Massachusetts based biotech company Moderna is in the final stages of its COVID-19 vaccine approval process. The company, which focuses on drug discovery, drug development, and vaccine technologies based exclusively on messenger RNA, has a very promising COVID-19 vaccine candidate.
Moderna, which has already been deep in vaccine trials in America, is now engaging with international regulators to fast track the approval of its COVID-19 vaccine candidate. Specifically in Canada, health regulators will evaluate the clinical trial data from the vaccine candidate in real-time in order to speed up the approval process in Canada.
Moderna’s rolling submission was accepted last week under the Canadian Minister of Health’s Interim Order, which permits companies to present safety and efficacy data and information as they become available, rather than waiting until a clinical trial ends.
Prior to initiating the fast tracked approval process in Canada, Moderna released encouraging data about its preclinical viral challenge study and its Phase 1 study of its vaccine candidate in healthy adults (ages 18-55 years) and older adults (ages 56-70 and 71+).
Moderna’s vaccine candidate is now the third COVID-19 vaccine candidate accepted by Canada for this rolling submission process. Canada has already accepted BioNTech and Pfizer’s candidate and AstraZeneca’s candidate for the fast-tracked review process. Although several of Moderna’s testing subjects experienced adverse side effects, the trials have gone through relatively smoothly with positive results.
The Canadian government is attempting to be as transparent and as safe as possible with this rolling review program. No vaccine candidate can be approved for this program until all necessary safety measures are met. Canada will also publish all evidence and data following the approval of the vaccine. The government also pledged to order up to 20 million doses of Moderna’s vaccine once it fully completes the approval process.