Global SARS-CoV-2 Outbreak – Pandemic to Blockbuster Vaccine Discovery
Since an initial outbreak of SARS-CoV-2 in Wuhan at the end of 2019, to a pandemic of over 110 million infections and 2.41 million deaths in 2021, a global effort has been made to structurally elucidate this virus and develop new vaccines to reduce its transmission. Currently, Pfizer/BioNTech, Moderna, AstraZeneca, Gamelaya, J&J, Novavax, Sinovac and Curevac have developed the most prominent vaccines in the pipeline. At the time of writing, 234 million people have been vaccinated globally, the majority being in the US, China and the EU.
Challenges of Mutations and Threats of Future Variants
The emergence of SARS-CoV-2 spike protein mutations globally have enabled the virus to become more infectious. Sequencing thousands of samples have enabled the identification of the most common mutations thus far including B.1.1.7 (UK), B.1.351 (South Africa) and P1 lineage (Japan/Brazil). Mutations such as these give the virus an evolutionary advantage for selection as they allow for protein structural changes in the spike protein.
This is most notable in Ireland which had a 5% prevalence of the B.1.1.7 strain in December 2020, which increased dramatically to 90% prevalence by February 2021. The B.1.1.7 strain contains numerous mutations in the spike region which give it a higher affinity to attach to human cells. Studies to date estimate that this variant is between 30-50% more infectious than the original strain.
Will this Have an Effect on the Efficacy of Vaccines?
Mutations arising in the spike protein of variants pose a potential problem for the efficacy of vaccines. This is due to the fact that vaccines to date target the spike protein, and so neutralizing antibodies and the T cell response are primed against the original spike protein structure. With regards the South African B1.351 variant, serum from individuals who received the Moderna mRNA-1273 vaccine were shown to have lower neutralization ability in in vitroassays. However, even though neutralization ability was lower, it was still significant.
A similar study demonstrated that neutralization of a virus containing three mutations from the South African variant from sera from individuals vaccinated with Pfizer/BioNTech BNT162b2 was lower than the UK variant. However, the study indicated that differences in neutralization was very small. This study indicates that the Pfizer/BioNtech vaccine still works against the South African strain, but is slightly less effective. Similarly, the AstraZeneca, Novavax and J&J vaccines also show slightly less protection.
A recent report in the New England Journal of Medicine evaluated a study group of 596,618 vaccinated people (matched to unvaccinated controls) in Israel for BNT162b2 COVID vaccine effectiveness. Their results indicated that BNT162b2 vaccination is highly effective in a real world population, and mirrors clinical trial results thus far.
Vaccines Penetrating the Market
Currently, there are a range of vaccines penetrating the COVID market, most notably using mRNA technology (Pfizer/BioNTech/Moderna/CureVac), recombinant proteins (Novavax), viral vectors (AstraZeneca/J&J/Gamaleya) and inactivated virus (Sinovac/Sinopharm/Bharat Biotech).
SARS-CoV-2 will continue to exist as influenza and RSV does, and so it will become an endemic virus in the future. It is forecast that we will always potentially be fighting a variant of the original virus and vaccines will adapt to this over time. Regulatory pathways will also need to adapt in concert.
What Vaccines are in the Pipeline?
Currently there are 94 Phase III clinical trials investigating vaccines and SARS-CoV-2 registered globally. The majority of these are located in Europe (25) and the US (25), with 10 being performed in Brazil, 6 in South Africa, 7 in Japan, 8 in Russia and 9 in China. Some of these agents are inactivated SARS-CoV-2 including Covaxin from Bharat Biotech, BBIBP-CorV from the Beijing Institute of Biological Products and Sinopharm and also one from the Wuhan Institute of Biological Products. Pfizer/BioNTech’s BNT162b2 is also continually being investigated in ongoing Phase III trials as is Moderna’s mRNA-1273. Novavax’s CoV-2373 is being investigated in the UK and Mexico. Medicago has a two-dose protein based vaccine, Co-VLP that is being trialled in North America, Latin America and Europe. AstraZenecas ChAdOx1 vaccine is being further evaluated in Phase III trials. Other adenoviral based vaccines in Phase III include J&J’s Ad26COVs1, Gamaleya’s Sputnik V and CanSino Biologicals Ad5-nCov.
Our analysis noted 70 Phase II trials investigating COVID vaccines globally registered. A number of the major players (Pfizer, BioNTech, Moderna, CureVac, SinoVac, Gamelaya, AstraZeneca) continue to investigate their vaccines, however the Phase II environment is also full with new players such as Sanofi, GSK, SK Bioscience, Genexine, Takeda, R-Pharm, Medigen Vaccine Biologics, Covaxx, GeneOne Life Science, Clover Biopharmaceuticals, Valneva, Arcturus Therapeutics, Cellid and AnGes.
93 registered Phase I trials are investigating COVID vaccines globally with newer players such as Providence Therapeutics, SK Bioscience, R-Pharm, Beijing Minhai Biotechnology, Bharat Biotech, ImmunityBio, Genexine, Takeda, Aivita Biomedical, GeneOne, Valneva, Altimmune, Cellid, Codagenix, Entos Pharmaceuticals, Merck, Vaxart, Arcturus Therapeutics and Medigen all expecting positive results.
So, from having zero vaccines available and knowing little about SARS-CoV-2 at the start of 2020, to having a handful of vaccines authorized for use at the start of 2021, the COVID market literally has broken every pharma and global trend.
Learn More About the COVID Vaccine Market
For more in-depth information, see our recently published SARS-CoV-2 COVID Vaccine Market Analysis & Forecast to 2026. This report describes the evolution of such a huge market in 8 chapters supported by over 74 tables and figures in over 137 pages. The report focuses on the following:
- An overview of the SARS-CoV2 virus that includes: genetic and structural analysis, mutation and variant characterization
- Global COVID vaccine market, global landscape analysis, vaccine technology breakdown and leading market players
- Advance purchase agreements, marketed/pipeline products, financial analysis and business strategy of the major companies in this space
- Focus on current trends, business environment, pipeline products, clinical trials, and future market forecast for COVID vaccines to 2026
- Clinical trial timelines for major vaccines in the pipeline
- Insight into the challenges faced by stakeholders, particularly manufacturers and governments
- Insight into the emergence of variants and their impact on vaccine effectiveness and the overall market
- Financial market forecast through 2026 with CAGR values of all market segments – vaccine technology, geography (US, EU, UK, Japan, RoW) and major players
- Influence of the molecular diagnostics, PCR testing and POC testing landscapes
- Numbers of vaccine doses available by each manufacturer per annum
- Geographical analysis and challenges within countries with respect to advance purchase agreements and distribution channels