There may be a combined vaccine for Covid-19 and flu in our future, although she’s not ready for this year’s flu season. On Monday (10), vaccine manufacturer Moderna announced positive results from late-stage trials for its combined Covid and flu vaccine, called mRNA-1083.
Calling the late-stage trial results “groundbreaking results,” Francesca Ceddia, Moderna’s chief medical officer, told CNN that people in the trial who received mRNA-1083 showed an improved immune response compared to those who received the separate flu and Covid vaccines that are available now.
You results were true even for people in the test who were 65 or older. Generally, older people do not have as robust a response to vaccines as younger people.
“When we think about the combination vaccine, we often just think about the convenience element, one shot instead of two, but what’s really, really innovative is the fact that you’re not only offering that advantage, but you’re also offering proof of clinical benefit. . I think that’s the most important message,” says Ceddia.
Other companies have been testing a combined Covid and flu vaccine, but Moderna is the first to announce positive results from late-stage trials.
Public health leaders say the world could use more ways to protect people from both viruses. Millions of people get sick with the flu and now Covid every year. For the last flu season, the US Centers for Disease Control and Prevention estimate that 35 to 64 million people have become ill with the flu in the United States. Between 390,000 and 810,000 people became so sick that they were hospitalized, and up to 71,000 people died.
Last fall and winter alone, Covid sent more than half a million people in the US to the hospital and killed 40,000, according to data presented last week to the US Food and Drug Administration’s (FDA) independent vaccine advisers, who were discussing how to update Covid vaccines for the fall.
Moderna’s phase 3 trial was a randomized, observer-blind, active-controlled study, meaning even the doctors administering the shots didn’t know who received which vaccines. The trial studied the vaccine in two different age groups with around 4,000 adults in each age category.
For one part of the study, Moderna compared the immune response of adults aged 65 and over who received mRNA-1083 with another group in the same age group who received the Covid-19 vaccine, Moderna’s Spikevax, and a vaccine against reinforced flu, Fluzone HD. Doctors recommend that seniors receive more potent flu shots due to their weakened immune systems.
In the other part of the trial, researchers compared how slightly younger adults, ages 50 to 64, fared when receiving the mRNA-1083 vaccine with another group within the same age group who received Spikevax and a flu vaccine from standard dose called Fluarix.
The results of the study showed that, in both age groups, the experimental combined vaccine provoked a significantly greater immune response against three strains of influenza and against Covid-19, compared to the vaccines administered separately.
“The titles are significantly larger,” says Ceddia. “This is actually better.” A titer is a laboratory test that measures the amount of antibodies in the blood and can be used to see how immune someone is to the disease.
In terms of safety, the combined vaccine was well tolerated, according to Moderna, and adverse reactions were similar to those people experienced with the vaccines administered separately. The most common complaints were pain at the injection site, tiredness, muscle pain and headache.
The study has not yet been peer-reviewed, but Moderna said it plans to present data from this late-stage trial at an upcoming medical conference and will also submit the study for publication. Moderna also said it will discuss possible next steps with the FDA.
“We need to engage with regulators, but our aspiration is to have the vaccine approved by autumn 2025,” says Stéphane Bancel, CEO of Moderna, to CNN .
Sue Peschin, president and CEO of Alliance for Aging Researcha nonprofit dedicated to improving aging and health that encourages more equitable access to vaccines, says a combination vaccine could be a significant help to public health.
In addition to intensifying vaccine hesitancy in the U.S., people have developed a kind of vaccine fatigue in the wake of the pandemic, Peschin says. He pointed to the decline in uptake of standard vaccines, such as the MMR vaccine, as well as seasonal vaccines.
Few people have taken the latest Covid vaccine, studies show. Only about 25% of the eligible population has received the latest Covid-19 vaccine, according to a presentation to the FDA last week. Many more adults have gotten a flu shot, with nearly half the adult population receiving one last season, according to the CDC, a slightly higher number than the previous year.
“We want to see that number increase, and if there’s a way to do that by combining vaccines, then that’s better for everyone because it helps protect everyone in the community,” Peschin says. “We would love to see combination vaccines come to market if the FDA deems them safe and effective.”
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*CNN’s Meg Tirrell contributed to this story.
Source: CNN Brasil
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