Biotechnology company Moderna will soon enter the final stage of human trials for their potential COVID-19 vaccine. The trial is expected to conclude in late October, although early results should be available before then.
In a statement, the company announced they will enter Phase 3 of human testing on July 27. Phase 3 will involve 30 000 participants in the US, half of whom will receive the mRNA-1273 vaccine and the other half placebos. Their reactions will be monitored over two years to determine the efficacy of the vaccine. Preliminary results are expected to be available before October, when the study is expected to conclude.
The Moderna vaccine was the very first to be tested on humans, and has already yielded positive results. In a preliminary study to evaluate the safety and immunogenicity of the vaccine, researchers found that the mRNA-1273 vaccine induced anti–SARS-CoV-2 immune responses in all 45 healthy adult participants, aged 18 to 55 years of age. They all developed neutralising antibodies in levels similar to recovered COVID-19 patients, which has been shown to inactivate the virus in lab tests.
Experts agree that the results are encouraging, but still in early stages. The presence of antibodies does not necessarily make someone immune to COVID-19, and more testing is necessary. Moderna asserts that their results are positive, and they look forward to results on Phase 3.
“These Phase 1 data demonstrate that vaccination with mRNA-1273 elicits a robust immune response across all dose levels and clearly support the choice of 100 µg in a prime and boost regimen as the optimal dose for the Phase 3 study,” said Dr Tal Zaks, Chief Medical Officer of Moderna. “We look forward to beginning our Phase 3 study of mRNA-1273 this month to demonstrate our vaccine’s ability to significantly reduce the risk of COVID-19 disease.”
“These positive Phase 1 data are encouraging and represent an important step forward in the clinical development of mRNA-1273, our vaccine candidate against COVID-19, and we thank the NIH for their ongoing collaboration. The Moderna team continues to focus on starting our Phase 3 study this month and, if successful, filing a BLA,” said Stéphane Bancel, Chief Executive Officer of Moderna.
“We are committed to advancing the clinical development of mRNA-1273 as quickly and safely as possible while investing to scale up manufacturing so that we can help address this global health emergency.”
If the vaccine is deemed a success, Moderna aims to deliver approximately 500-million doses per year and possibly up to 1-billion doses per year from 2021.
Moderna is the leading company in the race to find a COVID-19 vaccine. According to the World Health Organization (WHO), there are currently 23 candidate vaccines in clinical evaluation and 140 candidate vaccines in preclinical evaluation.