The Food and Drug Administration’s vaccine advisory panel approved Moderna’s new flu vaccine, which uses the same mRNA technology as the COVID-19 jab, for older adults.

The committee overwhelmingly backed the vaccine, known as mFlusiva or mRNA-1010, for two age brackets.

One vote was for adults ages 50 to 64, while the other was for the 65-and-older age group.

Both votes were 9-0 in favor of approving the mRNA jab.

Fierce Biotech explained further:

During the daylong event, panelists discussed the vaccine’s efficacy and safety data (PDF), plus existing options for influenza vaccination and the current flu landscape in the U.S.

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While presenters acknowledged the range of available influenza vaccines, several argued that an mRNA option could enable speedier production and therefore help officials match each year’s vaccine to circulating strains more accurately.

In Moderna’s presentation to the panel, Rituparna Das, M.D., Ph.D., SVP of clinical development in infectious and rare diseases at the company, noted that “current influenza vaccine technologies can be affected by the long interval between strain selection and vaccination.

“By directly encoding the selected antigen sequence, avoiding egg adaptation and supporting a more flexible manufacturing timeline, mRNA-1010 has the potential to address important limitations of current influenza vaccines and improve protection in a population that continues to experience substantial influenza disease burden,” she said.

Brownstone Institute President Jeffrey Tucker said the approval happened because of “profits.”

Moderna isn’t the only COVID-19 jab manufacturer to receive a recent thumbs-up for its products.

According to reports, the Centers for Disease Control and Prevention (CDC) awarded Pfizer $1.24 billion for COVID-19 jabs.

Vaccine Manufacturer Receives Over $1.2 Billion For Pediatric And Adult COVID-19 Jabs, Report Says

More from the Associated Press:

At the meeting, FDA vaccine reviewer Dr. Timothy Brennan suggested the agency was open to approving the vaccine for older adults ahead of the coming flu season, despite the need for more information about its use in frail seniors or people with weak immune systems.

If it’s approved, Moderna is planning its required next-step study to include 400,000 people 65 and older, half given the mRNA vaccine and the rest given one of today’s special-for-seniors shots. It’s supposed to repeat that study for two flu seasons.

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Moderna’s data showed no major safety issues although the shot did cause some temporary reactions including injection-site pain, fever, headache, tiredness and aches. The latter reactions are common in a variety of vaccines, but occurred somewhat more often than with today’s flu shots. The FDA said that’s typical of mRNA vaccines.

Those temporary reactions can be a signal that “your immune system is responding,” said Dr. Hayley Gans, a Stanford Medicine pediatrician and FDA adviser who stressed it will be important to explain that to vaccine recipients.

Earlier this year, Moderna’s data was at the center of a highly unusual public dispute as a then-top FDA official blocked the company’s application for its first-of-its-kind shot.

The embattled vaccine chief at the time, Dr. Vinay Prasad, said the company should have compared its shot to a high-dose flu vaccine recommended for seniors rather than a standard-dose brand. It was a sign of FDA’s heightened vaccine scrutiny under Health Secretary Robert F. Kennedy Jr.

 

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