Needle Tips

July 22nd, 2014 (last updated)

Needle Tips is a publication written for health professionals who provide immunization services to children, teens, or adults. Every issue includes the Ask the Experts feature by CDC experts who answer challenging and timely questions about vaccines and their administration; the Vaccine Highlights section which contains vaccine news from ACIP and CDC; and ready-to-print materials from IAC to photocopy and hand out to staff and patients. The technical content of Needle Tips is reviewed for accuracy by CDC. Subscribe to Needle Tips – it’s free!

needle tips Click here

Source:
Immunization Action Coalition

Seasonal influenza and vaccine herd effect

July 21st, 2014 (last updated)

The seasonal influenza vaccine programs in many regions aimed to protect most vulnerable population, but current trivalent influenza vaccine does not provide sufficient effectiveness among people under high risk for severe outcome of the influenza. The vaccine herd effect (VHE) is the extra protection of non-immune high risk persons, with increase of immunity among vaccinated healthier persons which prevents circulation of influenza in the community. Accumulating evidences are supporting the immunization of extended population with regard to the VHE.

Seasonal influenza and vaccine herd effect Click here

Source:
Clinical and Experimental Vaccine Research

HPV Vaccination in India: Critical Appraisal

July 20th, 2014 (last updated)

Cervical cancer is the third most common cancer in women worldwide. The role of human papilloma virus (HPV) in the genesis of cervical carcinoma is well documented. The HPV 16 and 18 are found to be most commonly associated with invasive cervical carcinoma. The advent of cervical carcinoma vaccine has advanced the hopes that eradication of cervical carcinoma might be possible in future. The scenario of prevention of cervical carcinoma is completely different in developed and developing countries. The implementation of the vaccination as a routine in India is still controversial. Here we have tried to critically analyse these issues in Indian context. However it is clear that cervical cancer vaccine is not an immediate panacea and cannot replace the cervical cancer screening which is mandatory in Indian context.

HPV vaccination Click here

Source:
ISRN Obstetrics and Gynecology

Extra dose of inactivated polio vaccine boosts immunity in children and could speed up global eradication efforts

July 19th, 2014 (last updated)

Giving children under 5 years old an extra dose of inactivated polio vaccine (IPV) helps to boost their immunity to the poliovirus and should be added to vaccination programmes in polio-endemic countries and those facing a high risk of imported cases, suggests new research published in The Lancet.

Lead author Dr Jacob John from Christian Medical College, India explains, “Adding a supplementary IPV dose to children already vaccinated with oral poliovirus vaccine (OPV) may hasten polio eradication by boosting herd immunity in endemic regions, act as a booster to prevent international spread by travellers, and minimise the risk of polio outbreaks due to imported wildtype or vaccine-derived polioviruses.”

Mass vaccination with OPV has successfully eliminated wild poliovirus from most of the world, although it remains endemic in Afghanistan, Nigeria, and Pakistan, and imported cases have led to large outbreaks in Africa, Asia, and Europe.

Although OPV is highly effective, easy to administer, and relatively inexpensive, its ability to generate a strong intestinal immunity to infection wanes as early as a year after vaccination. Thus, vaccinated children and adults can still be infected and shed wild poliovirus, contributing to the spread of the disease.

In an attempt to increase protection in children whose immunity might have waned, scientists from India and the UK examined the effect of an additional dose of IPV on both systemic and intestinal immunity in children from Vellore, India (aged 1 to 4 years) who had received at least five doses of OPV as part of routine immunisation at least 6 months previously. Children were randomly assigned to receive a dose of IPV (225 children) or no vaccine (225) at enrolment. The researchers used shedding of the virus (testing stool specimens) after a challenge dose of bivalent OPV containing serotypes 1 and 3 poliovirus to measure the immune response.

The additional IPV dose substantially boosted levels of protective antibodies in the blood and intestinal immunity against poliovirus compared with no vaccine. One week after challenge with OPV, 43 (19%) and 57 (26%) children given no vaccine shed serotype 1 or 3 poliovirus compared with 27 (12%) and 17 (8%) of those receiving IPV. Among children in the no vaccine group, the first dose of bivalent OPV did not reduce poliovirus shedding following a second challenge dose of this vaccine.

According to Professor Grassly, senior author of the study from Imperial College London, UK, “The substantial benefit of using IPV rather than further doses of OPV to boost intestinal immunity in children within the typical age range for mass vaccination supports its use as part of the global eradication programme.”

Writing in a linked Comment, Professor Kimberly Thompson from the University of Central Florida College of Medicine, USA discusses the results in the context of national immunisation strategies saying that, “Giving an extra dose of IPV or OPV to already OPV-vaccinated children with waned immunity will provide some incremental individual benefit…[however] the effects on overall population immunity and cost-effectiveness of an extra dose remain uncertain…Some results from models that explore the potential addition of an IPV dose at the same time as the last OPV routine immunisation dose suggest that the benefit on overall population immunity and thus on poliovirus transmission might be small.”

end polio now

Source:
Science Daily

Ongoing Ebola outbreak sparks debate on experimental vaccine testing

July 18th, 2014 (last updated)

International debate is brewing over whether to give experimental vaccines to people in regions of the current Ebola outbreak in West Africa as part of an effort to thwart the deadly virus’ spread.

In a recent Reuters article, Jeremy Farrar, a professor of tropical medicine and director of The Wellcome Trust charity, said the current standard of care for Ebola, which relies on supportive care, is “unacceptable.” Farrar is advocating for the use of experimental vaccines and other investigational therapies to contain Ebola, which has so far caused 518 deaths with 844 confirmed cases, according to a July 8 update from the World Health Organization.

“It’s ridiculous that we haven’t got these [experimental] products out of labs and animal trials and into human testing, and at least offered to people,” Farrar told Reuters.

Despite the severity of the disease, which causes hemorrhagic fever and kills up to 90% of its victims, some experts are urging against using experimental vaccines for safety reasons. There are no approved drugs to treat Ebola.

ebola

Dr. David Heymann, a professor of infectious diseases at the London School of Hygiene and Tropical Medicine and former assistant director at the WHO, told the Ottawa Citizen that it would be “unethical” to roll out experimental vaccines in at-risk populations in Africa now. Heymann was a member of the team that responded to the first Ebola outbreak in 1976.

One of the Ebola therapies in development – Tekmira Pharmaceuticals’ RNA interference therapeutic, which is intended to work by “silencing” disease-causing genes – has been placed on clinical hold by the FDA over safety concerns.

Tekmira’s investigational drug is an RNAi therapeutic, not a vaccine. However, the few Ebola vaccines that in development are still in very early stages. Currently, Inovio Pharmaceuticals and Vaxart are testing Ebola vaccines in animals, and last year GlaxoSmithKline acquired Swiss biotech Okairos, which has an Ebola vaccine in the preclinical phase.

The challenge with drug development for Ebola is the relatively low incentive for biotech and pharma companies. The virus is still rare, and has yet to spread outside Africa, although outbreaks have been increasing in frequency since Ebola was discovered in 1976.

ebola

Source:
Fierce Vaccines

HPV vaccine doesn’t increase blood clot risk, study finds

July 17th, 2014 (last updated)

There is no connection between the HPV vaccine and an increased risk of blood clots, according to a new study. The new post-approval study followed 1.6 million Danish women and has indicated that there is no heightened risk of developing a blood clot within 42 days after receiving the vaccination.

HPV vaccine

The study results are published in the July 9 edition of JAMA.

The authors said in a statement, “Safety concerns can compromise immunization programs to the detriment of public health, and timely evaluations of such concerns are essential.”

Two prior reports from the Centers for Disease Control and Prevention in the U.S. noted a possible link between this vaccination and rare instances of blood clots, helping to drive this study.

The study consisted of Danish women between the ages of 10 and 44, between October 2006 and July 2013. Included in the study were 500,345, or 31 percent, who were given the quadrivalent HPV vaccination. There were 4,375 incident cases of venous thromboembolism, or VTE. Of the total participants, 889 women, or 20 percent, received vaccinations within the study period.

Source:
Daily Digest News

First ever dengue vaccine to show efficacy against dengue fever & dengue haemorrhagic fever

July 16th, 2014 (last updated)

Sanofi Pasteur, the vaccines division of Sanofi, announced the publication in The Lancet of the detailed results of its first landmark phase III dengue vaccine efficacy study conducted in five countries in Asia. Results show overall efficacy against symptomatic dengue of 56.5% in children aged 2 to 14 years old after a three-dose vaccination schedule. Importantly, analyses show an 88.5% reduction of dengue haemorrhagic fever, the severe form of dengue, according to the WHO criteria. The study also showed a clinically important reduction in the risk of hospitalization due to dengue by 67% during the study. The favorable vaccine safety profile observed during the 25 month follow up of the phase III study in Asia is consistent with the safety profile documented in other studies (phase I, II, IIb).

Dengue is a threat to nearly half the world’s population, and is a pressing public health priority in many countries in Asia and Latin America where epidemics occur. The study confirmed the very high burden of disease by revealing that one in twenty children in the control group suffered from dengue each year, which was three-fold higher than initially expected. Each year, an estimated 500,000 people, including children, have severe dengue requiring hospitalization. This puts huge strain on hospitals and health care systems during outbreaks.

dengue

“The results of this first phase III study show the potential of the vaccine to have a significant impact on public health,” commented Dr. Maria Rosario Capeding, study principal investigator, Research Institute for Tropical Medicine, the Philippines. “The threat of severe dengue disease creates fear in the community. The vaccine’s impact on preventing dengue haemorrhagic fever is noteworthy. A vaccine that is able to avoid the personal suffering and reduce this significant health burden would change the lives of millions.”

Safety analyses (solicited reactions, unsolicited events and Serious Adverse Events SAEs) during the study showed similar reporting rates between the vaccine and control groups. SAEs were consistent with medical disorders in this age group and were mainly infections and injuries. Safety is continuously reviewed by an independent data monitoring committee. To date, 27,000 children, adolescents and adults have been vaccinated with three doses of the candidate dengue vaccine throughout the clinical studies.

“The high efficacy observed against severe dengue and the reduction of hospitalization by two thirds is an extremely important public health outcome. Furthermore this dengue vaccine continues to meet the highest safety expectations, which is very reassuring,” commented Professor Duane Gubler, Professor and Founding Director of the Signature Research Program on Emerging Infectious Diseases, Duke-NUS Graduate Medical School, Singapore, and Chairman of the Partnership for Dengue Control.

“These pivotal phase III vaccine efficacy study results take us closer to our ambition to bring the first vaccine against dengue to the world,” said John Shiver, Senior Vice President, R&D at Sanofi Pasteur. “After more than 20 years of commitment in collaboration with the scientific community, we are on course to make dengue the next vaccine-preventable disease. The public-health implications of a future dengue vaccine are significant and these findings are an important stride towards meeting the WHO’s strategic goals of reducing dengue mortality by half and morbidity by at least 25% by 2020.”

The four dengue virus serotypes have circulated during the study with a distribution representative of the epidemiology in Asia. The measured efficacy of the vaccine during the 25 months observation of the study is consistent across countries and appears to vary by dengue serotype (between 34.7% and 72.4%) and by age. The results of this first, large-scale efficacy study will be supplemented by results from a second, large-scale phase III study in Latin America and the Caribbean, including more than 20,000 children and adolescents aged 9 to 16 years old from Brazil, Colombia, Honduras, Mexico and Puerto Rico.

dengue vaccine program

About Sanofi Pasteur’s dengue vaccine program

Sanofi Pasteur has been working on a dengue vaccine for more than 20 years. The company’s goal is to make dengue the next vaccine-preventable disease with a safe and effective dengue vaccine accessible in all regions of the world where dengue is a public health issue. The company is committed to support the WHO’s ambition to reduce dengue mortality by 50% and morbidity by 25% by 2020.

Sanofi Pasteur’s dengue vaccine candidate is the most clinically and industrially advanced vaccine candidate in development. Over 40,000 volunteers are participating in the Sanofi Pasteur dengue vaccine clinical study program (Phase I, II and III).

Two pivotal Phase III efficacy studies involve more than 31,000 volunteers from Asia (Indonesia, Malaysia, the Philippines, Thailand and Vietnam) and Latin America (Brazil, Colombia, Honduras, Mexico and Puerto Rico). The Phase III evaluations provide pivotal data on efficacy, safety, and immunogenicity of the vaccine candidate in a broad population and different epidemiological environments and assess the potential public health impact of the vaccine on the disease burden.

Additional information, photos and videos about Sanofi Pasteur’s dengue vaccine candidate are available on the web at http://www.dengue.info and at http://asia.dengue.info/

Source:
Sanofi Pasteur

Research may be beating HIV, but a vaccine remains distant

July 15th, 2014 (last updated)

Three decades since the onset of the infection in a global population, HIV care and treatment is looking very different. Given the difficulties involved, it is remarkable that having developed good treatments, the global community is racing towards finding a vaccine cure.

The first clinical observation of AIDS was recorded in the US in 1981. The focus then was to identify what caused the new disease and to help people to a dignified death. Once HIV was identified, understanding the behaviour of the virus became vital.

Soon antiretroviral therapies were developed that attempted to disrupt the replication of the virus in the body. In the late 1990s, a combination of these therapies showed better results and had a huge impact on the future of HIV-infected individuals. In the UK the healthcare discourse changed from the person dying from AIDS to the person living with HIV. Today, those individuals diagnosed with HIV infection have a similar life expectancy to those without.

Now research is gathering pace to search for a cure. A recent advert from Cancer Research UK claims “research is beating HIV”. However, it is not that simple.

HIV

There have been claims of a cure for a few individuals: the now famous Timothy Ray Brown, known as the “Berlin patient”, became clear of his HIV while receiving bone marrow transplantation for his leukaemia. In Mississippi in the US, a baby was treated with antiretroviral therapies for the first 18 months of her life and appears to be infection-free. The “Visconti group” consisting of 14 patients with HIV who have had their antiretroviral therapies stopped with no sign of further infection.

However, bone marrow transplantation would not be the most appropriate way forward as the procedure carries risks in itself. Also two men undergoing treatment for lymphoma in Boston, US showed a return to HIV infection some months after their transplants. Seeking a cure is still needed.

The development of a vaccine for HIV is complex and this is what leads to its elusiveness. The purpose of a vaccine is to provide a protective immune response to a particular microorganism. The body’s immune system produces antibodies that purge the microorganism with weapons tailored to specifically attack it.

But this is where the difficulties begin: HIV undergoes many mutations, as do most viruses and, therefore, we are not dealing with just one-size-fits-all weapon to fight a virus. The virus also has the ability to evolve resistance to immune control. Our understanding of HIV’s adaptive evolution must improve if vaccination development is going to be effective.

In creating an appropriate approach to vaccine development the response of the immune system to the virus is important as we want to encourage the development of antibodies to the proteins within the virus. According to a new review published in the journal Science, two approaches to elicit antibody protection in HIV are being pursued: a vaccine that is potent and produces broadly reactive neutralising antibodies (bnAbs) and vaccines that induce “conventional antibodies”.

Broadly reactive neutralising antibodies (bnAbs) are considered important as they are more likely to cope with mutations of viruses. When developed they ought to be potent and induce high levels of protection. But there are complexities with their structure and it may take months to years in order to evolve a response.

On the other hand, conventional antibodies are less potent but they are produced by the majority of infected individuals and are the only antibodies that have been seen in vaccine trials to date. Unlike bnAbs, conventional antibodies take only weeks to months to evolve a response.

While bnAbs are probably the desired approach to vaccine development, vaccines that support conventional antibodies should not be ignored as they have shown some success in clinical trials. It is not the time to put all our eggs in one basket and research into the development of a vaccine should concentrate on both approaches.

Source:
Medicalxpress

The misinformation about vaccines is an epidemic in itself

July 14th, 2014 (last updated)

We are breaking a new record in the U.S., and it is not one we want to break: According to the Centers for Disease Control and Prevention, measles cases are at a 20-year high. As of May 23, more than 288 cases have been reported this year. To put that in perspective, only 37 cases were reported in all of 2004. In 2002, measles had been declared eliminated in the Americas.

The CDC reports that most Americans have either contracted measles in the past, and are now immune, or have received the measles-mumps-rubella vaccine, among the most effective vaccinations available. Yet, measles is now an epidemic in Minnesota, where a 2.5-year-old child was identified by the science journal Pediatrics last month as patient zero, ultimately responsible for exposing more than 3,000 people in its community to the disease.

The child had traveled with family to Kenya and there came in contact with measles, subsequently spreading it to a family member and three other toddlers in daycare. The child had not been vaccinated, as the parents believed vaccines to be dangerous, having bought into the same misinformation that has spread far and wide across America.

The family lives in Minnesota, in a small community of Somali immigrants where rates of the MMR vaccination are very low, and which has seen dramatic decrease in vaccinations, from 91 percent in 2004, down to 54 percent in 2014, according to Pediatrics. Of the more than 3,000 people exposed, 21 showed symptoms of the disease and 16 of those were not vaccinated. Dr. Abdirahman Mohamed of the Axis Medical Center in Minneapolis said of these cases, “Every family will tell you that, ‘We’re not going to give our children the MMR. We’re afraid that they’re going to get autism.’”

The Minnesota case is a wakeup call, a reminder of why we vaccinate in the first place. One child was able to bring a previously all-but-eradicated disease back into the United States, putting an entire population at risk. What is more alarming is this is not an isolated incident; outbreaks have been reported in New York City and 18 states.

child abuse

Wakefield is a disgraced former doctor who had his medical license revoked due to his unethical behavior in publishing a paper asserting that the MMR vaccine was linked to autism, a claim that was contradicted by his own findings and the findings of other studies. His paper, even though discredited, is used widely as evidence of the dangers of vaccines, and the anti-vaccination movement hails Wakefield as a hero to their cause, even today.

This misinformation has deadly consequences. When it comes to measles, an unvaccinated American child has a 1-in-500 chance of dying if infected. In serious cases, the disease can also result in brain damage or hearing loss. It takes very few people to start an epidemic or outbreak, as the measles case in Minnesota shows. It only takes one child to infect a community, and if each child has the potential to expose many more to the disease, and those exposed are not vaccinated, an epidemic could well be born.

It is far too easy to find misinformation on vaccines today. Celebrities such as Jenny McCarthy and Jim Carrey use their fame to tout scientifically disproven claims that vaccines cause autism or that mercury in vaccines is deadly to young children. Liberal firebrand Bill Maher even waxed apocalyptic about flu vaccines. A proliferation of organizations claim to offer parents a safe place to learn the truth about vaccines yet offer no scientifically credible resources, offering scientifically disproven claims to parents.

We easily forget that it takes just one person to bring a disease back inside the U.S. borders. We forget that infants and people with immune deficiency rely on others to be vaccinated in order to stay healthy. Minnesota has reminded us of the dangers that this type of misinformation can have.

Source:
Salon (www.salon.com)

A surprising reason why you should get a shingles vaccine

July 13th, 2014 (last updated)

Now, there’s another reason to get a shingles vaccine. New research finds that by lowering your risk for shingles, you also lower your risk for heart attack and mini-stroke.

To arrive at this finding, researchers at University College London scoured existing patient medical records looking for patterns between shingles and cardiovascular disease.

After factoring in other conditions, they determined that herpes zoster – the virus associated with shingles – is an independent risk factor for heart attack.

Scientists think that the increased risk might lie in chronic inflammation of blood vessels, which shingles causes.

The study, published in Neurology, also found that major stroke risk increased in patients who had shingles at or under the age of 40.

zostavax

Shingles not a cause of heart attacks, mini-strokes

It’s important to note that the findings do not suggest that shingles actually causes heart attacks, says Benico Barzilai, MD, Head of the Section of Clinical Cardiology in the Robert and Suzanne Tomsich Department of Cardiovascular Medicine at Cleveland Clinic. He did not take part in the study, but reviewed the results.

“The UK study raised interesting questions that do warrant further study, but it doesn’t say that shingles causes heart attacks, because the relationship found is an association, not cause and effect,” he says.

This means that while researchers did find a relationship between shingles and these cardiovascular events, they did not find data to support shingles as a direct cause of them, an important distinction.

Who should get the shingles vaccine

Experts say people age 60 and older should ask their doctor about the shingles vaccine. This is keeping with current Centers for Disease Control (CDC) recommendations.

“Generally, young and middle-aged adults don’t need vaccination,” Dr. Barzilai says.

Andrea Sikon, MD, Chair of the Department of Internal Medicine and Geriatrics in the Medicine Institute at Cleveland Clinic, explains current guidelines:  “The vaccine is approved for use at age 50, but the optimal time to vaccinate might not be that early, as effectiveness may wane over time.”

Exceptions and warnings

Not everyone age 60 and older should receive the vaccine because it can be dangerous for people with some pre-existing conditions.

Drs. Barzilai and Sikon both stress that the vaccine can be dangerous for cancer patients, transplant patients, patients with HIV and those on medications that supress their immune system, such as systemic steroids and chemotherapy, among others.

This is because the herpes zoster vaccine contains a live, attenuated (weakened) virus. Doctors must carefully assess the health status of each patient before administering it.

Source:
Cleveland Clinic