Moderna, of Cambridge, Mass., said it granted an option to the European Commission to buy up to 80 million additional doses of mRNA-1273 and is set to manufacture 500 million to 1 billion doses globally in 2021. The company said the vaccine, if approved, will ship to the EU beginning in December.
The company’s shares (NASDAQ:MRNA) had a solid day Nov. 25, with shares closing 10.78% upward at $109.18.
Moderna’s European manufacturing partners are Lonza Ltd. in Switzerland and Madrid, Spain-based Laboratorios Farmacéuticos Rovi SA. Rovi will provide vial filling and packaging capacity with a new production line and equipment for compounding, filling, automatic visual inspection and labeling.
Moderna and the vaccine are on a roll. On Nov. 16, the candidate met statistical criteria prespecified in a phase III study protocol for efficacy in an interim analysis, with efficacy of 94.5%. More than 30,000 U.S. participants were enrolled in the Cove study.
The mRNA vaccine encoding for a prefusion stabilized form of the spike protein received a U.S. government award of up to $1.525 billion for 100 million doses, with an option for the government to buy up to another 400 million doses.
Moderna agreed to a supply agreement with the U.K. government Nov. 24 to supply mRNA-1273 beginning in March 2021 if it is approved for use by regulatory authorities.
SVB Leerink analyst Mani Foroohar wrote Nov. 24 that he expects most of the non-pediatric U.S. and EU population will be vaccinated by the end of 2021. That realization caused Leerink to increase Moderna’s fiscal year 2021 risk-adjusted revenue estimates from $2.4 billion to $4.5 billion but Foroohar added that mRNA-1273 will face “significant competition likely eroding a revaccination market over time, and that [Pfizer Inc./Biontech SE] will take majority share among mRNA vaccine players.”
Both vaccines posted eerily similar numbers. Final efficacy analysis numbers on the Pfizer-Biontech COVID-19 vaccine jumped to 95% from the 90% found in a Nov. 9 interim analysis. The phase III study showed BNT-162b2 met all the primary efficacy endpoints with a “p” value of <0.0001 for those without a prior SARS-CoV-2 infection, which was the first primary objective, and also for patients with and without a prior SARS-CoV-2 infection, the second primary objective.
The two companies agreed to supply the EU with 200 million doses of their mRNA vaccine along with an option to request another 100 million doses. The deal called for delivery to begin by the end of 2020.
Covaxx vaccine purchased for emerging countries
Privately held Covaxx, of Hauppauge, N.Y., and Hsinchu, Taiwan, said more than 140 million doses of its COVID-19 vaccine, worth about $2.8 billion, have been purchased for delivery in emerging countries that include Brazil, Ecuador and Peru.
The multitope, peptide-based vaccine, UB-612, was given to the first volunteers in a phase I study held in Taiwan in late September.
The vaccine comprises amino acid sequences of the SARS-CoV-2 receptor binding domain (RBD) further formulated with designer Th and CTL epitope peptides derived from the S2 subunit, membrane and nucleoprotein regions of SARS-CoV-2 structural proteins for induction of memory recall, T-cell activation and effector functions against SARS-CoV-2.
Preclinical data have demonstrated exceptionally high immunogenicity and neutralizing titers against live virus as compared to published data from other vaccine candidates to date, the company said. In guinea pigs, the Covaxx vaccine generated anti-RBD titers of greater than 1 million as measured by ELISA, and neutralizing titers exceeding 8,120 (100% neutralization in cytopathic effect) assays. Those titers are about 400 times higher than those seen in patients’ convalescent plasma.
Covaxx, a unit of United Biomedical Inc., of New York, touts UB-612 as boostable, not a one-and-done vaccine, something it has been shown effective at without side effects. The company also said the vaccine is stable at 35.6 degrees to 46.4 degrees Fahrenheit so it can be delivered and stored with normal refrigeration. Covaxx has signed a deal with Maersk for global distribution and Diagnosticos da America SA in Brazil.