- The Washington Times - Wednesday, July 24, 2019

A Maryland medical company is developing a more effective flu vaccine, as federal health researchers are striving to create a vaccine that will negate the effects of all variations and strains of the influenza virus.

Novavax, headquartered in Gaithersburg, Maryland, received approval last month from the Food and Drug Administration to fast-track a clinical trial for a flu vaccine that is said to trigger stronger immune responses. It also addresses viral strain drift, which occurs when one influenza strain gives way to a different strain during the flu season — a key reason for the ineffectiveness of last season’s vaccine.

Novavax CEO Stan Erck said his company’s flu shot, which is produced using an insect cell, is a marked improvement over traditional egg-based vaccines.

“Influenza vaccines have a lot of room for improvement,” Mr. Erck said. “We’re somewhere between better than the current list of vaccines and maybe on our way to making a universal vaccine.”

“We’re just trying to get a better flu vaccine than what has been produced to date,” he added.

The company makes the flu antigen, a substance that induces the immune response, in the insect cell. The process clones the exact sequence of the virus’ genetic code and loads it into the cell, which then produces large amounts of the protein that is found on the surface of the virus.

The vaccine protects against four strains of influenza, and has stimulated an immune response that is “broader” and “more robust” than some flu vaccines on the market, Mr. Erck said.

The phase 3 vaccine trial, which will include about 2,500 participants, will start this fall before the flu season.

National health experts last month cited a 29% effectiveness rate for the vaccine for the most recent flu season. The flu shot’s effectiveness dipped from 47% in February due to viral strain drift.

This year’s flu shot had the lowest effectiveness rate since the 2014-2015 season, when the vaccine was 19% effective.

Historically, effectiveness rates of flu vaccines have been below 50%, averaging just under 40% over the last 15 seasons.

“The effectiveness of influenza vaccines varies depending on a number of factors, such as the age and health of the recipient, the types and subtypes of circulating influenza viruses, and the degree of similarity between circulating viruses and those included in the vaccine,” the Centers for Disease Control and Prevention told The Washington Times.

Each year, the CDC and the World Health Organization have to guess which strains of the virus will circulate during the next season.

Health researchers are working to create a universal vaccine so that they don’t have to chase the flu season to season, said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.

“If you had a universal flu vaccine, you could do what we do with a variety of other viruses,” Dr. Fauci said. “You could actually make one vaccine and stockpile it instead of having that race against time to pick what you think will be the strain next season and then rush to make a vaccine that would be directed against that strain.”

The National Institutes of Health so far have enrolled nearly two dozen people in the first human clinical trial of a universal flu vaccine, Dr. Fauci told The Times. The trial, which involves an experimental vaccine that protects against one group of viruses, will conclude at the end of the year.

Dr. Fauci said the NIH is aiming to test a vaccine that protects against a second group of flu viruses next year. The ultimate goal would be to combine both vaccines to combat all types of influenza.

“You can’t just jump from where we are right now to universal flu vaccines. You have to start off by making vaccines that are not necessarily universal, just more effective,” Dr. Fauci said. “That’s sort of part of the pathway to a universal flu vaccine. So you shouldn’t forget about the fact that you should try to make even the seasonal vaccines more effective.”

The last flu season saw between 37 million to 43 million illnesses, 531,000 to 647,000 hospitalizations, and 36,400 to 61,200 deaths in the U.S., the CDC reported in late June.

• Shen Wu Tan can be reached at stan@washingtontimes.com.

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