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A combination COVID-19 and flu vaccine developed by Moderna is nearing approval after early clinical trials proved successful, the pharmaceutical company reported this week.
Key points:
Moderna is just one pharmaceutical company currently developing a combination COVID-19 and flu vaccine.
The earliest we could expect one of these vaccines to be approved in Australia is 2025.
Combined COVID/flu/RSV vaccines are also in development
The vaccine, called mRNA-1083, is one of several COVID-19 and flu vaccines currently in development, with pharmaceutical companies Pfizer and Novavax also conducting clinical trials with their own versions.
In a press release, Moderna said its combined Phase 1 and 2 trials evaluated the safety and effectiveness of their COVID/flu vaccine compared to:
one dose of Fluarix flu vaccine for adults aged 50 to 64
one dose of enhanced influenza vaccine, Fluzone HD, in adults 65 to 70 years old
the Spikevax booster (Moderna’s COVID-19 vaccine) for both age groups.
The vaccine was found to be safe, according to the company’s statement, with only about 4% of trial participants experiencing “third-level adverse reactions,” which are “medically significant” but not life-threatening. .
mRNA-1083 did not cause any new reactions not already linked to Flurarix, Fluzone or Spikevax, and provided similar or greater viral protection against influenza and COVID-19, according to Moderna.
The company announced plans to begin phase 3 trials in adults aged 50 and older soon and hopes to obtain regulatory approval in the United States in 2025.
Director of infectious diseases at Mater Health Services, Paul Griffin, said it was important to wait for peer review of the results, but early results looked promising.
“Their combined mRNA vaccine had a similar safety profile and efficacy levels (to current standalone vaccines), which is obviously very positive news.”
He said that when developing combination vaccines, it is important to ensure that the protection offered by one vaccine is not diminished by the other.
“This trial has established that that’s not the case, so it really paves the way for continued progress of the combination vaccine.”
Phase 3 will show the effectiveness of the vaccine
Dr Griffin said early-stage clinical trials were focused on safety and ensuring the vaccine generated sufficient levels of antibodies.
“But we can’t say that this absolutely translates into good levels of protection.
“This will have to be demonstrated in phase 3, which it should be.”
Dr. Griffin has worked on clinical trials of Novavax’s combined COVID-19/flu vaccine, and says phase 3 testing is underway after also seeing promising early results.
Novavax’s vaccine differs from Moderna’s and Pfizer’s because it is protein-based, meaning a spike protein form of the virus is injected into the body, leading to the production of antibodies.
Moderna and Pfizer make mRNA vaccines. They use strands of genetic code to instruct the body to build spike proteins, which then trigger an immune response.
Add the RSV to the mixture
Dr. Griffin says because Pfizer, Moderna and Novavax have all demonstrated their COVID-19 vaccines are “adaptable” to a combination vaccine, he expects more COVID-19 and flu vaccines are manufactured by other pharmaceutical companies.
“They will have a huge impact.”
Clinical trial stages
Pre-clinical: Animal testing. Does the vaccine produce antibodies? Does it protect against disease? What dose is needed?
Phase 1: Test on a small number of humans. This phase involves making sure the vaccine is safe.
Phase 2: More human testing: does the vaccine really work?
Phase 3: Test on a larger number of humans to confirm its effectiveness.
Phase 4: Once the vaccine is rolled out, ongoing monitoring is carried out to ensure its long-term safety.
But he’s most excited about a combined COVID-19/flu/RSV vaccine, which he’s also testing with Novavax.
RSV – respiratory syncytial virus – is a common and highly contagious respiratory virus that usually causes mild, cold-like symptoms.
“We didn’t have a vaccine for RSV until very recently in some parts of the world,” Dr. Griffin said.
“Being able to combine all of that into one vaccine is going to make a huge difference, I think.”
There is, however, a limitation to combination vaccines: the viruses they cover do not necessarily peak at the same time of year.
“COVID has not yet become seasonal, so the optimal timing for these combination vaccines will need to be carefully considered,” Dr. Griffin said.
“But, overall, I think this limitation is offset by the increase in the overall adoption rate of these vaccines.”
Combined vaccines will make vaccination easier
Many Australians have fallen behind on their COVID-19 vaccination, according to the Australian Technical Advisory Group on Immunization (ATAGI).
As of last month, only 53 percent of people aged 65 and over had received a booster dose in the past six months.
ATAGI recommends that all adults aged 75 and older receive an additional booster if six months have passed since their most recent dose.
Dr Griffin believes the combination vaccines will increase vaccine uptake because they will mean one less visit to the GP or pharmacist.
“These combination vaccines will make things simpler and easier, and will certainly help people who are less inclined to receive multiple injections.”
He believes the earliest Australia will see combined COVID-19/flu vaccines will be 2025, but that depends on positive results from upcoming clinical trials.
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