One of the leading Biotech companies worldwide, Moderna, is all set to file for a quick authorization of its vaccine against COVID-19 as the results prove it to be the most effective one to date.
Based in Massachusetts, Moderna is a biotech company that uses mRNA to treat viral diseases. The company has been previously in the news for having the highest IPO for a biotech based company.
The aspiring company has now finished its Phase 3 Cove study for the COVID-19 vaccine. After the success of its interim study, the novel vaccine entered the phase 3 study that included 30,000 people who were given the vaccine. The study was performed in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) and monitored by NIH appointed Data Safety Monitoring Board (DSMB).
Moderna, in its press release, stated:
‘’Primary efficacy analysis of the Phase 3 COVE study of mRNA-1273 involving 30,000 participants included 196 cases of COVID-19, of which 30 cases were severe
Vaccine efficacy against COVID-19 was 94.1%; vaccine efficacy against severe COVID-19 was 100%’’
Its development
The vaccine, like most of the other potential COVID-19 vaccines, is an mRNA based one. Initially, a total of 95 cases were made subjects for the vaccine trial in the interim analysis phase. What determined the vaccine’s fate (primary endpoint in scientific language) was the analysis result from the confirmed COVID-19 cases two weeks after the administration of the second dose of the vaccine.
The study included a placebo group and an mRNA-1273 group. The former was not given the actual vaccine, while the latter was. 30 severe cases arose, none of which were from the group that was given Moderna’s vaccine.
The results were analyzed against various parameters, including age, gender, and ethnicity. The vaccine proved to be efficient at a striking rate of 94.1% in the mRNA-1273 group, way past the benchmark set by the Food and Drug Administration, which is 50%. The trial was carefully monitored to keep all the safety concerns in check. Fortunately, no safety concerns have been reported as of yet.
Other vaccines that have made it this far include Pfizer and BioNTech’s vaccine. The vaccine showed a success rate of 90% among the vaccinated and placebo groups. The companies have filed in the EU for vaccine authorization. The only problem with this vaccine is its distribution to developing countries and underdeveloped areas. The vaccine ought to be stored at -70°C, a temperature that can be quite challenging to maintain in areas that do not have adequate resources and consistent power supply.
Moderna’s official press release did not include any such conditions. However, the distribution of the COVID-19 vaccine is still going to be a challenge, with or without such conditions. The vaccine might not be within the financial reach of numerous countries. Moderna intends to charge $32-37 per dose in the developed countries. We may expect a reduced rate for the developing and underdeveloped countries. So far, the company has only said that it will be ready with 20 million doses for the US. While its competitor candidate, Pfizer and BioNtech did insinuate towards the global distribution of the vaccine by saying that they will be preparing 50 million doses for the US and other countries.
What experts say
Deborah Dunn-Walters, Chair of the British Society for Immunology COVID-19 and Immunology taskforce and Professor of Immunology at the University of Surrey, commented:
“Today’s announcement from Moderna provides further information on the results from their phase 3 trial for the mRNA-1273 vaccine against COVID-19. While the reported vaccine efficacy of 94.1% is very positive news, we still need to see the complete dataset to be able to accurately assess the full results and implications. The fact that no serious cases of COVID-19 were reported in the vaccinated group should be a cause for optimism. We await the full trial results with anticipation.”
While many biotech companies are making their efforts to solve one of the worst healthcare crises of the decade, hearing from the experts on this vaccine by Moderna surely is relieving.
Further, Stéphane Bancel, Chief Executive Officer of Moderna, said:
“This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1% efficacy and importantly, the ability to prevent severe COVID-19 disease. We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations and death,”
Moderna has now filed in the EU for emergency authorization of its vaccine. We should expect to hear more about it any time around the mid of December.
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