Serbia confirms high efficiency of Sputnik V vaccine
Minister for Innovation and Technological Development of the Republic of Serbia, Nenad Popovic, said in his Twitter account that Serbia is the European leader in vaccination with 28% of its population fully vaccinated, which is twice the European average. The use of @sputnikvaccine, with its efficiency reaching 97.6%, contributed to that. Serbia decided on procurement of vaccine without political bias.
Serbia is the European leader in vaccination with 28% of its population fully vaccinated, which is twice the European average. The use of @sputnikvaccine, with its efficiency reaching 97.6%, contributed to that. Serbia decided on procurement of vaccine without political bias. pic.twitter.com/vfHJoV4xHt
The Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund) for its part, announces that the latest official vaccination data in Serbia confirms Sputnik V Russian coronavirus vaccine to be the safest among COVID vaccines included in country’s national portfolio.
The data confirms that Sputnik V demonstrates the highest safety profile:
No vaccination-related serious adverse events (SAE) registered;
No vaccination-related deaths reported;
No cerebral vein thrombosis (CVT) cases after vaccination observed.
Sputnik V has helped Serbia to become a European leader in vaccination against COVID. To date over 1/4 of the population of Serbia has been fully vaccinated with various vaccines included in country’s portfolio (28%), twice as many as in Europe on average (14%).
A set of measures, including an active program of immunization allowed Serbia to reduce the daily average infection rate twelve times vs the peak rate in late March – early April 2021, and the current infection rate is lower than the European average.
The effective vaccination campaign had an impact on the COVID-19-related death rate — the daily average number of deaths decreased almost four times vs the peak rate in early April.
CEO of the Russian Direct Investment Fund
Serbia made choices on inclusion of various vaccines against COVID in the national vaccine portfolio free of political bias. High safety profile of Sputnik V has been once again confirmed while inclusion into Serbia’s vaccine portfolio enabled the country to become the European leader in vaccination against COVID. We appreciate the partnership with Serbia and stand ready to provide other countries with Sputnik V to help people feel safe again.
Minister of Innovations and Technological Development and Co-Chairman of the Intergovernmental Committee for Cooperation between Serbia and Russia
Serbia was independent in the selection of vaccines and made decisions without political bias. The health and lives of our citizens were endangered, and the most effective way to preserve them was to obtain as many vaccines as possible. I would like to express my gratitude to our Russian partners for their support in the delivery of vaccines, and also for the opportunity to soon, as the first country in South Europe to do so, start the production of the Sputnik V vaccine in the Republic of Serbia. The launch of the production of the Russian vaccine in Serbia is the result of an agreement between two presidents, Aleksandar Vučić and Vladimir Putin. It is a confirmation of the closest cooperation and the highest degree of mutual trust between Serbia and Russia.
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 uses two different vectors for the two shots in a course of vaccination, providing 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.
The storage temperature of Sputnik V at +2+8 C means it can be stored in a conventional refrigerator without any need to invest in additional cold-chain infrastructure.
The price of Sputnik V is less than $10 per shot, making it affordable around the world.
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.
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%.
This review contains the latest information related to inspection of manufacturers of veterinary medicinal products manufactured outside the Russian Federation for compliance with the requirements of the Good Manufacturing Practice (GMP). These inspections are conducted 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. GMP rules Since January 2021, the GMP Rules of the Eurasian Economic Union (EAEU GMP Rules), approved by the Resolution of the EEC Council No. 77 of November 3, 2016, entered into force with respect to medicinal products for veterinary use . In January 2021, on the Official Internet Portal of Legal Information publication.pravo.gov.ru the Order of Rosselkhoznadzor No. 1231 of November 17, 2020 “On approval of the application form for issuing a conclusion on the compliance for a manufacturer (foreign manufacturer) of veterinary medicinal products with the GMP Rules requirements, the form of the inspection report based on the results of the inspection of the manufacturer (foreign manufacturer) of veterinary medicinal products for compliance with the GMP Rules requirements and the form of the conclusion on the compliance of the manufacturer (foreign manufacturer) of veterinary medicinal products with […]
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.
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 […]
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.
The minister also revealed that the Karaganda pharmaceutical plant will produce extra 1,7 million doses of Sputnik V vaccine. They will be distributed among regions of the country according to the approved schedule.
CureVac shares fell by as much as 52% on Thursday after the German biotech’s COVID-19 vaccine proved only 47% effective in an initial trial, denting investor confidence in its ability to take on established rivals, reports Reuters . The disappointing efficacy of the shot known as CVnCoV emerged from an interim analysis in a study of about 40,000 volunteers in Europe and Latin America, with CureVac saying on Wednesday that new variants had proved a headwind. Late-stage trials of BioNTech/Pfizer and Moderna vaccines, which like CureVac’s are based on mRNA technology, had efficacy rates of well above 90% but took place when the original version of the coronavirus was dominant. Data on their products have, however, so far suggested only somewhat weaker protection against new variants. “This could cast doubt on competitiveness of its mRNA platform,” Jefferies said in a research note on CureVac’s study. CureVac shares were down 44% at 1005 GMT in Germany, trading at their lowest in more than seven months and wiping more than 6 billion euros off the company’s market value. Public health representatives across the globe are pushing for a fast deployment of available vaccines to counter highly contagious mutations of COVID-19 such as […]
The acquisition includes Teneobio’s proprietary bispecific and multispecific antibody technologies, which will enable significant acceleration and efficiency in the discovery and development of new molecules.
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 […]
Vietnamese Prime Minister Pham Minh Chin has requested accelerating the transfer of vaccine production technology and the testing and production of home-grown vaccine for COVID-19, so that Vietnam will be able to produce COVID-19 vaccines no later than June 2022. The Company for Vaccine and Biological Production No.1 (Vabiotech) – the biggest vaccine manufacturer and supplier for the EPI in Vietnam is in talks with Russia to produce Sputnik V vaccine in the country. He made the order during working sessions with several producers of vaccines, biological products and medical supplies in Hanoi on June 24. At the Vaccine and Biological Production Company No. 1 under the National Institute of Hygiene and Epidemiology, the PM also reiterated the need to carry out the vaccination campaign in the quickest, most effective and safest manner. (VietnamPlus, Vietnam News Agency) During a working session with Medicon company which specialises in producing test kits for medical needs, the PM asked the company to keep up its creative spirit in research and production of medical products, including medical supplies for COVID-19 prevention and control. Successful realization of the vaccine strategy is the top solution to prevent and push back the COVID-19 pandemic as Vietnam, one […]
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 […]
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 […]
TriRx Pharmaceutical Services Inc., a leading international CDMO, today announced an agreement to acquire two facilities from Elanco Animal Health Incorporated. Elanco is a global animal health leader dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets. The sites are located in Shawnee, Kansas and Speke, United Kingdom, and will expand the manufacturing footprint of TriRx, adding to its existing pharmaceutical facilities in Huntsville, Alabama, and Segré, France. The sale of the Shawnee and Speke sites includes the physical assets at both locations and the transfer of approximately 600 employees. The two companies have also entered into long-term supply agreements for both facilities to continue to manufacture existing Elanco products. We are excited about this opportunity, taking us into a long-term partnership with Elanco, and welcome the employees at both Speke and Shawnee into our organization, – said Tim Tyson, Chairman and CEO at TriRx. – We have been impressed with the high caliber of people and capabilities at both sites and we look forward to acquiring additional customers at the sites to increase efficiency and utilization and to assure a long-term success. Jeff Simmons, President and CEO at Elanco Animal […]
R-Pharm`s project on the development of olokizumab has been declared as the Runner-up in the category “Good Health and Well Being” of the BRICS Solutions for SDG Awards 2021. The awarded project was launched by R-Pharm in 2016. The Phase 3 clinical trial of olokizumab, a novel treatment to manage RA was designed in cooperation with FDA and EMA and enrolled 2,444 patients from 19 countries. It is one of the largest projects in Russian pharma: R-Pharm invested over 300 million dollars in its development since the launch of the project. The 2021 contest was held under the Indian BRICS Chairmanship and brought together participants from five BRICS countries: Russia, India, Brazil, China, and South Africa. This year all projects were focused on solutions meeting United Nation’s Sustainable Development Goals (SDGs): zero hunger, good health and well-being, quality education, gender equality, affordable and clean energy and clean water and sanitation. The nominations were put through a rigorous evaluation by an esteemed jury comprising experts from all the BRICS member nations. The international jury evaluated the application with reference to the project`s relevance, approach, efficiency, sustainability, collaboration, uniqueness and scalability. The awarding ceremony to honor the finalists and winners will be […]
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.
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.
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.
It is envisaged to implement the project in three stages from 2021 to 2024, the amount of investment from the company “SOLYPHAR” will be more than 20 million US dollars, in accordance to the international GMP standards.
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 […]
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 […]
The World Health Organization (WHO) and its COVAX partners are working with a South African consortium comprising Biovac, Afrigen Biologics and Vaccines, a network of universities and the Africa Centres for Disease Control and Prevention (CDC) to establish its first COVID mRNA vaccine technology transfer hub. The move follows WHO’s global call for Expression of Interest (EOI) on 16 April 2021 to establish COVID mRNA vaccine technology transfer hubs to scale up production and access to COVID vaccines. Over the coming weeks, the partners will negotiate details with the Government of South Africa and public and private partners inside the country and from around the world. South African President Cyril Ramaphosa said: “The COVID-19 pandemic has revealed the full extent of the vaccine gap between developed and developing economies, and how that gap can severely undermine global health security. This landmark initiative is a major advance in the international effort to build vaccine development and manufacturing capacity that will put Africa on a path to self determination. South Africa welcomes the opportunity to host a vaccine technology transfer hub and to build on the capacity and expertise that already exists on the continent to contribute to this effort.” This is great news, particularly 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 […]
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.
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 […]
The European Medicines Agency (EMA) announced on June 11, 2021 that its committee for human medicines (CHMP) has approved a new manufacturing site for the production of Moderna COVID-19 vaccine finished product. The site, operated by Recipharm, is located in Monts, France. In addition to the new manufacturing facility for this vaccine, the CHMP has also given a positive opinion for the addition of several alternative sites responsible for batch control/testing. Already on 4 June 2021, two new sites for the manufacturing of active substance and finished product intermediates, located in the US (ModernaTX, Inc., Norwood, Massachusetts and Lonza Biologics, Inc., Portsmouth, New Hampshire), were approved by CHMP. Together, these changes are expected to allow the production of an additional one to two million vials of ready-to-use vaccine for the European Union market every month. This will increase the supply of the vaccine in the European Union. This recommendation does not require a European Commission decision and the site in Monts can become operational immediately. The changes described will be included in the publicly available information on this vaccine.
The production of Sputnik V, a vaccine for the coronavirus developed by Russia, began at an Iranian company on Saturday, 26 June. In a ceremony attended by Iranian Health Minister Saeed Namaki, the production of Russia’s Sputnik V vaccine under license started in Iran. Iran has become the first country in the Middle East to produce Sputnik V. The vaccine produced in Iran will be used in the national vaccination program. To date, Sputnik V has been registered in 67 countries globally with a total population of over 3.5 billion people. The data obtained by regulators of a number of countries during the vaccination of the population, including Argentina, Serbia, Bahrain, Hungary, Mexico and others, demonstrates that Sputnik V is one of the safest and most effective vaccines against coronavirus. Sputnik V is based on a proven and well-studied platform of human adenoviral vectors and uses two different vectors for the two shots in a course of vaccination, providing immunity with a longer duration than vaccines using the same delivery mechanism for both shots. Officials say the permission for the rollout of another homegrown vaccine developed jointly by Cuba and the Pasteur Institute of Iran will be granted in the […]
The EpiVacCorona-N coronavirus vaccine will be released into civil circulation in the near future, Tatiana Nepomnyashchikh, a deputy head of the Vector State Research Center of Virology and Biotechnology, told TASS on Thursday. EpiVacCorona-N has not yet been released into the stream of commerce because we received the authorization only on Thursday. As soon as our industrial partners manufacture the series, the health regulator will give authorization for the release into the civil circulation. It will be in the near future, she said on the sidelines of the Eastern Economic Forum (EEF). The EpiVacCorona-N coronavirus vaccine developed by the Vector Center was registered with the Russian health ministry last Thursday. The Center’s chief, Rinat Maksyutov, said earlier that were are no principal differences between the EpiVacCorona and EpiVacCorona-N vaccines. According to Maksyutov, the vaccines differ by technological specifics of the production process. However, new clinical tests were needed all the same.
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 […]
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 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.
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 […]
The FDA evaluated information on the use of a third dose of the Pfizer-BioNTech or Moderna Vaccines and determined that the administration of third vaccine doses may increase protection in this population.
VTB Capital has invested in the pharmaceutical holding company Binnopharm Group. Sistema’s wholly-owned subsidiary LLC Sistema Telecom Assets sold an 11.2% stake in Ristango Holding Limited, which owns 100% of the authorised capital of Binnopharm Group, to Nevsky Property Investments Limited (controlled by VTB Capital). The transaction totalled RUB 7 billion. As a result, Sistema’s effective stake in Binnopharm Group together with its financial partner (VTB Bank) stands at 75.3%; a consortium of investors consisting of the Russian Direct Investment Fund (RDIF), the Russia-China Investment Fund (co-founded by RDIF and China Investment Corporation) and leading Middle Eastern funds holds 12.5%; VTB Capital, represented by Nevsky Property Investments Limited, holds 11.2%. The remaining 1% of shares in Binnopharm Group are owned by a minority shareholder (an individual). Binnopharm Group is a full-cycle Russian pharmaceutical holding company that combines five production sites located in different regions of Russia: JSC Alium (formerly OBL Pharm in the Serpukhov district of the Moscow region), JSC Binnopharm (two sites: Zelenograd and Krasnogorsk), OJSC Sintez (Kurgan) and CJSC Biocom (Stavropol). The Binnopharm Group companies produce a wide range of drugs across therapeutic groups and have the largest portfolio of drugs among Russian manufacturers (more than 450 marketing […]
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.