Rotavirus

GAVI - Routine vaccines, extraordinary impact: Rotavirus

Holly Lutmer PharmD

Before rotavirus vaccines became available in 1983, many children were infected by their fifth birthday, causing an estimated 500,000 deaths and two million hospitalizations worldwide annually.

Rotavirus vaccines and improved sanitation have dramatically reduced the toll of diarrhoeal illness in recent decades, but too many children still die from the dehydration it causes.

Linda Geddes with GAVI reported on March 30, 2023, routine immunization significantly reduced this toll in many countries.

As of April 5, 2023, four rotavirus vaccines had been prequalified by the World Health Organization for use globally.

In 2006, oral vaccines known as Rotarix and RotaTeq were licensed in Europe, the U.S., and Canada.

However, the current generation of vaccines doesn't provide complete protection against infection.

They are most effective in countries with the lowest rates of rotavirus-associated death and least effective in countries with the highest rates.

Scientists are still trying to understand why.

But malnutrition and stunting appear to play a role. In addition, recent studies have suggested that intestinal inflammation is linked to poor sanitation and hygiene, and differences in the gut microbiome composition may also be implicated.

Gavi has supported their rollout in 52 low and middle-income countries, which means now more African countries are using rotavirus vaccines than in Europe.

However, various next-generation rotavirus vaccines that may be even better than current ones are currently in development.

Next-generation oral vaccines, designed to be taken at birth and followed by two further infant doses, are also being tested, with preliminary evidence suggesting that one such candidate may be more effective than existing vaccines.

The next generation of rotavirus vaccines may address critical barriers to their uptake and further reduce this toll.

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Rotavirus vaccines are US FDA approved

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Global Agreement Delivers Rotavirus Vaccine to Children

Don Hackett — Thu, 04 Mar 2021 22:47:48 +0000

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WHO: Rotavirus vaccines made available for use in humanitarian crises

Médecins Sans Frontières (MSF), Save the Children, UNICEF, and the World Health Organization (WHO) announced a rotavirus vaccine would become available to more children living in humanitarian crises.

Thanks to a landmark agreement with the vaccine manufacturer GSK, children living in refugee camps, displaced communities, or other emergencies now have a better chance of being protected against severe diarrhoeal disease with these rotavirus vaccines.

GSK has committed to supply the Rotarix vaccine at its lowest global price.

Rotarix is a live, attenuated rotavirus vaccine derived from the human 89-12 strain, which belongs to G1P type.

The new agreement disclosed on March 4, 2021, builds on GSK’s existing commitment to the Humanitarian Mechanism for its PCV (pneumococcal conjugate vaccine), Synflorix, at the lowest global price for its four-dose vial presentation.

GSK has been providing Synflorix through the Mechanism since 2017.

Nearly 1 million doses of pneumococcal vaccine were approved for use through the Mechanism in 12 countries: Algeria, Central African Republic, Chad, the Democratic Republic of the Congo, Ethiopia, Greece, Kenya, Lebanon, Niger, Nigeria, South Sudan, and Syria.

The pneumococcal vaccine protects against childhood pneumonia, also a leading cause of childhood deaths during emergencies.

“We welcome this engagement from manufacturers and hope it will be a step towards making more vaccines available in the future at affordable prices,” commented Dr. Kate O’Brien, Director of Immunization, Vaccines, and Biologicals at WHO, in a related press statement.

Rotavirus is the most common cause of severe diarrhoeal disease in children under five years globally, responsible for up to 200,000 child deaths each year. Children in refugee camps and displaced communities are among the most vulnerable in the world to such diseases due to population density, poor hygiene and sanitation, and higher rates of malnutrition.

Vaccination is therefore especially critical for these children, who may otherwise lack access to essential health services.

“Save the Children sees the devastating impacts the rotavirus has on children every day, so we welcome this important commitment as a vital step in protecting some of the most vulnerable children from life-threatening, yet easily preventable diseases,” added Rachel Cummings, Director of the Humanitarian Public Health Team at Save the Children.

Once secured through the Mechanism, the vaccines are offered to humanitarian organizations working in camps and other emergency settings, making applications to access the vaccine at these lower prices.

The Humanitarian Mechanism was founded in 2017 to enhance access to vaccines in emergencies by civil society organizations in countries that are not otherwise eligible for Gavi support.

PrecisionVaccinations publishes research-based vaccine news.

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GSK Rotarix is a live, attenuated rotavirus vaccine

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GSK makes landmark pricing agreement for rotavirus vaccine, Rotarix, for use with children living in humanitarian crises

Rotarix Rotavirus Vaccine

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New Ways to Prevent Rotavirus

Don Hackett — Wed, 14 Oct 2020 13:05:12 +0000

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Biomedical Sciences Researchers Find New Way to Prevent and Cure Rotavirus, Other Viral Infections

A combination of substances secreted by the immune system can prevent rotavirus infection, as well as potentially treat other viral infections that target epithelial cells, according to researchers in the Institute for Biomedical Sciences at Georgia State University (GSU).

The substances identified in this pre-clinical GSU study which was published on October 2, 2020, officially known as cytokines, are interleukin 18 (IL-18) and interleukin 22 (IL-22). IL-18 and IL-22 are produced when the body detects a protein in the whip-like appendage of bacteria.

The study, which investigated how these cytokines inhibit rotavirus infection, found when mice were treated with both IL-18 and IL-22, the cytokines promoted each other’s expression, but also impeded rotavirus by independent, distinct mechanisms that involved activating receptors in intestinal epithelial cells.

According to the GSU researchers, the actions resulted in rapid and complete expulsion of rotavirus, even in hosts with severely compromised immune systems.

Furthermore, this combo therapy was also found to be effective for norovirus, a contagious virus that causes vomiting and diarrhea.

“Our study reports a novel means of eradicating a viral infection, particularly viruses that infect epithelial cells,” said Dr. Andrew Gewirtz, senior author of the study and a professor in the Institute for Biomedical Sciences at GSU, in a press release. “The results suggest that a cocktail that combines IL-18 and IL-22 could be a means of treating viral infections that target short-lived epithelial cells with high turnover rates.”

The study is funded by grants from the US National Institutes of Health.

Rotavirus is an enteric infection that can cause severe morbidity and contributes to childhood mortality in resource-poor countries where the existing vaccine is of moderate efficacy, states the US Centers for Disease Control and Prevention (CDC).

Most children who get the vaccine will be protected from severe rotavirus disease. About 7 out of 10 children will be protected from rotavirus disease of any severity.

Each year, rotavirus vaccination prevents an estimated 40,000 to 50,000 hospitalizations among US infants and young children.

Two rotavirus vaccines are currently licensed for infants in the USA:

RotaTeq is given in 3 doses at ages 2 months, 4 months, and 6 months,
Rotarix is given in 2 doses at ages 2 months and 4 months.

The first dose of either vaccine should be given before a child is 15 weeks of age. Children should receive all doses of rotavirus vaccine before they turn 8 months old.

Both vaccines are given by putting drops in the child’s mouth, says the CDC.

PrecisionVaccinations publishes research-based vaccine news.

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Georgia State University research identifies a combination therapy for norovirus prevention

References:

IL-22–induced cell extrusion and IL-18–induced cell death prevent and cure rotavirus infection

CDC: otavirus vaccine is the best way to protect your child against rotavirus disease

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Study Suggests Separating Rotavirus & Oral Poliovirus Vaccinations

Danielle Reiter RN — Tue, 31 Dec 2019 15:56:24 +0000

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ntirotavirus IgA seroconversion rates in children who receive concomitant oral poliovirus vaccine

Holly Lutmer PharmD

A new study’s findings suggest that oral poliovirus vaccine (OPV) given concomitantly with rotavirus vaccine Rotarix was a substantial contributor to reduced antirotavirus IgA seroconversion.

This is an important finding published on December 30, 2019, since rotavirus vaccination is the primary method for preventing rotavirus infections and reducing the severity of rotavirus gastroenteritis among young children globally.

Despite the success of rotavirus vaccines over the last decade, rotavirus remains a leading cause of severe diarrheal disease among young children. Since the pivotal clinical trial results were released in 2006, rotavirus vaccines have been integrated into the national immunization programs of approximately 96 countries.

Further progress in reducing the burden of disease is inhibited, in part, by vaccine underperformance in certain settings.

Early clinical trials suggested that oral poliovirus vaccine, when administered concomitantly with rotavirus vaccine, reduces rotavirus seroconversion rates after the 1st rotavirus dose with modest or nonsignificant interference after completion of the full rotavirus vaccine course.

This study pooled individual-level data from GlaxoSmithKline’s Phase II and III clinical trials of the monovalent rotavirus vaccine (RV1), Rotarix, including 7,280 vaccinated infants (5–17 weeks of age at first vaccine dose) from 22 trials and 33 countries/territories.

Rotarix is a live, attenuated rotavirus vaccine derived from the human 89-12 strain which belongs to G1P type.

The researchers examined the relationship between individual- and country-level predictors and immune response to RV1 vaccination measured via serum antirotavirus immunoglobulin A (IgA) seroconversion and serum antirotavirus IgA titer.

This study’s findings suggest that OPV given concomitantly with RV1 was a substantial contributor to reduced antirotavirus IgA seroconversion, and this interference was apparent after the 2nd vaccine dose of RV1.

Moreover, this study highlights the importance of concomitant OPV and RV1 administration and provides encouraging evidence to suggest that the eventual withdrawal of OPV from national immunization programs could improve rotavirus vaccine performance.

Currently, there are 4 live attenuated, oral rotavirus vaccines administered during infancy that have received World Health Organization prequalification:

GlaxoSmithKline’s (GSK) monovalent rotavirus vaccine (Rotarix, “RV1”)
Merck’s pentavalent vaccine (RotaTeq)
Serum Institute of India’s pentavalent vaccine (Rotasiil)
Bharat Biotech’s monovalent vaccine (Rotavac)

The introduction of these vaccines has led to dramatic reductions in rotavirus disease in many settings.

Polio can be prevented with a vaccine. Inactivated polio vaccine (IPV) is the only polio vaccine that has been given in the United States since 2000. The IPV is given by a shot in the arm or leg, depending on the person’s age.

The OPV is used in other countries.

This study funding: JMB received financial support to conduct this research from the Laney Graduate School of Emory University. BAL’s work was supported by NIH grants R01AI112970 and R01GM124280 and the Modeling the Impact of Rotavirus Vaccination in GAVI Countries project supported by Imperial College London. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

These researchers disclosed industry relationships.

Rotavirus Vaccine news published by Vax-Before-Travel

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Rotavirus vaccination is the primary method for reducing the severity of rotavirus gastroenteritis among young children

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Newer Rotavirus Vaccines Can Save Lives and Budgets

Don Hackett — Wed, 04 Dec 2019 20:12:55 +0000

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Re-evaluating the potential impact and cost-effectiveness of rotavirus vaccination in 73 Gavi countries: a modelling study

A new study provides evidence that rotavirus vaccination is ‘still a cost-effective investment for most countries.’

And this study concluded that ‘countries should consider newly available rotavirus vaccine products, as they might offer more affordable options.’

Published on December 1, 2019, in The Lancet Global Health, investigators from PATH, the London School of Hygiene & Tropical Medicine, and the US Centers for Disease Control and Prevention analyzed the potential costs of rotavirus vaccinations in 73 countries from 2018 through 2027.

This study concluded that ‘rotavirus vaccination has the potential to prevent nearly 600,000 deaths in these 73 countries.’

And, rotavirus vaccines can avert outpatient visits and hospitalizations could lead to treatment savings of approximately $484 million dollars from the government perspective and $878 million from the societal perspective.

The study team used a “deterministic cohort model” to calculate numbers of rotavirus gastroenteritis cases, outpatient visits, hospitalizations, and deaths between birth and 5 years, with and without rotavirus vaccination. They also attempted to calculate treatment costs from both a government and a societal perspective.

These researchers based their analysis on the 4 rotavirus vaccines prequalified by the World Health Organization (WHO) at the end of 2018. They ran ‘what-if’ scenarios in which all 73 countries used the same product.

These vaccines were Rotarix (manufactured by GlaxoSmithKline, Rixensart, Belgium), RotaTeq (manufactured by Merck and Co, Kenilworth, NJ, USA), Rotavac (manufactured by Bharat Biotech, Hyderabad, India), and Rotasiil (manufactured by Serum Institute, Pune, India).

Rotarix was administered in a 2-dose schedule whereas the other vaccines were administered in a 3-dose schedule.

Like previous analyses, this analysis also shows that the health benefits of rotavirus vaccination are concentrated in the highest-burden regions.

Unsurprisingly, rotavirus vaccination is less cost-effective in some lower-burden regions that pay higher vaccine prices.

They said ‘This analysis serves as an important reminder to continue to prioritize immunization in the context of efforts to achieve universal health coverage, health equity, and other important priorities.’

‘Vaccination has always been considered one of the best buys in public health and the evolving norms in interpreting cost-effectiveness results have not fundamentally changed the outcome of our analysis.’

‘Rotavirus vaccination still represents good, if not excellent, value for money, which is an important message for everyone,’ concluded these researchers.

Rotavirus vaccine news published by Precision Vaccinations

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Rotavirus vaccination still represents excellent value for the investment

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Higher Dosage Rotavirus Vaccine Launched in India

Don Hackett — Tue, 03 Dec 2019 22:23:54 +0000

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Re-evaluating the cost and cost-effectiveness of rotavirus vaccination in Bangladesh, Ghana, and Malawi

Hyderabad-based Bharat Biotech announced the launch of its advanced version of the rotavirus vaccine Rotavac 5D, which is focused on the prevention of viral diarrhea.

While all other variants of rotavirus vaccine manufactured by competitors are at 2-2.5 ml per dose, the Rotavac 5D is a larger dose of 0.5 ml quantity, an official from the company said in a press release published on December 3, 2019.

Also, the Rotavac 5D higher dosage requires less storage space.

The current Rotavac vaccine, also manufactured by Bharat Biotech and catering to 80 percent of the Indian government’s need, requires to be stored at -20 degrees celsius, which is the same as the temperature that needs to be maintained in the cold chain for oral polio vaccine.

The newer Rotavac 5D will, however, require between 2 to 8 degrees celsius storage temperature, which is the normal refrigeration temperature.

The company said this temperature is the ‘new’ normal for vaccine storage.

Rotavirus commonly causes severe, watery diarrhea and vomiting in infants and young children. Children may become dehydrated and need to be hospitalized.

To ensure protection, an infant requires 3-doses of the Rotavac vaccine at sixth, tenth and fourteenth week after birth, say the company.

The Hyderabad-based facility of Bharat Biotech has the joint capacity to manufacture up to 200 million doses of both Rotavac and Rotavac 5D.

While the newer Rotavac 5D was licensed in India in August earlier this year, the government remains dependent on the older Rotavac vaccine.

The first generation, rotavirus vaccine Rotavac was developed under a Public-Private Partnership with the Department of Biotechnology, Govt. of India.

Between 2011 to 2013, Bharat Biotech tested Rotavac on approximately 6,800 children.

‘None of the Intussusception cases happened in the first 21 days after giving the vaccine to the babies.’

‘In the vaccinated arm though there were eight cases, while in the placebo arm there were three cases. Because the vaccinated arm was double the placebo arm, there is no significant difference in the case of Intussusceptions and the association to vaccination was ruled out,’ the official said in this press release.

According to a recent analysis by Gavi published in July 2019, the use of Rotarix, Rotavac, or Rotasiil would be highly cost-effective relative to no rotavirus vaccination in Bangladesh, Ghana, and Malawi.

Currently, the company is not looking at supplying the Rotavac 5D vaccine in the US, UK or Europe, as that effort would require additional clinical trials on the local population, for which massive resources will have to be invested.

“We do not have those many resources to expand into western markets as of now,” said a company official.

In the USA, the Centers for Disease Control and Prevention (CDC) says ‘rotavirus vaccines are very effective at preventing rotavirus disease.’

Infants should get either of the 2 available rotavirus vaccines:

RotaTeq is given in 3 doses at ages 2 months, 4 months, and 6 months
Rotarix is given in 2 doses at ages 2 months and 4 months.

Each year, the vaccine prevents an estimated 40,000 to 50,000 hospitalizations among U.S. infants and young children, says the CDC.

Rotavirus illness has also decreased among older children and adults that are not vaccinated. This ‘herd-immunity’’ protection is related to vaccinated children providing indirect protection to other people because they are less likely to get and spread the disease.

A person can get rotavirus disease at any time during the year but it is more common in the winter and spring.

Rotavirus vaccine news published by Precision Vaccinations

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Bharat Biotech Rotavac 5D vaccine helps prevent viral diarrhea in children

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Bhara Biotech: About ROTAVAC

Bharat Biotech launches Rotavac 5D vaccine for diarrhoea

VP Naidu launches new Rotavirus vaccine - ROTAVAC-5D®

Gavi-supported rotavirus vaccines profiles to support country decision making

CDC: Rotavirus in the U.S.

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Can Rotavirus Vaccines Reduce Type-1 Diabetes Risks

Don Hackett — Thu, 10 Oct 2019 22:05:18 +0000

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Kelley Lu, PharmD

More benefits to vaccination: rotavirus vaccines reduce the incidence of type-1 diabetes

‘There is a growing appreciation that viral infections can have long-lasting impacts, well after the original infection has been cleared,’ said Dr. Kaitlin A. Davis and Dr. Andrew Mehle in a new editorial published in PLOS.

Excepts from this October 10, 2019, editorial are inserted below:

One example is the proposed connection between childhood infections with rotavirus and the subsequent development of type 1 diabetes.

New evidence supports this correlation and suggests that vaccination against rotavirus may contribute to a global decrease in type 1 diabetes prevalence among young children.

This surprising effect of vaccination could be the first example of primary prevention of type 1 diabetes, something not currently possible.

In a powerful demonstration of the positive effects of public health campaigns, mortality associated with rotavirus infection has substantially decreased since the introduction of rotavirus vaccines.

Rotavirus, a member of the Reoviridae family, is a major cause of infantile diarrheal disease worldwide, accounting for over 215,000 deaths annually.

Rotavirus mortality and vaccine efficacy are known to vary significantly by country and environment, and similarly, factors promoting type 1 diabetes incidence are likely to be diverse, said these researchers.

Previously, multiple studies have described an associated decrease in type 1 diabetes incidence following vaccination.

How might rotavirus infection be tied to the development of type 1 diabetes?

Type 1 diabetes is an autoimmune condition characterized by the destruction of beta cells in the pancreas by the body’s own immune system, leading to the functional absence of insulin.

While there are some genetic determinants of type 1 diabetes, the precise triggers of this autoimmune disease are not fully understood.

Interestingly, portions of proteins on the surface of beta cells that are recognized by T cells – the killers of the immune system – are strikingly similar to a rotavirus capsid protein called VP7.

Both the beta-cell protein and its viral doppelganger VP7 are able to stimulate similar T cell responses, and this response can be observed in both humans and animals following infection and vaccination.

Previous studies have directly linked rotavirus infection to the production of antibodies associated with diabetes in young children, and similarly, infections in mice have been linked to pancreatic cell death and hyperglycemia.

Perhaps rotavirus infection trains the immune system to accidentally target beta cells.

Rotarix and RotaTeq are the most routinely used rotavirus vaccines, administered in the first six months of life.

These vaccines include HLA-mimic VP7 sequences and were fully introduced to communities worldwide from 2006-2008.

In studies from both Australia and the United States spanning this time period, type 1 diabetes prevalence decreased coincident with vaccine introduction.

In Australia, reported by Perrett, et al., the number of new cases of type 1 diabetes among children 0-4 years of age decreased by 15% following the introduction of rotavirus vaccines.

Excitingly, this finding was recapitulated in an American cohort, where a 33-37% reduction in the risk of type 1 diabetes was observed following completion of a rotavirus vaccine series.

"Usually, vaccinations are known for providing protection against infections. The rotavirus vaccination differs from the usual thought because it not only protects against the rotavirus infection but it also presents the exciting possibility of decreasing the chances of developing Type I diabetes in children," shared Saad Sajid, Pharmacy Intern for Brookshire Grocery Company.

Thus, if rotavirus infection is a trigger for the development of type 1 diabetes, preventing infections by vaccination would not only reduce viral disease but have the added benefit of reducing type 1 diabetes.

While trends are common between these two diverse studies, there are likely additional factors that contribute to protection.

An analysis of a Finnish cohort reports that associations between rotavirus vaccination and type 1 diabetes incidence were inconclusive.

This may in part be due to sample size variability between the studies, but also highlights the role of geographical and environmental differences in immunity.

If the associations outlined in these studies hold true for multiple groups and persist as children age, these findings could outline at least one ubiquitous factor that affects type 1 diabetes development worldwide.

About the editorial authors:

Kaitlin A. Davis received her Ph.D. in Biology from Johns Hopkins University. She is currently a postdoctoral research associate with Andrew Mehle at the University of Wisconsin Madison studying how ADP-ribosylation of influenza virus proteins regulates viral replication processes.

Andrew Mehle received his Ph.D. in Virology at Harvard University. He continued with postdoctoral training at the University of California Berkeley in the lab of Dr. Jennifer Doudna where his focus shifted to the influenza virus.

Rotavirus vaccine news published by Precision Vaccinations

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If rotavirus infection is a trigger for the development of type 1 diabetes, then preventing infections by vaccination would reduce disease incidences

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Association of Rotavirus Vaccination With the Incidence of Type 1 Diabetes in Children

Diabetes Risk Reduced With Rotavirus Vaccination

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Rotavirus Vaccines Continue Delivering Value

Don Hackett — Tue, 01 Oct 2019 20:35:18 +0000

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Association of Rotavirus Vaccination With Inpatient and Emergency Department Visits Among Children Seeking Care for Acute Gastro

Evidence from this large post-licensure study of rotavirus vaccine performance in the United States from 2010 to 2016 suggests that RotaTeq (RV5) and Rotarix (RV1) rotavirus vaccines continue to perform well.

These rotavirus vaccines helped prevent inpatient visits and severe infections among younger children, according to this study published on September 27, 2019, in JAMA.

The New Vaccine Surveillance Network (NVSN) has continuously monitored the effects and effectiveness of licensed rotavirus vaccines since the recommendation for universal US infant rotavirus vaccination by the Advisory Committee on Immunization Practices (ACIP).

These live, attenuated, oral vaccines RotaTeq and Rotarix have performed well in pre-licensure clinical trials, and were recommended by the ACIP in 2006 and 2008, respectively.

In this new post-market study, among 1,193 rotavirus-positive cases and 9,620 rotavirus-negative controls in this study, at least 1 dose of any rotavirus vaccine was 82% protective against rotavirus-associated inpatient visits.

And, the vaccines were 75 percent protective against rotavirus-associated ED visits.

Rotavirus vaccine effectiveness was highest in preventing the most severe cases of rotavirus gastroenteritis, and even 1 dose of rotavirus vaccine appeared to be associated with less severe outcomes.

Furthermore, there was not a statistically significant difference during this 7-year period observed for either rotavirus vaccine.

‘Unbiased assessments of rotavirus vaccine effectiveness are important to maintain public confidence in the US rotavirus immunization policy, said these researchers.

‘Furthermore, rigorous US vaccine performance assessments inform and influence policymakers throughout the world on the initiation and continuation of their own rotavirus vaccination programs.’

‘Our analyses demonstrate that relying only on rotavirus test-positive surveillance data, without considering the underlying factors of age and clinical severity, could potentially misgauge the true measurements of rotavirus vaccine performance,’ concluded these researchers.

Active, prospective surveillance through NVSN is funded by the US Centers for Disease Control and Prevention, and methods have been previously published.

No researcher conflicts of interest were disclosed.

Vaccine information published by Precision Vaccinations

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RotaTeq and Rotarix vaccines were 82% protective against rotavirus-associated inpatient visits

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Rotavirus vaccine efficacy: current status and areas for improvement

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Booster Rotavirus Vaccination In Infants May Not Be Needed

Don Hackett — Thu, 15 Aug 2019 14:32:00 +0000

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Study predicts modest impact from additional dose of rotavirus vaccine

According to a new study, giving children an additional dose of rotavirus vaccine when they are 9-months old would provide only a modest improvement in the vaccine's effectiveness.

In response to concerns about the rotavirus vaccines' effectiveness in low-income countries, a team of researchers led by Associate Professor Virginia Pitzer of the Yale School of Public Health and Professor Nigel Cunliffe of the University of Liverpool published on August 14, 2019, a detailed mathematical analysis of rotavirus vaccinations and diarrhea cases reported in southeastern Africa.

With access to 12 years of pre-vaccination and 5 years of post-vaccination data, the analysis predicted that 1 extra dose of rotavirus vaccine at 9-months of age would provide only a modest 5-16 percent reduction in overall case incidence over the first 3 years.

"Our analysis revealed that lower vaccine effectiveness during the 2nd year of life is not necessarily indicative of waning rotavirus vaccine protection," said Pitzer, the study's lead author and an expert in the epidemiology of microbial diseases in the Yale School of Public Health's public health modeling unit.

This study documented a high-rate of rotavirus transmission.

As a result, vaccination provides only partial protection and tends to delay cases among vaccinated infants to the second year of life, according to the study.

A poor immune response to oral vaccination due to other causes of inflammation in the gut and interference from other vaccines, such as those for polio, may also impact vaccine effectiveness.

"Strategies to enhance the immune response to initial vaccination, including the use of next-generation vaccines that are currently in development, may lead to enhanced and more durable vaccine impact," said Cunliffe, an expert in gastrointestinal infections at the University of Liverpool's Centre for Global Vaccine Research.

Other study contributors were: Aisleen Bennett, Naor Bar-Zeev and Khuzwayo Jere from the Malawi-Liverpool-Wellcome Trust Clinical Research Programme at the University of Malawi; Benjamin Lopman from the Rollins School of Public Health at Emory University; Joseph Lewnard from the University of California, Berkeley School of Public Health; and Umesh Parashar from the Centers for Disease Control and Prevention.

This research was supported by the National Institute of Allergy and Infectious Diseases (R01AI112970), a Wellcome Trust Programme Grant (091909/Z/10/Z), and two Wellcome Trust fellowships (102466/Z/13/A) and (201945/Z/16/Z).

Rotavirus is a leading cause of morbidity and death from diarrhea in children worldwide, says the World Health Organization (WHO).

Although the recent introduction of rotavirus vaccines has had a substantial impact on the incidence of rotavirus-associated gastroenteritis (RVGE) in high- and middle-income countries, the impact of vaccination in low-income countries is not as well defined.

The vast majority of deaths due to rotavirus occur in low-income countries in Asia and Africa, but estimates of vaccine efficacy are lower in these settings.

Whereas vaccine efficacy was 85 to 99% in clinical trials conducted in high-income countries, efficacy was 39 to 67% in trials conducted in low-income countries for all currently available oral rotavirus vaccines.

Nevertheless, the preventable burden of disease in low-income settings is potentially much greater.

Two key questions regarding the long-term impact of rotavirus vaccines are:

whether the direct protection conferred by rotavirus vaccination is reduced in low-income countries due to a poorer initial immune response or waning of vaccine-induced immunity
whether vaccination will confer sustained indirect (herd) protection similar to that observed in high-income countries.

Sub Title:

Additional rotavirus vaccination delivers modest protection

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Evaluating strategies to improve rotavirus vaccine impact during the second year of life in Malawi

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Rotavirus Vaccines Are Very Effective

Don Hackett — Mon, 24 Jun 2019 15:14:38 +0000

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Trends in the Laboratory Detection of Rotavirus Before and After Implementation of Routine Rotavirus Vaccination

The implementation of the rotavirus vaccination program has markedly reduced the prevalence of rotavirus disease in the United States, says the Centers for Disease Control and Prevention (CDC).

In a new report, the CDC says all post vaccine-era seasons from 2007–08 to 2017–18, rotavirus activity consistently fell below the 2000–2006 baseline, and seasons were shorter in duration.

This finding from the National Respiratory and Enteric Viruses Surveillance System (NREVSS) dataset further attests to the long-term benefits of the rotavirus vaccination program.

Some of the observed changes in rotavirus activity that occurred after vaccine introduction could be due to concurrent changes in rotavirus testing practices as PCR-based multi-pathogen detection assays are increasingly used.

Although this shift in testing practices might explain some of the declines observed in the total number of tests performed and the number of positive tests, the substantial reductions in the proportion of rotavirus tests that were positive, supports the attribution of the declines to the effects of vaccination.

Introduction of rotavirus vaccine has also modified the seasonality of rotavirus disease in the USA.

However, rotavirus vaccines will not prevent diarrhea caused by other viruses.

There are 2 very effective, approved rotavirus vaccines; Rotarix and RotaTeq.

RotaTeq (RV5) is given in 3 doses at ages 2 months, 4 months, and 6 months,
Rotarix (RV1) is given in 2 doses at ages 2 months and 4 months.

These vaccines help prevent approximately 40,000 to 50,000 hospitalizations annually in the United States, says the CDC.

Since rotavirus vaccine introduction, coverage has slowly increased and completed coverage has plateaued at approximately 70 percent.

The lower coverage of rotavirus compared with other childhood vaccines might be explained in part by the fact that rotavirus vaccine does not offer the same opportunity for a catch-up, because the first dose must be given by age 15 weeks, and the series must be completed by age 8 months.

The biennial trend observed in the United States could be attributed to this low vaccination coverage, with the number of susceptible children accumulating in low rotavirus activity years, resulting in a higher number of susceptible children and a subsequent rotavirus outbreak during the following season.

Countries that rapidly achieved and maintained rotavirus vaccination coverage of up to 95 percent, such as the United Kingdom, have experienced a sustained decline in rotavirus activity, without the biennial trend observed in the USA.

As of May 2019, research published by the Academy of Pediatrics found only 71 percent of the infants were fully immunized against rotavirus.

And, 14 percent of these children had not received any rotavirus vaccination.

As vaccination coverage and on-time vaccination continue to improve in the USA, the seasonality of rotavirus disease can be monitored to see whether the biennial trend continues.

Recent rotavirus news:

Rotavirus disease is most common in infants and young children, but older children and adults can get it too. People with this disease shed a lot of rotavirus in their stool.

If you get rotavirus in your mouth, you can get infected and sick. This can happen when you put your unwashed hands or a contaminated object, food, or liquid in your mouth.

Once you’ve been exposed, it takes about 2 days for symptoms to appear. The most common symptom is diarrhea. Which can lead to severe dehydration, hospitalization, and death, says the CDC.

The findings in this report are subject to at least three limitations.

First, aggregate NREVSS data are reported, without demographic or clinical characteristics, precluding examination of these characteristics.

Second, these data were collected from a passive surveillance system composed of a convenience sample of laboratories and might not be representative of all those in the United States.

Finally, because rotavirus testing does not affect clinical management (which focuses on rehydration and syndromic management), testing practices vary from site to site and year to year, which might affect data comparability.

However, NREVSS data have advantages, including the ability to describe trends in rotavirus activity in the United States in a timely fashion. In addition, NREVSS data have consistently aligned with rotavirus-related U.S. hospital discharge data and active surveillance data.

In summary, the CDC says ‘to maximize the public health impact of rotavirus vaccination, efforts to improve coverage and on-time vaccination should continue.’

Vaccines, like any medicine, can have side effects, says the CDC. You are encouraged to report negative side effects of vaccines to a healthcare provider or the CDC.

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Rotarix and RotaTeq will not prevent diarrhea caused by other viruses

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Diabetes Risk Reduced With Rotavirus Vaccination

Don Hackett — Fri, 14 Jun 2019 14:31:15 +0000

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Lower Incidence Rate of Type 1 Diabetes after Receipt of the Rotavirus Vaccine in the United States, 2001–2017

A University of Michigan (UM) study revealed positive news for diabetes type 1 prevention.

This new study found a 33 percent reduction in the incidence of type 1 diabetes in children who received the entire rotavirus vaccination series compared to children who did not receive the vaccine during the same time period.

Furthermore, there was no reduction in the incidence of type 1 diabetes for children who were only partially vaccinated with the rotavirus vaccine.

Additionally, the UM study reported children vaccinated against rotavirus had a 94 percent lower rate of hospitalization for rotavirus infection, and a 31 percent lower rate of hospitalization for any reason, in the first two months after vaccination.

But this study reported some concerning under-vaccination news as well.

The study finds that more than 25 percent of American children don’t get fully vaccinated against rotavirus and that the rate varies widely across the country.

The Centers for Disease Control and Prevention (CDC) recommends that infants receive the multidose vaccine starting no later than 15 weeks after birth and finish receiving it before they are 8 months old.

The UM paper’s authors, led by UM epidemiologist Mary A.M. Rogers, Ph.D., caution that they cannot show a cause-and-effect relationship between rotavirus vaccination and type 1 diabetes risk.

“This is an uncommon condition, so it takes large amounts of data to see any trends across a population,” said Dr. Rogers, in a press release.

“It will take more time and analyses to confirm these findings. But we do see a decline in type 1 diabetes in young children after the rotavirus vaccine was introduced.”

The new result echoes the findings of a study of Australian children published earlier this year, which found a 14 percent reduced risk of type 1 diabetes after the rotavirus vaccine was introduced in that country.

Both studies represent the first time a childhood vaccine has been shown to have an association with a lower risk of a later chronic condition.

It also fits with laboratory studies showing that rotavirus attacks the same kind of pancreas cells that are affected in people with type 1 diabetes.

The death of insulin-producing cells, called beta cells, means people with type 1 diabetes depend on injections of insulin and multiple daily checks of their blood sugar for life.

If the condition is not managed well, people with type 1 diabetes may develop problems with their kidneys, heart, eyes, blood vessels and nerves, says the CDC.

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The UM team used anonymous insurance data from 1.5 million American children born before and after the modern rotavirus vaccine was introduced in 2006.

The lifetime cost of caring for a person with type 1 diabetes has been estimated in the millions of dollars.

“Hopefully in years to come, we’ll have fewer new cases — but based on our study findings, that depends upon parents bringing in their children to get vaccinated, said Dr. Rodgers.

In the USA, there are 2 oral, live, attenuated rotavirus vaccines available:

The rotavirus vaccine cost varies depending on your insurance and which state you live. The CDC Vaccine Price List provides private sector vaccine prices for general information.

Vaccine financial support programs can be found at Vaccine Discounts.

Vaccines, like any medicine, can have side effects, says the CDC. You are encouraged to report negative side effects of vaccines to the FDA or CDC.

This UM study was funded by the National Institutes of Health (TR000433).

Sub Title:

Michigan study supports infant rotavirus vaccinations

References:

Lower Risk of Type 1 Diabetes in Children Vaccinated Against ‘Stomach Flu’ Virus

Association of Rotavirus Vaccination With the Incidence of Type 1 Diabetes in Children

Rotavirus Vaccine What You Need to Know

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Why Are Children ‘Missing’ Rotavirus Vaccinations?

Don Hackett — Mon, 13 May 2019 22:53:19 +0000

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Missed Opportunities for Rotavirus Vaccination

Kelley Lu, PharmD

According to new research published by the Academy of Pediatrics, only 71 percent of the infants were fully immunized against rotavirus, the most common cause of children severe gastroenteritis.

And, 14 percent of these children had not received any rotavirus vaccination, reported this research team led by Robert A. Bednarczyk, Ph.D., Emory University, Atlanta, Georgia, on May 1, 2019.

Addressing missed ‘rotavirus vaccination opportunities’ is essential to achieving the 80 percent target outlined by Healthy People 2020, said these researchers.

Missed opportunities for rotavirus vaccination were identified using guidelines from the Advisory Committee on Immunization Practices (ACIP) and the World Health Organization (WHO).

Among the 14 percent of 19 to 35-month-old children included in the 2014 National Immunization Survey, who received no doses of the rotavirus vaccine:

72 percent had ≥1 ACIP-defined missed opportunities
83 percent had ≥1 WHO–defined missed opportunities

Moreover, the child’s socioeconomic status plays a significant part. This study found:

lower socioeconomic status increased the likelihood of being unvaccinated for rotavirus
higher socioeconomic status increased the likelihood of having missed opportunities to complete the rotavirus vaccine series

Each year, the vaccine prevents an estimated 40,000 to 50,000 hospitalizations among U.S. infants and young children, says the Centers for Disease Control and Prevention (CDC).

Two rotavirus vaccines are currently licensed for infants in the United States:

RotaTeq (RV5) is given in 3 doses at ages 2 months, 4 months, and 6 months,
Rotarix (RV1) is given in 2 doses at ages 2 months and 4 months.

The first dose of either vaccine should be given before a child is 15 weeks of age. Children should receive all doses of rotavirus vaccine before they turn 8 months old, says the CDC.

Both rotavirus vaccines are given by putting drops in the child’s mouth.

Related rotavirus news:

These researchers concluded saying ‘understanding how to close these missed vaccination opportunities and developing effective public health measures to promote vaccine use is essential.’

Sub Title:

Rotavirus vaccinations are essential to achieving Healthy People 2020

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Rotavirus Vaccination

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Rotavirus Vaccination Decreased Type 1 Diabetes Incidence by 14%

Don Hackett — Thu, 14 Mar 2019 12:30:41 +0000

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After Rotavirus Vaccine, Australia’s Type 1 Diabetes Incidence Declines

The Rotavirus (RV) vaccine may have a surprising off-target benefit, protecting against type 1 diabetes.

According to a new analysis published in JAMA Pediatrics, new cases of the autoimmune condition decreased among children after the RV vaccine was introduced in Australia.

This is important news since there’s currently no way to prevent type 1 diabetes.

Scientists think unknown environmental exposure triggers the condition in genetically predisposed people, said this research.

If you have an autoimmune disease, your immune system attacks healthy cells in your body by mistake. There are more than 80 types of autoimmune diseases, and some have similar symptoms.

These authors previously linked rotavirus infection—the most common cause of gastroenteritis in children—to diabetes-associated antibodies in genetically susceptible kids.

In a mice study, they found that the Rotavirus triggers pancreatic cell death and transient hyperglycemia.

A rotavirus surface protein called VP7 structurally resembles pancreatic β-cell autoantigens involved in the development of type 1 diabetes, and this so-called molecular mimicry could confuse the immune system into launching an attack.

It’s therefore plausible that a vaccine against rotavirus infection could also protect against type 1 diabetes.

But, such molecular mimicry might suggest that the vaccine could promote the condition, concluded this research.

In this study, there were 16,159 new cases of type 1 diabetes in Australia during the study period.

New diabetes type 1 cases decreased by 14 percent among children up to age 4 years after the oral rotavirus vaccine for infants was introduced in 2007.

But diabetes type 1 cases didn’t decline in older kids, most of whom weren’t immunized with the RV vaccine.

“If our findings are confirmed, they would indicate that rotavirus infection is one environmental factor that can promote the development of type 1 diabetes in genetically susceptible children,” said senior author Leonard C. Harrison, MD, of the Walter and Eliza Hall Institute of Medical Research in Melbourne, Australia.

“The corollary is that rotavirus vaccination would prevent type 1 diabetes in a proportion of these children,” he added.

But, a small case-control study in Finland involving just 495 children didn’t reveal the same link.

As the Australian authors wrote in their study, “It is possible that response to RV vaccination could vary by geographical location owing to genetic and environmental differences at the population level.”

The Australian researchers are working to validate their findings in a case-control linkage study using electronic health records. The results should be available in late 2019.

Sub Title:

New cases of the autoimmune condition decreased among children after the rotavirus vaccine was introduced in Australia

References:

Association of Rotavirus Vaccination With the Incidence of Type 1 Diabetes in Children

Rotavirus Vaccination and the Risk of Celiac Disease or Type 1 Diabetes in Finnish Children at Early Life

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Rotavirus Vaccinations Create ‘Herd-Immunity’

Don Hackett — Thu, 28 Feb 2019 19:48:23 +0000

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Kelley Lu, PharmD