Inherent challenges to traditional flu vaccine manufacturing can easily be overcome with messenger RNA (mRNA) says Moderna, which is moving a candidate into Phase III trials.
The success of its COVID-19 vaccine Spikevax has encouraged Moderna’s pipeline of mRNA vaccines and therapeutics. Having already spoken brightly about the modality’s potential in tackling latent diseases – herpes, HIV, cytomegalovirus, for example – the company has lauded mRNA’s potential to overcome the “premature picking” issues seen in the yearly influenza vaccine production process.
“Traditional flu vaccines have struggled to show vaccine efficacy that’s better than the 20% to 60% range in a typical year,” Lavina Talukdar, Moderna’s SVP and head of Investor Relations said at the UBS 2022 Global Healthcare Conference yesterday.
“There are some thought processes in which why that maybe the case: the flu virus itself is highly mutative – there are many, many mutations that happen even within the season. And as a result of the structure of bringing flu vaccines to market, the strains that are picked are picked six months in advance due to bottlenecks or lead-time that’s required for the traditional manufacturers.”
She continued: “As a result of that premature picking, oftentimes you see strain mismatches happen which can lead to lower vaccine efficacy. So those are challenges that are kind of inherent to the traditional flu vaccine makers, but not inherent to mRNA.”
Moderna, with mRNA, claims it can select the strains far closer to the flu season, potentially bringing about a flu vaccine more matched to circulating strains, as well as adding additional antigens to the jab.
Moderna’s candidate mRNA-1010 has completed Phase II trials with promising readouts and the firm is looking set to move it into Phase III later this quarter.
While Talukdar said her firm is taking a “speed to market approach” she stressed it is following all the regulations in place for strain selection, following the World Health Organization’s (WHO’s) strain recommendations for the southern and northern hemispheres.
“The conventional path for getting a new product on to market in flu is to do the two Phase III studies (one of them is an immunogenicity study typically, and then that’s followed up with a vaccine efficacy study),” she said.
“There is an accelerated path that may be available to Moderna, in that we can show immunogenicity that is non-inferior to an active comparator, an already approved flu vaccine, and get on to the market just off of that data.
And then we would have to follow it up as a post-market commitment to do a vaccine effectiveness or vaccine efficacy study. We’re in discussions with regulators at this point in time to see if that path is available to us, and if it is then obviously we’ll take it. But we will also be very ready with a follow-up study with the vaccine efficacy in Phase III later this fall as well.”