Health
Moderna announces that its COVID-19 and influenza combination vaccine showed positive results in late-stage trials
A combination COVID-19 and influenza vaccine may be on the way in the future, but it won't be in time for this year's flu season. Vaccine maker Moderna announced positive results from a late-stage clinical trial of its combination COVID-19 and influenza vaccine, called mRNA-1083, on Monday. Moderna's chief medical officer Francesca Cedia called the late-stage clinical trial results “groundbreaking,” telling CNN that people who received mRNA-1083 in the clinical trial had improved immune responses compared to people who received the currently available influenza and COVID vaccines alone. The results also held true for people 65 and older who participated in the clinical trial. Older people generally don't respond as strongly to vaccines as younger people. “When we think about combination vaccines, we often just think about the convenience of getting one shot instead of two, but what's really groundbreaking is that it not only provides the benefits, but also provides proof of clinical utility. “I think that's the most important message,” Cedia said. Other companies are also testing combination COVID-19 and influenza vaccines, but Moderna is the first to announce positive results in a late-stage trial. Public health leaders say the world needs more ways to protect people from both viruses. Every year, millions of people get sick with the flu, and now COVID-19. The Centers for Disease Control estimate that 35 million to 64 million people in the U.S. got the flu last flu season. 390,000 to 810,000 people were hospitalized with severe illness, and up to 71,000 people died. Last fall and winter alone, COVID caused more than 500,000 hospitalizations and 40,000 deaths in the U.S., according to data presented last week to the Food and Drug Administration's Independent Vaccine Advisory Panel, which was discussing how to update the COVID vaccine for the fall. Moderna's Phase 3 trial was a randomized, observer-blind, active-controlled trial, meaning that even the clinicians administering the shots did not know who got which vaccine. The trial studied the vaccine in two different age groups, with about 4,000 adults in each age group. In one part of the study, Moderna compared the immune response of adults 65 and older who received mRNA-1083 with another group in the same age group who received a combination of Moderna's Spikevax, a COVID-19 vaccine, and Fluzone HD, an enhanced influenza vaccine. Doctors recommend that older adults receive a stronger flu vaccine because they are more immunosuppressed. In another part of the trial, researchers compared the outcomes of slightly younger adults, ages 50 to 64, who received the mRNA-1083 vaccine with the same age group who received Spikevax and a standard dose of Fluarix, a flu vaccine. The results showed that in both age groups, the combination vaccine elicited a statistically significantly higher immune response against the three strains of influenza and COVID-19 compared with the vaccines given at the same time. “We have significantly higher titers,” Cedia said. “Actually, that's a good thing.” Titers are a laboratory test that measures the number of antibodies in the blood and can be used to prove immunity to a disease.In terms of safety, Moderna said the combination vaccine was well tolerated and side effects were similar to those people experienced with the vaccines given at the same time. The most common complaints were pain at the injection site, fatigue, 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 submit it as a paper. “We will need to discuss this with regulators, but our goal is for it to be approved in the fall of 2025,” Moderna CEO Stephane Bancel told CNN. Sue Pessin, president and CEO of the Alliance for Aging Research, a nonprofit that works to improve aging and health and promote more equitable access to vaccines, said combination vaccinations could be a big help to public health. In addition to increased vaccine hesitancy in the U.S., people are experiencing a kind of vaccine fatigue after the pandemic, Pessin said. Pessin noted declining vaccination rates for standard vaccines such as the MMR vaccine and seasonal vaccines. Studies have shown that few people have received the latest COVID vaccine. According to a presentation to the FDA last week, only about 25% of the eligible population has received the latest COVID-19 vaccine. Nearly half of the adult population got a flu shot last season, a slightly higher figure than last year, according to the CDC. “We would love to see an increase in coverage, and if we can do that with a combination vaccine, that's good for everybody because it helps protect everyone in the community,” Pessin said. “We would love to see a combination vaccine on the market if the FDA determines it's safe and effective.” CNN's Meg Tyrrell contributed to this report.
While it may not be ready in time for this year's flu season, a combination COVID-19/flu vaccine may be on the way in the future.
On Monday, vaccine maker Moderna Announced The company has seen positive results from late-stage trials of a combination COVID-19 and influenza vaccine it calls “mRNA-1083.”
Moderna's chief medical officer, Francesca Cedia, called the late-stage trial results “groundbreaking results” and told CNN that trial participants who received the mRNA-1083 vaccine had improved immune responses compared with those who received the currently available flu and COVID vaccines alone. The results also held true for people over 65 who participated in the trial; older people generally don't have as strong a response to vaccines as younger people.
“When we think about combination vaccines, we often just think about the convenience factor of one dose instead of two. But what's really groundbreaking is the fact that it not only provides that benefit, but also provides evidence of clinical benefit. I think that's the most important message,” Sedia said.
Other companies I've been testing A combination COVID-19 and influenza vaccine is in the works, with Moderna becoming the first company to announce positive results from late-stage trials.
Public health leaders say the world needs more ways to protect people from both viruses. Millions of people get sick every year with the flu and now COVID. Last year's flu season: Centers for Disease Control and Prevention An estimated 35 million to 64 million people in the U.S. were sickened by the flu, 390,000 to 810,000 were hospitalized with severe illness, and up to 71,000 died. Last fall and winter alone, COVID caused more than 500,000 hospitalizations and 40,000 deaths in the U.S., according to data provided last week to independent vaccine advisers to the Food and Drug Administration, who were discussing how to update COVID vaccines for the fall.
Moderna's Phase 3 trial was a randomized, observer-blinded, active-controlled trial, meaning that even the clinicians administering the vaccine did not know who received which vaccine. The trial studied the vaccine in two different age groups, with about 4,000 adults in each age group.
In one part of the study, Moderna compared the immune responses of adults 65 and older who received mRNA-1083 with another group in the same age group who received a combination of Moderna's COVID-19 vaccine, Spikevax, and the enhanced flu vaccine, Fluzone HD. Doctors recommend Older people have suppressed immune systems and therefore require stronger influenza vaccines.
In the other part of the trial, the researchers compared outcomes in slightly younger adults, between 50 and 64 years of age, who received the mRNA-1083 vaccine with another group in the same age group who received Spikeevax plus a standard dose of the flu vaccine, Fluarix.
The study results showed that in both age groups, the combination vaccine elicited statistically significantly higher immune responses against the three strains of influenza and COVID-19 compared with simultaneous vaccination.
“We're seeing a significant increase in antibody titers,” Sedia said, “which is actually a good thing.” Antibody titers are a lab test that measures the number of antibodies in the blood and can be used to prove how immune someone is to a disease.
In terms of safety, Moderna said the combination vaccine was well tolerated and side effects were similar to those people experienced with the combination vaccine. The most commonly reported complaints were pain at the injection site, fatigue, muscle pain, and headache.
The study has not yet been peer-reviewed, but Moderna said it plans to present data from the late-stage trial at an upcoming medical conference and also plans to submit the results for publication. Moderna also said it will discuss possible next steps with the FDA.
“We need to discuss this with regulators, but our goal is to get approval in the fall of 2025,” Moderna CEO Stephane Bancel told CNN.
Sue Pessin, president and CEO of the Alliance for Aging Research, a nonprofit that works to improve aging and health and promote more equitable access to vaccines, said the combined shot could be a big help to public health.
Pessin said there is growing hesitancy about getting the vaccine in the U.S., as well as a kind of vaccine fatigue in the wake of the pandemic. Pessin pointed to declining vaccination rates for standard vaccinations. MMR vaccine, etc. It is used in vaccines as well as seasonal vaccines.
Study finds minority of people have received the latest COVID vaccine doses. According to a presentation to the FDA last week, only about 25% of the target population has received the latest COVID-19 vaccine. Nearly half of the adult population received the flu vaccine last season; even more of the adult population has received the flu vaccine. According to the CDC:This figure was a slight increase from the previous year.
“We would love to see those numbers go up, and if we can do that with a combination vaccine, it's better for everyone because it protects everyone in the community,” Pessin said. “Our hope is that we'll have a combination vaccine on the market if the FDA determines it's safe and effective.”
CNN's Meg Tyrrell contributed to this report.
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