The Food and Drug Administration (FDA) approved this Wednesday the first flu vaccine in the United States that uses mRNA technology: mFlusiva, from the pharmaceutical company Moderna.
The FDA granted authorization for two age groups – adults 50 to 65 years old and adults 65 years and older – with the condition that Moderna conduct an additional clinical trial in the older age group, the company said in a statement. In a late-stage trial, mFlusiva was found to be approximately 27% more effective than a conventional flu vaccine.
Many scientists and public health experts have promoted the idea of an mRNA-based flu vaccine, which uses the same messenger RNA platform as the Moderna and Pfizer COVID-19 vaccines. This is because mRNA vaccines can be manufactured much faster than traditional vaccines, allowing scientists to better adapt to circulating influenza strains.
Moderna said it takes two to three months from strain selection to release of its flu vaccine, compared to about six months for traditional flu vaccines.
“If the strain is chosen half a year in advance, how precise can we be?”said Dr. Ofer Levy, director of the Precision Vaccines Program at Boston Children’s Hospital.
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The flu sends hundreds of thousands of people to the hospital each year, according to the Infectious Diseases Society of America, and can cause tens of thousands of deaths. Young children and older adults are more likely to get seriously ill from the flu.
The effectiveness of the traditional flu vaccine ranges from 22% to 56%, according to the Mayo Clinic. “Frankly, we wish he was older,” Levy said.
Although mFlusiva outperformed the traditional flu vaccine in a late-stage clinical trial, its approval was not a certainty.
Health and Human Services Secretary Robert F. Kennedy Jr. – an anti-vaccine activist – has repeatedly criticized mRNA technology, calling COVID-19 vaccines “the most lethal vaccines ever made.” Last year, the Department of Health and Human Services (HHS), under Kennedy, canceled nearly $500 million in funding for mRNA vaccine research.
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The FDA initially declined this year to review Moderna’s application, before backing down a week later. Agency officials said they wanted more data because Moderna had compared its vaccine to a standard flu vaccine. in adults 65 years and oldereven though the Centers for Disease Control and Prevention recommends a high-dose flu vaccine for that age group. Moderna has said the FDA had previously approved the trial design.
In June, the FDA’s independent vaccine advisory committee unanimously recommended approving the vaccine.
That decision was based on a late-stage clinical trial with more than 40,000 older adults from 11 countries, including the United States. Rates of side effects – such as injection site pain, fatigue and headaches – were more common in the mFlusiva group, but were still mild to moderate.
A combination flu and COVID-19 vaccine from Moderna, which also uses mRNAwas approved by the European Union in April. Moderna withdrew its application for approval in the United States for that vaccine last year, despite positive results from late-stage trials.
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Moderna indicated that mFlusiva will be available for this fall’s flu season.
However, vaccines are usually formally recommended by the CDC’s vaccine advisory committee – called the Advisory Committee on Immunization Practices (ACIP) – before use. But a federal judge has blocked the committee from meeting.
Levy noted that mFlusiva could still be legally prescribed in the United States without ACIP approval.
However, he noted that patients would most likely not be able to get insurance coverage, since private insurers generally only cover ACIP-recommended vaccines, and public distribution of the vaccine would be severely limited without official federal guidance on who it should be administered to. Federal programs, such as Vaccines for Children and Medicaid, also are based on ACIP recommendations.
“That is a big concern,” he said.
