Officials with Health Canada and the U.S. Food and Drug Administration have given researchers in Quebec the go-ahead to begin testing a controversial vaccine designed to protect against the Zika virus, which is said to cause microcephaly, a birth defect resulting in decreased head circumference.
The testing will be conducted at three different locations, including Universite Laval in Quebec City, the Toronto Star is reporting.
Researchers recruited a total of 40 healthy volunteers from Quebec City, Miami and Philadelphia to serve as guinea pigs for the DNA-based vaccine. Yet, DNA vaccines are said to be even riskier than traditional vaccines.
The U.S. Centers for Disease Control defines DNA vaccines as "purified plasmid preparations containing one or more DNA sequences capable of inducing and/or promoting an immune response against a pathogen."
Health practitioners often prefer these vaccines because they are believed to be more stable, have a minimized risk of accidental infection by the pathogen, and require no refrigeration, according to Harvard College Global Health Review.
"These features are appealing to practitioners in the developing world, burdened with disease-susceptible populations and lack of proper infrastructure for maintaining traditional vaccines."
The scientific community first became interested in DNA vaccines in the early 1990s, "when it was reported that plasmid DNA, delivered into the skin or muscle, induced antibody responses to viral and nonviral antigens," reports the medical journal Clinical Infectious Diseases.
However, the safety of such vaccines remains uncertain. Past research suggests that DNA vaccines when injected may cause "insertional mutagenesis," meaning mutations may result due to the insertion of new genetic material into a normal gene.
"The possibility of insertional mutagenesis is a concern that needs to be more rigorously tested," wrote researchers in a report entitled The Emerging Role of DNA Vaccines.
"While there is no evidence that the introduced DNA integrates into the host genome, if it were to occur, it would raise the specter of carcinogenesis; oncongenes may be turned on or tumor suppressor genes inhibited.
"What if DNA circulated throughout the body after injection and integrated into germ cells? Might subsequent generations express the antigen from birth and develop tolerance, instead of immunity, to the pathogen? Anti-DNA antibody formation and the possibility of autoimmune diseases is another concern."
One of the greatest concerns about DNA vaccines is the adverse effects they may have on the immune system, say scientists, adding that unlike alternate forms of gene therapy which target sick patients, DNA vaccines target "the young and the healthy."
"If host cells express antigen for a prolonged period, what effect would that have on the immune response? Could it lead to host tolerance or an exaggerated, damaging attack on tissues expressing antigen?"
Some scientists say yes, adding that this could result in chronic inflammation.
Despite the risks, vaccine manufacturers looking to capitalize on the Zika hysteria are quickly moving forward with the experimental vaccine trials.
"In phase 1 we're looking only at safety and immunogenicity, or the building of immune protection," said Gary Kobinger, director of Universite Laval's Infectious Disease Research Centre.
"We look at immune responses in those volunteers and compare those to immune responses we have documented in animals that were protected from the infection."
DNA vaccines are regulated by the FDA's Center for Biologics Evaluation and Research. Thus far, the agency has given the green light for researchers to begin phase 1 clinical studies of DNA vaccines for malaria, hepatitis B and HIV.
The company producing the Zika vaccine, Inovio Pharmaceuticals, says the second phase of the trial will test its efficacy on a larger group of volunteers from the Caribbean or Latin America by 2017.
The timeline for developing the vaccine for human testing is one of the shortest ever, said Kobinger. "We're prepared to go as quickly as our regulators allow," added Inovio Pharmaceuticals CEO Joseph Kim.
The advice comes after four cases of the virus were confirmed to have been contracted from local mosquitoes in the popular holiday destination.
It’s not just while on vacation either, as Public Health England advises couples to use condoms for eight weeks after their return to assure that the virus is not spread.
Pregnant women are advised to consider postponing non-essential trips to the state of Florida because Zika is particularly dangerous for them, as it can cause severe birth defects or cause miscarriage.
A number of UK travel agents are offering expecting women the option of changing their destination free of charge.
Men who exhibit possible symptoms have also been advised to abstain from unprotected sex for six months.
“At present, only a zone of about one square mile in Miami-Dade County is considered at risk of active transmission,” the government said.
Europe’s first Zika-caused microcephaly baby born in Spain https://t.co/UztUL0G0FS— RT (@RT_com) July 25, 2016
Florida, Guinea-Bissau, Indonesia, and the Philippines have all been deemed to pose a moderate Zika risk by the European Centre for Disease Control. Areas in South and Central America are considered high risk, and pregnant women are advised to postpone non-essential travel there.
One such place affected in South America is Brazil, where the Olympic Games are being held from August 5.
Over 150 health professionals signed an open letter in May calling on the International Olympic Committee to consider postponing or even moving the games from Rio de Janeiro to another country due to the spread of the virus.
While Zika is usually transmitted through mosquito bites, the virus can be contracted through sexual contact as well.
Officials have said that at least four people in Florida have contracted the Zika virus and warn that the virus now appears to be spreading domestically either through contact with mosquitoes or direct human-to-human transmission. Until recently, the virus only appeared in individuals infected outside of the United States, primarily in South America.
In an alarming development, according to CNN, federal, state and local officials have been deployed to canvas neighborhoods in Florida. The stated purpose is to ask questions, request urine samples and determine the spread of the virus.
Officials believe the local transmission is confined to a small area north of downtown Miami within a single ZIP code. However, local, state and federal health officials are continuing their investigation, which includes going door-to-door to ask residents for urine samples and other information in an effort to determine how many people may be infected. Additional cases are anticipated.
As noted by Erin Elizabeth of HealthNutNews.com it is not clear whether officials are asking or “demanding” these samples.
Folks, you read this correctly. The feds and other local authorities are going DOOR TO DOOR to private residences asking (demanding?) urine samples.
What if a resident does not comply? What else are they testing for? Would you comply?
I can tell you right now I am not giving any local or federal agent my urine. If arrest were the alternative then let them arrest me. I have nothing to hide, but no way would I submit to such a test if the feds showed up at my door. Some experts I’m speaking with are saying they’re asking for urine under the guise of “Zika virus” when it is, in fact, for something much more sinister. This is very disturbing to me.
While many Americans may consider the actions of officials as looking out for the interests of the public, this is the first time in recent memory that the government has deployed teams of officers and agents to personal residences following a contagion concern. Perhaps the most recent example of a similar response by the federal government was when they declared a de facto state of martial law after the Boston Marathon bombing.
Given that Zika is not necessarily life threatening, and no actual captured mosquitoes in Florida have been shown to be carrying the virus, it is unclear why officials found it necessary to deploy teams to personal residences.
Perhaps they are doing it out of an abundance of caution, though for the reasons cited above that makes little sense.
One possible reason behind the moves is that, per President Obama’s Executive Order #13707 entitled Using Behavioral Science Insights to Better Serve the American People, the government is using this crisis as an opportunity to collect behavioral data on how residents respond to government officials knocking on their doors.
The ultimate goal of such studies and procedural exercises could have something to do with another EO signed by Obama and dubbed the Executive Doomsday Order. Under that order, the President merely needs to declare an emergency in order to implement a variety of responses including the allocation of health resources, the manpower to support health initiatives, detention of individuals considered to be posing a threat to the public, forced health testing, and the security to ensure the Secretary of Health and Human Services can implement its plans once ordered to do so.
Zika does not appear to be the kind of virus or deadly threat that would require door-to-door visits from government officials.
Thus, one can, arguably, conclude that, as Erin Elizabeth noted, there is something much more sinister at play.
Anytime the government starts knocking on doors their actions should be immediately suspect. In the words of President Ronald Reagan:
The nine most terrifying words in the English language are “I’m from the government, and I’m here to help.”