While CVnCoV was CureVac's first COVID-19 vaccine to enter development, the timing of potential approval in Europe is not expected until the second quarter of 2022. By this time, the company's improved second-generation candidates - which could have 10x higher immunogenicity - are expected to have reached late-stage clinical development.
CureVac also notes the ‘evolving dynamics of the pandemic towards a greater need for differentiated vaccines’, saying the second-generation candidates are better placed to address these.
Vaccine development setbacks
CureVac, a Germany-headquartered biotech pioneering mRNA-based drugs for vaccines and therapeutics, announced it had started developing a coronavirus vaccine in March 2020. The vaccine entered clinical trials in June; only a matter of weeks behind Pfizer’s candidate.
The company was quick to plan capacity expansion and secure supply agreements: with an order of up to 405 million doses from the EU (representing the largest of the EU’s initial orders) secured in November.
However, in June this year the company reported disappointing efficacy figures from the vaccine: with the Phase 2b/3 study reporting 48% efficacy for the shot. And last month the company was forced to reassess potential demand for the vaccine: terminating manufacturing contracts with Wacker and Celonic as a result.
Despite the setbacks, the company had started the approval process with the European Medicines Agency (EMA). However, in an announcement today, it says the earliest date potential approval could come is in Q2 2022.
As a result, it has withdrawn the candidate from the approval process and the Advance Purchase Agreement with the European Commission will cease.
The EU now has 4 approved COVID-19 vaccines while the US has 3: with these piling up orders.
This forces other vaccines in development to carefully consider their point of difference and the size of the market for their candidates.
Like CureVac, Sanofi recently pulled its mRNA-based COVID-19 vaccine to instead focus on its partnership with GSK for a protein-based vaccine. It also pledges to continue to pursue the mRNA tech as a potential vaccine against other diseases.
All efforts behind second generation candidates
By February, however, CureVac was already expanding its COVID-19 efforts with a ‘broad pipeline’ of both first and second generation vaccines: including a partnership with GSK for improved second generation vaccines – targeting multivalent vaccines or a vaccine against multiple respiratory diseases.
In developing a different mRNA backbone, the companies hope to be able to improve on important mRNA characteristics (such as protein expression level, low dose immune activation and stability); target COVID-19 variants; and improve vaccine administration formats.
It’s this program that CureVac is now focusing its efforts on, with candidates expected to reach clinical trials within months and potential regulatory approval next year.
Published pre-clinical results have shown the strong potential of the initial second-generation mRNA COVID-19 vaccine candidate, CV2CoV, compared to CureVac’s first generation candidate: with the data demonstrating up to 10x higher immunogenicity in animal models.
In parallel to the work on the second-generation mRNA vaccine technology, GSK and CureVac will accelerate efforts to progress the development of modified mRNA vaccine constructs.
“The global fight against COVID-19 continues, and we remain committed to making a difference with a safe and efficacious vaccine," said Franz-Werner Haas, Chief Executive Officer of CureVac. "This goal has not changed, but the requirements to effectively address the virus and emerging variants have changed.
"In the ongoing transition from acute pandemic to endemic, our decision to withdraw CVnCoV from the regulatory approval process and focus our efforts on second-generation mRNA vaccine candidates reflects expected changes in public health needs that our second generation can potentially address.
“We will now take advantage of CVnCoV learnings and infrastructures to focus our resources on advanced second-generation vaccines in close collaboration with GSK, a global leader in the vaccine field.”