The constantly changing nature of the influenza virus makes it an annual effort of scientists, manufacturers, and the medical community to devise and disseminate vaccines to combat the disease.
What if those efforts could be streamlined to develop a universal flu vaccine that could attack any strain of the virus? Researchers are getting closer to that possibility.
That was the message delivered by experts Wednesday to the U.S. House Energy and Commerce Subcommittee on Oversight and Investigations hearing, “Flu Season: U.S. Public Health Preparedness and Response.”
Anthony S. Fauci, director of the National Institute for Allergy and Infectious Diseases at the National Institutes of Health, told the committee that although “we are not going to get a universal flu vaccine next month or next year,” the government has made major progress toward such a vaccine. This year, the NIH began its first human clinical trial of a universal influenza vaccine candidate, one that attacks a different part of the virus than previous vaccines, making it less likely the candidate needs to be updated each season.
“We are certainly better off this year than we were last year in our quest for a universal flu vaccine. Last year we didn’t even have a candidate. This year we’re now eight months into Phase 1. And by early 2020 we’ll know whether our candidate will induce the kind of response that you would predict would be protective. So clearly there’s a difference between the last time we spoke at a hearing,” Fauci said.
In conjunction with these efforts, the U.S. government remains steadfast in its distribution of current flu vaccines. For the 2019-2020 flu season, more than 160 million doses of influenza vaccine were manufactured for the United States.
“No other vaccine is produced, FDA approved, and distributed every year across the nation with an approximately six-month time frame,” Peter Marks, director of the Center for Biologics Evaluation and Research at the U.S. Food and Drug Administration, told the committee.
Marks added that technologies are in development to compress this period to improve predictability and to more efficiently produce the influenza antigen.
Beyond the seasonal flu, officials are equally concerned about the emergence of pandemic influenza. In the last century there were three such incidences, the most devastating being the 1918 Spanish flu pandemic which killed 50-100 million people. The 2009 pandemic influenza, H1N1, resulted in 80 percent of virus-related deaths in people younger than 65 years of age. In comparison, most seasonal flu deaths occur in those over 65.
“There is no singular threat that could devastate our country, our health and our economy, and our social institutions more than pandemic influenza … the risk is we’ll have another severe one and that would devastate our country,” said Robert P. Kadlec, Assistant Secretary for Preparedness and Response, U.S. Department of Health and Human Services.
Domestic manufacturing is critical particularly for pandemics, because other nations the United States relies on for pharmaceutical production will allocate resources and protect their populations first, Kadlec said. More than 80 percent of the raw materials, finished products, and active pharmaceutical ingredients the United States counts on for pandemics emanate from China and India. When it comes to the U.S antiviral drug supply—the drugs needed to treat influenza once it is contracted— there are 67 million courses, short of the 80 million-person requirement for the U.S. stockpile, Kadlec said. The active ingredients for those antivirals come from Asia.
Developing improved technologies may lessen U.S. dependence on foreign sources. For example, messenger RNA technology will produce faster and better-matched vaccines to prevent both seasonal and pandemic flu.
“All of the platforms, be it recombinant DNA, messenger RNA, DNA nanoparticles … they are all recombinant technologies that don’t require growing the virus. And that’s very important,” Fauci said.
One of the problems that arises with current egg-based vaccine manufacturing is that candidate vaccine viruses can adapt and mutate in the egg. Most of these mutations don’t mean anything, but every once in a while it mutates to the point that the virus becomes a different form than what was originally put into the egg, complicating vaccine production, Fauci said.
These concerns may contribute to a public narrative, albeit false, that the flu vaccine doesn’t work.
“If we increase vaccine effectiveness by just 5 percent, we can prevent over 17,000 additional hospitalizations in a single year. Despite overwhelming and consistent scientific evidence that flu vaccines are safe and effective, nearly 40 percent of children and over half of adults did not receive their flu vaccine last season,” said Nancy Messonnier, director of the National Center for Immunization and Respiratory Diseases within the Centers for Disease Control and Prevention. “If you ask people why they don’t get the flu vaccine, and what’s different than other vaccines, is they don’t believe the flu vaccine works. We have to do a better job of educating people. Even if you can still get the flu with the flu vaccine, the flu is milder, and it can prevent hospitalizations and death.”
U.S. Rep. Joe Kennedy (D-MA) asked the panel if the United States was doing enough to bolster the work of public health departments, including public health surveillance programs, to monitor and respond to infectious diseases like influenza. He cited a June report by the Massachusetts Special Commission on Local and Regional Public Health that pointed to inconsistent funding for local public health agencies.
“My home state, like many across the country, has limited capacity to collect and measure health data. How do the CDC and its partners help states like mine be able to track the spread of influenza around the country as well as capture vaccination rates?” Kennedy asked.
The CDC has worked with the Association of Public Health Laboratories to build an electronic data system so information can travel from regional reference laboratories to the cloud, giving officials access to data sooner. In general, public health data systems are antiquated and fragmented, and the government needs to think about new investments to build the kind of solid systems health officials need, Messonnier said.
The CDC has a central role in every part of the influenza vaccine development administration.
Over the last decade, Messonnier said the agency has significantly improved worldwide surveillance characterization of influenza viruses and developed diagnostic assays for health laboratories in the United States and globally. The CDC was the first agency to establish a national system for the routine monitoring of the influenza vaccine effectiveness and is currently expanding this network.