Category: Covid-19 Vaccine

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In groups asked to join Covid-19 vaccine trials, concerns about inequities – STAT

September 27, 2020

While presenting the Covid-19 vaccine study shes running, Susan Little was asked for a promise she didnt have the power to make. A respected local politician refused to support the trials unless Little could ensure that the people of color being prioritized as volunteers would also be prioritized once an effective vaccine was approved.

They wanted some sort of guarantee that the communities we are asking to participate now are not left behind, said Little, the infectious disease doctor leading the AstraZeneca vaccine trial at University of California, San Diego.

At another virtual meeting this one put on by the Chicano Federation a potential participant expressed a related concern. If I experience side effects, what happens if I dont have health insurance? Nancy Maldonado, the organizations CEO, remembers someone asking.

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Lurking underneath both of those interactions was that old, oh-so-American anxiety about being unable to get medical care. It was just one of the everyday inequalities that made would-be volunteers hesitant as researchers scrambled to include more people of color in their studies a must to ensure that the shots are equally safe and effective for everyone.

That the communities hardest hit by Covid-19 have also been woefully underrepresented in clinical trials is no coincidence, and in racing to find 30,000 participants who could represent an even broader population, pharma companies have found themselves face to face with health cares deepest fault lines. Being Black, Latinx, Native American, or Pacific Islander, for instance, means you are more likely to go without health insurance than if youre white, and that makes a difference. If you want people to sign up as test subjects for experimental vaccines, it helps if they feel comfortable going to a hospital and are able to take sick leave.

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Much has been written on the ever-present specter of the Tuskegee study, which began in 1932, and for good reason. Government scientists recruited hundreds of Black men, falsely promised them free treatment, but instead simply observed without intervention as syphilis destroyed participants bodies and lives. Yet the sources of mistrust of Covid-19 vaccine trials arent just sepia-toned. The memory of Tuskegee is compounded by instances of racism, alienation, and exclusion all too tangible in 2020.

This is all playing out in the setting of George Floyd and Breonna Taylor, said Arleen Brown, a professor of medicine at the University of California, Los Angeles, who has been convening community discussions about the trials. There was a lot of concern that the powers that be are not going to treat them fairly.

In emphasizing the need for diversity in these studies, vaccine makers have tried to put their money where their mouth is. The Pfizer-BioNTech team proposed expanding the number of participants in their trial from 30,000 to around 44,000, to further increase trial population diversity. Moderna, meanwhile, slowed down its recruitment a big deal for an operation thats supposed to advance at Warp Speed out of concern that the pool of volunteers so far was too white.

Some of our sites, bluntly, are situated in a largely white population. We have had sites in those places that were told, You need to stop now and only recruit from minorities, said G. Paul Evans, president and CEO of Velocity Clinical Research, which is running vaccine trials in states across the country. When asked what sort of racial identity would fit the companys definition of a minority, he said, What the sponsors asking for is virtually anything thats not white.

That doesnt necessarily sit well with communities often alienated by medical institutions. The framing is delicate. What words you use and how you listen can make the difference between someone feeling heard and feeling like a potential guinea pig. Thats a vital distinction that Marvin Hanashiro, a community outreach coordinator at UCSD, is always trying to make clear: Its not a way of targeting people, its a way of including them.

The rationale behind this effort is valid, experts say. That is a goal that we should strive for, to make sure that anything we put forward a therapy or a drug is studied appropriately in all populations that will use it, and I think were getting there, said Jos Romero, the secretary of health for the state of Arkansas and chair of the Centers for Disease Control and Preventions Advisory Committee on Immunization Practices, specifying that he was not speaking on the agencys behalf.

The outreach to church leaders and social service organizations and unions is, in some ways, working. The Moderna trial jumped from having 7% Black or African American enrollees in late August to having 13% in mid-September a testament to the altruism that people like Brown, at UCLA, are witnessing as they broach the subject with community groups.

Yet those advances are highly dependent on geography. Our phones are going off the hook, said Devora Torrence, CEO of Centex Studies, who is working on both the Moderna and AstraZeneca trials, estimating that a majority of the volunteers at their site in McAllen, Texas, are Latinx.

Elsewhere, recruiting participants of color is harder, as demonstrated earlier this week, when Pfizers latest tally showed that 8% of its trials U.S. volunteers were Black, and 0.6% were American Indian or Alaska Native about half of where those numbers would need to be to represent the breakdown of the U.S. population.

You really cant separate participating in a clinical trial from how a person feels the system treats them, said Onyema Ogbuagu, the infectious disease doctor running the Pfizer trial at Yale. What surprised me is that it cuts across socioeconomic classes. Even my fellow African American physicians express some concerns you would not expect them to express. Its percolating in the back of their minds.

For those who are even less at ease in a clinic or hospital, the worries often run even deeper. The federal governments involvement in vaccine development makes some would-be participants many of whom are not U.S. citizens worry that they may not have control over who gets to see their data, and that that might affect their immigration status, explained Maldonado, the CEO of the Chicano Federation.

The focus on underserved communities is closely tied to the fact that many among them are frontline workers more likely, by the nature of their jobs, to be exposed to the coronavirus. Yet the logistics can be tough if your employer doesnt allow you the flexibility that would allow you take time to visit a clinic for injections and follow-ups, or if your local trial site is far from where you live and work.

Even if the logistics do work out, some arent sure they want to participate after seeing the governments indifference to their needs throughout the pandemic. There was little response when they were asking for personal protective equipment or sick leave, but suddenly when theres an opportunity to test out a vaccine, they felt they were being pushed to the front of the line, said Mona AuYoung, of Scripps Health, who has also been organizing community meetings about Covid-19 vaccine trials.

Little, the researcher at UCSD, has been careful to respond to these concerns as well as she can. She tells potential participants that she does not have the power to guarantee their neighborhoods will be prioritized for an approved vaccine, but that shell advocate for equitable distribution. She says that participants will be able to get care for vaccine-related side effects even if they dont have health insurance.

When building a website, she and her team consulted with their community advisory committee. Some of the pictures that we picked, they said, Thats a picture of a Latino man, but I dont identify with it, I think that looks staged, I would rather have something like this, Little said. To make participation easier, theyre running the study out of a mobile clinic, a mix of vehicles and tents set up in parking lots in some of the San Diego neighborhoods most deeply affected by the pandemic. Now theyre waiting for the AstraZeneca trial to start back up again in the U.S. Even once it does, though, they will have a lot of work ahead, well beyond giving injections and analyzing data.

We recognize that building trust is not something were going to do in a couple of weeks. This is going to take years, she said. Were not trying to reach out to underserved communities to say, We should talk about the AstraZeneca trial. Were reaching out to build trust, period. It would be great if, along the way, some also volunteered, but we have made no progress if we havent built enough trust that people are willing to take a licensed vaccine when it is available.

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In groups asked to join Covid-19 vaccine trials, concerns about inequities - STAT

Viruses Don’t Just ‘Go Away.’ The Toll of Reaching Herd Immunity Without a COVID-19 Vaccine – Healthline

September 27, 2020

There has been a lot of talk lately about the United States using herd immunity to combat the COVID-19 pandemic.

In a recent town hall with ABC News, President Donald Trump repeated claims that the coronavirus would go away [during] a period of time because people would develop a herd mentality.

He obviously meant herd immunity, or when a high enough number of people are immune to a disease so it cant spread through the population.

However, the presidents assertion isnt true.

Viruses dont just go away without vaccines. Even measles, once eradicated from the United States, now sees pocket infections among people who arent vaccinated, typically because of personal beliefs.

Nonetheless, at a congressional hearing Wednesday, Sen. Rand Paul, a Republican representing Kentucky, said herd immunity was responsible for a decrease in cases in New York City, once an epicenter of the pandemic where an estimated 22 percent of its citizens have contracted the coronavirus.

Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, scolded Rand for that assertion, as well as some of his other comments during the pandemic, including not heeding warnings from the Centers for Disease Control and Prevention (CDC).

If you believe 22 percent is herd immunity, I believe youre alone in that, Fauci responded.

While some experts have said certain pockets in New York City may have achieved herd immunity, they estimate for that to happen nationally, some 50 to 70 percent of the population needs to be exposed to the virus.

But to get there, millions of people would likely die and thats not even accounting for the fact that reinfections with this coronavirus are possible.

Such was the case of a 33-year-old man in Hong Kong who twice came down with the European strain of the novel coronavirus. The first time reportedly produced mild symptoms, while the second, less than 5 months later, showed no symptoms.

And since the coronavirus that causes COVID-19 is novel meaning its never been seen before experts are still learning about what it can do to individual people and the human population as a whole before normal life can resume.

One of the concerns is that reinfection can be common. In terms of herd immunity, that throws a monkey wrench into the whole thing, said Jeffrey Shaman, PhD, a professor in the department of environmental health sciences at the Mailman School of Public Health at Columbia University in New York.

Sweden took a shot at herd immunity by encouraging people to go about their lives as normal with minimal restrictions, such as limiting access to nursing homes where more vulnerable people live.

Swedes went out to eat, bars remained open, and the country waited to see what would happen.

But, as two researchers wrote in the Journal of the Royal Society of Medicine last month, Swedens herd immunity is still far off because the country suffered a clearly more severe death rate, and for much longer, than did its Scandinavian neighbors that established harsher lockdown restrictions.

Theres one glaring difference between the United States and Sweden.

That European nation has universal, government-funded healthcare. The U.S. healthcare system remains one of the most expensive in the world, dominated by private interests and largely tied to a person in the households employment.

So, besides potentially damaging and ending peoples lives, attempting to reach herd immunity by encouraging people to contract the coronavirus could be financially disastrous for millions of Americans.

The average hospitalization cost for COVID-19 treatment is between $34,000 and $45,000, according to a FAIR Health study.

Should the United States attempt to go the route of Sweden reopening shuttered businesses and letting nature take its course herd immunity wouldnt happen overnight.

Experts say it would happen more quickly in densely packed urban areas, such as Manhattan, but take longer to reach rural parts of the country.

Even then, many people are expected to needlessly get sick and die. The United States has surpassed 200,000 dead from COVID-19, and experts say the country is nowhere near herd immunity.

Shaman said about two-thirds of Americans would need to contract the novel coronavirus to have some effective level of herd immunity.

With about 330 million people in the United States, that means nearly 220 million people would need to get the virus.

That assumes everyone would have the same interaction rate, Shaman told Healthline.

And with Johns Hopkins University reporting the mortality rate of COVID-19 in the United States at almost 3 percent, thats calculating out to more than 6 million people dead without any breakthrough in treatments.

Other estimates are lower than the Johns Hopkins prediction.

While herd immunity does work for other infectious diseases such as polio, smallpox, and measles, theres a major difference between them and COVID-19.

That herd immunity was built off effective and widely available vaccines administered to anyone healthy enough to get them.

Attempting to reach that kind of herd immunity for the novel coronavirus without a vaccine or an effective treatment is something Dr. William Schaffner a professor of infectious diseases at Vanderbilt University in Tennessee calls a ghastly concept and very Darwinian, among other things.

This is an absolutely brutal way to reach a level of herd immunity, he told Healthline. Just letting a virus run without an intervention seems unnecessary.

While theres also campaign promises about a vaccine being available before Election Day, most medical professionals arent banking on it.

A recent Pew Research poll shows a growing number of adults in the United States say they wouldnt get it if it was available today.

That reluctance furthers the difficulty of safely achieving herd immunity.

There are going to be concentrated populations of unvaccinated people, Schaffner said.

He added, itll likely be among those who are resistant to basic pandemic safety measures such as wearing a mask when around other people.

Schaffner said its more likely that herd immunity with a vaccine could be possible around this time next year after a majority of Americans get all the necessary doses of an effective vaccine against COVID-19.

During that time, we have to keep masking and social distancing, Schaffner said. A vaccine isnt a magic wand.

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Viruses Don't Just 'Go Away.' The Toll of Reaching Herd Immunity Without a COVID-19 Vaccine - Healthline

First people to get COVID-19 vaccinations also will get daily health check-in text messages from the CDC – USA TODAY

September 27, 2020

It takes a lot of people to develop a COVID-19 vaccine. Volunteers may be one of the most important. Wochit

As the United States gears up for a massive immunization effort tobegin as soon as a coronavirus vaccine is available, health officials are planning the details of the rollout.

While all new vaccines are closely followed once they enter the market, because a COVID-19 vaccine is likely to be released under an Emergency Use Authorization, safety considerations are front and center.

To track reactions in real time,the first people to be vaccinated against COVID-19 will get daily email and text messages the first week after their shot asking how they're feeling. After that first week, they'll continue to getweekly messages for the next month and a half.

Thefirst wave of immunizations are expected to go to up to 20 million Americans classified as essential workers. These include frontline health care workers, police, firefighters and paramedics, critical food and industry workers and potentially teachers. At least one of several candidate vaccines may be available by the end of the year.

The emails and texts will come from the Centers for Disease Control and Prevention, said Dr. Tom Shimabukuro of the CDC's COVID-19 Vaccine Planning Unit. He spoke at ameeting Tuesdayof the CDC's Advisory Committee on Immunization Practices.

The first texts willask four questions:

Anyone who says they couldn't work, do their daily activities or needed to goto the doctorwill automatically be considered to have had a "clinically important adverse event" and would get a call from the CDC's vaccine call center, Shimabukuro said.

That information willbe shared with the Food and Drug Administration to track any problems the vaccine might be causing.

Because vaccine is expected to be in short supply in the first phase of distribution,thelimited group of essential workerswill have to sign up in advance to get their shot or shots. All but one of the current COVID-19 vaccine candidates requires two shots, so reminders forthesecond shot will be needed.

More: Feds: COVID-19 vaccine will begin moving 24 hours after the first one is approved

More: Data, data and more data will make a coronavirus vaccine safe, USA TODAY's vaccine panel says

More: 'Mind-bogglingly complex': Here's what we know about how COVID-19 vaccine will be distributed when it's approved

Anyone who gets the COVID-19 vaccine will have to sign agreements with their health care provider so they can get updates on follow-up vaccinations and other information. That will include their email address or cellphone number, which will be used to contact them for the adverse event reporting system.

"We're basically borrowing part of the information being collected as part of the registration process and that's to identify these essential workers for scheduling and reminder recalls (for their second shot)," Shimabukuro said.

Patients will be informed that their contact information will be used for doing outreach from the CDC for the health checks, he said. They'll also have the option to opt out of getting the follow-up health checks.

"We'll also give them the opportunity to opt back in even if they've opted out," he added.

(Photo: Getty Images)

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First people to get COVID-19 vaccinations also will get daily health check-in text messages from the CDC - USA TODAY

What it’s like to be in a Covid-19 vaccine trial – Quartz

September 27, 2020

Miguel Paniagua, 48, blocked off his morning on Thursday, Sept. 17. Normally, he spends his weekdays either developing assessments for medical students as a member of the National Board of Medical Examiners, teaching students at the University of Pennsylvanias school of medicine, or working in palliative care at one of the universitys hospitals. But on that morning, right at 8am, he walked into one of the universitys vaccine trial sites to begin a three-hour screening process that culminated with a quick jab in his right upper arm.

The University of Pennsylvania has partnered with Moderna to run one of the companys phase 3 clinical trials for a Covid-19 vaccine. Paniagua is one of what will be tens of thousands of participants receiving either the new mRNA-based vaccine, or a placebo. So far, Paniagua says he feels fine. The first three days I had some moderate soreness in my deltoid where they injected me, not unlike where I get a flu shot every year, he says. I dont know what that means If it was the vaccine, I didnt have a severe reaction. He posted a selfie on Twitter the next day.

To get emergency use authorization from the US Food and Drug Administration (FDA)a status that would fast-track production and distributionModerna has to show that the vaccine is safe and effective for eight weeks after the second of two injections. (Paniagua will get his second injection in about three weeks.)

That timeframe is both prolonged and not: Its long enough to make sure that, for most people, the vaccine is safe and has no long-term side effects, but short enough that Moderna could conceivably scale up and produce millions of doses by mid-2021 if the trial is effective. (The US has already pre-ordered millions of doses from Moderna.) Normally, vaccines take over a decade to make, from research to manufacturing to distribution; with the Covid-19 pandemic, pharmaceutical companies have been asked to do it in a little over a year. The best way to ensure these trials get done quickly is for everyone who can participate to do so. To me, its my duty, Paniagua says. I took an oath regarding my patient care.

Paniagua knows hes in a good position to help Moderna generate data on their vaccine candidate. For one thing, he gets regular exposure to Covid-19 through his work practicing palliative medicine. Once a week, he could potentially be exposed to someone who is dying of Covid-19 or other complications. Additionally, his wife is also a physician; she, too, could come into contact with the virus. Some exposure is necessary to assess if the vaccine works.

Paniagua is also Latino, a group that has been historically marginalized and neglected by the US medical community. As the pandemic has progressed, its become clear that Covid-19 disproportionately affects the Black and Latinx community. These groups have to be included in these trials to make sure that theyd actually benefit from a vaccines protection.

Paniagua heard about the trial through an internal communication from his employer; after filling out an online questionnaire assessing his eligibility, he received an email from someone running the trial, scheduling a date for him to come in. When he arrived, he received a physical assessment, including a Covid-19 screening, and gave 10 vials of blood so that the trial could assess other baseline measures of his health. Paniagua also had a chance to meet with the trials principle investigator to ask questions. Once those were answered (no, he cant donate blood during the trial, because it would reveal whether hed received a placebo; yes, he can get his annual flu shot), he got a jab, a thermometer, and instructions to download a smartphone app. The whole thing took less than three hours.

Paniagua will receive $225 in compensation for participating in the trial. For about a week after each jab, hell need to fill out a daily symptom diary, and update the team if he develops any unexplained symptoms or Covid-19 itself. Hell also do follow-up visits, and will have at least a phone call a month with the trials investigators for the next 25 monthsmore than two years.

Any outcome is valuable information for Moderna. If Paniagua got the real shot and has reactions, it could indicate that the vaccine isnt safe for him for whatever reason. If he got the shot and still gets Covid-19, it could be that the vaccine was ineffective or only partially effective. If he took a placebo but still gets sick, it could mean that the vaccine actually worked in people who got it. (If Paniagua does get sick, Moderna will send a doctor to his home.)

Normally, the FDA approves vaccines, a process that involves carefully evaluating three phases of clinical trials, each with more participants than the last. After the FDA signs off on a candidate, manufactures get to mass producing.

We dont have time for that with Covid-19. Instead, the FDA is planning to give vaccine candidates emergency use authorizationa status that means, given the state of the pandemic and the fact that there are no other alternatives, if the vaccine seems safe and effective based on the best available data, companies will be allowed to manufacture it and providers will be allowed to administer it. The US government has preemptively bought millions of doses of vaccines from various companies, even before results from their clinical trials are ready. Essentially, this means that the government is eating the cost of research; if a vaccine doesnt work out in a late-stage clinical trial, the drug company wont have lost money on mass producing it overall.

Even on an accelerated timeline, regulators have to factor in safety. Earlier this week, the Washington Post reported that the FDA would be upholding specific guidelines for authorizing a Covid-19 vaccine: First, all trials will have had to follow participants for at least two months after they receive their final injection. Second, at least five people will have to get severe cases of Covid-19 after receiving the placebo, which would indicate that the real vaccine was sufficiently effective at preventing these infections.

The data safety monitoring boards are charged with holding Covid-19 vaccines to the same standard as any other vaccines, says Paul Offit, a pediatrician who led the development of the rotavirus vaccine and served on the Advisory Committee on Immunization Practices to the US Centers for Disease Control (CDC). Most vaccine safety trials require at least 42 days of follow-up, or six weeks; two months, therefore, seems right in line.

For other vaccines, this two-month period is long enough to observe any common side effects caused by the vaccine itself. But what it wont be able to catch are uncommon side effects, those that occur in only a handful of individuals. Offit says those types of side effectslike Guillain-Barre syndrome, a progressive paralysiswouldnt show up in clinical trials anyway. Thats why its important to keep monitoring vaccines even after theyve been developed.

Thats true of any medical product, Offit says. Thats why we have to be honest about what we know and what we dont know. The question is when do you know enough.

US president Donald Trump, eager to have a vaccine before the election on Nov. 3, has said that he may reject the FDAs guidelines for authorization. Trump told reporters on Wednesday that he believes delaying the vaccines approval is a political move, rather than a scientific one. But scientists would likely be highly skeptical of a vaccine deployed on a faster timeline; without the data from clinical trials, its impossible to assess whether or not it would actually work. And an ineffective vaccine is just as bad as no vaccine at all.

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What it's like to be in a Covid-19 vaccine trial - Quartz

New Jersey Gov. Phil Murphy On COVID-19 Vaccine: ‘We’re Going To Have Our Own Process’ – CBS New York

September 27, 2020

TRENTON, N.J. (CBSNewYork) New Jersey Gov. Phil Murphy spoke briefly Friday about how the state will handle COVID vaccines when they become available.

Were going to have our own process and our own checks and balances, not just on efficacy, but also on equity and other factors in terms of how we think about not just is it safe, but whats the order of distribution, et cetera, he said.

This comes a day after New York Gov. Andrew Cuomo announced New York state will have its own health officials to screen any federally approved vaccine, saying, Im not going to trust the federal governments opinion.

MORE: Gov. Cuomo: Im Not Going To Trust The Federal Governments Opinion On Potential Approved COVID-19 Vaccine

Murphy, meanwhile, also announced hes extending the public health emergency by another 30 days.

Its the seventh time hes extended it.

You can get the latest news, sports and weather on our brand new CBS New York app.Download here.

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New Jersey Gov. Phil Murphy On COVID-19 Vaccine: 'We're Going To Have Our Own Process' - CBS New York

Vaccinations, Polio and COVID 19 – The Globalist

September 27, 2020

He was the cutest little boy. Like too many little children at the time and in the decades before, he was stricken by polio. He was three years old and I was eight. That was the first major shock of my life.

I remember hearing him cry through the window as I stood outside the hospital, waiting for my mother, who had gone to visit him. The anguish on her face was also not to be forgotten. I learned the big words quarantine and isolation (I thought my little brother had been put on ice).

My brother had the bad luck of being in the very last group of children to be stricken prior to the mass distribution of the Salk vaccine.

Now in his sixties, he wrote recently to ask what I remembered about the timing of the vaccinations, why he did not get one and when his other siblings got them.

So I checked my memory and did some research to offer some answers.

This task of the heart all of his siblings have a special place in their hearts for him, not only because of his fulsome humor and uproarious laughter, but also because he had this tough start in life taught me some things about those times in our early lives and made me think about current vaccination controversies.

My brother was born in that cruelest month of April on April 26, 1952, just as the number of polio cases was growing. The United States reported 57,628 cases in 1952, more than 21,000 of which were cases leading to some degree of paralysis.

As case numbers grew, parents grew more concerned and called for a vaccine.

My brothers initial question about why he had not been vaccinated as an infant was easily answered. In 1952, Dr. Jonas Salk and his colleagues at the University of Pittsburgh School of Medicine were only beginning initial trials of their killed-virus polio vaccine.

There are several uncomfortable moments for the contemporary reader in this history. One is that Dr. Salk and his team tried out the vaccine first on physically and intellectually disabled children.

Good thing that controls on clinical trials are so much tighter now. In 1953, however, Salk did publicly inject himself, his wife and children with the vaccine.

The National Foundation for Infantile Paralysis was a private effort founded by President Roosevelt in 1938 and later renamed The March of Dimes. That label is emblazoned in the minds of all Americans who were children at the time.

On April 25, 1954, the Vaccine Advisory Committee approved a field test of the Salk vaccine. That field test started the next day, April 26, 1954, my brothers second birthday.

However, the time leading up to the decision to launch a field test and then to immunize the population is fraught with tales of scientific assertions, dissents and controversies that can all be subsumed under the rubric of a calculated risk.

Suffice it to say that the contemporary reader has to admire the plain old everyday courage combined with deft scientific thinking exhibited by the many players in the design of the trials and in the decisions to carry out the vaccination program. Thomas Francis, Jr., MD, of the University of Michigan was a major leader.

Another admirable factor is the strong participation of state health departments in those halcyon days when public health was, well, healthy, respected and reasonably funded. That has not been the case in todays United States for some time.

More than 1.3 million children participated in the trial and it took a year to analyze the results, which Dr. Francis announced on April 12, 1955. There seems often to be same or next day happenings in this story: The United States government licensed the distribution of the vaccine on April 13, 1955.

My brother fell ill with polio that summer. The vaccinations had not reached South Carolina in time for him.

Progress was not easy, however. Merely weeks after the trial results had been made public, the so-called Cutter incident traumatized the country. Cutter Labs in California had produced batches of vaccine but had not heeded the instructions of Dr. Salk.

These faulty vaccines caused 11 deaths and paralysis among hundreds to thousands of people. The U.S. Surgeon General suspended use of the vaccine pending review.

Again, researchers and public health officials investigated and addressed the problems. They required manufacturers to make changes to safely produce the vaccine. Vaccinations were resumed.

In 1959, Albert Sabin, an American-Polish researcher, started trials in the Soviet Union of his live polio virus vaccine. Both the killed virus vaccine (Salk) and the live virus vaccine (Sabin) would be used over the next decades.

The worldwide effort to eliminate polio resulted in a 90% reduction of the disease by 2000. The battle toward complete elimination continues to this day.

This history is telling with regard to the vaccination battles raging among the Trump Administration, scientists and government regulators, as well as in the press and social media these days.

I have been struck by the lack of any level of scientific understanding by many people, including the well-educated. This is definitely not the time to say that everyone should be encouraged to do their own thing.

Teaching the basics of epidemiology and public health in every country of the world is clearly in order.

The history of the polio vaccine shows science and government working at deliberate, but not warp, speed.

It is important to note, as responsible scientists and regulators in U.S., European and other institutions are insisting, that the production, clinical trials, data analysis and distribution of vaccines require time and expertise.

In the public interest (what a concept), calculated risk in the hands of expert decision-makers working cooperatively makes sense, but there must be no rush.

My brother had a relatively light case of polio, but some vestiges remained. Once he told me that one of his college professors joked about seeing him walking across campus, remarking that Langston was loping along, like a southern boy in no rush.

I asked him if he had ever told the professor that he had had polio. He said, No, I wouldnt want to embarrass him.

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Vaccinations, Polio and COVID 19 - The Globalist

With COVID-19, vaccine messaging faces an unprecedented test – Salon

September 27, 2020

The Centers for Disease Control and Prevention had a problem: A new vaccine could save lives and end a viral epidemic that had infected millions of Americans. The immunization was safe, effective, and widely available. Most insurance companies planned to cover it. But few people were taking it.

That epidemic was human papillomavirus, or HPV, a sexually transmitted infection that sometimes causes cervical cancer and other serious conditions. In 2006, after federal regulators approved the first HPV vaccine, the CDC officially recommended that all adolescent girls be immunized. In 2011, the agency extended the recommendation to boys, too.

But uptake of the vaccine was, by all accounts, abysmal. So the agency launched a campaign to promote the importance of the HPV vaccine.

Extensive fact sheets, created by a consulting firm and released on the CDC's website, addressed parents' concerns that the vaccine would encourage their kids to become sexually active. Doctors and nurses began delivering talking points, provided by the CDC's communications team and disseminated by partners such as the Immunization Action Coalition, a foundation-, industry-, and government-funded nonprofit, that touted the vaccine's cancer-preventing qualities.

Immunizations jumped. By 2017, 49 percent of adolescents were up to date with the HPV vaccine.

That figure is still below CDC goals. But the HPV campaign, focusing on a vaccine that is entirely optional and given after early childhood, has become the subject of extensive research in the years since. And, as scientists edge closer to finalizing vaccines for Covid-19, lessons from HPV and other vaccine messaging campaigns are suddenly more relevant than ever.

Indeed, while it's possible a vaccine could be approved for public use as early as this fall, and widely available sometime next year, it's unclear how many Americans will be willing to take it. Many analysts are optimistic that an effective vaccine will be welcomed, but surveys indicate widespread suspicion. Officials appear to be preparing a response: In early July, CDC Director Robert Redfield testified at a Senate hearing that the agency has spent months developing a plan to build Covid-19 vaccine confidence, though he offered few details.

A preliminary CDC vaccine rollout plan, published in mid-September, describes good communication as "essential" to "a successful Covid-19 vaccination program," and notes the agency will "engage and use a wide range of partners, collaborations, and communication and news media channels" in an effort to reach different audiences.

"There's often this assumption that if we build it, they will come," said Kaitlin Christenson, vice president of vaccine acceptance and demand at the Sabin Vaccine Institute, a global nonprofit funded by a mix of government, pharmaceutical industry, and foundation sources. "But even the most effective vaccine is not going to produce results if it isn't taken up and delivered effectively."

Sometimes overlooked, vaccine messages from brochures in doctor's offices to Instagram posts are as vital to a vaccine campaign as the vaccine itself, some experts say. Over the years, vaccine messaging specialists have homed in on tactics, from those generating fear to others that evoke community values, that can boost compliance.

But results have been mixed, and fundamental debates remain over the best messaging strategies. And it's not yet clear what Covid-19 vaccine messaging campaigns launched amid a global pandemic unfolding in the shadow of intense political polarization will look like, let alone if they will work.

* * *

Before the early 2000s, said Glen Nowak, a health communications expert at the University of Georgia and former communications director for the CDC's National Immunization Program, CDC leadership believed that vaccines needed little fanfare to convince the public of their value. Up until then, Nowak said, it was "assumed that vaccines will speak for themselves." Policymakers also often leaned on state day care and school vaccination mandates to win compliance.

But "telling people to do something because you say so isn't a really effective way of getting them to feel confident," Nowak added. He recalled that when flu recommendations changed to include children in the early 2000s, it became "clear that public and provider communications would be needed to foster awareness and compliance with the new recommendations." The HPV vaccine, released a few years later, underscored the idea that just posting new vaccine guidelines wasn't enough.

With the advent of Facebook and other online social media in the 2000s, anti-vaccine messages proliferated online, sharing stories of children harmed by vaccines. At the same time, more parents began taking advantage of philosophical and religious exemption policies that let them send their kids to school unvaccinated. That trend raised alarm among public health experts and created a need for persuasive messaging, wrote Xiaoli Nan, director of the University of Maryland's Center for Health and Risk Communication, in an email.

Today, the creation of vaccine messages, sitting at the intersection of marketing and medicine, can take months or years to unfold. Sometimes the process is spearheaded by vaccine manufacturers, hospitals, or pharmacies. Often, though, the campaigns are the work of government agencies trying to boost vaccine use or address looming concerns among hesitant parents.

The CDC's National Center for Immunization and Respiratory Diseases has a contract with a communications firm that develops millions of dollars' worth of educational materials and campaigns, mostly directed at flu and HPV messaging, according to Nowak. It also has its own communications team to develop materials, targeting messages based on data from the previous year about who did or did not have high vaccination rates.

In recent years, vaccine messaging has proliferated to include Twitter accounts, TV commercials, online ads, satirical campaigns, cartoon characters, doctor education efforts, brochures, posters, billboards, radio ads, and even dedicated YouTube channels.

What makes for an effective messaging campaign, though, is a more elusive question. Jody Tate, director of research and policy for the Health Policy Partnership, a consultancy, said effective messaging digs into survey and focus group data to understand people's reluctance whether it's based on concerns about safety, or something more fundamental, such as a language barriers or access to medical care and then tailors itself accordingly.

Who delivers those messages is also crucial, Tate said. Overwhelmingly, surveys find that doctors and nurses are the most trusted sources of vaccine information. A 2018 Wellcome Global Monitor survey found that roughly three-quarters of adults around the world trust their doctor or nurse ahead of family and friends, religious leaders, and celebrities. Doctors "are the ideal messengers," Nan wrote.

Rejecting the flash of some advertising, many experts favor a simple, fact-based approach. And simple messages, repeated often, can potentially be effective, said Christopher E. Clarke, a health and environmental risk communication scholar at George Mason University. (Indeed, in a metanalysis of 14 years' worth of influenza-related communications by the CDC, Nowak found that "visible and frequent reminders" raised vaccination rates).

Experts are divided, though, on whether a straightforward tell-the-facts approach is really enough. "There is growing evidence that traditional communication of vaccines e.g., messages focusing on statistics has not worked well," Nan wrote. "More successful strategies," she added, "rely on trustworthy messengers, telling stories rather than using statistics, and appeals to moral values."

For all of Undark's coverage of the global Covid-19 pandemic, please visit our extensive coronavirus archive.

In 1999, when Nowak, then director of communications for the CDC's immunization program, looked at why more people 65 years and older weren't getting the flu vaccine, he discovered they didn't think the CDC's fact-based materials which urged high-risk groups, including the frail and elderly, to get vaccinated applied to them. They were, after all, in their 60s and 70s. They weren't frail or elderly, they told Nowak in focus groups. They were healthy and active.

Over the years, the agency has remade its flu and other vaccine messaging to be more positive and appeal to people's desire to stay healthy and maintain their quality of life.

Positive framing has proven, in some cases, to work well. A study published this May, which looked specifically at HPV vaccine messaging, found that negatively worded messages could actually increase the perception of risk associated with taking vaccine itself. "Negative messaging was not a good way to communicate," said Porismita Borah, an author of the study and an associate professor of communications at Washington State University. Kelly Moore, associate director for immunization education at the Immunization Action Coalition (IAC) and a former CDC adviser, said that "fear and uncertainty can lead to inaction."

Instead, she said, "it is messages that are positive messages of hope and optimism and empowerment that encourage people to take action, because they believe that by what they are doing, they can change their destiny."

But some experts argue that fear can offer a more effective push. The chickenpox vaccine was licensed and recommended for all children in 1995. But its uptake was poor for the first few years, said Paul Offit, director of the Vaccine Education Center at the Children's Hospital of Philadelphia and a frequent government adviser on vaccine policy who also helped invent a rotavirus vaccine that is produced by Merck.

"I think people thought of chickenpox as a benign right of childhood passage," he said. But as many as 13,000 people were hospitalized and 150 people died each year in the early 1990s as a result of chickenpox and the vaccine's maker, Merck, used those figures to create a more aggressive advertising TV commercial campaign, which included interviews with parents who had lost children to chickenpox. "It was dramatic, and they were criticized for that," Offit said. But the campaign, in conjunction with increasing public school mandates, also worked: By 2014, 91 percent of U.S. children 19 to 35 months old had received one dose of the vaccine.

Similarly, HPV vaccine messaging has sometimes preyed on people's fear: In 2016, for example, its maker, also Merck, ran ads that featured adults with cervical cancer, asking their parents if they knew a vaccine could have prevented it. Some research suggests that, at least when it comes to the HPV vaccine, anticipated regret can be a powerful motivator.

"What convinces people?" Offit asked. "Sadly, I think fear is more powerful than reason."

* * *

Some vaccine messaging campaigns simply fail. And some messengers can also endanger messaging campaigns.

In 2002, fearing that terrorists would use smallpox as a weapon, President George W. Bush ordered half a million military members to be vaccinated against the disease before launching a voluntary program for health care and emergency workers the following year. Amid concerns that the vaccine wasn't safe, he had himself vaccinated and announced it to the press.

But fewer than 40,000 health care workers accepted vaccination. Some people still didn't feel the vaccine, which can cause rare but serious complications, was safe. The administration didn't consult with doctors, critics say, and didn't anticipate that politics would play a role in people's decision to be vaccinated. The program was launched just months before the U.S. went to war with Iraq, and many liberals believed the vaccination campaign was propaganda.

Today's climate poses a distinctive, uncharted challenge: No other vaccine has been made at such breakneck speed, amid such publicity, and with such political division, said Clarke.

"There is no precedent for" this challenge, he said.

With at least several months likely remaining until the most ambitious Covid-19 vaccine will potentially go to market, a recent Gallup survey found that around one in three Americans say they would not get a free, FDA-approved Covid-19 vaccine. Surveys also suggest that Black Americans are more hesitant about the vaccine than White Americans potentially a legacy of longstanding discrimination against Black people in the health care system.

Partisanship matters, too. The Gallup survey also found that only around half of Republicans currently plan to take the vaccine when available. The country has been divided along partisan lines on many preventative measures against Covid-19. That "political divide will likely spill over to the upcoming Covid-19 vaccine," warned Nan, who, like Clarke, believes tailoring messaging to people's political or religious views could be essential to uptake. While other kinds of public messaging campaigns match messages with the receiver's worldview, Nan explained the technique has rarely been used in vaccination messaging.

But Graham Dixon, a science and risk communication professor at The Ohio State University, said that a Covid-19 vaccine messaging strategy that presents a consensus not only in the scientific community, but among policymakers, could be effective in increasing vaccination. "There has been a great deal of political polarization in this issue," he said, "and it's almost inevitable that people's decision to get a Covid-19 vaccine will land in the same way if we don't create a messaging strategy that emphasizes a depoliticized message."

In the past, other messaging campaigns have drawn on anti-polarization strategies to try to build consensus around contentious issues. A climate change awareness campaign from 2008, for example, featured famous political adversaries including the left-wing pastor Al Sharpton and the right-wing evangelist Pat Robertson sitting together on couches, talking about their shared concern about the environment.

"If and when a Covid-19 vaccine becomes available, messaging should be consistent across the political spectrum, and in a perfect world should feature influential leaders from the Republican and Democratic parties," Dixon wrote in a follow-up email. But, he added, it was probably "wishful thinking to believe that Joe Biden and Donald Trump would appear together in a PSA encouraging Covid-19 vaccination."

* * *

Despite what Redfield has described as months of planning at the CDC for how to build vaccine confidence, it's unlikely the agency will unveil official campaigns until a vaccine goes to market.

Asked in July for details about its plan, a CDC spokesperson sent Undark a link to the agency's existing framework for vaccinating with confidence and referred further questions to the U.S. Department of Health and Human Services. HHS declined repeated requests for comment and provided only unattributed information via email, writing that Operation Warp Speed (OWS) the federal initiative to deliver 300 million doses of a safe and effective Covid-19 vaccine by January 2021 is committed to "maximum transparency."

Since then, CDC has released some additional details of the campaign as part of a 57-page "interim playbook" that outlines vaccination plans for local and state public health officials.

Some journalists, legislators, and scientists have accused OWS of a lack of transparency about its process for selecting vaccine candidates. That opacity, critics say, exacerbates concerns over any potential vaccines' safety and efficacy.

If the operation's name foreshadows more messaging from government agencies, experts caution there is reason to be wary. "The term 'warp speed' was an unfortunate term," Offit said. That particular message, he said, suggests corners are being cut to create a vaccine.

"Constantly saying you're going fast makes people think you're going recklessly fast," said Arthur Caplan, a medical ethicist at New York University's Grossman School of Medicine.

Beth Bell, a clinical professor of global health at the University of Washington and member of the CDC's Advisory Committee on Immunization Practices, said she's not sure how the name came about. (The committee is not directly involved in the nuts and bolts of vaccine messaging.) "I think those of us who are looking at recommendations are quite serious about not cutting corners and not sacrificing safety for speed," Bell said.

To convince Americans already concerned about vaccine safety to take a vaccine developed at record or warp speed, transparency will be key: "Loud and clear throughout this period of preparation, and when a vaccine is available, it's going to need to be very clear what we know about the vaccine, and frankly, what we don't know," said Jason Schwartz, a health policy scholar at Yale University.

Experts believe that vaccine messaging that presents more information even if that information is incomplete, or changes as more evidence emerges can sway people toward vaccine confidence. "I understand why members of the public are skeptical and hesitant right now," said Moore, the Immunization Action Coalition staffer, during a conversation in July. "Someone recently asked me if I would take the first vaccine that rolls off the line, and I said, 'I would like to see the data and then I'll make my decision.' If that's my approach, then I respect others for having the same approach."

Nonetheless, experts hope that a safe, effective vaccine and any messaging that accompanies it will be welcomed by the majority of Americans who will have to receive it to reach herd immunity.

"I'd like to think it would be like the end of the movie 'Contagion,'" Offit said, "where everybody's lining up to get this vaccine."

* * *

Jillian Kramer is a journalist whose work has appeared in The New York Times, National Geographic, Scientific American, and more.

This article was originally published on Undark. Read the original article.

See original here:

With COVID-19, vaccine messaging faces an unprecedented test - Salon

Half a million sharks could be killed to make Covid-19 vaccines using their liver oil, conservationists warn – MEAWW

September 27, 2020

Conservationists have warned that half a million sharks lives are in danger as companies rush to manufacture vaccination for Covid-19. According to reports, a vital ingredient used in some of the vaccines now under development is squalene, which comes from sharks. Squalene is a natural oil, which is collected from these marine species.

It has been said that pharmaceutical company GlaxoSmithKline has already started using squalene in its adjuvant - an immunological agent used to enhance the immune response of a vaccine. A few months back, the firm said that it would produce a billion doses of the shark-based adjuvant for their use in coronavirus vaccines. But Shark Allies, a US-based campaign group dedicated to the protection of sharks and rays, mentioned in an online petition that this could spell potential disaster for sharks and humans since this resource is neither sustainable nor reliable for the mass production of a COVID-19 vaccine. The group stated, Shark squalene production requires relying on a finite, wild animal population. Most shark species are already at critical levels and will not withstand an increase in demand for a global vaccine.

Shark Allies has instead urged companies that are making Covid-19 vaccines to replace shark squalene with non-animal squalene ASAP. It added: Include non-animal squalene in all tests for current and future products that use squalene. Support and develop large-scale production of non-animal squalene. Reports have stated that nearly 3000 sharks are slaughtered to produce a ton of squalene. So if one dose of vaccine with squalene is enough to immunize the world population against coronavirus, it would need around 250,000 dead sharks, conservationists estimated, adding if two doses would be needed to save people from the deadly virus, the number would automatically increase to half a million.

Writing against this animal cruelty, Shark Allies said in the petition, which has been signed by over nine thousand people, Squalene made from shark liver oil is used most commonly because it is cheap to obtain and easy to come by, not because it is more effective than other sources. Countries producing shark squalene may soon need the oil for their own vaccine. The supply chain has never been tested at the scale that a coronavirus vaccine would demand. There is also very little quality control and transparency in the shark squalene industry. In a nutshell, exploiting sharks for a key vaccine ingredient that can be derived from more sustainable and reliable non-animal alternatives is a detrimental and destructive approach.

Making the argument stronger, the group backed its statements with facts and wrote on its website, Why would a company choose to use shark-derived squalene in their adjuvants, over sustainable plant-based alternatives? The only answer we can see is cost. Plant-based squalene is approximately 30% more expensive than shark squalene. One of the reasons shark squalene is cheaper is because of the ease of extraction of squalene from the shark.

Squalene with a purity of >98% is obtained directly from the liver oil of a shark after a single distillation phase in a vacuum at temperatures of 200-230 degrees Celsius. This process takes only 10 hours whereas nearly 70 hours of processing are required to obtain olive oil squalene with a purity higher than 92%. The purity of non-shark-derived squalene, however, can be comparable to that of shark squalene.

Shark Allies concluded: We want to make this clear, Shark Allies is no way asking these companies to slow down the process of a COVID-19 vaccine. Instead, we are asking these companies to replace the shark squalene in some of these vaccine adjuvants with alternative non-animal-derived squalene.

Here is the original post:

Half a million sharks could be killed to make Covid-19 vaccines using their liver oil, conservationists warn - MEAWW

‘Warp speed’ was an unfortunate term: With Covid-19, vaccine messaging faces an unprecedented test – Nieman Journalism Lab at Harvard

September 27, 2020

The Centers for Disease Control and Prevention had a problem: A new vaccine could save lives and end a viral epidemic that had infected millions of Americans. The immunization was safe, effective, and widely available. Most insurance companies planned to cover it. But few people were taking it.

That epidemic was human papillomavirus, or HPV, a sexually transmitted infection that sometimes causes cervical cancer and other serious conditions. In 2006, after federal regulators approved the first HPV vaccine, the CDC officially recommended that all adolescent girls be immunized. In 2011, the agency extended the recommendation to boys, too.

But uptake of the vaccine was, by all accounts, abysmal. So the agency launched a campaign to promote the importance of the HPV vaccine.

Extensive fact sheets, created by a consulting firm and released on the CDCs website, addressed parents concerns that the vaccine would encourage their kids to become sexually active. Doctors and nurses began delivering talking points, provided by the CDCs communications team and disseminated by partners such as the Immunization Action Coalition, a foundation-, industry-, and government-funded nonprofit, that touted the vaccines cancer-preventing qualities.

Immunizations jumped. By 2017, 49 percent of adolescents were up to date with the HPV vaccine.

That figure is still below CDC goals. But the HPV campaign, focusing on a vaccine that is entirely optional and given after early childhood, has become the subject of extensive research in the years since. And, as scientists edge closer to finalizing vaccines for Covid-19, lessons from HPV and other vaccine messaging campaigns are suddenly more relevant than ever.

Indeed, while its possible a vaccine could be approved for public use as early as this fall, and widely available sometime next year, its unclear how many Americans will be willing to take it. Many analysts are optimistic that an effective vaccine will be welcomed, but surveys indicate widespread suspicion. Officials appear to be preparing a response: In early July, CDC Director Robert Redfield testified at a Senate hearing that the agency has spent months developing a plan to build Covid-19 vaccine confidence, though he offered few details.

A preliminary CDC vaccine rollout plan, published in mid-September, describes good communication as essential to a successful Covid-19 vaccination program, and notes the agency will engage and use a wide range of partners, collaborations, and communication and news media channels in an effort to reach different audiences.

Theres often this assumption that if we build it, they will come, said Kaitlin Christenson, vice president of vaccine acceptance and demand at the Sabin Vaccine Institute, a global nonprofit funded by a mix of government, pharmaceutical industry, and foundation sources. But even the most effective vaccine is not going to produce results if it isnt taken up and delivered effectively.

Sometimes overlooked, vaccine messages from brochures in doctors offices to Instagram posts are as vital to a vaccine campaign as the vaccine itself, some experts say. Over the years, vaccine messaging specialists have homed in on tactics, from those generating fear to others that evoke community values, that can boost compliance.

Before the early 2000s, said Glen Nowak, a health communications expert at the University of Georgia and former communications director for the CDCs National Immunization Program, CDC leadership believed that vaccines needed little fanfare to convince the public of their value. Up until then, Nowak said, it was assumed that vaccines will speak for themselves. Policymakers also often leaned on state day care and school vaccination mandates to win compliance.

But telling people to do something because you say so isnt a really effective way of getting them to feel confident, Nowak added. He recalled that when flu recommendations changed to include children in the early 2000s, it became clear that public and provider communications would be needed to foster awareness and compliance with the new recommendations. The HPV vaccine, released a few years later, underscored the idea that just posting new vaccine guidelines wasnt enough.

Today, the creation of vaccine messages, sitting at the intersection of marketing and medicine, can take months or years to unfold. Sometimes the process is spearheaded by vaccine manufacturers, hospitals, or pharmacies. Often, though, the campaigns are the work of government agencies trying to boost vaccine use or address looming concerns among hesitant parents.

The CDCs National Center for Immunization and Respiratory Diseases has a contract with a communications firm that develops millions of dollars worth of educational materials and campaigns, mostly directed at flu and HPV messaging, according to Nowak. It also has its own communications team to develop materials, targeting messages based on data from the previous year about who did or did not have high vaccination rates.

What makes for an effective messaging campaign, though, is a more elusive question. Jody Tate, director of research and policy for the Health Policy Partnership, a consultancy, said effective messaging digs into survey and focus group data to understand peoples reluctance whether its based on concerns about safety, or something more fundamental, such as a language barriers or access to medical care and then tailors itself accordingly.

Who delivers those messages is also crucial, Tate said. Overwhelmingly, surveys find that doctors and nurses are the most trusted sources of vaccine information. A 2018 Wellcome Global Monitor survey found that roughly three-quarters of adults around the world trust their doctor or nurse ahead of family and friends, religious leaders, and celebrities. Doctors are the ideal messengers, Nan wrote.

Rejecting the flash of some advertising, many experts favor a simple, fact-based approach. And simple messages, repeated often, can potentially be effective, said Christopher E. Clarke, a health and environmental risk communication scholar at George Mason University. (Indeed, in a metanalysis of 14 years worth of influenza-related communications by the CDC, Nowak found that visible and frequent reminders raised vaccination rates).

Experts are divided, though, on whether a straightforward tell-the-facts approach is really enough. There is growing evidence that traditional communication of vaccines e.g., messages focusing on statistics has not worked well, Nan wrote. More successful strategies, she added, rely on trustworthy messengers, telling stories rather than using statistics, and appeals to moral values.

In 1999, when Nowak, then director of communications for the CDCs immunization program, looked at why more people 65 years and older werent getting the flu vaccine, he discovered they didnt think the CDCs fact-based materials which urged high-risk groups, including the frail and elderly, to get vaccinated applied to them. They were, after all, in their 60s and 70s. They werent frail or elderly, they told Nowak in focus groups. They were healthy and active.

Over the years, the agency has remade its flu and other vaccine messaging to be more positive and appeal to peoples desire to stay healthy and maintain their quality of life.

Positive framing has proven, in some cases, to work well. A study published in May, which looked specifically at HPV vaccine messaging, found that negatively worded messages could actually increase the perception of risk associated with taking vaccine itself. Negative messaging was not a good way to communicate, said Porismita Borah, an author of the study and an associate professor of communications at Washington State University. Kelly Moore, associate director for immunization education at the Immunization Action Coalition (IAC) and a former CDC adviser, said that fear and uncertainty can lead to inaction.

Instead, she said, it is messages that are positive messages of hope and optimism and empowerment that encourage people to take action, because they believe that by what they are doing, they can change their destiny.

But some experts argue that fear can offer a more effective push. The chickenpox vaccine was licensed and recommended for all children in 1995. But its uptake was poor for the first few years, said Paul Offit, director of the Vaccine Education Center at the Childrens Hospital of Philadelphia and a frequent government adviser on vaccine policy who also helped invent a rotavirus vaccine that is produced by Merck.

I think people thought of chickenpox as a benign right of childhood passage, he said. But as many as 13,000 people were hospitalized and 150 people died each year in the early 1990s as a result of chickenpox and the vaccines maker, Merck, used those figures to create a more aggressive advertising TV commercial campaign, which included interviews with parents who had lost children to chickenpox. It was dramatic, and they were criticized for that, Offit said. But the campaign, in conjunction with increasing public school mandates, also worked: By 2014, 91 percent of U.S. children 19 to 35 months old had received one dose of the vaccine.

Similarly, HPV vaccine messaging has sometimes preyed on peoples fear: In 2016, for example, its maker, also Merck, ran ads that featured adults with cervical cancer, asking their parents if they knew a vaccine could have prevented it. Some research suggests that, at least when it comes to the HPV vaccine, anticipated regret can be a powerful motivator.

What convinces people? Offit asked. Sadly, I think fear is more powerful than reason.

Some vaccine messaging campaigns simply fail. And some messengers can also endanger messaging campaigns.

In 2002, fearing that terrorists would use smallpox as a weapon, President George W. Bush ordered half a million military members to be vaccinated against the disease before launching a voluntary program for health care and emergency workers the following year. Amid concerns that the vaccine wasnt safe, he had himself vaccinated and announced it to the press.

But fewer than 40,000 health care workers accepted vaccination. Some people still didnt feel the vaccine, which can cause rare but serious complications, was safe. The administration didnt consult with doctors, critics say, and didnt anticipate that politics would play a role in peoples decision to be vaccinated. The program was launched just months before the U.S. went to war with Iraq, and many liberals believed the vaccination campaign was propaganda.

Todays climate poses a distinctive, uncharted challenge: No other vaccine has been made at such breakneck speed, amid such publicity, and with such political division, said Clarke.

There is no precedent for this challenge, he said.

With at least several months likely remaining until the most ambitious Covid-19 vaccine will potentially go to market, a recent Gallup survey found that around one in three Americans say they would not get a free, FDA-approved Covid-19 vaccine. Surveys also suggest that Black Americans are more hesitant about the vaccine than white Americans potentially a legacy of longstanding discrimination against Black people in the health care system.

Partisanship matters, too. The Gallup survey also found that only around half of Republicans currently plan to take the vaccine when available. The country has been divided along partisan lines on many preventative measures against Covid-19. That political divide will likely spill over to the upcoming Covid-19 vaccine, warned Nan, who, like Clarke, believes tailoring messaging to peoples political or religious views could be essential to uptake. While other kinds of public messaging campaigns match messages with the receivers worldview, Nan explained the technique has rarely been used in vaccination messaging.

But Graham Dixon, a science and risk communication professor at The Ohio State University, said that a Covid-19 vaccine messaging strategy that presents a consensus not only in the scientific community, but among policymakers, could be effective in increasing vaccination. There has been a great deal of political polarization in this issue, he said, and its almost inevitable that peoples decision to get a Covid-19 vaccine will land in the same way if we dont create a messaging strategy that emphasizes a depoliticized message.

In the past, other messaging campaigns have drawn on anti-polarization strategies to try to build consensus around contentious issues. A climate change awareness campaign from 2008, for example, featured famous political adversaries including the left-wing pastor Al Sharpton and the right-wing evangelist Pat Robertson sitting together on couches, talking about their shared concern about the environment.

If and when a Covid-19 vaccine becomes available, messaging should be consistent across the political spectrum, and in a perfect world should feature influential leaders from the Republican and Democratic parties, Dixon wrote in a follow-up email. But, he added, it was probably wishful thinking to believe that Joe Biden and Donald Trump would appear together in a PSA encouraging Covid-19 vaccination.

Despite what Redfield has described as months of planning at the CDC for how to build vaccine confidence, its unlikely the agency will unveil official campaigns until a vaccine goes to market.

Asked in July for details about its plan, a CDC spokesperson sent me a link to the agencys existing framework for vaccinating with confidence and referred further questions to the U.S. Department of Health and Human Services. HHS declined repeated requests for comment and provided only unattributed information via email, writing that Operation Warp Speed (OWS) the federal initiative to deliver 300 million doses of a safe and effective Covid-19 vaccine by January 2021 is committed to maximum transparency.

Since then, CDC has released some additional details of the campaign as part of a 57-page interim playbook that outlines vaccination plans for local and state public health officials.

Some journalists, legislators, and scientists have accused OWS of a lack of transparency about its process for selecting vaccine candidates. That opacity, critics say, exacerbates concerns over any potential vaccines safety and efficacy.

If the operations name foreshadows more messaging from government agencies, experts caution there is reason to be wary. The term warp speed was an unfortunate term, Offit said. That particular message, he said, suggests corners are being cut to create a vaccine.

Constantly saying youre going fast makes people think youre going recklessly fast, said Arthur Caplan, a medical ethicist at New York Universitys Grossman School of Medicine.

Beth Bell, a clinical professor of global health at the University of Washington and member of the CDCs Advisory Committee on Immunization Practices, said shes not sure how the name came about. (The committee is not directly involved in the nuts and bolts of vaccine messaging.) I think those of us who are looking at recommendations are quite serious about not cutting corners and not sacrificing safety for speed, Bell said.

To convince Americans already concerned about vaccine safety to take a vaccine developed at record or warp speed, transparency will be key: Loud and clear throughout this period of preparation, and when a vaccine is available, its going to need to be very clear what we know about the vaccine, and frankly, what we dont know, said Jason Schwartz, a health policy scholar at Yale University.

Experts believe that vaccine messaging that presents more information even if that information is incomplete, or changes as more evidence emerges can sway people toward vaccine confidence. I understand why members of the public are skeptical and hesitant right now, said Moore, the Immunization Action Coalition staffer, during a conversation in July. Someone recently asked me if I would take the first vaccine that rolls off the line, and I said, I would like to see the data and then Ill make my decision. If thats my approach, then I respect others for having the same approach.

Nonetheless, experts hope that a safe, effective vaccine and any messaging that accompanies it will be welcomed by the majority of Americans who will have to receive it to reach herd immunity.

Id like to think it would be like the end of the movie Contagion, Offit said, where everybodys lining up to get this vaccine.

Jillian Kramer is a journalist whose work has appeared in The New York Times, National Geographic, Scientific American, and more. This article was originally published on Undark.

Read the original post:

'Warp speed' was an unfortunate term: With Covid-19, vaccine messaging faces an unprecedented test - Nieman Journalism Lab at Harvard

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