Inovio, which is based in Plymouth Meeting, Pennsylvania, and GeneOne Life Science, which is based in Seoul, South Korea, worked together on the vaccine. They previously collaborated to create vaccines for Ebolaand MERS, both of which are being tested.
The Zika vaccine, with the clinical-sounding name GLS-5700, will first be tested in 40 healthy volunteers. The first tests in humans should start in the next few weeks, Inovio said in a news release.
In the animal testing stage, the vaccine caused a strong antibody response, the company said. It is still very early in the vaccine’s development. Phase I of a vaccine trial ensures that it can be tolerated well in human subjects. If successful in this first round of human testing, it will need additional approval for further testing.
At the next stage, the vaccine would be tested on people who have Zika. Then there would be a stage to see how well it works on a larger group of people. Dr. Anthony Fauci, director of the National Institute for Allergy and Infectious Disease at the National Institutes of Health, is leading a team that is trying a few approaches to a vaccine, including an approach using DNA like Inovio’s does. He believes that trial could start by the end of August. In the coming months, he said, we will probably be hearing about a number of vaccine candidates going into Phase I trials. “This is all good news,” Fauci said.
In 2013 a boy who was given the HPV vaccine died almost two months later.
Two quick questions: First, does this worry you? And second, do you believe that the vaccine caused the boy’s death?
This is a real case reported in the Vaccine Adverse Event Reporting System (VAERS). VAERS is monitored by health experts at the Centers for Disease Control and Prevention and Food and Drug Administration to detect very rare or emergent harms that may be caused by vaccines. The vast majority of adverse events reported in VAERS are mild (such as fever), but a few are serious, like death and permanent disabilities. Staff follow up on certain cases to better understand what happened.
A growing number of parents are refusing to vaccinate their children, and one reason they often state is that they do not trust that doctors and government agencies sufficiently research the potential harms of vaccines. Given that, we wanted to find out whether telling people about VAERS and the information it gathers could influence their beliefs about vaccine safety.
Vaccine refusal and the importance of trust
It’s important to stress that just because a case like the one mentioned above is reported to VAERS doesn’t mean that the vaccine caused the problem. That’s because VAERS is an open-access reporting system.
Health care providers are required to report certain adverse events, but they are not the only ones who can contribute to the database. Anyone can make a report in VAERS for any reason. Similarly, anyone can access VAERS reports and data. In fact, advocates both for and against vaccines refer to VAERS data as evidence of either the existence of harms or the rarity of harms.
This open-access feature makes VAERS a potentially rich source of information about possible vaccine-related harms. It also means, however, that the events reported in VAERS often turn out to have nothing to do with a vaccine.
Take for example, the boy who died less than two months after receiving the HPV vaccine. Here’s what the full VAERS report says: “Sudden death. He was perfectly healthy. The vaccination is the only thing I can think of that would have caused this. Everything else in his life was normal, the same.”
The fact that there were no reported problems for almost two months between the vaccine and the child’s death might make you, like us, skeptical that the vaccine was the cause. Yet, it is important that the death was reported so that it can be followed up.
Being transparent about risks is critical to building trust. In fact, that’s part of the reason that VAERS data is available to everyone.
Does VAERS make people trust vaccine safety?
It seems plausible that describing VAERS in depth could build trust. Doing so would demonstrate that every effort is being made to collect information about potential vaccine harms, and that even with such a comprehensive effort very few serious events are reported. Further, transparency would also show that these few serious events are not necessarily caused by the vaccine, and this information is available for anyone to view and evaluate.
We decided to test this idea in a recent internet survey. We surveyed over 1,200 people, who were divided into three groups.
One group received the standard CDC Vaccine Information Statement for the HPV vaccine. We chose the HPV vaccine because this vaccine is particularly underutilized. The second group was given detailed information about VAERS – what it is, what it is for and what it contains – as well as the number of serious adverse event reports received about HPV. To be specific, this group was told that there were seven deaths and 24 permanent disabilities reported for the HPV vaccine in 2013 out of a total of approximately 10 million vaccine doses given that year. A third group received all of that information and then also read the actual adverse event reports in detail. We hoped that reading these reports would show this group that not all of these deaths and permanent disabilities were caused by the vaccine.
We found that telling participants about VAERS, without having them read the actual reports, improved vaccine acceptance only very slightly. Even worse, when participants read the detailed reports, both vaccine acceptance and trust in the CDC’s conclusion that vaccines are safe declined significantly.
What we found next surprised us: The vast majority of our survey respondents, the same ones who were less accepting of vaccines and less trusting of the CDC, said that they believed the vaccine caused few or none of the reported deaths and disabilities. This means that the individual stories of perceived vaccine harms were highly influential, even when people didn’t believe they were true.
We are influenced by information even when we don’t believe it
Think back to your reaction to reading about the tragic death we described earlier. Our data suggest that just learning about this death may have caused you to feel more negatively toward the HPV vaccine, even if you believed that the vaccine did not cause the death.
While we can’t say that everyone reacted to the stories the same way or to the same degree, it seems clear that at least some people didn’t believe that the vaccine caused the reported harms, but they were nonetheless negatively influenced by those reports.
Systems like VAERS are essential for public health, providing an opportunity to learn about and investigate every possible case of potential harm caused by vaccines. But the power and emotion evoked by the stories of VAERS reports may influence us and undermine trust in vaccines, no matter what our rational mind might think.
Parents have a responsibility not only to their own children, but to their communities—it’s only by achieving a very high level of population immunity that outbreaks can be prevented. Vaccination is particularly crucial for children with cancer and other diseases that cause immunosuppression. They cannot be vaccinated safely, but are at high risk of severe consequences if they are infected—and, thus, they depend on the community’s so-called “herd immunity” for protection against a potentially fatal illness.
While some parents continue to express concern about a possible link between vaccines and autism spectrum disorders, the original report claiming this connection has been debunked and retracted. A large number of carefully designed follow up studies have been carried out, and the overwhelming weight of scientific evidence shows no evidence for such a link. That’s why it continues to be so important to get the word out to parents: Have your kids vaccinated.
September 16th’s Republican debate put vaccines back in the headlines, when Ben Carson, a former neurosurgeon, was asked to comment on Donald Trump’s statements linking vaccinations to autism. Carson said:
We have extremely well-documented proof that there is no autism associated with vaccinations, but it is true that we’re giving way too many in way too short a time and a lot of pediatricians recognize that.
This is a discussion that we have covered again and again and again at The Conversation.
Yet these messages don’t seem to have counteracted misinformation about vaccines. That’s because these explanations often repeat the very falsehoods they are trying to correct. As Norbert Schwarz and Eryn Newman from the University of Southern California write:
[M]edia reports that intend to correct false information can have the unfortunate effect of increasing its acceptance. Using anecdotes and images makes false information easier to imagine – and by highlighting disagreement, they distort the amount of consensus that actually exists.
A better strategy, they say, is to stick to the facts.
Kristin S Hendrix, a professor of pediatrics at the Indiana University School of Medicine, examined the research on parent-provider conversation about vaccines. She writes:
What is clear from existing research is that respectful, tailored communications and recommendations to immunize coming directly from the health-care provider are associated with increased vaccination uptake.
Before the measles vaccine was introduced in the US in the 1960s, we thought of measles as a “mild” illness, even though it killed 400-500 Americans a year. Today, suggesting that measles is benign is controversial. And that is because vaccines change how we think about the disease they prevent. As Emory historian Elena Conis writes:
Vaccines shine a spotlight on their target infections and, in time, those infections – no matter how “common” or relatively unimportant they may have seemed before – become known for their rare and serious complications and defined by the urgency of their prevention.
Marcel Salathé, now a professor at École polytechnique fédérale de Lausanne, points out everyone who can be vaccinated, should be vaccinated, to help protect those who are too young or too ill to receive the vaccine. Tony Yang, a professor of health administration at George Mason University, looked at the impact vaccine exemption polices have on outbreaks of vaccine-preventable diseases. And Michael Mina, an MD/PhD candidate at Emory, explained how the introduction of the measles vaccine in Europe prevented deaths from other diseases.
Speaking of other diseases, just over a year ago, news that a handful of people in the United States had contracted Ebola was dominating the headlines. William Moss, an epidemiologist at Johns Hopkins, pointed out that Americans should worry less about Ebola and more about the measles.
Unfortunately, the “issue” of vaccines was brought up in the most recent GOP debate on CNN, and as one would suspect, the candidates performed poorly in regards to this subject.
First of all, here at CauseScience, we have posted NUMEROUS times trying to dispel any beliefs that parents should not vaccinate their children. Vaccines work and they are not linked to autism. period.
So what exactly happened at the debate? The Donald has been criticized for his adamant stance that vaccines cause autism, and so debate moderator Jake Tapper asked the other doctors on the debate panel if there was any validity to this. Obviously, we know Trump’s stance is just plain wrong, but I’d like to point out anti-quotable responses from the DOCTORS on the panel: Ben Carson and Rand Paul.
“We have extremely well-documented proof that there’s no autism associated with vaccination, but it is true that we are probably giving way too many in too short a period of time. I think a lot of pediatricians now recognize that and are cutting down on the number and the proximity in which those are done.” ~Ben Carson
“I’m for vaccines, but I’m also for freedom. Even if the science doesn’t say bunching them up is a problem, I ought to be able to spread my vaccines out a little bit, at the very least.” ~Rand Paul
“Vaccines are very important. Certain ones. The ones that would prevent death or crippling. There are others, there are a multitude of vaccines which probably don’t fit in that category, and there should be some discretion in those cases…” ~Ben Carson
At LEAST these doctors agree vaccines are important and not linked to autism. HOWEVER, the timing of vaccines and adhering to a vaccination schedule is INCREDIBLY important. In the New York Times, Dr. Paul Offit, a pediatrician specializing inin infectious diseases at the Children’s Hospital of Philadelphia explained, “When you delay vaccines, you increase the period of time in which you are susceptible to those diseases. We are seeing the effects of that. The outbreak we saw this year in Southern California was among parents who had chosen to delay or withheld vaccines for their children.”
Furthermore, WHAT are the “multitude” of other vaccines in which discretion should be used? That’s just not right. I’m sure more issues like these will arise as the election season warms up, but its disheartening to see candidates so eager to appeal to their base that they will completely ignore facts and scientific data (I guess that’s not surprising for politics). Importantly, in this situation, it’s irresponsible for these doctors to make such blatantly false statements regarding vaccines.
A former Iowa State University scientist was sentenced to four-and-a-half years in prison for altering blood samples to make it seem like he’d achieved a breakthrough in creating an HIV vaccine.
Dong-Pyou Han will receive prison time for making false statements in research reports and will have to pay back $7.2 million to the government agency that funded his research. He entered a plea agreement in February admitting guilt in two counts of making false statements.
Han’s made up data wasted A LOT of tax-payer funding, and took money and time away from other REAL HIV vaccine research. Thus holding up a much needed vaccine for his personal ‘gain.’ Let this serve as a lesson to researchers that misconduct and fraud will be punished accordingly. There is no place for this type of fraud in science (especially when there are anti-science groups waiting for any type of ammunition against science and vaccines).