American pharmaceutical and biotechnology company Moderna, Inc., which partnered with the U.S. National Institutes of Allergy and Infectious Diseases (NIAID) to develop an mRNA COVID-19 vaccine being distributed in the United States under an Emergency Use Authorization (EUA) announced that it is developing a combined single-dose booster vaccine for COVID-19 and seasonal influenza.1
In a press release, Stéphane Bancel, CEO of Moderna, stated:
I am proud of the progress that the Moderna team has made in advancing our best-in-class mRNA pipeline while addressing the global COVID-19 pandemic. We believe our mRNA platform can solve the world’s greatest health challenges, from diseases impacting millions, to ultra-rare diseases impacting dozens, to medicines personalized down to the individual level. Today we are announcing the first step in our novel respiratory vaccine program with the development of a single dose vaccine that combines a booster against COVID-19 and a booster against flu.2
Moderna’s mRNA COVID-19 and Influenza Vaccine Combo Candidate
Moderna said it is developing a new booster vaccine, mRNA-1073, that combines their existing COVID-19 vaccine booster dose mRNA-1273 with its mRNA experimental influenza vaccine in a single dose.3
According to FDA News, the combination vaccine candidate is designed to target both the SARS-CoV-2 spike protein that the coronavirus uses to enter human cells and the influenza hemagglutinin (HA) glycoprotein found on the surface of influenza viruses that plays a key role in influenza infectivity.4
Testing for the mRNA-1073 vaccine began in July 2021 and will not be available for the upcoming winter 2022 season as it is still in the initial development stages.5
Moderna’s Bancel said:
So in the same single shot, you get a high efficacy flu vaccine, the appropriate virus variant for that given year, and you walk into your CVS or go to your [general practitioner], you get one dose and you’re all set for flu and for COVID.6
Moderna’s Stock Price Up Eight Percent After Announcement of Combination Vaccine
Following its announcement of the development of the combination COVID-19 and influenza vaccine, Moderna’s stock (MRNA) price increased by eight percent, making it one of the best performing stocks in the financial market.7
On Sept. 9, 2021, Moderna was trading at $456 per share after its latest announcement of the combination vaccine. Moderna started trading in the market in early 2021 at $111 per share but it has steadily increased by more than 300 percent.8
Novavax’s Combination COVID-19 and Seasonal Influenza Vaccine Candidate
Novavax, Inc., a biotechnology company based in Gaithersburg, Maryland, announced its enrollment of the first participants in a Phase 1/2 study to evaluate the safety and immunogenicity of a combination vaccine using Novavax’s experimental seasonal influenza and COVID-19 vaccines.9
Novavax’s combined vaccine candidate uses Novavax’ COVID-19 recombinant protein-based NVX-CoV2373 and NanoFlu™ vaccine candidates and a patented saponin-based Matrix-M™ adjuvant in a single formulation known as COVID-NanoFlu Combination Vaccine.10
NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 infection. NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike protein. It is formulated with Novavax’s patented saponin-based Matrix-M™ adjuvant to stimulate an enhanced immune response and high levels of neutralizing antibodies.11
NanoFlu™ is a quadrivalent recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced by Novavax in its SF9 insect cell baculovirus system. NanoFlu uses HA amino acid protein sequences that are the same as the recommended wild-type circulating virus HA sequences. NanoFlu also contains the company’s patented saponin-based Matrix-M™ adjuvant.12
Saponin-Based Adjuvant Stimulates Strong Immune Responses
Saponin based adjuvants are derived from saponins, which are glycosides of steroid or triterpene found in some plants. They have the ability to activate the mammalian immune system and, therefore, vaccine manufacturers are interested in using saponin-based adjuvants in vaccines. Saponin adjuvants show a strong adjuvant potential to induce cytokine production in the mammalian body. The most extensively used saponin-based adjuvants are isolated from the bark of the South American tree Quillaja saponaria.13
According to Gregory M. Glenn, MD, President of Research and Development at Novavax, “This study is the first-of-its-kind to evaluate the vaccine’s potential to induce a robust immune response, augmented by our Matrix-M adjuvant, against two life-threatening diseases simultaneously.”14
Phase1/2 Clinical Trial to Be Conducted in Australia
Novavax said that it has begun its early-stage Phase 1/2 clinical trial of its COVID-NanoFlu Combination Vaccine. The trial will be conducted in Australia and will enroll 640 adults between the ages of 50 and 70 years and who have either been previously infected with SARS-Cov-2 or given an authorized COVID-19 vaccine at least eight weeks prior to the study. As part of the clinical trial, participants will receive the combination of Novavax’s COVID-19 vaccine candidate, NVX-CoV2373, and its influenza vaccine NanoFlu along with the Matrix-M™ adjuvant. Novavax expects to release the clinical trial results in the first half of 2022.15
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1 Moderna. Moderna Announces Significant Advances Across Industry-Leading mRNA Portfolio at 2021 R&D Day. Sept. 9, 2021.
3 FDA News. Moderna Prepping Single-Dose COVID-19 and Flu Booster. Sept. 13, 2021.
5 Dangor G. Moderna Is Developing A One Dose Covid-And-Flu Booster Shot. Forbes Sept. 9, 2021.
6 Mukherjee S. Moderna is working toward a single shot for both COVID and flu protection. Fortune Apr. 27, 2021.
7 Maishera H. The Shares Of Moderna Rally After The Company Introduces Single-Shot Vaccine Booster For Covid And Flu. Yahoo! Sept. 9, 2021.
9 Novavax. Novavax Initiates Phase 1/2 Clinical Trial of Combination Vaccine for COVID-19 and Seasonal Influenza. Sept. 8, 2021.
13 Creative Biolabs. Saponin.
14 Novavax. Novavax Initiates Phase 1/2 Clinical Trial of Combination Vaccine for COVID-19 and Seasonal Influenza. Sept. 8, 2021.
15 Reuters. Novavax begins early-stage trial for combined influenza/COVID-19 vaccine. Sept. 8, 2021.