Drugs are modern magic. We expect medical drugs to ease pain, prevent sickness, and cure illness. Safely. Reliably. At lower cost is work in progress. We expect new drugs to work against more problems every year. Expectations meet reality with events like Covid-19. Science research and manufacturing came up with preventative vaccines very quickly compared to fearful expectations. Expectations for the mRNA Vaccine process are still expanding as the technology is used to build more, or improve, vaccines.
In this segment EkaLore looks at the background of the mRNA Vaccine technology.
Background
Pfizer and Fosun Pharmaceuticals each invested in BioNTech, a leading creator of Covid-19 vaccines, in early 2020. The intention for each was to bring mRNA vaccines to market, originally for multiple diseases as a basal technology, with intense focus rapidly turning to Covid-19 vaccines. Moderna, another developer with USA Federal Government research cooperation, also sought to bring a slightly different Covid-19 vaccine to commercialization also exploiting mRNA vaccine technologies.
At the end of the globally declared health emergencies for Covid-19 there are clear market choices for Covid-19 vaccines and treatments. There are multiple vaccine technologies brought to market under the intense pressures of a deadly global pandemic to produce drugs to reduce the severity and mortality of the Covid-19 viruses. More than 150 research projects looked at many technologies including Viral Vector (Astro-Zenica, Johnson and Johnson, Sputnik V), Protein-Subunit/recombinant protein (Novavax), and Inactivated Virus (SinoVac, CanSino). Each vaccine completing multi-stage clinical trials also faced the issues of scaling production, managing distribution, and obtaining regulatory approvals.
The clear preference of the marketplace three years onward looks to the successes, and public expectations, for large-scale vaccine effects in the global populations. The emergence of rapidly changing variations of the Covid-19 virus (Delta, Omicron, XBB) also changed the efficacy of field vaccines across large populations. The regulatory approval of ‘bivalent’ vaccines saw another round of clinical studies, regulatory approvals, and manufacturing changes in a cycle to “keep up” with mutation and change in the epidemic nature of the vaccines. The likely need to administer slightly modified vaccines (going onward from the ‘bivalent’ to more complex vaccines like the changes annually to the ‘quadrivalent’ influenza vaccines in global markets) also puts pressures on transnational health authorities, governments, researchers, and manufacturers. The Covid-19 virus variations wait for no governance or research or manufacturing process and is thus an external compelling driver of decisions and spend.
The development of the manufacturing and distribution processes for mRNA viruses were technologically difficult. Procedures for “cold chain”, “traceability”, and “mass inoculation” were developed, improved, and re-deployed as hard lessons amid work, in the glare of global media, went on. Early assumptions on the viability and market preferences for Covid-19 vaccines were confirmed, in part, and proven false, in part. Expectations met public and political fears.
Pfizer/BioNTech have reaped a windfall of global attention and profit margins for a successful technology development and manufacturing. Distribution and delivery management technologies were successful in maintaining a high quality level measurable in multiple jurisdictions. Other developments (China, Russia, EU) had some success without creating the high levels of confidence in the drugs given to mRNA vaccines such as Pfizer/BioNTech and Moderna. In the cold view of financial success or failures the global pandemic see some clear success in this wave of the pandemic experiences.
Ongoing research for inoculation with multiple types, or technologies, are ongoing with the preference for combining the mRNA bivalent vaccines with prior viral vector or protein subunit vaccines considered an emerging technique. As an indicator of possible directions these recommendations are frequently found for immunocompromised or high vulnerability populations. Expectations are high even as clinical research looks for answers.
Novavax saw initial clinical trial success with their protein subunit vaccine, and then severe manufacturing problems beset the mass production and distribution of the vaccine. The delays led to significant financial problems for the enterprise. Investor expectations for Covid-19 successes weren't met.
The “vaccine diplomacy” sought in many media and political circles became more muted as the lethality of subsequent rounds of Covid-19 variations eased somewhat. The EU, India, and China did see their manufacturers with some success. The longer term success of these vaccines competing in global markets is not yet known while the high costs and difficulties of research continue.
The intense pressures to “replicate” manufacturing production and rapidly increase global distribution of vaccines also have lessons for introduction of radical and complex technological systems. Replicating and scaling the different technologies for vaccines in the midst of a global pandemic proved difficult for the most sophisticated contract and partner manufacturing producers in China (Fosun), Japan (Takeda), India (SII), USA (Emergent), and Korea (Samsung Biologics). China did not provide regulatory approval for a locally produced mRNA vaccine until early 2023 for CSPC Pharmaceutical Group. Ongoing global efforts to decentralize and distribute vaccine production and distribution sees the need for significant continuing investments and public health process development.
Promoters of mRNA technology are working to expand the use cases and disease types where the effectiveness of the design, testing, and production can be leveraged.
Combinations with influenza, and other contagious diseases are ongoing. The profit margins from successes with Covid-19 vaccines are positioning future drugs for these enterprises.
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