- A Phase 3 trial of Moderna’s experimental flu vaccine won’t be stopped early because investigators can’t determine whether it prevents disease as well as existing vaccines, the company said Tuesday.
- Preliminary study results indicate Moderna’s shot sparked a greater immune response than another vaccine for two types of influenza A, and a similar response for two types of influenza B. That outcome surpassed results from an earlier Phase 3 study, in which the shot struggled against B strains of the virus. Still, shares fell 4% in early trading after Moderna revealed the study would continue.
- While Moderna is expected to continue generating billions of yearly revenue from its COVID-19 vaccine, Wall Street analysts are increasingly focused on other sources of growth. The flu shot is one prospect being closely watched by investors. Others include a vaccine for respiratory syncytial virus as well as a personalized cancer treatment.
The success Moderna had developing a COVID-19 vaccine has led to high expectations for the rest of its pipeline, which includes shots for flu, cancer and other diseases. Prospective vaccines for flu and RSV are furthest along, with the latter headed for a regulatory review in the near future.
Still, Moderna faces its share of critics. Several Wall Street analysts are skeptical the biotech can reach the $8 billion to $15 billion in annual revenue it believes its respiratory vaccines will eventually generate.
That skepticism has been fueled by the mixed results Moderna’s flu vaccine has accrued so far. The shot, if approved, would need to compete against entrenched products from big drugmakers like Sanofi and GSK, each of which are based on more traditional vaccine technologies.
Moderna has argued that advantages in the speed and manufacturing of messenger RNA vaccines should enable it to make a more effective shot. The Phase 3 data it’s released since February, however, have cast doubt on whether the vaccine, dubbed mRNA-1010, could achieve that goal.
In one Phase 3 trial designed to evaluate its immune response, Moderna’s shot was as better than available vaccines in stimulating a response to two circulating strains of influenza A, but wasn’t able to meet a goal of being statistically “non-inferior” on two B strains.
In the second Phase 3 study discussed Tuesday that Moderna designed to test the vaccine’s ability to prevent illness, trial monitors couldn't determine whether mRNA-1010 was statistically “non-inferior” to approved vaccines after 200 cases of influenza were identified.
Moderna did say that a preliminary analysis confirmed the strength of the immune responses mRNA-1010 generated in the new trial. However, comparing immune responses was not a pre-specified study goal, making it difficult to extrapolate the findings to the more than 22,000 patients in the study, SVB Securities analyst Mani Foroohar wrote in a note to clients.
The flu data were announced as part of a special investor presentation on vaccines, which included updates on experimental shots for HIV, norovirus, and Lyme disease, as well as a refrigerator-stable version of its COVID-19 vaccine.