It was just over a decade ago, and the H1N1 influenza virus was rampaging across the country.
“We invested huge amounts in 2009,” said Moore, now associate director of the vaccine education organization Immunization Action Coalition, describing a whirlwind of spreadsheets and brainstorming sessions that ultimately brought 1,500 pharmacies, hospitals and clinics in her state together in a coordinated operation.
“Then, everybody went back to business as usual, knowing the next pandemic was coming,” Moore said. “We knew we would have to rebuild everything all over again.”
Now, as the United States ramps up for a vaccination drive against the novel coronavirus, boosted by reports of promising results from two major clinical trials, Moore and other experts are frustrated that many of the lessons of the 2009 H1N1 pandemic have not been addressed, from ongoing investments in public health infrastructure to the use of transparent, fact-based communication strategies. Some of those insights have been neglected, some blatantly ignored, while other conundrums loom, unsolved, over the upcoming distribution of the coronavirus vaccines.
Federal officials have been urging state and local health departments to heed lessons from 2009 even as they warn that the immunization program ahead will be far more complex.
Instead of tweaking an influenza vaccine to attack a new strain as they did in 2009, the two companies that reported this month that their vaccines show above 90 percent efficacy — pharmaceutical giant Pfizer and biotech firm Moderna — are inventing new technologies to counter a new disease. While H1N1 disproportionately affected people under age 65, those at greatest risk from covid-19, the illness caused by the coronavirus, include the elderly and people with preexisting conditions, whose weakened immune systems typically render vaccines less effective. And next year, people will probably need two doses — spaced three or four weeks apart — of a vaccine that may be delivered in large batches and have to be stored at ultralow temperatures.
The most frequently cited lesson from the H1N1 response is common to the current pandemic and may already be hampering the upcoming distribution of the coronavirus vaccines: the danger of overly ambitious government messaging.
During fall 2009, production problems delayed delivery of the federal pandemic vaccine just as deaths were mounting, notably among children. People stood in line for lifesaving inoculations, but by mid-October, only about a quarter of the quantity that officials had been promising for months was available.
Uncertain when further supplies would arrive, public health departments canceled immunization clinics. People were confused and lost confidence in the government’s strategy. By the time enough vaccine was available, the threat from H1N1 had diminished, and many people lost interest in being immunized.
In 2010, at a meeting of vaccine experts, Kathleen Sebelius, then secretary of Health and Human Services, referred to that overpromising as one of the pandemic’s “teachable moments.”
In a recent interview, Sebelius acknowledged the dangers of raising expectations too high, even as she drew a sharp distinction between the messaging under President Barack Obama, whom she described as “absolutely committed to following the science and leading with the science,” and the “garbled and contradictory” messaging that has pitted science against politics under President Trump.
The current administration, public health experts say, has referred to a coronavirus vaccine as if it will end the pandemic quickly instead of taking to heart the lessons of a decade ago and the more complex hurdles ahead. Administration officials such as Health and Human Services Secretary Alex Azar continue to strike a far more upbeat note about the swift impact of a vaccine than infectious-disease experts who have been closely involved with previous efforts.
“It’s a cautionary note about how much hope to pin on a vaccine,” said Thomas Frieden, referring to 2009, when he became director of the Centers for Disease Control and Prevention.
“Lots can go wrong,” said Frieden, now president of Resolve to Save Lives, a global initiative targeted at epidemics. “Lots.”
The politicization of public health and explosion of conspiracy theories have exacerbated the threat of misinformation and disinformation that Gigi Gronvall, an immunologist and senior scholar at the Johns Hopkins Center for Health Security, helped counter in 2009, in both her professional life and personal interactions.
Gronvall remembers her inbox filling with messages from acquaintances concerned about the safety of the H1N1 vaccine.
“I keep reading about it, and nothing is really proving [to] me that it is safe,” wrote one mother about the H1N1 vaccine, wondering whether to take her child for a shot or nasal spray. “But I also realize that it is not safe to not get it.”
Gronvall wrote back providing a newspaper article and CDC materials on safety data.
“I would be very cautious about a lot of the stuff on the Internet about vaccines as a lot of it is total garbage,” Gronvall explained to the mother.
Those old concerns — about an H1N1 vaccine with the same manufacturing process as the seasonal flu vaccine — now strike Gronvall as minimal compared with the combination of inflated optimism and outright skepticism whipped up around the coronavirus vaccines. The need for frank, fact-based communication was clear in 2009, she said, but now she is concerned that the adverse events that inevitably accompany any innovation “will be manipulated to cause discord.”
A key takeaway from the H1N1 vaccine was the role experienced health-care workers play in conveying safety information to patients.
“The most important people are the ones holding the syringe,” said Bruce Gellin, president of global immunization at the Sabin Vaccine Institute and a former HHS official. “They are going to be asked, ‘What do you think?’ ”
With flu and measles vaccines, years of compelling safety data exist. But health-care workers do not yet have the information to answer questions authoritatively about the coronavirus vaccines, which are not being tested in children, for example.
Those issues of building trust could prove particularly important when it comes to persuading people in communities of color to receive a new vaccine.
In 2009, African Americans and Latinos were vaccinated at lower rates than other groups, according to a 2012 HHS evaluation of the response that was intended to enhance preparedness. Just as they have historically been at greater risk of flu, including H1N1, people of color have been disproportionately affected by the coronavirus. But studies show that a combination of barriers to access, distrust of the medical system and the perceived risk of side effects means they are less likely to get vaccinated.
To counter those trends, minorities have been listed among high-priority groups for the coronavirus vaccine. But even that designation is a complicating factor when it comes to a mass vaccination program, experts say.
“Prioritization is important, but in a huge population, how do you carry that out in a way that is efficient?” Gellin said. “If you have a vial, and some [of the vaccine] is going to go bad, do you wait for the right people to show up?”
In 2009, vaccine was held in reserve for priority groups, including pregnant women and children, until it became clear that limited supplies were being wasted. Some states began relaxing their rules about targeting priority groups. In Maryland, Gronvall, who was pregnant and therefore at high risk for H1N1, found herself in line with others who weren’t high-priority recipients.
In the case of a two-dose vaccine that may arrive in large batches and have to be kept at extremely low temperatures, meeting prioritization goals is harder still. If a person receives one dose and then fails to show up for a second shot, they will have wasted a dose that could have been used for another recipient. And with numerous vaccines under development, some people in targeted groups may decide to wait in the hope there’s a better option in the pipeline.
But perhaps the most resounding lesson that emerged from 2009 — and promises to complicate the upcoming distribution — is the lack of ongoing investment in public health.
“We need a plan. We’ve needed a plan for quite a long time,” said Jason Terk, a pediatrician and chair of the Texas Public Health Coalition, who recalled running short of syringes and other supplies when administering the H1N1 vaccine.
Some of the logistical challenges in 2009 were met by temporarily expanding a 25-year-old federal program, Vaccines for Children, that provides immunizations free to minors who don’t have insurance coverage. The initiative formed the backbone of nationwide H1N1 distribution plans, and many states adapted its infrastructure to register new providers and create hotlines for health-care workers who ran into problems ordering, receiving or administering vaccines.
Launched in 1994, Vaccines for Children provides more than 50 percent of childhood vaccines, which are given to states that then distribute them to more than 40,000 private physicians’ offices and public clinics across the country. The program has been credited with preventing hospitalizations, saving lives, closing the immunization gap between White children and children of color, and saving billions in health-care costs.
“A system like [Vaccines for Children] expanded to cover the adults could yield enormous benefits,” Terk said, providing greater agility in the event of another outbreak while also shoring up public health. Increasing numbers of vaccines are available for adults that protect against shingles, pneumonia, hepatitis and other illnesses, many of which are underused.
Moore said the biggest stumbling block of 2009 still hasn’t been resolved: There is no broad adult immunization network engaged with federal and state immunization programs, meaning there is no database ready to recruit the thousands of clinicians who will be needed to administer coronavirus vaccines.
But she is choosing to look ahead, hoping the lessons that will be learned from the coronavirus vaccine program won’t be squandered.
“My hope is we will leverage this opportunity in a way we didn’t leverage 2009,” Moore said. “Episodic investment is no way to do public health.”