ECDC Report: Narcolepsy In Association With Pandemic Flu Vaccination

 

 

# 6567

 

Roughly two years ago GSK’s adjuvanted Pandemrix vaccine was associated with a perceived increase in narcolepsy among children and adolescents in Finland and Sweden (Note: Adjuvanted flu vaccines, like Pandemrix, were not used in the United States).

 

For early coverage of this story, you may wish to revisit Finland Suspends Use of Pandemrix Vaccine and EMA To Review Pandemrix Vaccine, both of which I wrote in August of 2010.

 

Despite some conflicting and incomplete data the European Medicines Agency issued a statement in July of 2011 recommending:

 

In persons under 20 years of age Pandemrix to be used only in the absence of seasonal trivalent influenza vaccines, following link to very rare cases of narcolepsy in young people.

 

Finland also convened a Narcolepsy Task Force (see Finland: Task Force Report On Pandemrix-Narcolepsy Link) that confirmed an association – as yet unexplained – between receipt of the vaccine and an increase in narcolepsy in children between the ages of 4 and 19.

 

Somewhat surprisingly, this increase in narcolepsy was not reported in many other countries where the Pandemrix vaccine was used, leading researchers to wonder what other factors might have contributed to this effect.

 

All of which serves as prelude to a new technical report released today from the ECDC that summarizes the results from two epidemiological investigations into the phenomenon.

 

The 164 page technical report below is highly technical, data-rich, and fairly daunting for non-scientists. 

 

 

Luckily, the ECDC has also produced a 2-page summary.

 

 

Technical report In Brief: Narcolepsy in association with pandemic influenza vaccination

Technical reports - 20 Sep 2012

Available as PDF in the following languages:

This document is free of charge.

ABSTRACT

This report summarises the results from two epidemiological studies to investigate a possible association between an unexpected increase in narcolepsy cases following the use of the influenza A(H1N1)pdm09 vaccines. The studies were conducted by the Vaccine Adverse Event Surveillance and Communication (VAESCO) Consortium under the auspices of ECDC and undertaken in Denmark, Finland, France, Italy, the Netherlands, Norway, Sweden and the United Kingdom.

 

This Technical Report In Brief accompanies the full Report ‘Narcolepsy in association with pandemic influenza vaccination- A multi-country European epidemiological investigation’.

 

The MAIN CONCLUSIONS FROM THE REPORT (lifted from the brief above) reads:

 

The case–control study confirms an association between vaccination with Pandemrix® and an increased risk of narcolepsy in children and adolescents (5 to 19 years of age) in Sweden and Finland that originally reported on this issue (signalling countries). No such association was found in adults in these two countries.

 

According to the strictest primary analysis, the kind of assessment designed to avoid most biases like media and diagnostic awareness biases, no significant risk was found in children and adolescents in other countries included in the study – Denmark, Italy, France, the Netherlands, Norway and the United Kingdom (non-signalling countries).

 

However, sensitivity analyses that assess the robustness of the results from the primary analysis, have highlighted the importance of several time-related factors that affect the strength of association between influenza pandemic vaccines and narcolepsy. An example of a time-related factor shown to influence results is the length of the chosen study period, that is, the inclusion of cases occurring before and after the period of media attention would give a different outcome.

 

One such sensitivity analysis was based on the date of onset of excessive day-time sleepiness before media attention. This identified an increased risk for narcolepsy for children and adolescents following influenza A(H1N1)pdm09 vaccination in both signalling and non-signalling countries.

 

A similar sensitivity analysis also addressed date of onset of excessive daytime sleepiness and showed an association in adults in non-signalling countries before awareness increased.

 

To further inform the regulatory actions and the public, the report recommends increasing the statistical power by ensuring completeness of the case–control study through an exhaustive case inclusion in all age groups in the primary study period before increased awareness.

 

 

While the Pandemrix vaccine is linked to an increase in narcolepsy among children in Sweden and Finland, we still don’t know why. 

 

Or why the same effect wasn’t observed everywhere the Pandemrix vaccine was used. 

 

From the main report, this analysis.

 

The observations are sufficiently strong and consistent for children in the signalling countries using different methodologies to warrant further investigations as to a possible mechanism.

 

While it is the case that the vaccine concerned is one with a novel adjuvant there is a confounding factor in Europe in that this was the only vaccine offered for children in any volume in Europe. Hence it cannot be concluded that the adjuvant is the cause of the observation.

 

Equally there is also the possibility that it is the combination of vaccination and influenza transmission or another unrecognised infection or environmental factor in individuals with
developing nervous systems.

 

There will be a role also for animal models and mechanistic studies. 

 

The cause of this Pandemrix-Narcolepsy link remains a medical mystery, and as these reports indicate, it will take more research to fully unravel this story.

»» Read More

BMJ: Another Pandemrix Study To Ponder

 

 

Photo Credit CDC 

 

# 5897

 

Whenever there is a hint or a suggestion that a vaccine might have caused some sort of serious side effect, it invariably becomes big news. 

 

Even when the reports are preliminary, and the evidence less than rock solid, these stories often end up on the front pages of newspapers and quickly become fodder for the anti-vaccination brigade.

 

When more reassuring vaccine studies come out, they rarely get that kind of media play, since it isn’t the sort of thing that sells newspapers. 

 

Case in point:

 

A little over a year ago GSK’s Pandemrix vaccine was associated with a perceived increase in narcolepsy among children and adolescents in Finland. For early coverage of this story, you may wish to revisit Finland Suspends Use of Pandemrix Vaccine and EMA To Review Pandemrix Vaccine, both of which I wrote in August of 2010.

 

Despite some conflicting and incomplete data the European Medicines Agency issued a statement last July recommending:

 

In persons under 20 years of age Pandemrix to be used only in the absence of seasonal trivalent influenza vaccines, following link to very rare cases of narcolepsy in young people.

 

Finland also convened a Narcolepsy Task Force (see Finland: Task Force Report On Pandemrix-Narcolepsy Link) that confirmed an association – as yet unexplained  – between receipt of the vaccine and an increase in narcolepsy in children between the ages of 4 and 19.

 

Complicating matters, more than a dozen countries reported an increase in narcolepsy during the 2009 pandemic, even those where the adjuvanted vaccine was not used.

 

You can find details on one such study in Stanford Study Finds Influenza – Narcolepsy Connection  that linked narcolepsy not to the vaccine . . . but to infection by influenza virus itself.

 

Confused yet?

 

Alas, science isn’t always neat and tidy.  Good studies take time, and we don’t always get consistent results.

 

Today, we’ve another study that appears in the BMJ that is a bit more reassuring on the safety of the Pandemrix vaccine, but fails to answer the question of narcolepsy. 

 

It is called:

 

Neurological and autoimmune disorders after vaccination against pandemic influenza A (H1N1) with a monovalent adjuvanted vaccine: population based cohort study in Stockholm, Sweden

OPEN ACCESS

Carola Bardage, epidemiologist, Ingemar Persson, professor of pharmacoepidemiology and senior expert, Åke Örtqvist, county medical officer and associate professor, Ulf Bergman, professor of pharmaco-epidemiology and clinical pharmacologist, Jonas F Ludvigsson, paediatrician and epidemiologist, Fredrik Granath, senior biostatistician

 

This was a population based cohort study conducted in Stockholm, Sweden during the 2009 pandemic where 1,024,019  people were vaccinated with the Pandemrix vaccine and 921,005 remained unvaccinated.

 

Using the detailed healthcare registers for Stockholm County Council, researchers tracked all admissions to hospitals and visits to specialists for autoimmune or neurological diagnoses.

 

The conditions flagged in this study included:

 

• Guillain-Barré syndrome
• Bell’s palsy
• multiple sclerosis
• polyneuropathy
• anaesthesia or hypoaesthesia
• paraesthesia
• narcolepsy
• rheumatoid arthritis
• inflammatory bowel disease (ulcerative colitis, Crohn’s disease)
• type 1 diabetes

 

This study further divided this cohort into those who received the vaccine within the first 45 days of its availability, and those who received it later. Those in high risk groups, with comorbid conditions, were more likely to be vaccinated during the first 6 weeks of the vaccination campaign. 

 

The results (which are far more detailed in the open access report) indicated:

 

Conclusions

Results for the safety of Pandemrix over 8-10 months of follow-up were reassuring —notably, no change in the risk for Guillain-Barré syndrome, multiple sclerosis, type 1 diabetes, or rheumatoid arthritis.

 

Relative risks were significantly increased for Bell’s palsy, paraesthesia, and inflammatory bowel disease after vaccination, predominantly in the early phase of the vaccination campaign.

 

Small numbers of children and adolescents with narcolepsy precluded any meaningful conclusions.

 

The report summary states:

 

What is already known on this topic

• Studies are lacking on adverse events (except for narcolepsy) with any of the three vaccines used in the European Union against H1N1 during the pandemic period

• Available data are limited to case series or highly selected populations with short follow-up or no control group

What this study adds

• Excess risks for Bell’s palsy, paraesthesia, and inflammatory bowel disease after H1N1 vaccination with adjuvanted Pandemrix in Sweden were small but significant among more than one million vaccinated, but only in high risk groups targeted for early vaccination and who were likely to have earlier comorbidity

• The risk of Guillain-Barré syndrome, multiple sclerosis, type 1 diabetes, and rheumatoid arthritis remained unchanged

• Small numbers of children and adolescents with narcolepsy precluded any meaningful conclusions

 

While the low number of children and adolescents with narcolepsy may have precluded making any firm conclusions, their scarcity is nonetheless a bit reassuring.

 

The authors suggest that the small, but statistically significant increase in Bell’s palsy, paraesthesia, and inflammatory bowel disease among the early recipients of the vaccine may be partly, or perhaps entirely, explained by the higher number of high risk patients in that cohort.

 

We are still left with the mystery of what caused the increase in narcolepsy reported in Finland, of course. And there will no doubt be additional studies that will look at the safety of the Pandemrix vaccine in other regions.

 

But for now, as the authors state,  the news is `reassuring’.

 

For previous reports on the safety of (adjuvanted and unadjuvanted) flu vaccines, you may wish to revisit.

 

IOM Report On Vaccine Safety Concerns

 

BMJ: No Substantial Link Between Flu Vaccines And Guillain-Barre Syndrome

 

Lancet: Immunogenicity and safety Of Adjuvanted Flu Vaccines

 

NEJM: Study On China’s H1N1 Vaccine Safety

 

Harvard Study Reaffirms Safety Of Flu Vaccine

 

»» Read More

Finland: Task Force Report On Pandemrix-Narcolepsy Link

 

 

 

# 5803

 

 

Just over a year ago reports began to come out of Finland suggesting a link between an increase in the rate of narcolepsy among adolescents and GSK’s adjuvanted Pandemrix vaccine.

 

For early coverage of this story, you may wish to revisit Finland Suspends Use of Pandemrix Vaccine and EMA To Review Pandemrix Vaccine, both of which I wrote in August of 2010.

 

Despite some conflicting and incomplete data the European Medicines Agency issued a statement last July recommending:

 

In persons under 20 years of age Pandemrix to be used only in the absence of seasonal trivalent influenza vaccines, following link to very rare cases of narcolepsy in young people.

 

 

Note: The use of GSK’s 2009 monovalent Pandemrix vaccine has been largely supplanted by the introduction of last year’s trivalent vaccine, so the impact of this ruling should be minimal.

 

Stockpiles were released last winter in the UK during their surge in flu cases (see UK: To Release Pandemrix Vaccine Stockpile). 

 

The EMA maintained, however, that despite these concerns over the Pandemrix vaccine, the overall benefit-risk remains positive.

 

Since then, we’ve seen a study that linked an increase in narcolepsy to the flu virus itself (see Stanford Study Finds Influenza – Narcolepsy Connection) -  further confusing matters.

 

 

Today, Finland’s National Institute For Health and Welfare Narcolepsy Task Force has released a report where they find an association between the Pandemrix vaccine and increased rates of narcolepsy in children between the ages of 4 and 19.

 

 

Association between Pandemrix and narcolepsy confirmed among Finnish children and adolescents

1 Sep 2011

An association between Pandemrix and narcolepsy among children and adolescents in Finland is confirmed

 

In its final report, the National Narcolepsy Task Force confirms the tentative conclusion published in its Interim Report last January that the Pandemrix vaccine used in the winter of 2009–2010 contributed to the increased incidence of narcolepsy observed among 4–19-year-olds in Finland. According to the report, the increased risk associated with vaccination amounted to six cases of narcolepsy per 100 000 persons vaccinated in the 4–19 age group during the eight months following vaccination. This was 12.7 times the risk of a person in the same age group who had not been vaccinated. No increased incidence of narcolepsy was observed among children under the age of four or among adults over the age of 19.

 

In all the cases examined, narcolepsy associated with Pandemrix vaccination has been identified in persons who carry a genetic risk factor for narcolepsy. Because of this very strong association with the genetic risk factor which regulates immune responses, narcolepsy is considered an immune-mediated disease.

 

In approximately one quarter of those who developed narcolepsy following Pandemrix vaccination, the THL Immunology laboratory found antibodies binding to the AS03 adjuvant component of the vaccine. Adjuvants containing squalene have not previously been reported to induce the production of antibodies. The significance of this preliminary observation will be the subject of further research.

(Continue . . . )

 

 

While more research is needed to nail down exactly what happened, and why, a few key points to ponder.

 

• Of the 3 dozen countries that used the Pandemrix vaccine in 2009-2010, only Finland and Sweden have documented an increase in Narcolepsy that they can link to the Pandemrix vaccine.
• At least a dozen countries reported increased rates of narcolepsy during that time period, including some countries where the vaccine was not used.
• In all the cases the task force examined, narcolepsy associated with Pandemrix vaccination was identified in persons who carry a genetic risk factor for narcolepsy
• Regarding the use of the vaccine, despite the the `unforeseen and deeply regrettable cases of narcolepsy’, Finland’s Narcolepsy taskforce found that its use probably saved lives and that `overall benefit-risk balance remains positive.’
• While unsure of its significance, researchers found antibodies binding to the AS03 adjuvant component of the vaccine in roughly 25% of the cases examined.
• And finally, adjuvanted flu vaccines like Pandemrix were not used in the United States. 

 

Despite rare adverse side effects such as narcolepsy, flu vaccines have an excellent safety profile, and remain our best weapon against a virus that kills tens of thousands every year.

 

Taking any medicine – including a flu vaccine – entails a small degree of risk.  But those risks pale when compared to the risks from catching the flu.

 

And with the potential for seeing an increase in antiviral resistant flu viruses that might limit your treatment options in the future (see Australia Reports Cluster Of Antiviral Resistant H1N1), doing what you can now to protect yourself against infection this winter makes a lot of sense.

»» Read More

Stanford Study Finds Influenza – Narcolepsy Connection

 

 

 

Photo Credit CDC – Sleep and Sleep Disorders

# 5772

 

Over the past year we’ve seen numerous reports linking GSK’s Pandemrix vaccine to an increased incidence of narcolepsy in children and adolescents. This recently led the EMA to recommend that the vaccine not be given to anyone under the age of 20.

 

Somewhat mysteriously, epidemiological investigations have confirmed elevated levels of childhood narcolepsy among Pandemrix vaccine recipients in some countries, but not in others.

 

And last year Iceland reported a similar surge in narcolepsy among children who had not received the vaccine.

 

Leaving many to question exactly what is going on here.

 

Today, in a study that appears in the Annals of Neurology, we’ve a new study that now suggests a link between contracting an upper respiratory infection and developing narcolepsy.

 

I’ve listed the full citation below, but as of this posting the link is not live.

 

"Narcolepsy Onset is Seasonal and Increased Following the H1N1 Pandemic in China." Fang Han, Ling Lin, Simon C Warby, Juliette Faraco, Jing Li , Song X. Dong, Pei. An, Long Zhao, Ling H. Wang, Qian Y. Li, Han Yan, Zhan C. Gao, Yuan Yuan, Kingman P. Strohl and Emmanuel Mignot, Annals of Neurology; Published Online: August 22, 2011 (DOI:10.1002/ana.22587). http://doi.wiley.com/10.1002/ana.22587

 

We do have a pair of press releases, however, that provide a fair amount of background on this intriguing finding.

 

And what these researchers found was: that in China, among a largely unvaccinated population, the incidence of Narcolepsy increased dramatically in the Spring, after the winter flu season. And that this increase was most pronounced following the emergence of the H1N1 swine flu virus in 2009.

 

Study finds narcolepsy cases in China peak in early spring

Significant spike following H1N1 pandemic not linked to vaccines

New research shows that the occurrence of narcolepsy in China is highly correlated to a seasonal pattern, with onset most frequent in April. A significant increase in narcolepsy cases was also observed following the 2009-2010 H1N1 pandemic, but the findings now available in Annals of Neurology, a journal of the American Neurological Association and the Child Neurology Society, report flu vaccination was unlikely the cause of the increase.

(Continue . . . )

Stanford study draws connection between narcolepsy and influenza

STANFORD, Calif. — The onset of narcolepsy appears to follow seasonal patterns of H1N1 and other upper airway infections, according to a new study of patients in China that was led by Stanford University School of Medicine narcolepsy expert Emmanuel Mignot, MD.

 

The findings, which will be published online Aug. 22 in Annals of Neurology, a journal of the American Neurological Association and Child Neurology Society, show that a peak in narcolepsy cases occurred five to seven months after a peak in flu/cold or H1N1 infections in the country.

 

"Together with recent findings, these results strongly suggest that winter airway infections such as influenza A (including H1N1), and/or Streptococcus pyogenes are triggers for narcolepsy," Mignot, a professor of psychiatry and behavioral sciences, and his colleagues wrote in the paper.

 

The study follows recent reports that a particular H1N1 vaccine, not one used in the United States or China, seemed to lead to narcolepsy. This new paper, however, found no correlation between vaccination and narcolepsy among the patients studied in China. "The new finding of an association with infection, and not vaccination, is important as it suggests that limiting vaccination because of a fear of narcolepsy could actually increase overall risk," the authors wrote.

 

(Continue . . . )

 

 

The results of today’s study is reminiscent to one we saw last year (see Lancet: The Influenza - Guillain Barré Syndrome Connection) that suggested the risks of developing GBS – another type of autoimmune disease - were far greater following a bout of the flu, than from receiving the flu vaccine.

 

And two years ago, Helen Branswell reported on a study that suggested that some influenza infections may set up some people to develop Parkinson's disease later in life (see More On The Influenza-Parkinson’s Link.)

 

One of the authors of today’s study, Dr. Emmanuel Mignot with the Stanford Center for Sleep Sciences and Medicine in Palo Alto, California, is quoted as saying:

 

"These findings are reminiscent of the encephalitis lethargica epidemic that followed the great Spanish influenza pandemic of 1917-1918. Not only narcolepsy, but also psychosis and Parkinson's disease may follow winter infections, and further research is needed in the area of autoimmune diseases of the brain.”

 

The epidemic of Encephalitis lethargica that swept the world between 1915 and 1926 remains one of the great medical mysteries of the last century, although a link to the Pandemic virus of 1918 has often been suggested.

 

As the press release states: The paper doesn't show cause and effect, but it does show a strong correlation between narcolepsy onset and this seasonal pattern.

More research is obviously needed, but this is more evidence that the real danger lies with contracting the flu, not with taking the vaccine to prevent it.

»» Read More

EMA Recommends Restrictions On Use of Pandemrix Vaccine

 

 

# 5708

 

 

Nearly 11 months ago we began seeing reports of a possible link between narcolepsy in children in a handful of European countries, and the receiving of GSK’s Pandemrix vaccine.

 

Since then, there have been epidemiological investigations that have confirmed elevated levels of childhood narcolepsy among Pandemrix vaccine recipients in some countries, but not in others.

 

And that, as you might imagine, has presented public health officials with a bit of a medical mystery.

 

A few earlier blogs on this subject include:

 

EMA Recommends Interim Measures For Pandemrix Vaccine

WHO: GACVS Statement On Narcolepsy And Vaccination

Finland: Statement On Pandemrix And Narcolepsy Link

EMA Update On The Pandemrix-Narcolepsy Investigation

Sweden: No Link Between Pandemrix And Narcolepsy

GSK Press Statement On Pandemrix Investigation

 

The EMA (European Medicines Agency) is a regulatory agency that is responsible for the scientific evaluation of drugs developed by pharmaceutical companies for use in the European Union.

 

It is roughly the EU equivalent to the United State’s FDA.

 

Today, in light of their ongoing investigation, they have issued a statement that recommends restricting the use of the Pandemrix vaccine – except under extraordinary circumstances -  to only those over the age of 20.

 

Note: The use of GSK’s 2009 monovalent Pandemrix vaccine has been largely supplanted by the introduction of last year’s trivalent vaccine, so the impact of this ruling should be minimal.

 

Stockpiles were released last winter in the UK during their surge in flu cases (see UK: To Release Pandemrix Vaccine Stockpile). 

 

The press release (below) provides intriguing glimpses at the avenues under investigation, including genetic predisposition, environmental factors, and perhaps even previous viral exposure as possible catalysts that - along with the vaccine - may have contributed to the increased rates of narcolepsy.

 

More study will be needed to determine the actual cause or causes.

 

 

21/07/2011

European Medicines Agency recommends restricting use of Pandemrix

In persons under 20 years of age Pandemrix to be used only in the absence of seasonal trivalent influenza vaccines, following link to very rare cases of narcolepsy in young people. Overall benefit-risk remains positive.

 

Finalising its review of Pandemrix and narcolepsy the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended that in persons under 20 years of age Pandemrix may only be used if the recommended seasonal trivalent influenza vaccine is not available and if immunisation against H1N1 is still needed (e.g. in persons at risk of the complications of infection). The CHMP confirmed that overall the benefit-risk balance of Pandemrix remains positive.

 

The review of Pandemrix was initiated to investigate a possible link between Pandemrix vaccination and narcolepsy, following an increased number of reported cases of narcolepsy among children and adolescents in Finland and Sweden. The reported cases of narcolepsy occurred following the H1N1 pandemic vaccination campaign in late 2009 and early 2010. The current review has been conducted in the context of seasonal use.

 

The CHMP considered all available data on the possible association between Pandemrix and narcolepsy and the impact on the overall benefit-risk balance of Pandemrix. These included the results of epidemiological studies carried out in Finland and Sweden, analysis of safety surveillance data performed in several Member States and case reports from across the European Union (EU).

 

They also included the preliminary results of an epidemiological study of narcolepsy and pandemic vaccines in eight EU Member States, coordinated by the European Centre for Disease Prevention and Control (ECDC) through a network of research and public health institutions (VAESCO).

 

The CHMP also took advice from a specially convened meeting of experts in fields such as paediatric neurology, vaccinology, immunology, sleep disorders, infectious diseases, epidemiology, as well as experts from Health Canada, the World Health Organization (WHO) and the ECDC, to consider the latest available data regarding the possible link between Pandemrix and narcolepsy.

 

The CHMP considered that the epidemiological studies relating to Pandemrix in Finland and Sweden were well designed and the results show an association between Pandemrix vaccination and narcolepsy in children and adolescents in those countries. The results indicate a six- to 13-fold increased risk of narcolepsy with or without cataplexy in vaccinated as compared with unvaccinated children and adolescents, corresponding to about an additional three to seven cases in every 100,000 vaccinated subjects. This risk increase has not been found in adults (older than 20 years). A similar risk has not been confirmed but cannot be ruled out in other countries.

 

The Committee noted that the vaccine is likely to have interacted with genetic or environmental factors which might raise the risk of narcolepsy, and that other factors may have contributed to the results. There are several initiatives being developed across the EU to further investigate this association.

 

The CHMP noted that similar epidemiological studies have not been completed in other countries. The preliminary results of the VAESCO study confirmed the signal in Finland. Results are still preliminary and do not allow conclusions in other countries (where vaccination coverage with Pandemrix was lower), but the final results of the VAESCO study are still awaited.

 

Exposure to specific infectious diseases (including H1N1) at different ages, particularly upper respiratory infections, may have contributed to the observations in the Nordic area. The CHMP considered that it would be helpful if ongoing epidemiological studies seek to address this question.

 

The CHMP stressed that further research is necessary.

(Continue . . . )

 

 

The Pandemrix vaccine was not used in the United States, although an equivalent H1N1 vaccine (Arepanrix) was widely used in Canada.

»» Read More

EMA Recommends Interim Measures For Pandemrix Vaccine

 

 

 

# 5494

 

The supposed link between GSK’s Pandemrix Vaccine and an increase in narcolepsy among children and adolescents in a handful of countries has been covered often in this blog over the past 6 months.

 

Today, new we’ve information from the EMA.  But first, a quick review of the story to date.

 

In late August of 2010, shortly after the declared end of the H1N1 pandemic, reports of a possible increase in narcolepsy among children and adolescents who received GSK’s adjuvanted Pandemrix vaccine began to emerge from Finland.

 

On August 25th, I reported Finland Suspends Use of Pandemrix Vaccine, and two days later I blogged on the European Medicines Agency’s plan to review the evidence (see EMA To Review Pandemrix Vaccine).

 

Since then we’ve seen several interim reports that failed to find conclusive evidence of a link between the Pandemrix vaccine and narcolepsy, but which did find reasons to continue the investigation.

 

Sweden: No Link Between Pandemrix And Narcolepsy

EMA Update On The Pandemrix-Narcolepsy Investigation

 

On February 1st, Finland’s National Institute for Health and Welfare released an interim report on what they called a probable link between GSK’s Pandemrix vaccination, and an increase in narcolepsy in children and adolescents 4-19 years of age.

 

Finland: Statement On Pandemrix And Narcolepsy Link

 

A week later, the World Health Organization’s GACVS (Global Advisory Committee on Vaccine Safety) has issued a statement on the potential link between GSK’s Pandemrix vaccine and an increase in rates of narcolepsy among recipients aged 4 to 19.

 

 

While stating that further investigation is warranted concerning narcolepsy and vaccination against influenza (H1N1) 2009 with Pandemrix and other pandemic H1N1 vaccines the advisory group also states that this does not appear to have been a world-wide phenomenon.

 

WHO: GACVS Statement On Narcolepsy And Vaccination

 

Roughly 10 days later, the European Medicines Agency (EMA) released a statement (see EMA: Added Concern, But Insufficient Evidence To Link Vaccine To Narcolepsy) that stated that that its Committee for Medicinal Products for Human Use (CHMP) has reviewed Finnish data on the suspected link between Pandemrix vaccine and an increase in narcolepsy, and has concluded that the new evidence `added to the concern’, but was as yet insufficient to establish a causal relationship.

 

 

Today (April 15th, 2011), in the latest installment in this ongoing investigation, the EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended that Pandemrix’s product information be amended to include concerns over a suspected link to narcolepsy.

 

 

15/04/2011

European Medicines Agency recommends interim measures for Pandemrix

Updated prescribing advice highlights preliminary results from epidemiological studies on narcolepsy; further research needed

 

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that the product information for Pandemrix should be amended to advise prescribers to take into account preliminary results from epidemiological studies on Pandemrix and narcolepsy, and to perform an individual benefit-risk assessment when considering the use of Pandemrix in children and adolescents. This is an interim measure pending the outcome of the European review, expected to conclude in July 2011.

 

The CHMP reviewed all available data, including new findings from Sweden and France on the suspected link between narcolepsy in children and adolescents and Pandemrix. The CHMP concluded that, following the earlier results of an epidemiological study from Finland, the new evidence strengthened the signal in children and adolescents, but that the data had methodological limitations. The relationship between Pandemrix and narcolepsy is still under investigation.

 

Preliminary results of the Swedish registry study from October 2009 to December 2010 on Pandemrix vaccination and the risk of narcolepsy indicates a four-fold increase of cases of narcolepsy in children and adolescents (below 20 years of age) who received Pandemrix compared with unvaccinated people of the same age. The additional risk corresponds to an additional 3-4 narcolepsy cases per 100,000 vaccinated subjects. These results are broadly in line with the study results from Finland indicating an association between Pandemrix and narcolepsy in children and adolescents. The study did not identify any increased risk in adults. The CHMP concluded that the study was well conducted, although it has inherent limitations.

 

An analysis of narcolepsy reports in France provides some further evidence.

 

The lack of a clear increase in reports of narcolepsy following Pandemrix in other EU and non-EU countries may point towards the influence of other unknown factors affecting the trend seen in some countries. Also, there is currently no clearly identified biological plausibility for an association between Pandemrix and narcolepsy, and further non-clinical studies, especially in the juvenile setting, are needed.

 

The CHMP considers it important to gather more data on the use of Pandemrix and related vaccines in a variety of countries to further assess this concern. A variety of research efforts are now ongoing. These include an epidemiological study of narcolepsy and pandemic vaccines conducted by the European Centre for Disease Prevention and Control (ECDC) through a network of research and public health institutions (VAESCO) in nine European Union Member States, and an epidemiological study conducted by Glaxo Smith Kline (the marketing authorisation holder of Pandemrix) in Canada. Preliminary results of the VAESCO study and of the Canadian study are expected by July 2011.

 

The CHMP is working with experts from across the EU to assess the possible safety concern and any impact on the benefit-risk balance of Pandemrix. The CHMP plans to hold an expert meeting with participation of international experts, the World Health Organization (WHO) and ECDC.

 

The European Medicines Agency will provide updates as new information becomes available.

(Continue . . . )

 

 

The increase in narcolepsy among children in just a few of the nations that deployed the Pandemrix vaccine remains a medical mystery.   Investigations continue.

 

While some link between the vaccine and the condition may well exist, researchers are looking for a third factor – an unknown catalyst – that may have affected residents of some countries but not others.

 

The Pandemrix vaccine was not used in the United States.

 

This is an evolving story, and for now there are more questions than answers.

»» Read More

EMA: Added Concern, But Insufficient Evidence To Link Vaccine To Narcolepsy

 

 

# 5324

 

 

A European Medicines Agency press release today stated that its Committee for Medicinal Products for Human Use (CHMP) has reviewed Finnish data on the suspected link between Pandemrix vaccine and an increase in narcolepsy among children in that nation, and has concluded that the new evidence `added to the concern’, but was as yet insufficient to establish a causal relationship.

 

This supposed link has has been the subject of a number of blogs in the past few months, including:

 

Finland: Statement On Pandemrix And Narcolepsy Link

GSK Statement On Pandemrix-Narcolepsy Report

WHO: Statement On Pandemrix Vaccine & Narcolepsy

 

While many have been quick to associate the Pandemrix vaccine with the uptick in narcolepsy cases in Finland and Sweden, it should be noted that in Iceland a similar surge in narcolepsy was noted among children who had not received the vaccine.

And in a number of other countries (including Canada) where the Pandemrix vaccine saw wide use, spikes in narcolepsy rates have not been reported.

 

All of which leaves us with a lot more questions than answers at this point.

 

 

The EMA website has been difficult to access this morning, so I’ve reproduced the press release below:

 

18/02/2011

European Medicines Agency reviews further data on narcolepsy and possible association with Pandemrix

Causal relationship not established; further study results awaited

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has reviewed further data from Finland on the suspected link between narcolepsy in children and adolescents and Pandemrix. The Committee concluded that the new evidence added to the concern arising from case reports in Finland and Sweden, but that the data were still insufficient to establish a causal relationship between Pandemrix and narcolepsy. Further analyses and study results are awaited to clarify the observations in Finland.

 

In addition to the data from Finland, research is ongoing in Sweden where there has also been an unexpected number of narcolepsy reports following vaccination with Pandemrix. However, other non-Nordic countries have not seen similar increased rates of reporting of narcolepsy. Additionally in Canada, where there has been substantial use of this type of vaccine, there has been no evidence of an increase in reports of narcolepsy. Therefore, at present definitive conclusions cannot be drawn and no changes to the recommendations for use of Pandemrix are proposed.

 

The Committee reviewed the preliminary results of the Finnish study, an epidemiological study that compared the incidence of narcolepsy in people aged 4 to 19 years vaccinated with Pandemrix between 1 January 2009 and 31 December 2010 with the incidence of narcolepsy in unvaccinated people of the same age. The study, conducted by the Finnish National Institute for Health and Welfare (THL), suggested a nine-fold increase in risk of narcolepsy in the vaccinated population studied (an increase from approximately 1 to 9 cases per 100,000 vaccinees), although the occurrence of narcolepsy was still very rare even with this apparent increase.

 

The Committee concluded that the THL study was well-designed, although it remains possible that unmeasured effects and biases could potentially have contributed to the observed increased risk. One possible explanation for the results is that Pandemrix may have interacted with an unknown local environmental and/or genetic factor in contributing to an increased risk of narcolepsy among those aged 4 to 19 years in Finland.

 

In order to conclude this review the CHMP considers it important to gather more data from the use of Pandemrix and related vaccines in a variety of countries to further assess this concern, and thereby understand the nature of any relationship between vaccination and narcolepsy. A variety of research efforts are now ongoing, including an epidemiological study of narcolepsy and pandemic vaccines conducted by the European Centre for Disease Control and Prevention (ECDC) through a network of research and public health institutions (VAESCO) in nine European Union Member States. The final results of this study are expected by the end of June 2011.

 

The European Medicines Agency will provide updates as new information becomes available.

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WHO: GACVS Statement On Narcolepsy And Vaccination

 

 

# 5296

 

 

The World Health Organization’s GACVS (Global Advisory Committee on Vaccine Safety) has issued a statement on the potential link between GSK’s Pandemrix vaccine and an increase in rates of narcolepsy among recipients aged 4 to 19.

 

It was just a week ago when we saw a series of statements from Finland’s Institute of Health and Welfare, the manufacturer of Pandemrix.

 

Finland: Statement On Pandemrix And Narcolepsy Link

GSK Statement On Pandemrix-Narcolepsy Report

WHO: Statement On Pandemrix Vaccine & Narcolepsy

 

 

While stating that further investigation is warranted concerning narcolepsy and vaccination against influenza (H1N1) 2009 with Pandemrix and other pandemic H1N1 vaccines the advisory group also states that this does not appear to have been a world-wide phenomenon.

 

To date, at least 12 countries have observed increased rates of narcolepsy over the past year.

 

That the rates of narcolepsy would go up in some countries, but not in others receiving the vaccine, complicates the investigation. And earlier reports suggest that in Iceland, narcolepsy rates increased in people who had not received a vaccine.

 

Which leads some researchers to suggest that the vaccine may not be the sole cause of this spike in narcolepsy, and that there may be some other genetic, environmental, or pathogenic factors involved.

 

Here then is the GACVS statement (reparagraphed for readability) from their website.

 

Statement on narcolepsy and vaccination

8 February 2011

Since August 2010, following widespread use of vaccines against influenza (H1N1) 2009, cases of narcolepsy, especially in children and adolescents, have been reported from at least 12 countries.

 

Narcolepsy is a rare sleep disorder that causes a person to fall asleep suddenly and unexpectedly. The rates reported from Sweden, Finland and Iceland have been notably higher than those from other countries.

 

The National Institute for Health and Welfare of Finland issued a preliminary statement on 1 February 2011 following an investigation into the cases in Finland. A systematic retrospective registry-based review was conducted of all new narcolepsy cases diagnosed during 2006-2010 and cases in 2009-2010, born in 1990 or later, were reviewed using newly developed Brighton collaboration criteria for the disease. During 2009-2010 they found a higher risk of narcolepsy among those aged 4-19 years old who had received the vaccination against influenza (H1N1) 2009 compared with those who had not been vaccinated.

 

The only pandemic vaccine used in Finland was Pandemrix, an adjuvanted influenza (H1N1) 2009 monovalent vaccine manufactured by GlaxoSmithKline. Pandemrix vaccine was used in 47 countries worldwide during the 2009-2010 season. Studies are ongoing to determine if the apparent increased risk of narcolepsy reported in Sweden is higher in vaccinated persons.

 

The National Institute in Finland (on the advice of the Finnish National Narcolepsy Task Force) has concluded that the risk of developing narcolepsy among those vaccinated aged between 4 and 19 years is about nine times greater than those unvaccinated in the same age group, corresponding to a risk of about 1 case of narcolepsy per 12,000 vaccinated in this age group.

 

The increased risk has not been seen in younger or older age groups. Narcolepsy is a condition that has a strong genetic linkage, being almost uniquely seen in persons who have the (HLA) DQB1*0602 genotype. Of the cases of narcolepsy tested so far in Finland (n=22), diagnosed during 2009-2010, all have that genotype.

 

The National Institute considers it probable that the Pandemrix vaccine was a contributing factor to this observed increase, and has called for further investigation of other co-factors that may be associated with the increased risk. They consider it most likely that the Pandemrix vaccine increased the risk of narcolepsy in a joint effect in those genetically disposed with some other, still unknown, genetic and/or environmental factor. The final report from the Finnish National Narcolepsy Task Force is expected by 31 August 2011.

 

WHO's Global Advisory Committee on Vaccine Safety (GACVS) reviewed this data by telephone conference on 4 February 2011. GACVS agrees that further investigation is warranted concerning narcolepsy and vaccination against influenza (H1N1) 2009 with Pandemrix and other pandemic H1N1 vaccines.

 

An increased risk of narcolepsy has not been observed in association with the use of any vaccines whether against influenza or other diseases in the past. Even at this stage, it does not appear that narcolepsy following vaccination against pandemic influenza is a general worldwide phenomenon and this complicates interpretation of the findings in Finland.

 

In collaboration with a number of European Union member states, the European Centre for Disease Prevention and Control (ECDC) is currently conducting epidemiological studies of narcolepsy and pandemic influenza vaccines. The findings from these studies and others, including further investigations in Finland, may help clarify the determinants of any increased risk of narcolepsy which currently appears to be restricted to the months following vaccination and by age group and country.

 

GACVS will continue to monitor the situation closely and updates will be provided as further information becomes available and is assessed.

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WHO: Statement On Pandemrix Vaccine & Narcolepsy

 

 

 

# 5276

 

 

Another major entity has weighed in on today’s report (see Finland: Statement On Pandemrix And Narcolepsy Link) from the Finnish National Institute for Health and Welfare report on what they are calling a `probable link’ between GSK’s Pandemrix vaccination, and an increase in narcolepsy in children and adolescents 4-19 years of age.

 

The World Health Organization agrees that further investigation is warranted, and expects a statement to be forthcoming over the next few days from WHO's Global Advisory Committee on Vaccine Safety (GACVS).

 

In the meantime, they are not recommending any changes on the use of seasonal 2010/2011 influenza vaccines in children and adolescents.

 

One should  note that – despite many of the imprecise headlines on today’s newswires claiming that the `Swine Flu Vaccine’ has been linked to narcolepsy -that this report only suggested a link with one  vaccine (Pandemrix) from one manufacturer (GSK), and only found elevated rates in 2 or 3 countries.

 

And no one has suggested any relationship to this year’s seasonal flu shot.

 

A couple of small, but important clarifications.

Here then is the WHO statement.

 

Pandemrix® vaccine and increased risk of narcolepsy

01-02-2011

The National Institute of Health and Welfare of Finland today issued a statement indicating an increased risk of narcolepsy (a rare sleep disorder that causes a person to fall asleep suddenly and unexpectedly) observed among children and adolescents vaccinated with Pandemrix®, an adjuvanted pandemic H1N1 vaccine manufactured by GlaxoSmithKline.

The National Institute (on the advice of the Finnish National Narcolepsy Task Force) concludes that the risk of falling ill with narcolepsy among those vaccinated in the 4-19 year age group is 9 times greater than those unvaccinated in the same age group. The National Institute considers it probable that the Pandemrix® vaccine was a contributing factor to this observed increase, but states that further investigation is required of other significant co-factors associated with the increased risk of narcolepsy. The final report from the Finnish National Narcolepsy Task Force is expected to be issued by 31 August 2011.

 

Pandemrix® vaccine has been used in 38 countries worldwide during the 2009/2010 season. An increase in cases of narcolepsy has been observed only in Finland, Sweden and Iceland.

 

The issue of an increased rate of narcolepsy has not been raised in association with the use of other influenza A(H1N1) pandemic vaccines, seasonal influenza vaccines or any other adjuvanted vaccines used in childhood immunization programmes.

 

WHO's Global Advisory Committee on Vaccine Safety (GACVS) is considering all available data relating to reports of increased rates of narcolepsy and is expected to issue a statement on its web site within the coming days.

 

WHO agrees that further investigation is required concerning narcolepsy and Pandemrix® vaccine. In collaboration with a number of European Union Member States, the European Centre for Disease Prevention and Control (ECDC) is currently conducting a joint epidemiological study of narcolepsy and pandemic vaccines.

 

Recommendations for the use of seasonal 2010/2011 influenza vaccines in children and adolescents remain unchanged.

 

WHO's attention was first drawn to reports of narcolepsy following vaccination with Pandemrix® in Finland and Sweden in August 2010  and committed, through GACVS, to monitor the situation as new data became available.

 

Updates will be provided as further information becomes available and is assessed.

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GSK Statement On Pandemrix-Narcolepsy Report

 

 

# 5275

 

 

GlaxoSmithKiline (GSK), the manufacturers of the Pandemrix vaccine which some researchers believe may be linked to an increase in narcolepsy among children aged 4-19 (see Finland: Statement On Pandemrix And Narcolepsy Link), has released a statement of their own today.

 

With other investigations underway, GSK believes it is premature to draw any conclusions on any link between their vaccine and increases in narcolepsy. 

 

I’ve just excerpted a few paragraphs from this press release.  Follow the link below to read it in its entirety.

 

 

Update on Pandemrix™ and interim Finnish report on narcolepsy

Issued: 1 February 2011

GSK is aware of today’s interim report by the Finnish National narcolepsy committee ^[1] on their investigation into reported cases of narcolepsy in Finland. This investigation is independent of a broader ongoing European Medicines Agency (EMA) investigation initiated in 2010. GSK is reviewing the report and believes it would be premature to draw any conclusions on a potential association between Pandemrix and narcolepsy until this European investigation has been completed.

 

Patient safety is of paramount importance to GSK and we have been working closely with the EMA and other national regulatory organisations to better understand the situation since reports of narcolepsy after vaccination with Pandemrix were first received. The company recognises the value of ongoing independent research to add further information.

 

The EMA’s Committee for Medicinal Products for Human Use (CHMP) reviewed all of the available data on the suspected link between narcolepsy and Pandemrix in September 2010 and stated at that time that the benefit risk balance for Pandemrix remained positive.  Since then GSK has continued to provide EMA with information on narcolepsy cases being reported to the company and to date there has been no change in EMA’s position.

 

(Continue . . . )

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Finland: Statement On Pandemrix And Narcolepsy Link

 

 

 

# 5274

 

As mentioned on Sunday, today the Finnish National Institute for Health and Welfare has released an interim report on what they now call a probable link between GSK’s Pandemrix vaccination, and an increase in narcolepsy in children and adolescents 4-19 years of age.

 

While citing a `a manifold increased risk of falling ill with narcolepsy during the 8 months following vaccination’, at this stage, the authors of this report state that this a `probable link’, and call it `Currently, the most likely explanation’.  

 

Two major points.

 

• While the Pandemrix vaccine was taken by 31 million people across 47 countries, other than Finland, Sweden and Iceland, no other countries reported an increase in narcolepsy in 2010. 
• Iceland, unlike Finland, reported an increase in narcolepsy among unvaccinated children during this same time period.

 

Both of which suggest that if there is a causal link between narcolepsy and the vaccine, there may be some other localized factors involved as well.

 

And over the next few months investigators will be looking at possible infectious agents, or other stimuli, that in conjunction with the vaccine might have conspired to raise the rates of narcolepsy in children aged 4-19.

 

We will await further details with interest, including any reports from Iceland and Sweden, the only other countries to report an increase in Narcolepsy in 2010.

 

Obviously, there is a lot here that investigators do not yet understand. And a final report is not expected until August 31st, 2011.

 

I’ve reproduced the official statement below, after which I’ll return with some comments. 

 

 

Increased risk of narcolepsy observed among children and adolescents vaccinated with PandemrixR

1 Feb 2011

Among those 4-19 years of age who received Pandemrix®-vaccine had a manifold increased risk of falling ill with narcolepsy during the 8 months following vaccination in comparison to those unvaccinated in the same age group. Based on the evaluation done so far, the National Narcolepsy Task Force finds it probable that Pandemrix®-vaccination contributed to the observed increase in incidence of narcolepsy among those 4 -19 years of age. Currently, the most likely explanation is that the increase in narcolepsy is by joint effect of the vaccine and some other factor(s). At the moment, there is no evidence that the increase in narcolepsy observed in Finland could be attributed to the vaccine lots used. The results can be read in the Interim Report of the Task Force which is published on February 1st, 2011.

 

The association of Pandemrix-vaccination and narcolepsy was studied using extensive registry based data. Data gathered from hospital discharge registries on patients fallen ill with narcolepsy during years 2009-10 was linked with data from primary care records on pandemic vaccination. The observed association is so evident that it is unlikely that other so-called confounding factors could fully explain the phenomenon.

 

In Finland during years 2009–10, 60 children and adolescents aged 4-19 years fell ill with narcolepsy. These figures base on data from hospitals and primary care, and the review of individual patient records by a panel of neurologists and sleep researchers. Of those fallen ill, 52 (almost 90 percent) had received Pandemrix® vaccine, while the vaccine coverage in the entire age group was 70 percent. Based on the preliminary analyses, the risk of falling ill with narcolepsy among those vaccinated in the 4-19 years age group was 9-fold in comparison to those unvaccinated in the same age group. This increase was most pronounced among those 5–15 years of age. No cases were observed among those under 4 years of age. Also, no increase in cases of narcolepsy or signs of vaccination impacting risk of falling ill with narcolepsy was observed among those above 19 years of age.

In addition to Finland, increase in cases of narcolepsy observed only in Sweden and Iceland

In 2009, among countries using similar pandemic vaccine as was used in Finland, an increase in cases of narcolepsy has been observed only in Finland, Sweden and Iceland. Contrary to the observations in Finland, narcolepsy has occurred in greater numbers than expected also among unvaccinated children and teenagers in Iceland.

The association between narcolepsy and PandemrixR vaccine requires more investigations

During the coming months, these preliminary register based results will be confirmed in Finland.  In further investigations, special attention will be given to infections and other stimuli in close time association with the pandemic vaccination. The significance of the possible joint effects will be explored.

 

In addition, other significant co-factors contributing to the onset of narcolepsy will be evaluated in epidemiologic, immunologic and genetic studies planned. The main aim of the immunologic studies is to clarify, whether the immunological responses to the different components of the Pandemrix® vaccine and to the A(H1N1) virus among those children and teenagers with genetic disposition to narcolepsy and those fallen ill with narcolepsy differ from the immunological responses of other children and teenagers not belonging to these risk groups.

 

It is also of utmost importance to find out whether the association is observed also elsewhere than in Finland. At present, Finland is participating in the ECDC contracted, VAESO led narcolepsy background incidence and case control studies which are being conducted in 9 European Union countries by pharmacovigilance researchers from Public Health Institutes, Regulatory Agencies and Universities. These studies will evaluate the contribution of the pandemic vaccines and other risk factors in the onset of narcolepsy, and confirm whether increase in incidence in narcolepsy is seen in other countries. The outcomes of these studies will be reported during early summer 2011.

 

By January 24, 2011, 56 notifications of narcolepsy in association with Pandemrix® vaccination have been received by the National Vaccine Adverse Events Register maintained at the National Institute of Health and Welfare in Finland. Of these, 54 cases belonged to the age group of 4–19 years. Among most of the notified cases, the onset of symptoms of narcolepsy had started approximately two months following Pandemrix® vaccination.

The final report from the National Narcolepsy Task Force will be released by 31st August 2011.

 

(Continue . . . )

 

 

While I’m sure the anti-vaccination forces will try to use this latest report to condemn flu vaccines, it should be noted that this appears to be a localized phenomenon, and it may be the result of some unusual confluence of factors.

Despite their excellent safety record, vaccines have never been billed as 100% safe.  When it comes to drugs, there simply is no such thing as a completely benign medication.

 

In clinical trials, even chemically inert placebos have produced adverse reactions.

 

Which is why one should always make a risk-benefit calculation when deciding to take any drug.

 

Vaccines can, and do, prevent serious – oft times life threatening – illness.  Their downside is a very slight risk of experiencing adverse reactions.

 

Most are mild, but occasionally they can be serious.

 

If the Pandemrix vaccine is partially responsible for an increase in narcolepsy, then we need to understand why, so that it may be prevented in the future.

 

At the risk of sounding callous: a few dozen cases of narcolepsy – as tragic as that is for those dealing with it – does nothing to undo the immense good that vaccines have done around the globe.

 

Everything in life is a tradeoff.

 

Including the admittedly double-edged sword of modern medicine.

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Finland To Release Interim Pandemrix – Narcolepsy Study On Feb 1st.

 

 

RECENT UPDATES TO THIS STORY:

National Institute for Health and Welfare Statement – Feb 1st

WHO Statement

GSK Statement

 

 

# 5270

 

An update to a story that first emerged last August (see Finland Suspends Use of Pandemrix Vaccine),we learn today that Finland will soon release an interim report on the potential link between the Pandemrix vaccine and an unusual spike in narcolepsy which was reported in Finland, Iceland, and Sweden.

 

While we don’t have the results at hand, we do have a report from YLE.fi where the head of Finland's National Public Health Institute has conceded that administering the shot to children may possibly have been a mistake.

 

Exactly why these countries should experience a rise in narcolepsy, while other countries using the same vaccine have not reported similar problems, is unknown. 

 

Since I’ve not seen this Interim report, there is little I can say about today’s report. You can read it at the link below.

 

Health Official: Swine Flu Vaccinations for Children Possibly a Mistake

published today 04:40 PM, updated today 04:45 PM

 

While stating that further research is warranted (and will take months), earlier reports from regulatory agencies in Europe stated that no link has been found between the Pandemrix vaccine and recent reports of narcolepsy.

 

On September 9th, I ran a story called Sweden: No Link Between Pandemrix And Narcolepsy, which linked to a CIDRAP report on the findings of Sweden’s Medical Products Agency’s investigation into the matter.

 

And two weeks later, the European Medicines Agency (EMA) said its Committee for Medicinal Products for Human Use had reviewed all available data and found insufficient evidence to confirm a causal link between cases of narcolepsy and the vaccine.

 

We’ll simply have to wait to see if this interim report has credible evidence to the contrary.

 

The CDC published a statement on these concerns last September, part of which states:

 

Pandemrix is not licensed for use in the United States. No adjuvanted influenza vaccines are licensed in the United States. The European Medicines Agency has launched a review of Pandemrix to investigate whether there is a link between cases of narcolepsy and vaccination with Pandemrix. This vaccine has been used in at least 30.8 million Europeans.

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UK: To Release Pandemrix Vaccine Stockpile

 

 

 

# 5209

 

Another story today from the UK.

 

National stockpiles of the 2009 Pandemrix H1N1 vaccine, largely spurned by an unreceptive public a year ago, are finding new life as recent demands for this year’s seasonal jab have reportedly resulted in localized shortages.

 

While not exactly ideal – since it doesn’t provide any protection against the influenza B or H3N2 strains of flu - this monovalent H1N1 vaccine should be largely protective against the predominant strain circulating in the UK at this time; Swine flu.

More than 12 million doses of GSK’s Pandemrix vaccine were left over after last year and are in the national stockpile. They will be released as needed to GPs in areas where the seasonal vaccine is in short supply.

 

This report form the Pharmaceutical Journal.

 

 

Pandemrix released from national stockpile to combat local flu vaccine shortages

Thu, 06/01/2011 - 16:44

 

 

It is a bit ironic to note that it wasn’t all that long ago that public health officials in the UK were coming under almost daily fire for ordering too much emergency vaccine in 2009 for what was later widely perceived to be a `mild’ pandemic virus.

 

Now, with the return of the virus this winter, the desire to get the jab has grown considerably.

 

Proving, I suppose, the old adage that it is better to have it and not need it . . . than to need it and not have it.

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EMA Update On The Pandemrix-Narcolepsy Investigation

 

 

# 4929

 

 

 

While stating that further research is warranted (and will take months), for the second time in about two weeks we’ve received word from regulatory agencies in Europe that no link has been found between the Pandemrix vaccine and recent reports of narcolepsy.

 

On September 9th, I ran a story called Sweden: No Link Between Pandemrix And Narcolepsy, which linked to a CIDRAP report on the findings of Sweden’s Medical Products Agency’s investigation into the matter.

 

Today, the European Medicines Agency (EMA) said its Committee for Medicinal Products for Human Use had reviewed all available data and found insufficient evidence to confirm a link between cases of narcolepsy and the vaccine.

 

An excerpt from their press release follows:

 

European Medicines Agency updates on the review of Pandemrix and reports of narcolepsy

Available evidence does not confirm a link; more research needed

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has reviewed all available data on the suspected link between narcolepsy and Pandemrix. The Committee concluded that the available evidence was insufficient to determine whether there is any link between Pandemrix and reports of narcolepsy, and that further studies were necessary to fully understand this issue.

 

The Committee agreed that at present the benefit-risk balance for Pandemrix continues to be positive, and that while the review is still ongoing there was no need for Europe-wide restrictions on use.

(Continue . . . )

 

 

While further investigation might turn up evidence of a link down the road, the feeling right now at the EMA is that any risk – if it exists at all – is too slight to warrant restrictions on using the vaccine.

 

All drugs can have side effects, and while historically very safe, even flu vaccines had the potential to cause rare, serious  health problems.

 

But then, so can catching the flu.  And almost always at a far greater rate than from the vaccine.

 

 

Eurosurveillance has a brief report on this update as well:

 

Eurosurveillance, Volume 15, Issue 38, 23 September 2010

European Medicines Agency updates on the review of Pandemrix and reports of narcolepsy

Eurosurveillance editorial team 

 

 

As does Reuters News with this report:

 

UPDATE 1-EU drug body finds no narcolepsy link to Pandemrix

• 15:35:08 BST

Thu Sep 23, 2010 4:28pm BST

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