents an important option for healthcare professionals and parents, – said Joanne Monahan, senior vice president, U.S. Vaccines, Merck. – Merck and Sanofi have been in contact with the major insurers and the appropriate pricing […]
Walmart announced the launch of the first-ever private brand analog insulin, which will revolutionize the access and affordability to diabetes care by offering customers a significant price savings without compromising quality. Available exclusively through Walmart’s private ReliOn brand, the new offering includes analog insulin vials ($72.88) and FlexPen® ($85.88). These products will save customers1 between 58% to 75% off the cash price of branded analog insulin products, which translates to a savings of up to $101 per branded vial or $251 per package of branded FlexPens®. The new private label ReliOn™ NovoLog® Insulin (insulin aspart) injection, manufactured by Novo Nordisk, is available in Walmart pharmacies this week, and Sam’s Club pharmacies in mid-July across the United States. ReliOn™ NovoLog® is a rapid-acting insulin analog used to control high blood sugar in adults and children with diabetes. Customers will need a prescription in order to purchase the products and should always consult with their doctor regarding their diabetes management. “We know many people with diabetes struggle to manage the financial burden of this condition, and we are focused on helping by providing affordable solutions. We also know this is a condition that disproportionately impacts underserved populations. With ReliOn NovoLog® insulin, we’re […]
Governments around the world struggle with the logistical challenges of procuring, deploying and administering vaccines at scale. To deliver the vaccines, pharmaceutical companies, logistical partners and governments have come together to create a “cold chain” that ensures vaccines are kept at precise temperatures—adding a major layer of complexity to the delivery of vaccines. The Role of Good Distribution Practices Clearly there’s still much that can be done from a logistical standpoint to ensure the various vaccines are able to reach the people who need them. Complexity and challenges can be found throughout the vaccine cold chain, but one major factor working in our favor is the emergence of new technology and infrastructure that will help ensure the integrity of the vaccine cold chain. Good Distribution Practices (GDP) that describe calibration of all temperature measurement instruments and storage devices are moving from recommendations to requirement—and the quicker they’re adopted and integrated into vaccine logistics globally, the sooner the promise of vaccine prevention could help end the pandemic. GDP was created in U.S. by the FDA, but at present they’re only recommendations and not requirements. Unfortunately, during the pandemic little progress has been made in implementing them more fully, but if they had […]