Moderna seeks regulatory authorization for its COVID-19 vaccine

Pharmaceutical company Moderna, which is among the organizations creating a vaccine for COVID-19, announced today it is submitting a request for an emergency use authorization (EUA) from the U.S. Food and Drug Association for its messenger RNA (mRNA) vaccine candidate.

Moderna will also be submitting an application for Conditional Marketing Authorization with the European Medicines Agency.

The company has already initiated the rolling review process with the EMA, Health Canada, SwissMedic, the United Kingdom Medicines and Healthcare products Regulatory Agency, Ministry of Health in Israel and Health Sciences Authority in Singapore, and intends to seek prequalification and/or emergency use listing with the World Health Organization.

The FDA's Vaccines and Related Biological Products Advisory Committee will review the safety and efficacy data package for the vaccine candidate, likely scheduled for Dec. 17, Moderna said in its release.

Additionally, Moderna reported that its data analysis indicates a vaccine efficacy of 94.1%.

WHAT'S THE IMPACT?

The primary data analysis was based on 196 COVID-19 cases, of which 185 were observed in the placebo group compared with 11 cases in the treatment group, resulting in a point estimate of vaccine efficacy of 94.1%.

Other analyses included severe COVID-19 cases, all 30 of which occurred in the placebo group. The researchers noted one death in the study to date, which also occurred in the placebo group.

Moderna's clinical trial, called the Phase 3 COVE study, is a one-to-one placebo-controlled study with more than 30,000 participants ages 18 and older in the U.S. The study group represents a diverse range of people, including more than 7,000 Americans over the age of 65, more than 5,000 Americans who are under the age of 65 but have high-risk chronic diseases and more than 11,000 participants from communities of color.

Efficacy was consistent across age, race and ethnicity, and gender demographics, according to Moderna. The 196 COVID-19 cases included 33 older adults and 42 participants who identified as being from diverse communities.

Using prior analysis, Moderna found that the most common adverse reactions to the vaccine was injection site pain, fatigue, myalgia, arthralgia, headache and redness at the injection site. The adverse reactions increased in frequency and severity following the second dose of the mRNA.

Moderna plans to submit the data from the Phase 3 COVE study to a peer-reviewed journal for publication.

The company is on track with its manufacturing goals, expecting to have approximately 20 million doses available in the U.S. by the end of the year. Further, Moderna said it was on target to reach between 500 million to 1 billion doses globally in 2021.

THE LARGER TREND

With this news, Moderna has become the second organization to submit for an EUA. Earlier in November, Pfizer applied for an EUA for its vaccine that it says has an efficacy of 90%.

AstraZeneca recently released findings from its COVID-19 vaccine trial showing its candidate resulted in an average efficacy of 70%. The company has yet to submit for an EUA but said it is preparing for global regulatory submission of its data.

The FDA has now authorized three drugs for the treatment of COVID-19.

The first was the antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years old and older and weighing at least 88 pounds for COVID-19 treatments requiring hospitalization.

Next was Eli Lilly and Company's investigational neutralizing antibody bamlanivimab, which is authorized for the treatment of mild to moderate COVID-19 in adults and pediatric patients 12 years and older with a positive COVID-19 test who are at high risk for progressing to severe COVID-19 and/or hospitalization.

The FDA also authorized Regeneron's monoclonal antibody therapeutics, casirivimab and imdevimab, to be administered together for the treatment of mild to moderate COVID-19 non-hospitalized adults and pediatric patients 12 years of age or older weighing at least 88 pounds who are at high risk for severe progression.

Once a vaccine is authorized, delivery will begin within 24 hours, according to officials from Operation Warp Speed.

Vaccine distribution will be based on the availability of the vaccine in proportion to the population of the jurisdiction and will be allocated based on CDC recommendations for high-risk populations.

ON THE RECORD

"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," said Stéphane Bancel, the CEO of Moderna. "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."

Twitter: @HackettMallory
Email the writer: mhackett@himss.org