Recommended Adult Immunization Schedule, United States, 2020* | Annals of Internal Medicine

FDA Cancels Pivotal Advisory Meeting About Next Season's Flu Vaccine

A Food and Drug Administration vaccine advisory committee meeting that was set to discuss what flu strains to include in next season's flu vaccine has been canceled, federal health agency said Thursday.

"A planned March 13 meeting of the FDA's Vaccines and Related Biological Products Advisory Committee on the influenza vaccine strains for the 2025-2026 influenza season in the northern hemisphere has been canceled. The FDA will make public its recommendations to manufacturers in time for updated vaccines to be available for the 2025-2026 influenza season," according to an FDA statement released on Thursday.

When asked if this means the FDA will issue the flu strain vaccine selection without input from its independent advisory panel, the FDA said: "Unfortunately, we have no further information to share."

In this Oct. 14, 2015, file photo, the U.S. Food and Drug Administration campus is shown in Silver Spring, Md.

Andrew Harnik/AP, FILE

The meeting was canceled in an email sent from the FDA to members who were planning to attend the annual meeting in about two weeks.

Some, however, are questioning whether the decision will delay next year's flu vaccine delivery schedule.

In this Oct. 14, 2015, file photo, the U.S. Food and Drug Administration campus is shown in Silver Spring, Md.

Andrew Harnik/AP, FILE

The high-profile, public meetings of the Vaccines and Related Biological Products Advisory Committee are where independent experts review scientific data and vote on a variety of vaccine related issues. Members of the March 13 meeting were set to vote on which flu strains would offer the most protection in next season's flu shot.

"Influenza vaccines aren't perfect and to get the best influence vaccine each year requires predicting the strain as best we can," said Dr. Andrew Pavia, professor of pediatrics and medicine at the University of Utah and a spokesperson for the Infectious Diseases Society of America. "There's a lot of complex data that needs to be reviewed and having a number of experts do it gives us the best chance of making the best prediction."

The meeting typically takes into consideration recommendations from WHO. It also receives input and data from the Centers for Disease Control and Prevention, the Department of Defense and vaccine manufacturers.

The timing of this meeting aligns with the six-month lead time typically required for vaccine manufacturing to ensure vaccines are ready for distribution in the fall -- before peak flu season hits in the United States.

"I can't think of any rational reason to do this other than to throw a hand grenade into vaccine production," Pavia said. "The impact is going to be felt in terms of our ability to reduce flu hospitalizations and flu deaths."

MORE: Flu activity 'elevated' in US but showing signs of abating, CDC data shows

Earlier in the week, officials and specialists at the CDC virtually joined the annual WHO meeting to discuss the upcoming flu vaccine strain for next year, despite being previously ordered to halt all communication with the global health organization.

Typically, the Vaccines and Related Biological Products Advisory Committee meets after the WHO meeting to finalize recommendations.

It remains unclear what impact the meeting cancellation may have on next season's flu vaccine. But experts are concerned about the timing because flu vaccines are made using chicken eggs to grow and harvest the virus before processing it into a vaccine.

"It's a very very tight timeline because it takes a long time to create the template viruses and then grow them in eggs," Pavia said. "It is a many months long process and any delay means it will be difficult to have vaccine in time for the next season."

U.S. Vaccine strains are usually picked by April. Manufacturing is completed over the summer and delivered for vaccination starting in September.

The timeline for flu vaccine selection, production and distribution in the United States.

Mayo Foundation for Medical Education and Research

Sanofi, one manufacturer of flu vaccines, told ABC News the company has already started the initial steps of manufacturing.

"Just as every year, we have already begun production for the 2025-2026 flu season in the Northern Hemisphere and will be ready to support final strain selections in time for the season," a spokesperson for Sanofi told ABC News.

However, the FDA must approve the final strains for the shots to be legally marketed and distributed in the U.S.

ABC News has reached out to both the FDA and Health and Human Services for comment.

MORE: Doctors' visits for flu continuing to reach record levels: CDC

Dr. Paul Offit, a member of the FDA's independent committee who was planning on attending the meeting said, "Who canceled this meeting? Why did they cancel it? Will the vaccine makers turn to the World Health Organization to determine which strains to include in this year's vaccine?"

"It's very concerning with regard to the ability to produce enough vaccine in time for next year's flu season," Pavia added. "Hopefully, there will be workarounds that could be developed. But what they are -- we don't know yet."

2020 Flu Vaccine Program

Medical experts are strongly emphasizing the importance of getting vaccinated against the flu this year. The goal is to prevent additional stress on the nation's healthcare system, already under significant strain from the COVID-19 pandemic.

To ensure our campus community has the best opportunity to be vaccinated against the flu, UAB Occupational Medicine will be hosting FREE drive-thru clinics this month. The clinics are available to UAB students and campus employees, and it's recommended to make an appointment in advance.

Make Your Appointment Now

Key Details:

Drive-thru flu vaccine clinic

Open to all UAB campus employees and students

9 a.M.-1 p.M.

Nov. 13th and 20th

Located in 12th Street Parking Deck (must enter on the 13th Street side)

Make appointment through UAB online system

Only 1-2 people can be vaccinated per vehicle

Both individuals must be on the driver's side of the vehicle and able to open their car door to receive the vaccine

Vaccine administered to left arm only

The vaccine is given in the upper arm, so plan your attire for easy access to that area.

You must have completed your daily Healthcheck and show your Event Passport

You must wear a mask

Your temperature will be taken

You must wait on location for 15 minutes after receiving the vaccine per CDC guidelines

Employees who are pregnant, allergic to eggs, or have previously had a adverse reaction and wish to receive their flu vaccine by Occupational Medicine should consult their primary care physician prior and have written permission to receive.

Visit uab.Edu/flu for more information

Vaccine Skepticism Wave Bodes Poorly For Next Pandemic

Five years after the COVID outbreak sparked a frantic push for vaccines to build what public health officials called "herd immunity," a growing number of Americans don't want to be part of the herd.

The rapid COVID vaccines rollout was credited with saving millions of lives. While scientists and health officials hailed it as a triumph of science and logistics, a potent mix of politics, fatigue, and misinformation has taken hold in recent years, leaving much of the public wary.

Health care providers, who strongly recommend vaccines as safe and effective, said such hesitation and outright resistance to vaccines have become disturbingly common even in Massachusetts, a state at the forefront of the campaign to develop and distribute COVID vaccines.

Indeed, a Globe data analysis shows vaccination rates in the state, which have long surpassed the US average, have now dropped below those of the nation for COVID — and even more dramatically for flu, where vaccine uptake has fallen by half among those 19 and younger.

Most alarming to doctors and health officials in Massachusetts is a decline in immunization for serious childhood diseases, such as measles and mumps, that were largely suppressed through vaccines.

The motives for those refusing vaccines vary. They range from a sense that past exposure to vaccines or COVID continues to convey immunity, to a belief that health officials overstated the value of the shots, to the embrace of discredited internet conspiracy theories that government leaders were using vaccines as levers of political control.

Farren, who said she's considering homeschooling her daughter in part to avoid school vaccine requirements, questions their effectiveness and objects to the "sheep mentality" behind inoculation drives.

She's far from alone. Only about 22 percent of adults in Massachusetts and 23 percent nationally received the most recent COVID booster this fall and winter, federal and state data show as of late January. By contrast, in the year after shots first became available, 2021, more than 82 percent in Massachusetts and nearly 70 percent of US adults were fully vaccinated.

"I don't think vaccines help," said retired schoolteacher Diane Grady of Swampscott. She similarly was vaccinated during the outbreak, bowing to what she now calls "scare tactics," but has stopped lining up for COVID or other vaccines in recent years. "I got on the bandwagon during COVID only so I could see my grandchildren," Grady said.

The new vaccine resistance dovetails with the rise of Robert F. Kennedy Jr., confirmed by the Senate last week as President Trump's secretary of health and human services. Kennedy, a longtime vaccine skeptic, told senators he is merely "pro-safety" and now believes vaccines play a critical role in health care.

But the mainstreaming of once-fringe anti-vax beliefs by Kennedy and others calls into question whether the nation can rally to blunt the next health threat.

"Not everyone's willing to accept my recommendations," said Dr. Hugh Taylor, president of the Massachusetts Medical Society, who practices as a family physician in the North Shore town of Hamilton and urges his patients to get vaccinated. "It's not hard to find people who've heard different opinions about vaccines on the internet or even at the grocery store or a soccer game."

Much of the COVID vaccination falloff can be attributed to the reality of broader immunity, said Jen Kates, senior vice president at the Kaiser Family Foundation. Most American adults got shots during the pandemic, many contracted COVID, and deaths from COVID have declined.

"The majority of people in the US don't feel the need to get the vaccine," Kates said. "They don't feel at risk. They feel COVID is over."

Plenty of people still believe in vaccines, of course, and have been keeping up with their COVID booster shots, which lower the risk of contracting severe disease or long COVID even if they don't prevent all infections, according to the Centers for Disease Control and Prevention.

Salem resident Steve Burrell, 82, a retired truck driver who walks and lifts weights, has received every recommended COVID booster. "You get used to it," said Burrell, a former Air Force medic. "One of the first things that happens in the service is you get bombarded by shots."

Researchers in Massachusetts and beyond are readying new vaccines to fend off diseases from bird flu to cancer. But scientists say the disconnect is striking between their capacity to mount a response to a viral outbreak — demonstrated in the COVID vaccine deployment — and the public's willingness to accept it.

"Our technical ability to make vaccines for new pathogens has exceeded the political and social instruments we have to make sure they're adopted in the population," lamented Dr. Peter Hotez, director of the Texas Children's Hospital Center for Vaccine Development.

Vaccine advocates point to Operation Warp Speed, which mobilized the production of COVID shots in record time, as a crowning achievement of the first Trump administration — "one of the greatest success[es] of American ingenuity," said Dr. Ashish Jha, who served as White House COVID-19 response coordinator in the Biden administration.

But as a backlash grew against what many saw as excessive government actions to contain the pandemic — mask mandates, lockdowns, and school closings — Trump and much of the Republican Party stopped hailing Operation Warp Speed and COVID vaccines. That cemented a partisan divide in vaccine attitudes, extending now beyond COVID to other shots, even some embraced broadly before the pandemic.

The share of the US population getting flu shots has declined to less than 45 percent this season from more than 50 percent in the 2019-2020 season. The current percentage nationwide is the lowest in more than five years. And for flu, the vaccination rate in Massachusetts is at 37.2 percent as of late January, below the national average.

In the South Shore Hospital emergency room, Dr. Will Tollefsen, who led the East Weymouth's health system's campaign to stand up COVID vaccination centers in 2021, sees more unvaccinated patients now.

"The pendulum has swung," said Tollefsen, chair of emergency medicine at South Shore Health. "Many didn't get a COVID booster," he said. "Some say, 'I don't want a flu shot,' even though they got it in past years."

With thousands of families declining shots, the number of kindergartners vaccinated against measles, mumps, and rubella — shots typically required by public school districts — has dropped 2.3 percentage points nationally and 0.8 percentage points in Massachusetts since the 2018-2019 and 2019-2020 school years.

Inoculations against other serious illnesses have likewise seen declines — of 2.4 percentage points for polio nationally and 1.1 points in Massachusetts and 2.6 points for diphtheria, tetanus, and pertussis nationally and 1.2 points in the state in the same period.

The Globe's analysis of state data shows worrying variations among races, ages, and regions in Massachusetts, suggesting demographic gaps in vaccination during the pandemic have returned.

Two in 10 white residents in the state have been vaccinated against COVID this season, but only one in 10 Black residents, 9.3 percent of Latinos, and 14 percent of Asian Americans.

Massachusetts health officials made special outreach during the pandemic to boost vaccination rates in rural parts of the state and underserved urban communities. They established mobile vaccination sites, went door to door to tout the vaccine, and communicated to residents in Spanish, Haitian, Creole, Arabic, and other languages.

Now, however, a vaccination divide has reemerged.

"Across all demographics — white, Black, Hispanic, Asian — vaccination rates are down," said Greg Wilmot, president of NeighborHealth, which runs nonprofit health centers in East Boston, the South End, Winthrop, Everett, and Revere. "But the gap is greater for Black and brown communities. The urgency that existed in 2021 is not there."

There are also wide discrepancies in regional data. Twenty-four percent of residents in suburban Middlesex County, north and west of Boston, have gotten the latest COVID booster, but just 12 percent of those in Bristol County in Southeastern Massachusetts got that shot.

The data echo political leanings in November's presidential election. While the Democratic candidate, Kamala Harris, bested Trump by a more than 2 to 1 margin in Middlesex County, she edged him only narrowly in Bristol County.

All of this is disheartening to many in the biomedical community in Massachusetts. Moderna, a Cambridge biotech, fielded one of the two messenger RNA vaccines and now has a crop of new vaccines under development. Pfizer, which distributed the other mRNA vaccine, produces key ingredients at a sprawling plant in Andover.

A third vaccine, sold by Johnson & Johnson, was based on science from the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in Boston.

Dr. Dan Barouch, a Harvard Medical School professor who heads the Beth Israel lab, said Operation Warp Speed offers two lessons in preparing for the next pandemic.

"We learned that the rapid development, the rapid testing, and the rapid approval of vaccines in the face of a raging pandemic is possible, and provides inspiration for the future," Barouch said. "However, we also learned that the sociopolitical climate and public acceptance of the vaccines is absolutely critical for the vaccines to work."

Share your memories of moments from the pandemic here:

Robert Weisman can be reached at robert.Weisman@globe.Com. Neena Hagen can be reached at neena.Hagen@globe.Com.

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