Interim data for Moderna’s COVID-19 vaccine shows glimmers of hope
pharmafile | May 19, 2020 | News story | Manufacturing and Production, Research and Development | COVID-19, Moderna, Vaccine, coronavirus, pharma
Biotech firm Moderna has unveiled interim data from its Phase 1 trial of mRNA-1273, its vaccine against SARS-CoV-2, the virus that causes COVID-19.
The study, led by the National Institute of Allergy and Infectious Diseases (NIAID), set out to evaluate the safety and efficacy of the prophylactic therapy in three different dosages: 25µg, 100µg and 250µg, each delivered by two injections a month apart.
Moderna said it had observed dose dependent increases in patient immunogenicity across all three dosages. Of particular note, two weeks after receiving the second vaccine dose, eight patients in the lowest two dosage groups exhibited levels of binding antibodies comparable to those seen in blood samples taken from recovered COVID-19 patients; furthermore, levels in the 100µg dose group “significantly exceeded” the levels seen in blood samples.
“These interim Phase 1 data, while early, demonstrate that vaccination with mRNA-1273 elicits an immune response of the magnitude caused by natural infection starting with a dose as low as 25 µg,” commented Moderna’s Chief Medical Officer, Dr Tal Zaks. “When combined with the success in preventing viral replication in the lungs of a pre-clinical challenge model at a dose that elicited similar levels of neutralising antibodies, these data substantiate our belief that mRNA-1273 has the potential to prevent COVID-19 disease and advance our ability to select a dose for pivotal trials.”
With these new data and support including $483 million from the US Biomedical Advanced Research and Development Authority (BARDA), the company now plans to push forward into larger Phase 2 trials involving around 600 participants. The success of those studies will be key to the company’s ability to realise its ambitions of entering Phase 3 trials with the candidate by summer this year.
Matt Fellows
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