French manufacturers of veterinary medicines and their inspection
Konstantin Morozov, GMP Specialist, Auditor of Pharmaceutical Enterprises
This article provides information on French manufacturers of veterinary medicines and the French Agency for Veterinary Medicinal Products (ANMV).In addition, the articlesummarizes 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 in the Decree no. 2005-374 of 20 April 2005. Use of veterinary autogenous vaccines as an alternative approach can successfully control numerous bacterial infections and reduce the need for antibiotic treatment. French manufacturers are ready to share their experience in this area. [2, 3, 4].
Today, three French companies (Ceva Santé Animale, Virbac, Vetoquinol) are in the world’s top ten manufacturers of veterinary medicines.
In 1933, Joseph Frechin developed a medicinal animal antiseptic based on oxyquinoline double sulfate. The new medicine was named Vetoquinol. It was with him that the long history of a successful family business began, which has grown over time into a well-known international corporation. .
Today, with a direct presence in 24 countries, with 2500 employees and with almost 100 distributors, the company has built a global network which allows it to be close to its clients all over the world. It is present in three areas: anti-infectious agents, anti-inflammatory agents, cardiology-nephrology.
In the 1960s, the various preparations manufactured by human pharmaceutical laboratories at that time did not make it possible to treat all the animal diseases. In 1968, while major groups were looking to invest in animal health, Pierre-Richard Dick, a veterinary doctor in Nice, founded Virbac with a desire to provide veterinarians, farmers and pet owners worldwide with a set of innovative solutions to fight animal diseases. .
Now the company has 4,900 employees and is present in over 100 countries with 33 sales subsidiaries. Its product range is designed to cover the main pathologies in companion animals and livestock: parasiticides, antibiotics, vaccines, diagnostic tests, dog and cat nutrition, dermatology, dental hygiene, reproductive, aquaculture, anesthesia, geriatrics and electronic identification.
Ceva Santé Animale
Established in 1999, the international veterinary pharmaceutical company Ceva Santé Animale (Ceva) specializes in the research, development, production and marketing of pharmaceutical products and vaccines for livestock and poultry, and companion animals .
The company operates in 110 countries of the world and employs more than 5700 employees, has its own research and development centers and large manufacturing sites. Its activities cover 4 main directions in the production of veterinary medicines: biological products and vaccines, antibacterial medicines, reproduction control, regulation of the nervous system and control of animal behavior.
Also, in France, veterinary medicines are produced by such largest international manufacturers as, for example, Boehringer Ingelheim Animal Health, MSD Animal Health and Elanco Animal Health.
French agency for veterinary medicinal products (anmv)
The French Agency for Veterinary Medicinal Products (Agence Nationale du Médicament Vétérinaire, ANMV) monitors the quality of medicinal products for veterinary use distributed in France. In addition, ANMV issues marketing authorizations for the veterinary medicinal products, the licensing of pharmaceutical sites for the manufacturing, distribution and export. The agency is located near Fougères (Brittany region) and has 85 staff members, mainly specialized scientists.
History of the agency
The adoption in 1975 of the legislation on veterinary pharmacy prompted the French authorities to set up in Fougères a laboratory charged with evaluating marketing authorization application dossiers for veterinary medicinal products and with conducting research on the quality, efficacy and safety of those products. The Veterinary Medicines Laboratory ensured these two missions for 20 years. The numerous studies carried out on the toxicity and pharmacokinetics of residues enabled the laboratory to develop expertise in the area of protection of public health and to be nominated National Reference Laboratory for control of medicinal product residues in food in 1990, and in 1991 European Reference Laboratory in charge of residues of veterinary medicinal product with antimicrobial properties.
The rapid and regular increase in the workload and its specificity related to evaluation of marketing authorization applications for veterinary medicinal products, specifically resulting from implementation of the European Registration system for these products, made it necessary in 1994 to create the French Agency for Veterinary Medicinal Products. The ANMV was established alongside the Veterinary Medicines Laboratory.
The Agency has been in operation since 1995 and has rapidly developed its activities in all its areas of expertise. The ANMV was integrated into the French Food Safety Agency (AFSSA) in 1999, and has been a part of the National Agency for Food, Environmental and Occupational Health & Safety (Anses) since 2010 .
Structure of the agency
The director of ANMV (Jean-Pierre Orand) is appointed by joint order of the ministers responsible for agriculture and health, at the suggestion of the general director of Anses.
To fulfill the missions entrusted to it (antimicrobial resistance, European and international relations, regulatory and cross-functional issues), the Agency has three departments:
Scientific Assessment Department
This department is responsible, in particular, for the examination of veterinary medicinal products applications subject to authorization, registration or declaration, as well as for scientific projects. It is made up of two units.
The Expertise Unit responsible, in particular, for the expertise:
requests for the granting of marketing authorizations for veterinary medicinal products;
maximum residue limits;
scientific projects related to the department.
The Coordination Unit, responsible, in particular, for:
reporting on the dossier;
supervision of procedures;
planning and management of scientific projects related to the department;
coordination and spearheading of a mission focused on innovative treatment methods.
The Department of Administrative Decisions
This department is responsible, in particular, for validation, administrative review, preparation and monitoring of decisions concerning veterinary medicinal products and pharmaceutical sites, as well as certification.
The Department of Inspection, Surveillance and Pharmacovigilance
This department is responsible for compliance control and supervision of veterinary medicinal products on the market, pharmacovigilance and inspection of pharmaceutical sites, testing facilities and manufacturers of autogenous vaccines.
In particular, it provides:
inspecting and controlling establishments that manufacture, develop, import, distribute and export veterinary medicinal products, as well as establishments that manufacture autogenous vaccines, inspecting establishments in accordance with good practice applicable to these activities;
market surveillance and compliance control of veterinary medicinal products;
spearheading and coordination of the national veterinary pharmacovigilance system;
monitoring the balance of benefits and risks of medicinal products.
The Department includes:
The Inspection unit, responsible, in particular, for inspection and investigations related to establishments, testing facilities and products. This unit is headed by Grégory Verdier.
The Market Surveillance and Pharmacovigilance unit, in particular, for information, health monitoring, pharmaceutical monitoring (advertising, shortages…) and compliance control of veterinary medicinal products (quality defects…), as well as for the spearheading and coordination of the national veterinary pharmacovigilance system, in particular for the directing and following up the activities of the Veterinary Pharmacovigilance Centre in Lyon .
International activities of the agency
Thanks to its expertise, ANMV is an agency highly involved in European as well as international activities. In 2013, it obtained recognition for its expertise and management in this area through ISO 9001 certification, with both national and international scope. The Agency is certified to “provide international expert appraisal and developmental support in the area of veterinary medicinal product governance”.
Within Anses, the ANMV acts as the competent French authority in relation to the European Medicines Agency (ЕМА). It contributes actively to discussions on veterinary medicinal products and to the drafting of various regulatory and technical texts.
The Agency evaluates dossiers on veterinary medicinal products at the European level, carries out inspections in third countries on behalf EMA and is strongly committed to the project to revise EU veterinary medicinal product legislation. It is also involved in the system for monitoring antimicrobial resistance, and participates in discussions held by expert groups from the EMA and by other groups internationally. The Agency sits on the Board of the Med-Vet-Net Network of Excellence, which has the primary aim of developing and disseminating scientific knowledge on zoonoses.
The Agency works as a collaborating center for the World Organization for Animal Health (OIE) since 1995, and participates in work by the UN Food and Agriculture Organization (FAO), PIC/S and the WHO. It is heavily involved in programs concerning regulated diseases but also in those on emerging or re-emerging exotic diseases, and thus pools expertise with its European and international partners. As part of the OIE network, the ANMV is a leader in terms of research, expert appraisals, standardization, training and communication of applicable methodologies within its area of expertise .
Contacts with Russian competent authorities
In June 2019, a meeting of the Russian-French Working Group (CEFIC) on Agriculture was held in Paris. This event was attended by a representative of Rosselkhoznadzor. During the meeting, the parties discussed a wide range of issues related to cooperation between Russia and France in the field of veterinary supervision. In particular, they discussed scientific cooperation between ANMV and FSBI “VGNKI”. Taking into account the interest of both parties in the development of such cooperation, the parties agreed on the need to agree with the subsequent signing of a protocol agreement between FSBI “VGNKI” and ANMV .
In September 2019, the IV All Russia GMP Conference with international participation, organized by the Ministry of Industry and Trade of Russia together with the FSI “SID & GP”, was held in Svetlogorsk. As part of this Conference, a panel discussion and a round table for manufacturers of veterinary medicines were organized by the FSBI “VGNKI”.
Vincent Neuviale, inspector of manufacturers of veterinary medicines, provided information on the inspection for compliance with the GMP requirements conducted by ANMV in France and, in particular, highlighted the following points:
Programming and Planning: risk level-based approach (the frequency of site inspections depends on the number of points);
Preparation for inspection: notice for inspection, documentary study, on-site inspection agenda;
Carrying out the inspection: different types of inspection, viewed points;
Writing and sending initial report: templates for reports, contents (observations and GMP deficiencies);
Assessment of QP responses (including proposed corrective and preventive actions – CAPA) and conclusion (satisfactory, partially satisfactory, unsatisfactory);
Determination of the compliance status of the enterprise and joint decision of the inspectors.
He said that GMP inspections carried out in France can be divided into the following types:
Inspection target: system or product inspection;
Knowledge of inspectee: routine, concise or follow-up inspection (scope of inspection, number of days);
Subject of inspection: routine, quality systems review or special inspection;
Sponsor of inspection: inspection initiated by a national or European competent authority – The Committee for Medicinal Products for Veterinary Use (CVMP).
In ANMV, the classification of GMP deficiencies regarding to their significance is based on PIC/S and EMA documents: Critical, Major and Others. The most common deficiencies are associated with environmental monitoring, cleaning validation, redevelopment of manufacturing facilities.
In France, all manufacturers of medicinal products must have a GMP certificate issued by the regulator. If the enterprise does not meet the GMP requirements with the conditions for CAPA, then the GMP certificate is not issued or this certificate is issued with limitations .
Dialogue with an expert
ANMV Inspector Vincent Neuviale
ANMV Inspector Vincent Neuviale has kindly agreed to answer some of my questions regarding inspection issues.
Please tell me how many inspectors are there in your unit? How many inspectors are usually involved in an inspection? How many inspections are usually carried out in a year?
There are 6 inspectors in the inspection unit, head of unit included. All are veterinarians but in the past, some inspectors were pharmacists. We inspect manufacturers, distributors (French “exploitants”, i.e. MAH representative in France) and wholesalers of veterinary medicinal products (VMPs), Pharmacovigilance Head Quarters and Test facilities in France and manufacturers of VMPs in Third Countries. We check the compliance with GMP, GDP, GVP, GLP and soon GCP. For distributors and wholesalers, generally one inspector is needed. For manufacturers, it depends on the site size: 1 or 2 inspectors but more often 2. About 70 inspections are carried out per year, half of which are for manufacturers.
Does ANMV have an advanced training program for inspectors? Do agency inspectors participate in external training?
For new inspectors, there is an initial training: theoretical and practical with tutors (experienced inspectors). The training period could last up to one year. The new inspector has to be qualified in several domains with increasing complexity: distribution then non sterile production then sterile production and finally biologic production. Inspections are performed in pairs until the new inspector is qualified in each domain. Once qualified, a continuous training is in place: It is about 2 or 3 theoretical trainings per year per inspector that corresponds about minimum 5 days per inspector per year. Training is intern or extern according to the subjects and budget. Most of them are extern. Supervision inspections are performed regularly between inspectors to ensure that their requirements are the same and to maintain their qualification as inspector at ANMV. ANMV is also a PIC/S member and participate to the different seminar or training organized by PIC/S.
The COVID-19 pandemic has created restrictions that may affect and/or impede the conduct of on-site inspections. In this regard, the remote format of inspections is becoming more and more relevant. Does ANMV conduct inspections in this new format?
Due to the COVID-19 pandemic and travel restrictions, inspections were stopped for 3 months in 2020 (from March to May). During this lockdown, inspection team had worked on remote assessment SOP. Since June 2020, remote inspections have been put in place in addition to on-site inspections when it was possible. 18 remote inspections of distributors (“exploitants”) and manufacturers, pharmacovigilance Head Quarters were conducted until now. It is not the preferred format for manufacturers, considering that on-site inspections are more suitable.
Should French manufacturers inform ANMV about upcoming Russian inspections, about the results of these inspections? Is there any monitoring of deficiencies identified during Russian inspections?
Some French manufacturers inform AMNV about upcoming Russian Inspections. Once ANMV informed and if the French manufacturer wishes it, a French inspector can assist to the Russian inspection as an observer. Russia may inform both the French Ministry of Agriculture and the Ministry of Foreign Affairs about the different deficiencies observed by Russian inspectors and if any, this information is transmitted to ANMV. If deficiencies observed by Russian inspectors concern requirements also present in the EU cGMP, those deficiencies could be monitored during a future inspection of the site by ANMV.
In Russia, the European practice of using autogenous vaccines is of growing interest. As far as I know, ANMV is planning to take part the Autogenous Vaccines Meeting “Quality of Production and Movement in a Common Market” (Munich, September 2021). Does the agency expect specific GMP Rules for autogenous vaccines to be developed and adopted in the future?
Autogenous vaccines are important in France specially for minor species like fish, we use more than 160 million of doses per year. We have a great experience of such products. Annex 1 and Annex 5 of the EU cGMP guide are not very suitable to autogenous vaccines. In France, since 2008 there has been a specific good manufacturing guide for autogenous vaccines. The new Vet Regulation expects GMP guide for autogenous vaccines at EU level. ANMV wishes to participate and share its knowledge and experience to the future EU drafting group on this topic.
In 2019, you participated in the All Russia GMP Conference. Did you enjoy this event? If you were invited to Russia to one of the following conferences, would you take part in this?
Yes, it was a great experience: the possibility to exchange with inspectors from others countries (inside EU and from Third Countries) and better understand the requirements of the Russian authorities. For the following conferences, I think the director of the agency or the head of the inspection unit may assist to them if available and if the presentation of a subject is asked.
Russian GMP inspections of French manufacturers of veterinary medicines
Russian inspectors began to conduct GMP inspections of foreign manufacturers of medicinal products for veterinary use in June 2017, and the first inspections of French manufacturing sites took place in September 2017.
According to the register of issued conclusions published on the Rosselkhoznadzor website 18.03.2021 , in 2017-2020 the largest number of conclusions (20%) was made by Rosselkhoznadzor in relation to manufacturers from France. During this time, 21 inspections were conducted at manufacturing sites located in 9 out of 13 French regions.
To date, the number of refusals to issue GMP conclusions to French sites is still high, however, by January 2021 they received they have already received six positive conclusions. The results may indicate that these veterinary medicines manufacturers have begun to better prepare for inspections.
For 2021, six Russian GMP inspections of manufacturing sites located in France are already planned (including follow-up inspections). French manufacturers openly share their experience in passing inspections .
The attractiveness of France in matters of animal health lies in its scientific and technical expertise, manufacturing capacities and high-quality products.On the other hand, the Russian market is also attractive for French manufacturers of medicinal products for veterinary use. Proper preparation to Russian GMP inspections is very important for all manufacturers.The experience of the French Agency for Veterinary Medicinal Products may also be of interest to Russian inspectors.
The National Agency for Food, Environmental and Occupational Health & Safety (Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail, Anses) is a French agency who undertakes monitoring, expert assessment, research and reference activities in a broad range of topics that encompass human, animal and plant health
The European Medicines Agency (EMA) is an agency of the European Union in charge of the evaluation and supervision of medicinal products
The World Organization for Animal Health (Organisation Mondiale de la Santé Animale), formerly the Office International des Epizooties (OIE) is an intergovernmental organization coordinating, supporting and promoting animal disease control
The Food and Agriculture Organization of the United Nations (FAO) is a specialized agency of the United Nations that leads international efforts to defeat hunger and improve nutrition and food security
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is a non-binding, informal co-operative arrangement between Regulatory Authorities in the field of GMP of medicinal products for human or veterinary use.
The Committee for Medicinal Products for Veterinary Use (CVMP) is the EMA’s committee responsible for elaborating the opinions on all questions concerning veterinary medicines
The Russian-French Council on Economic, Financial, Industrial and Trade Issues (Conseil économique, financier et commercial, CEFIC) is the main working structure of the Russian-French Commission on Bilateral Cooperation at the level of heads of government
The Federal State Budgetary Institution “The All-Russian State Center for Quality and Standardization of Veterinary Drugs and Feed” (FSBI “VGNKI”) is an institution authorized to conduct inspections of manufacturers of veterinary medicinal products manufactured outside the Russian Federation for compliance with the GMP rules requirements
The Federal State Institution “State Institute of Drugs and Good Practices” (FSI “SID & GP”) is an institution authorized to conduct inspections of manufacturers of medicinal products for human use manufactured outside the Russian Federation for compliance with the GMP rules requirements
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 […]
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.
Etten-Leur, Tokyo, Moscow, June 9, 2021. R-Pharm Group announces the signing of a distribution agreement with PHC Europe B.V., one of the largest suppliers of biopharmaceutical and medical equipment, formerly known as Panasonic Biomedical Sales Europe B.V.. The agreement provides for R-Pharm to register and promote in Russia, Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Tajikistan, Uzbekistan and Ukraine its high-tech refrigeration equipment, biotech incubators, climate chambers and an entire line of equipment for laboratories, biotech facilities, and medical institutions. PHCbi refrigeration equipment covers a temperature range from +23 to -150 ℃, making it possible to store all known types of vaccines and biologics, as well as blood and its components. It is important to note that the PHC refrigeration equipment is designed not only for medical institutions, but also for research laboratories and biopharmaceutical production. As of today, R-Pharm’s production sites have already purchased more than 20 units of equipment to support the vaccine project. Denis Cherednichenko, Vice-President for Medical Systems at R-Pharm Group: We welcome the agreement between R-Pharm and PHC Europe B.V. coming into force. It represents an important milestone in the development of the strategic partnership between Russia and Japan. Regarding the organization of this cooperation, […]
Yposkesi, a leading Contract Development and Manufacturing Organization (CDMO) specializing in cell and gene therapies, announces the launch of project SKY, the construction of Yposkesi’s second commercial cell and gene therapy facility and new global resource for drug developers of biologics, also called ATMPs (Advanced Therapy Medicinal Products). ATMPs treat patients living with rare and life-threatening diseases. To accelerate innovation, in March 2021 Yposkesi welcomed SK Pharmteco, a global CDMO player, as a new majority equity shareholder in its company. Backed by SK Pharmteco, Yposkesi is investing €58M (approx. $71M) in the new 5,000m² site, making it one of the largest ATMP facilities in Europe. Project SKY will create approximately 80 new jobs by 2023. With this new state-of-the-art facility, designed for European and American GMP compliance, Yposkesi will double its production surface to 10,000m². This new resource equips it to address the shortage in manufacturing capacity for drug developers seeking to advance clinical trials and commercialize new therapeutic drugs. Yposkesi is proud and excited to embark full speed on this new phase in our development. SKY is the culmination of our industrial strategy, guaranteeing clients a range of quality services from early clinical drug development through all phases to […]
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 […]
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 […]
The Russian health ministry’s Smorodintsev Flu Research Institute has finished pre-clinical tests of its own coronavirus vaccine and plans to begin trials on volunteers by the yearend, the institute’s director, Dmitry Lioznov, told a news conference on Monday. We have finished pre-clinical tests and are filing documents for the approval of the coronavirus vaccine’s clinical trials. We expect that this vaccine will protect against both the coronavirus infection and type A influenza. Such research is going on and I hope if everything is all right, we will begin clinical tests of this vaccine before the New Year, he said. The institute told TASS earlier that its specialists were working on a coronavirus vaccine on the basis of the flu virus. A weakened flu virus will be used as a vector to deliver coronavirus proteins and prompt an immune response. The conserved part of the virus will be used to enter cells. The vaccine will be in the form of nasal drops or a spray.
Scientists claim the nanoparticles obtained can carry an increased antibiotic “load” and easily penetrate tissues from the bloodstream and back, ensuring continuous drug delivery to the site of infection.
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.
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 […]
EMA has started evaluating an application for the use of a booster dose of Comirnaty to be given 6 months after the second dose in people aged 16 years and older. Booster doses are given to vaccinated people (i.e. people who have completed their primary vaccination) to restore protection after it has waned. EMA’s human medicines committee (CHMP) will carry out an accelerated assessment of data submitted by the company that markets Comirnaty, including results from an ongoing clinical trial in which around 300 adults with healthy immune systems received a booster dose approximately 6 months after the second dose. The CHMP will recommend whether updates to the product information are appropriate. The outcome of this evaluation is expected within the next few weeks, unless supplementary information is needed, and will be communicated by EMA. Separately, EMA is also assessing data from the literature on the use of an additional, third dose of an mRNA vaccine (Comirnaty or SpikeVax) in severely immunocompromised people (i.e., with weakened immune systems). People with severely weakened immune systems who do not achieve an adequate level of protection from their standard primary vaccination may need an ‘additional’ dose as part of their primary vaccination. EMA […]
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 […]
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 […]
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 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.
There are currently 59 Ph. Eur. texts – covering a variety of topics including vaccines for human use, blood products, antibiotics, radiopharmaceuticals and containers – that refer to the RPT and will be affected.
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.
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 […]
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 […]
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 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 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.
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 […]
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 […]
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%.
Joint-stock company “Grindeks” has invested 800 thousand euros in the site of production of active pharmaceutical ingredients (APIs) and installed new, state-of-the-art laboratories and technological equipment for industrial production, which has allowed the unit to become multifunctional. After the investments, the facility will be used for the development and production of active pharmaceutical ingredients. They will be used for production of Grindeks finished dosage forms or medicines, as well as for export. The department has the opportunity to work with equipment with a volume of 100ml to 20l, which allows the production of various of active substances from milligrams to kilograms. To ensure the safety of workers and the protection of the environment, a reduced-pressure insulator with filtration systems has been installed for production to prevent highly effective API contact with humans and the environment. This is the first device of its kind in the Grindeks API factory. The site is also equipped with a modern monitoring and communication system for rapid response in case of non-standard situations. Chairman of the Council of JSC Grindeks Kirovs Lipmans: “For the Grindeks Group to be able to grow rapidly, investments are necessary for the development of production. Every year we invest at […]
A Russian military research unit that was involved in the development of Sputnik V is working on a new coronavirus vaccine in the form of chewing gum, the RBC news website reported Friday. The Defense Ministry’s 48th Central Research Institute collaborated with the state-run Gamaleya Research Institute in Moscow to develop and trial Sputnik V last year. Russia, facing accusations of rushing human trials, touted the adenoviral vector vaccine as the world’s first to be approved for widespread use. Citing an unnamed Defense Ministry source and confirmation from the 48th Central Research Institute’s director, RBC said “work is underway” toward developing a mucosal Covid-19 vaccine in the form of chewable tablets and pastilles. “After testing, the drug will be included in various treatment and prevention regimens for coronavirus,” the source was quoted as saying. Col. Sergei Borisevich, who heads the 48th Central Research Institute, confirmed work on the new vaccine but did not specify what stage it was at. Russia has registered a total of four coronavirus vaccines and has reached agreements with close to 70 countries on selling Sputnik V or sharing the technology to manufacture it. Moscow’s active efforts to market the two-shot vaccine around the world has been viewed […]
Nanolek, a biopharmaceutical company, announces a plan to invest 5 billion rubles over 3 years in its full-cycle vaccine production facility in the Kirov region and an R&D Center for Biotech Medicines in Moscow.
Russian pharmaceutical company NovaMedica (part of the RUSNANO portfolio) and the corporation Bayer signed an agreement to provide Bayer with an exclusive license to commercialization of an innovative product developed by NovaMedica, including its manufacturing and promotion. The product in question is used for the treatment of proctologic diseases and has been developed as part of NovaMedica’s own R&D program. Bayer intends to commercialize it under the trade name Reliefipin. The product is a combination of two active ingredients with a therapeutic and pain relieving effect and will be manufactured in the form of topical water-based gel, which ensures effectiveness and convenience in the treatment of such diseases. In developing the product, NovaMedica used technologies that allowed combining previously incompatible active ingredients in one form, while improving their physical and chemical properties manifold. The formulation is patent-protected. Reliefipin will be available at Russian pharmacies as early as this June. The parties do not disclose financial details of the deal. Elena Litvinova, CEO, NovaMedica: “We are building our R&D program with a view to find out-of-the-box solutions to meet the current needs of patients. This is our focus. The fact that Bayer showed interest in our product means recognition of NovaMedica’s […]
The Russian Health Ministry has issued a permit to conduct the post-registration clinical trials of the CoviVac shot against the coronavirus infection with the participation of 32,000 volunteers. The corresponding information was published on the website of the state register of clinical trial permits of the Russian Health Ministry on Tuesday. (TASS) “An open comparative study of the preventive efficacy and a non-comparative study of the immunogenicity and safety of the CoviVac preparation (a whole-virion inactivated concentrated purified coronavirus vaccine), produced by the Federal State Budgetary Scientific Institution Chumakov Federal Scientific Center for Research and Development of Immune and Biological Products of the Russian Academy of Sciences on healthy volunteers aged 18-60. The beginning of the trials kicked off on June 2, 2021, and will end on December 30, 2022. The number of patients amounts to 32,000,” – according to the information posted on the website. The register also indicates that the trials will be held on the basis of 16 medical organizations in Kirov, St. Petersburg, Moscow, Obninsk, Chelyabinsk, Tatarstan, Zheleznogorsk, Stary Oskol, and Novotroitsk. On February 19, the Russian Healthcare Ministry certified the whole-virion inactivated CoviVac vaccine, developed by the Chumakov Federal Scientific Center for Research and Development […]
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 […]
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.
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 […]
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 […]
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 […]
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 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, […]
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 […]
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 […]
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 […]