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COVID-19 Vaccine: Moderna Gets $483M Funding Boost from BARDA
By Rajaneesh K. Gopinath, Ph.D.
Moderna, the Cambridge-based, clinical-stage biotech, specializes in mRNA therapeutics and vaccines. It was the first to attempt human testing of a potential COVID-19 vaccine in an NIH-funded study conducted at the Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle. On April 16th, it announced an award of US$ 483 million received from the Biomedical Advanced Research and Development Authority (BARDA), an assistance that will hugely back its efforts. BARDA is funding two other COVID vaccine efforts – one with Sanofi and another with Johnson & Johnson that is worth US$ 1 billion.
The phase I study of the mRNA vaccine candidate, mRNA-1273 has completed the enrollment of the 45 healthy volunteers belonging to the age group of 18-55 years. They are tested with 3 concentrations (25, 100, 250 μg), administered on a two-dose vaccination, scheduled 28 days apart. In order to expand the scope of the vaccine, recently the NIH revised the study to incorporate 3 cohorts of older adults between ages 56 and 70 and three cohorts of adults 71 and above. Moderna intends to begin a Phase 2 study in the second quarter under its own IND application after analyzing Phase I results. Following positive safety and efficacy data, a Phase 3 study could also begin as soon as fall this year, post discussions with regulators.
“Vaccines are a critical tool for saving lives and stopping the spread of the SARS-CoV-2 virus,” said BARDA Director Rick Bright, Ph.D. “Delivering a safe and effective vaccine for a rapidly spreading virus requires accelerated action. BARDA’s goal is to have vaccine available as quickly as possible and preparing now for advanced stage clinical trials and production scale-up while the Phase 1 is underway could shave months off development of COVID-19 vaccines.”
Under the terms of the agreement, BARDA will fund Moderna to get its vaccine to FDA licensure by supporting its late-stage clinical development programs and large scale manufacturing. For the same, Moderna plans to get on board 150 new employees in the skilled manufacturing, clinical and regulatory departments to ramp up production and clinical development.
“We are thankful for BARDA’s support to fund the accelerated development of mRNA-1273, our vaccine candidate against SARS-CoV-2,” said Stéphane Bancel, Moderna’s CEO. “Time is of the essence to provide a vaccine against this pandemic virus. By investing now in our manufacturing process scale-up to enable large scale production for pandemic response, we believe that we would be able to supply millions of doses per month in 2020 and with further investments, tens of millions per month in 2021, if the vaccine candidate is successful in the clinic.”
In a conference call this morning, Bancel mentioned that these expansions will be at their dedicated in-house manufacturing facility in Norwood and also in other locations within and outside the US with the help of a partner CMO that would be revealed shortly. He clarified that this grant does not support any vaccine stockpiling efforts. In terms of the safety and efficacy data, he said they look forward to understanding two major outcomes from the early trails; the ability of the vaccine to induce neutralizing titers consistently and the optimum dosage. Secondly, how effectively can these antibodies offer protection, the determination of which will also depend on data from their parallel studies. The relationship data between dosage and ability itself would allow them to design further trials with decisive clinical endpoints.
Related Article: Pioneers Sanofi, GSK to Jointly Develop COVID-19 Vaccine
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