Moderna Announces Publication of Phase 1 Data for mRNA Vaccines Against Two Potential Pandemic Influenza Strains
Published in the journal Vaccine, data show vaccines targeting the H10N8 and H7N9 influenza viruses to be highly immunogenic and well-tolerated in healthy adults
Results are from Moderna’s first human studies of mRNA vaccines; demonstrates a new technological approach to flu vaccine development and production
Published in the scientific journal Vaccine, the findings include results from two randomized, placebo-controlled, double-blind Phase 1 studies. Both studies met their primary safety and secondary immunogenicity endpoints, and there were no vaccine-related serious adverse events (AEs) reported. In both studies, injection site pain was the most common solicited local AE.
Both H10N8 and H7N9 influenza infections have demonstrated high fatality rates, however neither have an approved vaccine.
“Both seasonal and pandemic influenzas are serious public health
problems, and there is a clear need for effective vaccines that can be
quickly developed and deployed. Production of current flu vaccines takes
significant time and requires virus or antigen production in
cell-culture or eggs and in dedicated facilities,” said
H10N8 Study Design and Results
In the H10N8 study, 201 healthy volunteers aged 18 to 64 years received two doses of vaccine or placebo three weeks apart, intramuscularly (IM) at dose levels from 25 μg to 400 μg, or intradermally (ID) at dose levels of 25 μg or 50 μg. The 100 μg IM dose induced seroprotective immunity of hemagglutination inhibition (HAI) ≥ 1:40 in 100 percent of participants and microneutralization (MN) titers ≥ 1:20 in 87 percent of participants. The 25 μg ID dose induced HAI titers ≥ 1:40 in 64.7 percent of participants compared to 34.5 percent of participants receiving the IM dose. HAI titers of 1:40 and MN titers of 1:20 are expected to be protective in seasonal flu vaccines.
H7N9 Study Design and Results
In the H7N9 study, 156 healthy volunteers aged 18 to 49 years received two doses of vaccine or placebo three weeks apart (IM) at dose levels of 10 μg, 25 μg and 50 μg. A small subgroup also received two doses of 25 μg or 50 μg IM six months apart. IM doses of 10 μg, 25 μg and 50 μg achieved HAI titers ≥ 1:40 in 36 percent, 96.3 percent and 89.7 percent of participants, respectively. MN titers ≥ 1:20 were achieved by 100 percent in the 10 μg and 25 μg groups and by 96.6 percent in the 50 μg group.
Future development of Moderna’s pandemic influenza program is contingent on government or other grant funding.
A link to the publication, mRNA Vaccines Against H10N8 and H7N9 Influenza Viruses of Pandemic Potential are Immunogenic and Well Tolerated in Healthy Adults in Phase 1 Randomized Clinical Trials, can be found here.
This is the third peer-reviewed publication of human data using
About Moderna’s Prophylactic Vaccines Modality
Moderna has 21 mRNA development candidates in its pipeline, with 11 programs now in the clinic. These investigational medicines are grouped together into six modalities based on similar mRNA technologies, delivery technologies and manufacturing processes. Typically, programs within a modality will also share similar pharmacology profiles, including the desired dose response, expected dosing regimen, target tissue for protein expression, safety and tolerability goals, as well as their pharmaceutical properties.
Vaccine is the pre-eminent journal for those interested in
vaccines and vaccination. It is the official journal of
Special Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995, as
amended including, but not limited to, statements concerning: the
immunogenicity, tolerability, and future expectations regarding
mRNA-1440 and mRNA-1851; the potential of mRNA-based vaccines to quickly
and effectively address pandemic influenza strains; the potential of
Moderna’s mRNA platform to demonstrate similar or better immunogenicity
than existing vaccines that can be rapidly produced; and Moderna’s mRNA
development candidates’ ability to have a therapeutic or preventive
benefit and their potential to address a broad spectrum of diseases. In
some cases, forward-looking statements can be identified by terminology
such as “will,” “may,” “should,” “expects,” “intends,” “plans,” “aims,”
“anticipates,” “believes,” “estimates,” “predicts,” “potential,”
“continue,” or the negative of these terms or other comparable
terminology, although not all forward-looking statements contain these
words. The forward-looking statements in this press release are neither
promises nor guarantees, and you should not place undue reliance on
these forward-looking statements because they involve known and unknown
risks, uncertainties and other factors, many of which are beyond
Moderna’s control and which could cause actual results to differ
materially from those expressed or implied by these forward-looking
statements. These risks, uncertainties and other factors include, among
others: whether Phase 1 results for mRNA-1440 and mRNA-1851 will be
predictive of any future clinical studies; whether mRNA-1440 and
mRNA-1851 will be unsafe or intolerable during future clinical studies;
clinical development is lengthy and uncertain, especially for a new
class of medicines such as mRNA, and therefore our clinical programs or
development candidates may be delayed, terminated, or may never advance;
no mRNA drug has been approved in this new potential class of medicines,
and may never be approved; mRNA drug development has substantial
clinical development and regulatory risks due to the novel and
unprecedented nature of this new class of medicines; and those risks and
uncertainties described under the heading “Risk Factors” in Moderna’s
most recent Annual Report on Form 10-K filed with the