Development of modern Pharmaceuticals, Vaccines and more. Part 2
Life in a globalized world offers opportunities as well as risks in many areas. One example would be information technology with the ‘hot topic’ of artificial intelligence and its opportunities and risks. Others would be supply chain challenges vs. production cost optimization or health risks such as pandemics or rare diseases vs. global scientific resources in drug and vaccine development, especially modern biological therapy options. Of course, the development of modern pharmaceuticals, vaccines and advanced therapy medicinal products (ATMPs) offers many opportunities. They make it possible to treat and cure previously incurable diseases, improve people's quality of life and contribute to continuous progress in medicine. The pandemic has shown that new medicines and vaccines can save lives and improve public health.
On the other hand, there are risks that must be considered when developing such products. Undesirable side effects can occur that compromise patient safety. Another risk is the possible development of resistance to drugs, as is the case with antibiotics, for example. This can make certain diseases more difficult to treat and reduce the effectiveness of medication. It is therefore important to manage the use of antibiotics and other medicines responsibly in order to minimize the development of resistance. In addition, ethical issues may also arise in relation to the development and use of pharmaceuticals, vaccines and ATMPs. It is important that research and development is carried out in accordance with ethical principles and that the interests of patients and society are taken into account.
Overall, the development of modern pharmaceuticals, vaccines as well as other novel developments offer great opportunities for medicine, health and people's everyday lives. However, it is important that these opportunities are accompanied by a conscious approach to the risks in order to ensure the safety and efficacy of these products.
Part 2: Vaccines in today's world
One of the major challenges in today's era of globalization, rapid travel and global mobility is to be adequately prepared for pandemics. This requires, among other things, the development of modern vaccines that fulfil a number of requirements:
• Safety: adverse vaccine reactions are minimized through extensive clinical trials and post-market surveillance
• Efficacy: Vaccines should have a high protective effect against the respective disease and be tested as comprehensively as possible in clinical trials
• Long-term protection: Protection should be as long-lasting as possible
• Stability and storage: Ensuring the highest possible stability under different storage and transport conditions while complying with quality and safety standards for worldwide use
• Adaptability: Flexible adaptation of the vaccine to new variants of the pathogen should be as simple as possible
• Production and availability: options for rapid production, prepared distribution channels
• Acceptance by the population: Clear communication and education about the benefits, risks and advantages of vaccination
• Ethics and accountability: Ethical standards must be adhered to in the development and distribution of vaccines. Distribution should be equitable and transparent to ensure that all population groups have access
When we talk about possible pandemics and how to prepare for them, other measures are also relevant, e.g:
• Early warning systems, surveillance and response: improved surveillance systems for early detection of potential pandemics (artificial intelligence, big data analysis and telemedicine) with cooperation between international organizations and national health authorities, including in subsequent pandemic responses and including the development of pandemic plans.
• Research and development: Investment in potential new vaccines, antiviral drugs and other therapies will be increased - including with regard to platform technologies.
• Stockpiling: Many countries are stockpiling medicines, protective equipment and other essential resources to be better prepared in the event of a pandemic. This also includes the creation of emergency reserves for vaccines.
• Strengthening healthcare systems: Improving the capacity and flexibility of healthcare systems to cope with an increase in patients during a pandemic.
• Communication and education: Clear, repeated and transparent communication to the population about health risks, preventive measures and behavior during a pandemic.
One step in this direction is CEPI, the Coalition for Epidemic Preparedness Innovations, an international organization focused on accelerating the development of vaccines against new and emerging infectious diseases. CEPI was founded in 2017 in response to the lack of preparedness for epidemics, particularly the outbreak of Ebola in West Africa.
CEPI's main objectives in relation to pandemics are:
• Accelerated vaccine development: Especially for emerging diseases where conventional development approaches may be too slow.
• Promoting research and development: Funding/supporting research projects for the development of vaccines (and platform technologies) against various pathogens, including viruses that are considered potential pandemic triggers.
• Collaboration with partners such as governments, international organizations, academic institutions, testing laboratorie and pharmaceutical companies to effectively leverage resources and expertise for vaccine development.
• Prioritization of pathogens: CEPI identifies and prioritizes pathogens that are considered a threat to global health.
• Providing funding for vaccine projects and clinical trials to support vaccine development.
CEPI's Centralized Laboratory Network plays a critical role in strengthening global pandemic preparedness, particularly by fostering innovation and accelerating vaccine development. CEPI is the largest global group working to standardize the evaluation of vaccines being developed against some of the world's most dangerous, and in most cases deadly, diseases. Harmonizing vaccine performance testing strategies (readouts) under a common approach can accelerate the development and regulatory approval of vaccines to enable a faster response to future emerging threats and support the 100-day mission.
The network focuses on evaluating vaccine samples against the CEPI priority list of pathogens of public health concern or listed in the WHO R&D plan, including Lassa, Nipah, MERS, Ebola, Chikungunya, Rift Valley fever, COVID-19 and other betacoronaviruses. The members of the network also support the detection, containment and control of other viral threats with epidemic or pandemic potential, such as Mpox and Marburg.
They are also ready to accelerate the evaluation of vaccine samples against a disease X – a novel or as of yet unidentified pathogen - by developing standardized procedures, supporting the technology transfer of these procedures to other laboratories in the network and testing samples from clinical trials of potential vaccine candidates against such pathogens.
Providing additional laboratories and testing facilities for vaccines in each region will help reduce the time for clinical evaluation, supporting the CEPI-led and G7 and G20 endorsed goal of developing vaccines within 100 days of identifying a viral threat. More local testing will also reduce the financial and environmental costs normally associated with shipping vaccine samples long distances, while improving the sustainable infrastructure for outbreak preparedness in the region.
Months have passed since COVID-19 was mentioned in the media. However, we must not forget to take precautions to ensure a stable healthcare system. Many have contributed to combating and containing the COVID-19 pandemic. Many have fallen ill, died and/or suffered after-effects. However, despite problems with development, production and distribution, a vaccine was developed and distributed. This proved that rapid vaccine development is possible and that it is the most important medical treatment.
About the Authors:
Clemens Mundo has been with CONCEPT HEIDELBERG since 2023 as operational director and is in charge of the area of biotechnology.
Dipl. Biol. Axel H. Schroeder has been working at CONCEPT HEIDELBERG since 2008 and is head of the microbiology department
Literature:
• Coalition for Epidemic Preparedness Innovations (CEPI), 2016, https://cepi.net/
