Moderna Submits Data for COVID Vaccine Booster to EMA

Moderna, Inc. (MRNA) revealed that it has submitted data to the European Medicines Agency (EMA) for conditional marketing approval (CMA) for the evaluation of its COVID-19 vaccine booster at the 50 µg dose level.

The 50 µg dose of the company’s booster taken six months after the second vaccine is said to induce strong antibody responses of more than 40 times against the deadly delta variant. Shares of the vaccine maker closed up 4.8% at $416.70 on September 3. (See Moderna stock charts on TipRanks)

Commenting on the efficacy of the booster dose, Stephane Bancel, CEO of the company, said, “The amended Phase 2 study and additional analyses shows that a 50 µg booster dose of our COVID-19 vaccine induces robust antibody responses against the Delta variant…We remain committed to staying ahead of the virus and following the evolving epidemiology of SARS-CoV-2.”

The company conducted an amended Phase 2 study in which it offered a 50 µg booster dose of mRNA-1273 to participants. According to the company, the efficacy of the neutralizing titers had diminished significantly approximately six months after the second dose. However, the booster dose elevated the neutralizing titers well above the Phase 3 benchmark across all age groups, especially in adults above 65 years of age.

The safety profile following dose 3 was similar to that observed before dose 2 of the vaccine. Markedly, Moderna will submit this data to a peer-reviewed publication.

Furthermore, along with inducing strong antibody responses, the additional 50 µg dose of the booster meaningfully increased the geometric mean titers (GMT) by 42.3-fold for all variants, including Beta (B.1.351) by 32- fold, Gamma (P.1) by 43.6-fold, and Delta (B.1.617.2).

Moderna has been granted emergency use by the U.S. FDA for its COVID-19 vaccine Spikevax in adults 18 years and above. It has also received emergency authorization for its vaccine use from health agencies in more than 50 countries, as well as an Emergency Use Listing (EUL) from the World Health Organization (WHO).

Recently, Jefferies analyst Michael Yee maintained a Hold rating on the stock with a price target of $425, implying 2% upside potential to current levels.

The analyst noted, “the ACIP still appears to be hesitant on whether add’l doses are needed despite waning antibodies and increasing infections…ACIP cited continued protection from severe disease, lack of correlates of protection and global “inequity” as reasons why a third dose should not be administered yet.”

Yee added, “We think the ACIP could be leaning toward just a narrow 3rd dose recommendation for high-risk people (healthcare workers, elderly) vs. the more blanket recommendation the White House favors.”

Overall, the stock has a Hold consensus rating based on 4 Buys, 7 Holds, and 2 Sells. The average Moderna price target of $285.30 implies 31.5% downside potential to current levels. Shares have exploded 666.8% over the past year.