The rapid development and distribution of highly efficacious messenger ribonucleic acid (mRNA) vaccines has been regarded as a great success, especially during the ongoing pandemic. As COVID-19 cases continue to soar in some countries, demand for Pfizer and Moderna’s vaccines is fast exceeding production capabilities. Restrictions placed on AstraZeneca and Johnson & Johnson’s adenovirus-based vaccines due to links with rare blood clots have placed additional pressures on global vaccine rollouts, particularly in Europe. CureVac’s expected entry into the COVID-19 vaccine market may provide a viable alternative and help address vaccine inequality because of its vaccine’s unique properties.
CureVac is developing an mRNA vaccine that encodes the spike protein of the SARS-CoV-2 virus, similarly to Moderna and Pfizer’s vaccines. In November 2020, CureVac’s vaccine candidate CVnCoV was shown to elicit a significant immune response in Phase I studies, while also being safe and well tolerated in the trial population. After releasing the positive Phase I data, CureVac signed collaborations and partnerships with larger pharmaceutical companies, such as Bayer and Novartis, to aid vaccine production, as well as GlaxoSmithKline to produce next-generation COVID-19 vaccines.
CVnCoV is undergoing Phase II/III studies in Europe and Latin America, with a special focus on areas with a high number of variant cases. CureVac aims to publish data from the study in the coming weeks. However, as the vaccine mainly targets the highly transmissible variants, due to the trial’s location, its efficacy may be reduced compared with the other mRNA vaccines.
In February 2021, the European Medicine Agency (EMA) began a rolling review for CVnCoV to determine whether to grant expedited approval following an assessment of the Phase II/III clinical trial data. The potential approval of CVnCoV comes at an important time, when global confidence in adenovirus-based vaccines has suffered as a result of AstraZeneca and Johnson & Johnson’s vaccines being linked to rare blood clots.
While CureVac’s delayed approach has led to the company losing ground to Pfizer and Moderna, especially in the US market where it is not thought to be seeking approval currently, it was able to produce a more stable vaccine. While Pfizer’s BNT162b2 needs to be stored at -70°C and Moderna’s mRNA-1273 at -20°C, CureVac’s CVnCoV can be stored in standard refrigeration at 5°C. This makes it far easier to distribute, making it a much better bet for developing countries, many of which are expecting significant outbreaks and have not yet had sufficient access to mRNA vaccines because of procurement barriers and the logistical and infrastructure challenges of ultra-cold storage.
Additionally, CureVac’s CVnCoV Phase II/III trial is assessing two doses of 12µg of CVnCoV, significantly lower than Pfizer’s 30µg dose and Moderna’s 100µg dose, potentially allowing for faster manufacturing. The low dosage coupled with favorable storage conditions may meet the current urgent demand for easily transportable, safe, and efficacious vaccines, and could help address vaccine inequality in poorer regions, assuming regulatory approval.