CureVac – whose vaccine is under regulatory review with the European Medicines Agency (EMA) but has not yet been authorized – notes a ‘reduced short-term peak demand for vaccines following the first wave of pandemic vaccination efforts and corresponding changes in the demand of its first-generation COVID-19 vaccine candidate, CVnCoV’.
The EU has administered 549 million doses across its four authorized vaccines (Pfizer/BioNTech, Moderna, AstraZeneca and Johnson & Johnson) since the first vaccine was authorized in December: with around 62% of the population now fully vaccinated.
Cancelled contracts reduce capacity by 200 million doses a year
Noting the need to align supply with demand, CureVac is cancelling its COVID-19 vaccine manufacturing contracts with Wacker and Celonic.
Announced in November, CureVac’s manufacturing contract with Wacker Chemie AG had seen the latter manufacture mRNA drug substance for CVnCoV at its biotech site in Amsterdam: with the contract allowing for production of more than 100 million doses a year at the site with potential for expansion.
Meanwhile, a deal with Celonic was announced in March this year: covering manufacture of another 100 million doses a year from Celonic’s Heidelberg facility in Germany (including 50 million doses in 2021).
CureVac’s existing agreements with Rentschler Biopharma and Novartis for mRNA production remain in place.
The production of clinical trial material for CV2CoV, the second-generation COVID-19 vaccine candidate jointly developed with GSK, is also unaffected. This candidate is expected to enter the clinic in the fourth quarter of 2021.
“The continuous increase in mRNA manufacturing capacity together with the progress of large-scale vaccination efforts have strongly changed the demand for our first-generation COVID-19 vaccine, CVnCoV, over the last months,” said Dr. Malte Greune, COO, CureVac.
“The development from a very high, short-term pandemic demand to broader availability of vaccines has led us to re-evaluate our immediate manufacturing capacity requirements in order to align the capacity with actual commercial and clinical capacity needs for CVnCoV. We would like to thank both our manufacturing partners for their dedication and effort in achieving our common goal to combat the pandemic with this key technology.”
CureVac and the EU signed an Advance Purchase Agreement for CureVac’s COVID-19 agreement in November, covering 225 million doses with the option for an additional purchase of 180 million doses.
In June, CureVac’s Phase 2b/3 trial, ‘Herald’, reported the vaccine was 47% effective against COVID-19 diseases of any severity: putting its efficacy figures some way below that of other mRNA COVID-19 vaccines.
However, the company remains focused to further COVID-19 vaccine development. In particular, its second-generation vaccines are taking a new mRNA backbone to its initial CVnCoV candidate in the hope of offering improved characteristics, such as low dose immune activation and stability, as well as targeting variants over the original strain.
A €150m (US$180m) partnership with GSK, announced in February, is focusing on developing second generation vaccines. This could also include a multivalent vaccine – addressing multiple strains in one vaccine – or vaccines that address multiple respiratory viruses (including COVID-19).
Results from a preclinical study, released by CureVac in August, suggested the second-generation vaccine had ‘strongly improved immune responses’ compared to the first-generation mRNA backbone.
