Moderna releases Interim Phase III results of its COVID-19 vaccines with 94.5% efficacy

November 17, 20200

Moderna’s interim readout of Phase 3 results of its COVID-19 mRNA vaccine brings cheer at the heel of last week’s announcement from Pfizer. Moderna has reported interim analysis from the Phase 3 COVE study that has completed enrolment of 30,000 participants. As on date of interim reporting, 5 cases of COVID-19 were reported in the vaccinated group versus 90 cases of COVID-19 in the placebo group, indicating a 94.5% efficacy of the vaccine. Moderna is conducting the trial in collaboration with National Institute of Allergy and Infectious Disease (NIAID), National Institute of Health (NIH) and Biomedical Advanced Research and Development Authority (BARDA).

The primary endpoint of Phase III COVE study is based on confirmed and adjudicated COVID-19 cases, starting two weeks following the second dose of vaccine. A secondary endpoint was also analysed amongst the 95 participants for severe COVID-19 cases observed in 11 cases. All the 11 with the severe condition were from the placebo group. The results did not indicate any safety concerns. Majority of adverse events were mild or moderate in severity and very short lived which included injection site pain (2.7%), and after the second dose included fatigue (9.7%), myalgia (8.9%), arthralgia (5.2%), headache (4.5%), pain (4.1%) and erythema/redness at the injection site (2.0%)The data would however change base on the final analysis from all participants of the study. Based on the results in upcoming weeks, Moderna has also indicated that it will be submitting for Emergency Use Authorization and applications for authorizations to global regulatory agencies. The vaccine received FDA’s fast track designation on 12 May this year. Moderna expects to have approximately 20 million doses of mRNA-1273 ready to ship in the U.S, by the end of 2020 and 500 million to 1 billion doses globally in 2021. 

The dissemination of interim results by Pfizer and Moderna manufacturers can be seen as a promising sign to have effective vaccines disseminated early next year and draw attention to mRNA-based vaccines. With the data presented in interim results, there is a need to understand the period of immunity provided by the vaccine and the possibility of the need for subsequent booster doses. While these questions on vaccine efficacy exist, the concern around large scale manufacture for global access prevails. While multiple government deals have been signed by US and EU, to ensure global access of vaccines, more deals need to be forged that provide vaccine availability in other parts of the world. The other vaccine developers also need to accelerate their clinical activities in order to meet the demand supply gap. Another major challenge is in the logistics for supply chain to transport these vaccines with Pfizer’s vaccine requiring –70 degrees and Moderna vaccine at –20 degrees. While companies are focussed at designing existing vaccines to be thermostable, these mRNAbased COVID-19 vaccines are heat sensitive making last mile deliveries a substantial challenge that need to be addressed. 

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