Flu Vaccines Given to Prevent Disease, Not Just to Support Pandemic Vaccine Manufacturing - FactCheck.org

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Seasonal influenza vaccines are recommended because they help prevent illness and death. Dr. Robert Malone incorrectly suggested that the annual shots are only given in the U.S. to support vaccine manufacturing in case of an influenza pandemic.

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Since the 2010-2011 season, the Centers for Disease Control and Prevention has recommended that everyone 6 months and older get an annual flu shot, with rare exceptions. This is based on evidence that vaccination can prevent people from getting sick with flu and reduce the severity of disease if someone does fall ill.

For the past 10 flu seasons prior to the COVID-19 pandemic, the CDC estimates that on average vaccination has prevented more than 5 million illnesses, over 70,000 hospitalizations and 6,000 deaths each season.

Dr. Robert Malone, however, recently suggested that flu vaccines are given not because they help protect people from flu, but so that manufacturing capacity exists in case of an influenza pandemic.

"The annual influenza vaccine program, if you dig down through all the logic of the federal funding, et cetera, it's wrapped around the idea that we should force — we should coerce, basically, the population to take a product on an annual basis so that we can maintain warm base manufacturing in case something like 1918 ever happens again," he said in remarks at a paid event in Florida on Oct. 22, referring to the worst influenza pandemic of the 20th century.

A clip of his comments spread on social media two days later.

Malone, who was speaking at an event featuring members of the Front Line COVID-19 Critical Care Alliance, a group that has promoted unproven COVID-19 treatments, has repeatedly been a source of COVID-19 vaccine misinformation.

He went on to argue that the concern about pandemic flu is misplaced.

"And it's all built on, basically, a lie: the 1918 outbreak was just driven by a particular influenza virus," he said. "And there's a lot of data suggesting that's absolutely not the case, it was a combination bacterial and viral infection that caused that rampant pneumonia."

Malone is correct that research, including a 2008 National Institutes of Health study co-authored by Dr. Anthony Fauci, indicates that most of the deaths in the 1918 pandemic were caused by bacterial pneumonia after infection with influenza. But that doesn't mean that pandemic flu isn't a worry or that countries shouldn't try to develop protective vaccines against pandemic flu — it just means countries should also be prepared with bacterial vaccines and antibiotics.

Malone also falsely accused the CDC of classifying all pneumonia deaths as flu deaths "in order to increase the perceived risk of influenza virus." Because many deaths involving flu are not captured as such on death certificates, the agency estimates the number of people who die each year from influenza using statistical methods.

Manufacturing Claim

Experts told us that the notion that seasonal flu vaccines are recommended only to ensure enough vaccine capacity in the event of a pandemic is incorrect.

An annual flu shot "is recommended for use because it reduces illnesses, hospitalizations and deaths from influenza among those who receive it," Dr. Jesse L. Goodman, a professor of medicine and infectious diseases at Georgetown University, told us in an email.

"A potential benefit of the use of seasonal vaccination, but not the reason for its use, is that the production of the vaccines helps keep manufacturing infrastructure and capacity in place that potentially could help respond to future influenza pandemics," he added.

It's true that the more people who get the flu vaccine, the bigger the market, the more attractive it is for vaccine makers, which is helpful for maintaining vaccine manufacturing capacity, Dr. Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security, told us.

But that's true for any vaccine — and isn't why health authorities recommend the shot.

"The vaccine is safe and effective — it works and benefits individuals. That is why it is recommended," Adalja said.

The CDC, based on recommendations from its independent advisory panel, first recommended annual flu vaccines for everyone 6 months and older for the 2010-2011 season. Before then, the shots were recommended for higher-risk populations only, as is still done in countries such as the U.K. But by 2009, those groups already accounted for about 85% of the population in the U.S., according to the advisory panel's published 2010 recommendations.

Adalja said that in 2010, when the shift was made to a universal recommendation, "there was definite talk about how that would help maintain vaccine capacity and increase market size." Flu vaccine shortages had occurred in recent years, and the H1N1 flu pandemic had also just happened in 2009. 

"But vaccine capacity maintenance isn't why the flu vaccine [is] recommended — it is recommended because it is beneficial," he said, calling the benefits to vaccine capacity a "good externality."

The CDC told us it "strongly disagrees" with Malone. "To claim that CDC only recommends annual influenza vaccination to keep a 'warm base' for pandemic influenza vaccine production ignores the significant annual burden of seasonal influenza epidemics and the long list of benefits conferred by influenza vaccination," the agency said in a statement.

The CDC noted that influenza pandemics "are rare events and vary in severity and impact." They also introduce novel influenza viruses that continue to cause illness and death when they circulate as seasonal viruses, sometimes to a larger degree than in the pandemic. The agency emphasized the numerous ways that flu vaccines help people, including children, pregnant people and newborns, and those with certain chronic conditions, by preventing infections, hospitalizations and deaths.

An HHS spokesperson told us in an email that a federal "pandemic influenza preparedness program" was "a separate effort" from seasonal influenza vaccination, citing several steps taken by the Biomedical Advanced Research and Development Authority. "In a pandemic, some of the facilities that currently produce seasonal vaccine would produce pandemic vaccine. However, the seasonal effort as a program – FDA approval, CDC recommendation, surveillance, etc. – is separate from BARDA-support pandemic influenza preparedness efforts."

Photo via Getty Images/FatCamera.

The effectiveness of the flu vaccine varies each year, depending on how well the strains selected for inclusion in the vaccine match those that ultimately circulate, but on average is around 40% in preventing an outpatient medical visit due to lab-confirmed flu. Flu vaccines also tend to not work as well in older people, who are more vulnerable to severe influenza. For these reasons, Georgetown's Goodman said there are "lots of efforts to try to make improved influenza vaccines."

Still, the shots, which only about half of Americans get every year, prevent millions of illnesses and thousands of deaths each season — and could have an even bigger impact if more people got them. Flu vaccines are most important for those at high risk, but are a good idea for everyone.

It's not entirely clear what the 2022-2023 flu season will look like, but CDC surveillance data as of the end of last week suggests the season is getting an early start and could be worse than normal. In some parts of the country, particularly in the South, flu activity is already high. So far, it appears that this year's vaccine is a good match for the circulating influenza strains, but fewer people have been vaccinated than in the past couple of years. 

This year, for the first time, the CDC is preferentially recommending that people 65 years of age and older get a high dose or adjuvanted flu vaccine, since there is evidence that those shots may work better than standard flu shots in that group.

How the CDC Estimates Flu Deaths

As part of Malone's effort to undermine confidence in flu shots, he incorrectly claimed that the CDC classifies all pneumonia deaths as flu deaths "in order to increase the perceived risk of influenza virus" — and said the agency has "grossly overstated the threat of influenza."

It's true that one way the CDC keeps track of the flu burden is by looking at a composite measure that includes illnesses and deaths from influenza and pneumonia. But the agency doesn't claim that all of those deaths are from influenza — and it's not collecting the data to artificially increase flu deaths. Rather, because flu deaths are well known to be underreported, the agency uses established statistical methods to estimate how many people have died of influenza each year.

"The CDC has historically grouped pneumonia and influenza mortality together (in some — not all — metrics it uses) because fatal influenza causes pneumonia and it is difficult to tease the two apart especially when many influenza cases are not specifically diagnosed," Adalja said. "It is also the case that during influenza seasons, there is a clear mortality increase that is strongly linked to influenza activity."

In a statement, the agency told us it does not "count all pneumonia deaths as influenza deaths in an effort to inflate influenza burden numbers." 

"Because pneumonia is a common complication of influenza, CDC does combine counts of pneumonia & influenza (P&I) deaths to monitor weekly trends in mortality during the fall and winter influenza season. These trends are presented in the weekly surveillance report FluView," the agency continued. "However, that is separate from CDC's estimates of annual influenza deaths, which are based on 5 decades of statistical modeling that CDC has undertaken to convey an accurate picture of the burden of flu influenza."

"There were earlier studies, 60+ years ago, where P&I deaths above a baseline were assumed to be influenza if they occurred during the typical season. Improvements to this methodology have been developed to better attribute excess deaths to influenza using viral surveillance data," the CDC added. "However, that methodology has not been used by CDC to estimate the burden of influenza deaths in the U.S. population in more than a decade."

We reached out to Malone to ask for support for his claims, but did not receive a reply.

His claim about flu is similar to those made about COVID-19 when the agency began tracking COVID-19 deaths along with those from pneumonia and influenza as a mortality surveillance measure. As we have written, the metric is used for monitoring purposes, and the agency was not counting all such deaths as COVID-19 deaths.

A CDC website explains that the agency estimates the number of flu deaths using a model that applies a ratio of deaths-to-hospitalizations. First, the agency looks at in-hospital laboratory-confirmed deaths recorded in FluSurv-NET, which covers a network of hospitals in 14 states. That number is adjusted for under-detection of influenza by factoring in how often people with respiratory illnesses were tested for influenza, and how sensitive those tests are.

Next, the agency looks at death certificates that have pneumonia or influenza causes, or others, since not all influenza deaths will have occurred in a hospital or have had influenza listed as a cause of death. Rather than including all pneumonia and influenza deaths, as Malone alleged, the agency says that it uses information on the causes of death from FluSurv-NET to determine how many of the non-hospitalized pneumonia and influenza or other deaths to include. Once the agency scientists estimate the proportion of influenza-associated deaths that happened outside a hospital, they estimate the deaths-to-hospitalization ratio.

The method isn't perfect — and the agency doesn't claim to provide an exact number, only an estimate — but the approach is necessary because otherwise, flu-related deaths would be vastly underreported.

"CDC feels it is important to convey the full burden of seasonal flu and thus uses well-established scientific methods that have been reviewed by scientists outside of CDC to make comprehensive estimates of the total numbers of annual flu illnesses, flu-associated hospitalizations, and flu-associated deaths that occur each year," an agency webpage reads.

The CDC notes that most people are not tested for influenza or may seek medical care at a point when tests can no longer easily detect the virus. The tests are also not particularly sensitive to begin with. States are also only required to report flu deaths in children, not adults. Death certificates often fail to mention flu, not only because of the lack of testing, but because many people die from complications weeks after an infection, such as after developing a secondary bacterial infection or from aggravation of a chronic illness.

"Only counting deaths where influenza was recorded on a death certificate would be a gross underestimation of influenza's true impact," a CDC page reads.

Editor's note: SciCheck's COVID-19/Vaccination Project is made possible by a grant from the Robert Wood Johnson Foundation. The foundation has no control over FactCheck.org's editorial decisions, and the views expressed in our articles do not necessarily reflect the views of the foundation. The goal of the project is to increase exposure to accurate information about COVID-19 and vaccines, while decreasing the impact of misinformation.

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