Why Scientists & Public Health Officials Need To Address Vaccine Mistrust Instead of Dismissing it

Recent polls indicate that more than a third of the country has concerns about a vaccine that in all likelihood will be the only reliable way to end to the COVID-19 pandemic.

These results reflect a similar public sentiment in the U.S. in the 1950s when a polio vaccine was introduced. There are likely multiple reasons for this suspicion, including safety concerns, lack of transparency from the scientific community, lack of trust in the government and the desire to wait until a longer track record of safety can be established.

We are experts in media literacy, health and political communication and biostatistics and biomedical research for future health care providers, from Washington State University’s Edward R. Murrow Center for Media & Health Promotion Research and the Elson S. Floyd College of Medicine. We also live in the communities we hope to serve with our science.

Based on our research, we believe that officials need to use this testing period to build trust, not to create reasons for diminishing it. Respect and forthrightness can turn the tone from adversarial to collaborative, and from a provider-directed practice to a shared decision-making process. Scientists and public health officials must anticipate and address people’s concerns and not brush aside concerns, a process that has become commonplace across other areas of the provider-patient relationship, but vaccine decisions remain a notable exception.

Vaccines and complications

Vaccines are among the safest, most transformative drugs on Earth, with adverse events so low that very nearly universal vaccination is a reasonable expectation. With such a safety record, and with so much at risk with diseases like COVID-19, measles and influenza, vaccine advocates have good reason to stress the overwhelmingly positive safety record.

History has included some vaccines of questionable quality as well as vaccination tactics of even more concern. Certain minority groups have been targeted with egregious coercion. This included cases of forced vaccination for smallpox of African Americans at gunpoint in the southern United States in the early 1900s. At a tenement house in Manhattan’s Little Italy, over 200 men in 1901 in essence performed a smallpox vaccination raid in the middle of the night, trying to vaccinate as many people as they could.

When the miracle vaccine for polio was widely distributed in 1955, speed took precedent over safety, and many doses were distributed that contained live polio virus. As a result, 70,000 children developed muscle weakness, 164 were paralyzed permanently and 10 children died. This led to direct government intervention that has led to thousands of required tests in order to ensure safety and effectiveness.

Why can’t vaccines bounce back from mistakes?

As medical and public health researchers, we have found it interesting that corporations that have been lax and dishonest have bounced back without lasting damage to their reputations. For example, Volkswagen was caught in 2014 for outright lying to the public about their emissions. By 2019, the company topped its prescandal sales record of 2014.

We accept these occasionally fatal flaws and ethical missteps because cars are essential to our lives. The documented safety record of vaccines is staggering, not unlike the impressive safety record boasted by most automobiles on the road today.

Why do vaccines get special scrutiny? Have scientists and health care providers engaged in scientific snobbery by assuming people should do what we advise, without question or any decision-making process? Can scientists and health care providers communicate the good and positive (and bad) background of vaccines better? Has social media sown doubt in an authority that can be perceived to be overconfident? Personal health care decisions have a lasting impact on our kids and our families, so let’s rise to the occasion and utilize this unique opportunity to reframe the conversation about vaccines.

Embrace shared decision-making

The existence of a little-known but critical government office both acknowledges past problems with some vaccines and also provides a method of recourse for those injured by vaccines. The National Vaccine Injury Compensation Program, launched in the 1980s, is a powerful tool for transparency and accountability that should help shape this important, shared decision-making process. For example, between 2006 and 2018 over 3.7 billion doses of covered vaccines were distributed in the U.S. During this same period, 5,233 filed petitions to this office were compensated out of a total of 7,482 petitions. This means that for every 1 million vaccine doses distributed, one individual received compensation.

Rather than brushing off concerns among parents and others who are concerned about safety, experts should listen. When they do talk, they should explain safety issues and should use metaphors such as the safety of vehicles and other medical breakthroughs (e.g., insulin, heart valve surgery) so often relied upon in an effort to work toward the same goal together as a country, and as health care provider and patient.

Experts should acknowledge that the practice of medicine and public health research is a relatively new field of science to drive public health, medical practice advancement and policies when compared to other, far more established scientific disciplines such as physics or chemistry. Building public support requires more than citing solid evidence in the peer-reviewed scientific literature. Owning up to setbacks in vaccine development that the current administration may be on the brink of repeating – and then making the necessary repairs to move forward again, as the auto manufacturers do – also builds confidence. AstraZeneca’s public announcement about a serious adverse event in one of their trials, which led to a pause of participant enrollment, was a great first step.

Let’s begin by acknowledging that all parties want to achieve the same end goal of a healthy, safe return to daily life. Despite the explosion of misinformation about COVID-19, a clear, consistent and respectful approach can reset the vaccine conversation.

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Next, let’s acknowledge that vaccines are not now and have not been 100% perfect (nor is any medicine or car). We should also note that the same science that produces vaccines also produces myriad breakthroughs in specialties such as cardiology and oncology, along with over-the-counter medications such as ibuprofen that mitigate minor ailments but also have limitations and warning labels.

Finally, invite skeptics to a conversation and acknowledge up front that, like any other scientific advancement of things that now work, there was a time when they didn’t work as well, or at all.

Instances like these undoubtedly fuel people’s concerns. Such occurrences should give us all pause, scientist or not, to do better next time and strive to never repeat such notable grievances.

By: Sterling M. McPherson/ Associate Professor, Director and Assistant Dean for Research, Washington State University

Erica Weintraub Austin/ Professor and Director, Edward R. Murrow Center for Media & Health Promotion Research, Washington State University

Porismita Borah/Associate Professor, health communication, Washington State University

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CBC News: The National

Misinformation about vaccines have public health officials in Canada looking for guidance on how to combat medical mistrust. As CBC’s Katie Nicholson reports, the answers they are looking for might be half a world away. »»» Subscribe to The National to watch more videos here: https://www.youtube.com/user/CBCTheNa… Voice Your Opinion & Connect With Us Online: The National Updates on Facebook: https://www.facebook.com/thenational The National Updates on Twitter: https://twitter.com/CBCTheNational »»» »»» »»» »»» »»» The National is CBC Television’s flagship news program. Airing six days a week, the show delivers news, feature documentaries and analysis from some of Canada’s leading journalists.

FDA Approves Remdesivir For Covid-19 Treatment

The Food and Drug Administration on Thursday approved remdesivir as a treatment for hospitalized coronavirus patients, Gilead Sciences said, making it the first FDA-approved drug for Covid-19.

Key Facts

The drug was previously granted an emergency use authorization in May, which allowed healthcare providers to administer the treatment even though it wasn’t formally approved by the FDA.

Remdesivir, which is sold under the brand name Veklury, “should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care,” Gilead said.

The drug is approved for adults and children 12 and older weighing at least 88 lbs. for coronavirus treatment requiring hospitalization.

Clinical trial data has been mixed: A randomized trial from the National Institute of Allergy and Infectious Diseases found remdesivir improved recovery time, but a study from the World Health Organization, which has not yet been peer reviewed, found last week the drug did not increase the chances of survival or result in faster recovery.

Gilead shares jumped 3.8% in after hours trading following the announcement. 

Crucial Quote

“It is incredible to be in the position today, less than one year since the earliest case reports of the disease now known as COVID-19, of having an FDA-approved treatment in the U.S. that is available for all appropriate patients in need,” said Gilead CEO Daniel O’Day in a statement.

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Key Background

President Donald Trump took remdesivir when being treated for the coronavirus earlier this month. Follow me on Twitter. Send me a secure tipRachel SandlerI’m a San Francisco-based reporter covering breaking news at Forbes. I’ve previously reported for USA Today, Business Insider, The San Francisco Business Times and San Jose Inside. I studied journalism at Syracuse University’s S.I. Newhouse School of Public Communications and was an editor at The Daily Orange, the university’s independent student newspaper. Follow me on Twitter @rachsandl or shoot me an email rsandler@forbes.com.

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Remdesivir is a prodrug of an adenosine triphosphate (ATP) analog, with potential antiviral activity against a variety of RNA viruses. Upon administration, remdesivir, being a prodrug, is metabolized into its active form GS-441524. As an ATP analog, GS-441524 competes with ATP for incorporation into RNA and inhibits the action of viral RNA-dependent RNA polymerase. This results in the termination of RNA transcription and decreases viral RNA production.

Remdesivir has an FDA Emergency Use Authorization for use in adults and children with suspected or confirmed COVID-19 in hospital with an SpO2 ≤94%.[L13239] This is not the same as an FDA approval.[L12609] The FDA Emergency Use Authorization suggests a loading dose of 200mg once daily in patients ≥ 40 kg or 5 mg/kg once daily in patients 3.5 kg to less than 40 kg, followed by a maintenance dose of 100mg once daily in patients ≥ 40 kg or 2.5 mg/kg once daily in patients 3.5 kg to less than 40 kg.[L13239] Patients not needing invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) should be treated for 5 days (including the loading dose on day 1), up to 10 days if they do not show improvement.[L13239] Patients requiring invasive mechanical ventilation or ECMO should be treated for 10 days.[L13239]

Clinical trials used a regimen of 200mg once daily on the first day, followed by 100mg once daily for another 9 days.[A191931,L12174,L12177] Early data suggests that some patients may benefit from only 5 days of treatment.[A198810] Remdesivir was originally investigated as a treatment for Ebola virus, but has potential to treat a variety of RNA viruses.[A191379] Its activity against the coronavirus (CoV) family of viruses, such as SARS-CoV and MERS-CoV, was described in 2017,[A191382] and it is also being investigated as a potential treatment for SARS-CoV-2 infections.[A191427,A193254]

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CNBC Television 1M subscribers The FDA has approved Gilead’s Remdesivir as a Covid-19 treatment. Previously, the drug was approved only for emergency authorization. Gilead stock was up 4 percent after the news. Meg Tirrell joins ‘Closing Bell’ to discuss. For access to live and exclusive video from CNBC subscribe to CNBC PRO: https://cnb.cx/2NGeIvi » Subscribe to CNBC TV: https://cnb.cx/SubscribeCNBCtelevision » Subscribe to CNBC: https://cnb.cx/SubscribeCNBC » Subscribe to CNBC Classic: https://cnb.cx/SubscribeCNBCclassic Turn to CNBC TV for the latest stock market news and analysis. From market futures to live price updates CNBC is the leader in business news worldwide. The News with Shepard Smith is CNBC’s daily news podcast providing deep, non-partisan coverage and perspective on the day’s most important stories. Available to listen by 8:30pm ET / 5:30pm PT daily beginning September 30: https://www.cnbc.com/2020/09/29/the-n… Connect with CNBC News Online Get the latest news: http://www.cnbc.com/ Follow CNBC on LinkedIn: https://cnb.cx/LinkedInCNBC Follow CNBC News on Facebook: https://cnb.cx/LikeCNBC Follow CNBC News on Twitter: https://cnb.cx/FollowCNBC Follow CNBC News on Instagram: https://cnb.cx/InstagramCNBChttps://www.cnbc.com/select/best-cred…#CNBC

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Final Results In Remdesivir Trial Confirm It Shortens Length Of Covid-19 Cases, But Has Small Impact On Death

Topline

A long-awaited study of Gilead Sciences’ experimental antiviral remdesivir published Thursday in the New England Journal Of Medicine shows that patients with Covid-19 who took the drug recovered from the disease faster compared to patients who took a placebo.

Key Facts

The trial, which was led by the National Institute of Allergy and Infectious Diseases (NIAID), was double-blinded and involved more than 1,000 Covid-19 patients from around the world.

The trial  found that hospitalized patients who took remdesivir recovered from the disease in 10 days on average, five days faster than those taking a placebo.

The greatest benefit occurred when remdesivir was given to patients early in their illness who were hospitalized and receiving supplemental  oxygen but not yet on a ventilator.

The researchers also say that the data suggests that remdesivir may prevent patients from getting more severely ill and needing more oxygen or ventilation.

While the study itself didn’t find a statistically significant reduction in death for patients taking remdesivir, a later analysis suggested a small benefit, finding that 11.4% of patients who took remdesivir died by day 29, compared to 15.2% of patients that took the placebo.

Key Background

While there is no drug approved yet to treat Covid-19, remdesivir has been a frontrunner for months. In May, after preliminary study results showed that it helped patients recover from Covid-19 four days faster than a placebo, the FDA issued an Emergency Use Authorization for remdesivir (brand name Veklury) to be used in hospitalized patients with severe Covid-19. In August the agency expanded the recommendation and said that remdesivir could be used for any patients hospitalized with Covid-19, no matter the severity of their symptoms. Last week, President Trump’s doctors announced that the president received infusions of remdesivir after his diagnosis of Covid-19. There is currently a global shortage of the drug, and Gilead has announced plans to manufacture 2 million treatment courses of the drug by December. 

Quote

“For patients who are hospitalized with Covid-19, the importance of speeding up recovery by five to seven days cannot be underestimated,” wrote Gilead CEO Daniel O’Day in an open letter published Thursday. “This represents a significant benefit in a disease where every day counts.”

Chief Critic

Overall, the final report does not change the preliminary conclusions,” wrote Joshua Niforatos, an emergency room physician at Johns Hopkins Hospital. “Based on the research to-date, for critically ill covid-19 patients, remdesivir is unlikely to change survival or the need for mechanical ventilation. The only drug to-date that has shown to improve mortality remains dexamethasone, a generic and inexpensive drug.”

What’s Next

Gilead will likely use the results of this study to apply for official FDA approval of remdesivir, which has never been approved by the agency before. If the FDA accepts the company’s application, it would be the first approval of a drug specifically to treat Covid-19.

Full coverage and live updates on the Coronavirus / Follow me on Twitter. Send me a secure tip

Leah Rosenbaum

Leah Rosenbaum

I am the assistant editor of healthcare and science at Forbes. I graduated from UC Berkeley with a Master’s of Journalism and a Master’s of Public Health, with a specialty in infectious disease. Before that, I was at Johns Hopkins University where I double-majored in writing and public health. I’ve written articles for STAT, Vice, Science News, HealthNewsReview and other publications. At Forbes, I cover all aspects of health, from disease outbreaks to biotech startups.

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We regret that the WHO prematurely posted information regarding the study, which has since been removed. The investigators in this study did not provide permission for publication of results,” a Gilead spokesperson said in a statement to CNBC. “Furthermore, we believe the post included inappropriate characterizations of the study. Importantly, because this study was terminated early due to low enrollment, it was underpowered to enable statistically meaningful conclusions,” according to Gilead. “As such, the study results are inconclusive, though trends in the data suggest a potential benefit for remdesivir, particularly among patients treated early in disease.” For more coronavirus live updates: https://www.cnbc.com/2020/04/23/coron… For access to live and exclusive video from CNBC subscribe to CNBC PRO: https://cnb.cx/2JdMwO7 » Subscribe to CNBC TV: https://cnb.cx/SubscribeCNBCtelevision » Subscribe to CNBC: https://cnb.cx/SubscribeCNBC » Subscribe to CNBC Classic: https://cnb.cx/SubscribeCNBCclassic Turn to CNBC TV for the latest stock market news and analysis. From market futures to live price updates CNBC is the leader in business news worldwide. Connect with CNBC News Online Get the latest news: http://www.cnbc.com/ Follow CNBC on LinkedIn: https://cnb.cx/LinkedInCNBC Follow CNBC News on Facebook: https://cnb.cx/LikeCNBC Follow CNBC News on Twitter: https://cnb.cx/FollowCNBC Follow CNBC News on Instagram: https://cnb.cx/InstagramCNBC

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Anti-viral drug remdesivir effective against coronavirus, study finds

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Anti-viral drug remdesivir cuts recovery times in coronavirus patients, according to the full results of a trial published Friday night, three weeks after America’s top infectious diseases expert said the study showed the medication has “clear-cut” benefits.

Complete results from the research, which was carried out by US government agency the National Institute of Allergy and Infectious Diseases (NIAID), were published by leading medical periodical the New England Journal of Medicine.

The United States authorized the emergency use of remdesivir in hospitals on May 1, followed by Japan, while Europe is considering following suit.The study found that remdesivir, injected intravenously daily for 10 days, accelerated the recovery of hospitalized COVID-19 patients compared to a placebo in clinical tests on just over a thousand patients across 10 countries.

On April 29, NIAID director Anthony Fauci, who has become the US government’s trusted face on the coronavirus pandemic, said preliminary evidence indicated remdesivir had a “clear-cut, significant and in diminishing the time to recovery.”The National Institutes of Health, of which the NIAID is a part, said Friday in a statement online that investigators found “remdesivir was most beneficial for hospitalized patients with severe disease who required .”

But the authors of the trial wrote that the drug did not prevent all deaths.”Given high mortality despite the use of remdesivir, it is clear that treatment with an anti-viral drug alone is not likely to be sufficient,” they said.About 7.1 percent of patients given in the trial group died within 14 days—compared with 11.9 percent in the placebo group.

However, the result is just below the statistical reliability threshold, meaning it could be down to chance rather than the capability of the .

A total of 1063 patients underwent randomization. The data and safety monitoring board recommended early unblinding of the results on the basis of findings from an analysis that showed shortened time to recovery in the remdesivir group. Preliminary results from the 1059 patients (538 assigned to remdesivir and 521 to placebo) with data available after randomization indicated that those who received remdesivir had a median recovery time of 11 days (95% confidence interval [CI], 9 to 12).

As compared with 15 days (95% CI, 13 to 19) in those who received placebo (rate ratio for recovery, 1.32; 95% CI, 1.12 to 1.55; P<0.001). The Kaplan-Meier estimates of mortality by 14 days were 7.1% with remdesivir and 11.9% with placebo (hazard ratio for death, 0.70; 95% CI, 0.47 to 1.04). Serious adverse events were reported for 114 of the 541 patients in the remdesivir group who underwent randomization (21.1%) and 141 of the 522 patients in the placebo group who underwent randomization (27.0%).

Conclusions

Remdesivir was superior to placebo in shortening the time to recovery in adults hospitalized with Covid-19 and evidence of lower respiratory tract infection. (Funded by the National Institute of Allergy and Infectious Diseases and others; ACCT-1 ClinicalTrials.gov number, NCT04280705. opens in new tab.)

Source: https://medicalxpress.com

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