Moderna says Covid-19 vaccine 100% effective in preventing severe disease, applies for FDA authorization
The final clinical trial results from Moderna’s coronavirus vaccine candidate have answered the critical question regarding how effective it is in averting severe Covid-19. It had 100% success in preventing severe cases of the disease that has killed close to 15 million people globally. The analysis is based on 196 confirmed cases of Covid-19.
Only 11 people in the trial who received two doses of the vaccine developed coronavirus versus 185 cases in a placebo group. That is an efficacy of 94.1%, the company said. Nobody who was vaccinated with it developed severe disease, announced the company, kickstarting the approval process with regulators around the world.
The Phase 3 study, known as the COVE study, enrolled more than 30,000 participants in the US and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA).
“The data analysis indicates a vaccine efficacy of 94.1%. Safety data continue to accrue and the study continues to be monitored by an independent, NIH-appointed Data Safety Monitoring Board (DSMB). A secondary endpoint analyzed severe cases of Covid-19 and included 30 severe cases (as defined in the study protocol) in this analysis. All 30 cases occurred in the placebo group and none in the mRNA-1273 vaccinated group. There was one Covid-19-related death in the study to date, which occurred in the placebo group,” Moderna explained in a statement.
The company will submit data from the Phase 3 study to a peer-reviewed publication. The efficacy was consistent across age, race, ethnicity and gender demographics. The 196 coronavirus cases included 33 older adults, 65 years and older, and 42 participants identifying as being from diverse communities, including 29 Hispanic or Latino, six Black, four Asian Americans and three multiracial participants.
On November 16, Moderna’s interim analysis revealed that their experimental vaccine was 94.5% effective in preventing Covid-19. The primary efficacy analysis of the Phase 3 study of mRNA-1273 confirms the high efficacy observed at the first interim analysis, the company noted.
“This positive primary analysis confirms the ability of our vaccine to prevent Covid-19 disease, 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,” said Stéphane Bancel, chief executive officer of Moderna.
The safety profile suggests that no new serious safety concerns have been identified by the company. Based on prior analysis, the most common adverse reactions included injection site pain, fatigue, myalgia or muscle pain, arthralgia or joint pain, headache, and erythema/redness at the injection site. “Solicited adverse reactions increased in frequency and severity in the mRNA-1273 group after the second dose,” it added.
20M doses could be available for Americans by 2020-end
Moderna also announced that it will submit an Emergency Use Authorization (EUA) application with the US Food and Drug Administration (FDA) on November 30 and an application for conditional approval from the European Medicines Agency (EMA). It is the second vaccine maker to apply for EUA in the US. Pfizer submitted its application on November 20,and the FDA’s advisory committee is scheduled to meet on December 10 to discuss the same.
Moderna said that the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to review its request will likely be scheduled for December 17.
Moderna is working with the US Centers for Disease Control and Prevention (CDC), Operation Warp Speed and McKesson, a coronavirus vaccine distributor contracted by the US government, as well as global stakeholders to be prepared for the distribution of the vaccine in the event that it receives EUA and similar global authorizations and approvals.
By the end of 2020, the company expects to have approximately 20 million doses of the vaccine available in the US. Moderna explained that it remains on track to manufacture 500 million to 1 billion doses globally in 2021.
“The company expects that the CDC Advisory Committee on Immunization Practices (ACIP) will make a recommendation on immunization priorities. The company anticipates that the shipping of mRNA-1273 to designated distribution points throughout the US will occur shortly after EUA is granted,” it added.
What experts are saying
Dr Penny Ward, visiting professor in pharmaceutical Medicine at King’s College London, noted it is particularly encouraging that no severe cases were documented among those who were given the vaccine. “Prevention of severe disease and hospitalization can be expected to significantly reduce pressure on overstretched health services, provided that a sufficient proportion of the high-risk population can be vaccinated,” Ward added.
Dr Michael Head, senior research fellow in global health at the University of Southampton, said the revised findings are very much in line with those previously announced by Moderna. “This is essentially good news, in that there continues to be a very high level of observed effectiveness, this effectiveness was consistent across older populations and ethnic minorities. There were also no serious adverse events caused by the vaccine. We must, of course, reserve a little caution as we await the final published results, but for now, we can retain the existing optimism that this new generation of vaccines may be deployed in the near future,” he emphasized.
Stephen Evans, professor of pharmacoepidemiology, London School of Hygiene & Tropical Medicine, said it was important not to pay too much attention to the exact percentage value of the efficacy. “While the best estimate is 94.1% against all Covid-19 disease, the statistical uncertainty in this is such that the data are compatible with a true efficacy of about 87%. This is still a very good efficacy. Similarly, the 100% efficacy against more severe disease is compatible with an efficacy of 90%, this is very good and is some evidence that severe as well as mild disease is prevented,” he explained.
Azra Ghani, professor of infectious disease epidemiology at Imperial College London, stressed that she is looking forward to the full results, which would include some data on whether the vaccine prevents asymptomatic infections. “Although not yet reported, the trial includes a secondary endpoint of asymptomatic infection – efficacy against this would be very welcome as it would give the first indication of the broader indirect impact that widespread vaccination could have in reducing onward spread,” stated Ghani.