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With weeks left in flu season, the FDA is already working on next year’s vaccine

February 16, 2018 By Sarah Faulkner

Photo Credit: USACE

There are still weeks left in this year’s flu season, according to the FDA, but the agency is already planning on how to better protect the nation’s public health next year.

An initial report from the Centers for Disease Control and Prevention concluded that this year’s flu vaccine sported a 36% efficacy rate. Although that’s better than some public health experts predicted, FDA chief Dr. Scott Gottlieb said in a statement that “there is still clearly significant room for improvement.”

Influenza viruses can quickly alter their genetic make-up, so scientists and public health agencies have to constantly rethink which strains to include in the annual vaccine. This year, the illness that has taken the lives of dozens of children was largely caused by a single strain of influenza A called H3N2.

The FDA is planning to gather a panel of experts in just two weeks to help the agency pick strains for next year’s flu vaccines, Gottlieb said. He added that the agency is also working with the CDC and the National Institutes of Health to monitor what strains of influenza are circulating amongst the public and to evaluate the safety of the vaccine that is administered.

Most vaccine doses are made using chicken eggs, but some are made in mammalian cells or using recombinant DNA. An analysis of the data collected by the CDC found that this year, the cell-based flu vaccine was slightly better at preventing influenza compared to the egg-based vaccine. Researchers are still trying to figure out why this could be, Gottlieb said.

Flu vaccines are also designed to target three or four of the most likely flu viruses of the season. After the agency has determined which strains to include in the season’s vaccine, the FDA makes materials, such as seed vaccines, which help vaccine manufacturers do their job.

Although some organizations dream of a universal vaccine that can protect people against an array of flu viruses, Gottlieb pointed out that such a vaccine is years away.

“In the meantime, the FDA is collaborating with federal partners and with industry to improve the manufacturing of the current generation of influenza vaccines. In particular, our scientists are interested in looking at continuous manufacturing technologies for cell-based and recombinant vaccines, which could facilitate much more agility in responding to changes in influenza strains. It could have the potential to allow manufacturers to increase production quickly, if necessary,” he added.

“During the current flu season, remember to wash your hands frequently and get vaccinated if you have not yet done so. There are still weeks of flu activity to come. People who are very sick or who are at high risk of serious flu complications who get flu symptoms should see a health care provider as soon as possible to see if they should be treated with antiviral drugs. The FDA remains committed to collaborating with other public health agencies and manufacturers to use the lessons that we are learning—and will continue to learn—from this year’s flu outbreak to prepare for the next one.”

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Filed Under: Drug-Device Combinations, Featured, Pharmaceuticals, Regulatory/Compliance, Research & Development, Wall Street Beat Tagged With: Centers for Disease Control & Prevention, FDA, National Institutes of Health

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