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First reports of the outbreak were dire, spreading from a foreign country with a 41% mortality rate and triggering a crash race for a vaccine.
The year was 2009, and the illness was the H1N1 flu, the last time the US rolled out a new nationwide vaccine in response to a pandemic.
That 2009 H1N1 flu vaccine, produced in a $2 billion sprint from April to November of 2009, has now emerged as a political football in the 2020 presidential election. Last week, White House press secretary Kayleigh McEnany tweeted that the Obama and Biden team’s response to the emergence of the pandemic flu strain — which ultimately killed more than 12,000 Americans — was “FAILED.”
Scientists stress that the comparison is not entirely valid, in large part because of the vast differences between the flu strain and the novel coronavirus. But as the US prepares an unprecedented national rollout of SARS-CoV-2 vaccines, with millions of doses already being manufactured in preparation, the story of the 2009 vaccine — with its low coverage rates, up-and-down demand, and initial shortages followed by oversupply — serves as a cautionary tale for both Joe Biden and President Donald Trump.
“Nothing went flawless or perfect, and the deaths were tragic and disappointing,” said Howard Koh, a former Obama administration Department of Health and Human Services official. “There were a lot of challenges, but everyone pulled together, which I worry about now.”
On Wednesday, the CDC’s Advisory Committee on Immunization Practices met to discuss two Operation Warp Speed coronavirus vaccines and outline strategies for inoculating the first wave of people — most likely healthcare workers — with their first doses, if they prove safe and effective.
“The H1N1 vaccine experience is only partly applicable to COVID-19, but it does offer the lesson that a strong communication plan needs to be in place ahead of time, starting, well, now,” said health communications expert K. Viswanath of Harvard’s T. H. Chan School of Public Health.
Biden has pledged to add $25 billion toward vaccine development and distribution, if elected. (His campaign did not provide a response when asked about the 2009 vaccine, which was largely managed by federal science officials.) The Trump administration’s Operation Warp Speed has invested around $8 billion in developing vaccines and treatments for COVID-19 so far and promised to deliver 300 million doses of a coronavirus vaccine to the US by January. (Operation Warp Speed’s federal leaders backtracked on this pledge in a New England Journal of Medicine report on Wednesday, setting the goal as 300 million doses, where many of its candidates are two-shot inoculations, by July.)
“A huge lesson from H1N1 is that it takes just a tremendous amount of work and preparation that all has to be done ahead of time to roll out a new vaccine,” former HHS official Nicole Lurie of the Coalition for Epidemic Preparedness Innovations told BuzzFeed News. (Lurie is a medical adviser to Biden but emphasized she was not speaking on behalf of the campaign.) “You really have to be ready months before the vaccine is ready for shipment.”
In reality, the Obama administration response to H1N1 was well run, University of Michigan medical historian Howard Markel told BuzzFeed News, featuring regular updates from medical officials to the public and producing a vaccine in record time. “There really was terrific communication and coordination between state, local, and federal health officials,” said Markel, who sat on an outside expert panel monitoring the response as it happened.
Markel added that the Trump criticism of Biden for the Obama administration’s handling of the 2009 pandemic seemed misplaced, since the Trump administration has overseen a pandemic response that has led to more than 177,000 Americans dying.
Despite those deaths, public confidence in a coronavirus vaccine’s safety is in poor shape, with 35% of Americans saying they wouldn’t take a free vaccine from the FDA, according to a recent Gallup poll. Similar safety concerns led to a disappointing rollout of the H1N1 vaccine, amid dissipating alarm about an influenza strain that turned out less deadly than was initially feared.
“It was a success, but a lot less people ended up getting the vaccine than they should have, ” Markel said. “That’s the first lesson of any vaccination program: You have to get people on board with getting the vaccine.”
The 2009 Vaccine
In some ways, the 2009 H1N1 outbreak was a reverse image of the novel coronavirus pandemic: While it wasn’t even clear to the world that SARS-CoV-2 spread from person to person until weeks into the outbreak, the earliest cases of H1N1 emerged in a report from Mexico in March of 2009, with news of a disease that struck 6.5% of patients with critical cases and killed 41% of those.
The H1N1 outbreak spread to the US, Canada, and Europe by April of 2009, with the CDC releasing a successful test for the virus globally on the first day of May. (In the case of SARS-CoV-2, the CDC’s first batch of tests turned out to be botched.) By June, the flu virus had reached 75 countries, leading the World Health Organization to declare it a pandemic. “The demand for a vaccine was borne from those first few months — April, May, June, everyone wanted a vaccine,” said Markel.
In another difference from COVID-19, the 2009 flu targeted the young rather than the old, with 85% of deaths occurring to people younger than age 60. The elderly turned out to have greater immunity due to childhood infections with a distantly related H1N1 influenza strain.
Clinical trials of H1N1 vaccines began in July of 2009, with federal officials planning to have 120 million doses for a rollout. But since the flu virus is heavily seasonal, cases faded in the northern hemisphere with summer, and with it, public concern over the virus faded as well. By August, a poll found that only 40% of parents planned to get the H1N1 shot for their children. Meanwhile, right-wing radio host Rush Limbaugh and comedian Bill Maher were among those bad-mouthing the risks of the rapidly developed vaccine, raising popular fears. The US H1N1 vaccine was just as safe as the regular flu shot, subsequent studies have shown.
In early October, the Obama administration first began distributing the vaccine with only 2.4 million doses available and, facing an early fall flu season, recommended children and pregnant women be prioritized for the two-shot vaccine. The result was a surge in demand in some places with not enough supply. Former HHS official Lurie said the agency ended up placing observers in manufacturing facilities to oversee production. "There are going to be delays no matter whatever happens," Lurie said.
By the end of the month, HHS had distributed only 23 million doses. When hundreds of millions of doses later became available, demand for the vaccine died down, leaving a patchwork of coverage around the country. In Rhode Island, about 85% of children were vaccinated while in Georgia, home to the CDC, only 21% were.
"One lesson of H1N1 is that when supply is more plentiful, people are less likely to want it," said Lurie. "It's just human nature to really want something more when it is scarce. But it means you have to keep working to get people vaccinated even after you have ironed out supply problems."
In the end, while 40% of adults got the single shot for the seasonal flu in the 2009 flu season, only 23% were vaccinated against H1N1, according to the CDC. “That was a failure, and a main driver was a perception of safety,” said Rally Health behavioral scientist Ezequiel Galarce, who led a 2011 study finding low vaccination rates among Black and Latino communities in 2009.
“There’s a risk-to-benefit calculation that people make about vaccinations, with a huge emotional aspect,” he added. “I think we will see that now, just like then.”
The 2020 Vaccines
“What keeps me up at night is that the first vaccines are going to roll off the assembly line, or gonna roll off first, because they were the easiest to construct and the fastest to mass-produce,” not the most effective or best ones, Children's Hospital of Philadelphia vaccine expert Paul Offit said at a medical press briefing on Monday.
The FDA has set the bar for approval of a COVID-19 vaccine at 50% effectiveness in blocking transmission of the virus. But to halt an epidemic, a coronavirus vaccine should prevent at least 70% of infections as long as at least three-quarters of the population is inoculated, according to an American Journal of Preventive Medicine analysis released on Tuesday.
“We are facing mountains of misinformation we didn’t have then,” said Viswanath. Like any vaccine, coronavirus inoculations will doubtless have side effects like sore arms or occasional fevers. That’s normal. But how will reports of those totally foreseeable side effects play out in today’s social media–amplified world of viral conspiracy theories and organized anti-vaccine campaigns?
“I worry all of these things will come together to undermine a coronavirus vaccine,” said Viswanath.
What’s more, the politicization of the pandemic, with masks, hydroxychloroquine, and death rates from COVID-19 all becoming matters of partisan disagreement, points to a likely politicization of vaccines as well, with some imagining attitudes toward a vaccine flipping with ownership of the White House.
Others fear Trump pressuring the FDA to release a shoddy vaccine in a desperate bid for reelection. The chaos of FDA scientists likely resigning over the decision, vaccine trial scientists protesting, and loud blowback from outside vaccine experts, all of them facing off with a Trump campaign now down by more than 7% in an average of national polls, would be awful, said Koh, wrecking the trust in vaccines that is the first condition needed for a successful rollout.
The Infectious Diseases Society of America warned FDA commissioner Stephen Hahn against taking such a step in a letter released on Wednesday. “Making a vaccine available before sufficient safety and efficacy data are available could significantly undermine COVID-19 vaccination efforts and seriously erode confidence in all vaccines,” it read.
Hahn’s credibility has come under fire in his handling of an emergency authorization for use of blood plasma as a treatment for COVID-19, where he bungled the statistics about its effectiveness amid political pressure from Trump. He apologized for the statistical mistake, but then raised eyebrows on Wednesday by promoting a vaccine advisory committee meeting on Oct. 22, in a Twitter thread touting enrollment in the vaccine candidate trials.
“We really will need national unity of some kind, to have high vaccination rates,” said Galarce. “Sometimes the messenger matters more than the message,” he added.
Short of the “October surprise,” there are plenty of pitfalls pointed out by the 2009 experience. Both the CDC and the National Academies of Science, Engineering, and Medicine are looking at making COVID-19 vaccines more easily available to Black and Latino people, trying to avoid disparities seen in the 2009 vaccine rollout. The key to that effort will be reaching out to community leaders and finding out how to make the vaccines more accessible, so that people don’t have to take three buses and stand in line for hours to get a shot.
“It’s a lot easier to remove barriers than to increase people’s motivation,” said Galarce.
At Wednesday’s CDC vaccine advisory panel meeting, requirements for refrigeration raised concerns about the shelf life of the first two vaccines in the Operation Warp Speed pipeline, one made by Pfizer and one made by Moderna, which could lead to the kinds of shortages that plagued the H1N1 vaccine rollout.
Advisory committee members were asked to consider scenarios for the rollout of the two vaccines as soon as October. If both vaccines were successful, that would provide 35 to 45 million doses — enough to inoculate half that many people because the vaccines require two shots — by the end of December.
Given local COVID-19 outbreaks and varied capabilities to store vaccines, the CDC’s Nancy Messonnier said federal officials will need to “leave state local health departments some flexibility to deal with their own local situations” during the coronavirus vaccine rollout. She recalled the H1N1 experience to make this point, calling it “very different but with certain similarities.”
The individual calculus that people did in 2009 drove older folks away from getting a shot, because H1N1 was widely seen as dangerous only to the young. Galarce expects to see the flip side of that calculation for a coronavirus vaccine, with young people deciding to skip a shot because of their lowered risk, potentially undermining herd immunity. The rise of anti-vaccination attitudes among parents, as well as the drastically lower chances of serious illness in children, could also reduce inoculations among kids. Such decisions undermine herd immunity to the virus, because infected kids can pass along the coronavirus.
One important step is letting people know right now that the FDA and CDC are planning an intense vaccine safety monitoring effort, said Vanderbilt University’s Kathryn Edwards, scientific director of the Vanderbilt Vaccine Research Program. Her program will be headquarters for a consortium with six other schools running a 24-hour hotline for doctors with any safety questions once a coronavirus vaccine is available.
At the CDC’s vaccine meeting, officials described a number of FDA, CDC, and Defense Department programs to watch for any signs of adverse events in vaccines, ranging from the Vaccine Adverse Event Reporting System (VAERS), created in 1986, which tallies reports from manufacturers, to the PRISM system, stood up by Lurie and other officials in the H1N1 crisis, which collects rapid reports of adverse vaccine events from Medicare and insurers, feeding them directly to federal overseers.
On top of building the vaccine safety hotline system, Edwards also participates in the safety monitoring of one Operation Warp Speed vaccine that is currently in clinical trials and planned for testing in 30,000 patients.
“We are really seriously looking for any concerns. I work from Sunday to Saturday, and so do a lot of other people,” Edwards said. “People should know this.”