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Sunday, April 14, 2024

Vaccines Are Here. We Have to Talk About Side Effects

Since Monday, eagerly awaited Covid-19 vaccines have been going into the upper arms of health care workers around the United States, the first slender tranche of millions of doses to come. But the joy that has greeted the shots’ arrival is already being muted by worries. Billions of dollars were spent to achieve the formulas. Prepping the US population to receive them got much less attention.

This may turn out to be a mistake. The documentation provided by Pfizer and Moderna to the Food and Drug Administration notes that both vaccines have side effects—minor ones that fade after roughly two days, but that occurred in substantial percentages of people who received them in the trials—and a few serious reactions have been reported. Descriptions of those side effects are beginning to circulate, via news reports and also social media accounts written by trial participants.

Those descriptions are reaching the public in the absence of any effort to contextualize or counter them. There has not, to this point, been a coordinated national campaign that reassures people the vaccine not only works, but is safe to take and will not cause long-term illness. Planners and health researchers are getting concerned that it is already getting late to start.

“It's really important, at this juncture when vaccines are about to be distributed, to talk to people about the predictable side effects from the vaccine,” says Eric Toner, a physician and senior scholar with the Johns Hopkins Center for Health Security. “The worst case scenario would be that we don't tell people this, and they have a reaction, and they either believe that they got Covid from the shot or that there's something wrong.”

That is a pressing concern, for two reasons. First, fear of side effects turns out to be one of the main reasons why people doubt these vaccines. And second, mistrust opens the door not just to confusion but to weaponized disinformation, and those will prevent people taking a vaccine that they need.

The Henry J. Kaiser Family Foundation’s KFF Covid-19 Vaccine Monitor, a rolling survey of 1,600 people 18 and older that launched this week to provide an ongoing measure of public feeling, reveals that, overall, people are feeling more positive about the shot than they were earlier this year. In November, 71 percent of participants said they are likely to take the vaccine, up from 63 percent in a survey done in September. But the remaining 27 percent said they would probably or definitely never take it, a proportion that rose to 33 percent among Black adults, 33 percent among essential workers, and 29 percent among people working in health care. For those who are hesitant, the leading worry was fear of side effects.

This is a tricky thing to create reassurance about, because the side effects are real. Though the Pfizer vaccine was only granted emergency authorization last weekend, and the Moderna one is not authorized yet, tens of thousands of people received them earlier this year in clinical trials. In news accounts and on social media, participants have described experiencing “a severe hangover,” “fever … fatigue and chills,” “full-on Covid-like symptoms.” One participant told CNBC he shook so hard with chills that he cracked a tooth.

Those accounts match the data submitted by the companies to the FDA’s Vaccines and Related Biological Products Advisory Committee, which reviews safety and efficacy. According to briefing documents, the Pfizer formula caused fatigue in 59.4 percent of trial participants after their second dose, headaches in 51.7 percent, muscle pain in 37.3 percent, joint pain in 21.9 percent, chills in 35.1 percent, and fever in 15.8 percent. The numbers for the Moderna formula, which were released Tuesday, are similar: fatigue in 68.5 percent of recipients, headache in 63 percent, aches and pains in 59.6 percent, chills in 43.4 percent, and fever in 15.6 percent.

These reactions aren’t mild to people experiencing them, but they are expected, and pass quickly. There have been very few serious adverse events recorded. In the United Kingdom, two vaccine recipients who already suffered from severe allergies had anaphylactic reactions to their first shot of the Pfizer formula, but recovered. On Tuesday, a health care worker in Alaska who had just been vaccinated also suffered an allergic reaction and was hospitalized, according to The New York Times. During the trials, four US recipients of the Pfizer formula and three of the Moderna formula developed Bell’s palsy, which is a paralysis of nerves on one side of the face that can last for several weeks. But FDA officials told JAMA this week that the number of cases matches the background rate of the disorder in the whole population—about 30 people out of every 100,000 every year—and was not caused by the vaccine.

Having a modest reaction to a vaccine is normal, a sign of the immune system revving up in response. (In fact, in both trials, percentages of participants who received inert placebo injections also reported side effects.) But people misinterpret that reaction even with well-known, well-studied vaccines: Every year, people have to be reassured that receiving the flu vaccine doesn’t infect them with influenza, because the reaction to receiving the shot can feel like the beginnings of the flu itself.

Flu is not a benign disease, and preventing it is important. But with the Covid vaccine, the stakes are even higher. “I worry that [the side effects] could be a major barrier to vaccine uptake,” Kristen R. Choi, a nurse and health services researcher at UCLA’s Fielding School of Public Health, wrote last week in a JAMA Internal Medicine essay describing her own reactions of chills, nausea, dizziness, and 104.9 degree fever. “Clinicians will need to be prepared to discuss with patients why they should trust the vaccine and that its adverse effects could look a lot like COVID-19.”

A particular challenge right now is that the vaccines are so new. No trial recipient has been tracked longer than a few months, and while the number of people who received them was substantial, it is still a small fraction of the number who will. It is possible that a side effect that occurs once in a million doses could surface at some point after millions of doses are administered. This happened in the 1976 swine flu vaccination campaign, in which more than 500 people in the US came down with Guillain-Barré paralysis, and in the 2009 H1N1 swine flu pandemic, in which a small number of children in Scandinavia who received a flu vaccine came down with narcolepsy. Given those still-remembered episodes, health planners may not want to commit to reassurances that they might later have to walk back.

“This is the age-old problem public health officials face, where you need to reassure the public without having full information on hand,” says Josh Michaud, an epidemiologist who is the Kaiser Foundation’s associate director for global health policy. But even given incomplete information, pro-vaccine messaging has to get started, he adds: “It's going to be absolutely critical to get ahead of the inevitable disinformation and misinformation that's going to be out there, before it takes root.”

People being hesitant to accept vaccination is not a new problem, of course, and social science has studied hesitancy for years. Researchers are quick to point out that what looks like one block of opposition to vaccination is really many overlapping populations, with different motivations for being hesitant, from suspicion of science to historic mistreatment to political affiliation to lack of access to information (or to the vaccine itself, in rural areas and “pharmacy deserts.”)

But specific fear of side effects hasn’t been as well-researched as some other motivations, says Sema Sgaier, cofounder and CEO of Surgo Ventures, a nonprofit that applies data science to public health problems. “There is not that much evidence in terms of what kinds of messaging works,” she says. “There will be an opportunity here to test different messages and see how we're going to alleviate these concerns.”

Meanwhile, misinformation isn’t waiting. Two weeks ago, the BBC collected some of the wilder claims—that the vaccine contains a microchip or fetal tissue or will alter the body’s DNA—in a debunking effort. Claims such as these aren’t merely misinformed; they are malicious. Joan Donovan, a social scientist and research director at the Harvard Kennedy School’s Shorenstein Center, has been tracking the increase in mis- and disinformation since the pandemic began.

“Since very early on in January, we’ve had a concerted misinformation campaign to make the public doubt the science around the pandemic, pushing claims that this is a conspiracy, a lab-created bioweapon, an attack on the United States by China,” she says. “This is a big problem, because when people search for things like, ‘Where did the coronavirus come from?’ they're not finding thoughtful discussions of the science. This part of the information market has been really cornered by disinformers.”

Which makes it all the more urgent to get out in front. In the Lancet journal EClinical Medicine last week, the global health and vaccine experts Ali Mokdad, Pete Hotez, and Walt Orenstein called for a “national communications plan” to anticipate problems, writing: “The American public will need to hear public health information about vaccines from trusted organizations of the US Government and at frequent and regular intervals. We need fully engaged vaccine scientists and public health experts who possess top-flight communication skills.”

But here’s the problem. In normal times, the people who would be expected to speak for science on a national scale would be federal health leaders. But under the Trump administration, federal health leaders were sidelined and undermined, to the point that Anthony Fauci of the National Institute of Allergy and Infectious Diseases spoke to sports stars and lifestyle magazines to get his message out.

The incoming administration is working to reverse that loss of credibility. President-elect Joe Biden has announced a 100-day plan to combat Covid and volunteered to be vaccinated live on TV alongside former presidents Barack Obama, George W. Bush, and Bill Clinton. On Sunday, the transition team released a social media message on mask-wearing starring the incoming CDC director, the new Surgeon General, and a newly named national Covid-19 response coordinator. But the politicization and distrust remain so strong that federal leaders may not now be the right people to lead an educational campaign on the safety of the Covid vaccine.

Scott Ratzan, a physician and public health researcher who is currently Distinguished Lecturer at the CUNY Graduate School of Public Health and Health Policy, has been calling since March for “coordinated, trusted sources” to push vetted health information out to the public. On the site of the National Academy of Medicine, he and other academics proposed creating a public-private “Covid news bureau”—a nongovernmental, comprehensive stockpile of public health information and messaging that could serve as a fact-check for social media and the public.

“It has to be external to government, and also external to industry, because trust in all institutions is going down,” says Ratzan, who also cofounded an alliance of researchers called Convince (for Covid-19 New Vaccine Information, Communication, and Education) to draw businesses into promoting vaccine literacy. “It needs to be some group that can’t be politicized by the left or the right.”

The difficult reality may be that there is no time to wait for an organized messaging campaign, and that the answer to countering fear of side effects is volunteer action to fill the federal void. That would be the same kind of volunteer action that already birthed the Covid Tracking Project, Covid Exit Strategy, Covid Act Now, the Johns Hopkins Coronavirus Resource Center and a raft of other projects—including, most recently, the Covid-19 Vaccine Allocation Dashboard, created by Benjamin Renton, a senior at Middlebury College.

That kind of volunteering is also behind the personal storytelling that occurred organically on social media this week, as physicians and pharmacists and hospital janitors stepped up to show they were thrilled to take their shot. “It’s important to see people from different communities taking the vaccine and describing their experience of it,” Donovan says. “The way people message science, it's often very impersonal, very removed. The narratives that we need to tell now are compelling stories of people's humanity.”

It may be that it’s the responsibility of everyone who supports the vaccine, no matter where they are in the queue, to work to dispel concerns about it: to push back on disinformation, to flood social media and Zoom calls and socially distanced chats with support, to be what the writer Emily Willingham once called “nerd nodes” for personal networks. Choi, the nurse and trial participant, predicted that will be necessary. “Every physician and nurse in the US needs to be prepared to have a conversation about adverse effects with patients,” she warned in her essay last week. “I can already see the wrong message about the COVID-19 vaccine going viral.”

Updated 12-17-20, 11:30 am EST: The Pfizer vaccine caused 15.8 percent of trial participants to experience fever, not headaches as previously stated.

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