NEJM: Adjuvanted Flu Vaccine Found Effective In Children

 

# 5895

 

From the New England Journal of Medicine today, an analysis of 4,707 German and Finnish children aged 6 months to just under 6 years during the 2007-2008 flu season. 

 

These previously unvaccinated children were randomly assigned to 3 groups; 1941 received an adjuvanted flu vaccine, 1773 received the standard tri-valent flu shot, and 993 received no shot at all.

 

The adjuvant in question is the MF59 oil-in-water (Squalene) emulsion, which has been used in millions of adult flu vaccines in Europe since the late 1990s (it is not currently licensed for use in the United States).

 

 

The study was done to see if the adjuvanted vaccine would provide significantly better protection against influenza in young children than does the standard trivalent flu shot. Two shots – 30 days apart - were administered to both groups receiving the vaccine.

 

Oil-in-Water Emulsion Adjuvant with Influenza Vaccine in Young Children

Timo Vesikari, M.D., Markus Knuf, M.D., Peter Wutzler, M.D., Aino Karvonen, M.D., Dorothee Kieninger-Baum, M.D., Heinz-Josef Schmitt, M.D., Frank Baehner, M.D., Astrid Borkowski, M.D., Theodore F. Tsai, M.D., and Ralf Clemens, M.D.

N Engl J Med 2011; 365:1406-1416October 13, 2011

 

 

The results were impressive.

 

The adjuvanted vaccine proved 86% effective against all circulating viral strains of influenza during the 2 years of the trial, and 89% effective against vaccine-matched strains.

 

The effectiveness rates for the  standard flu vaccine, were roughly half that; 43% and 45% respectively.

 

In addition, in contrast to the standard flu shot, most of the subjects receiving the adjuvanted vaccine displayed a robust immune response after only 1 flu shot.

 

Vaccine-related adverse events were mild to moderate and similar between both vaccines. Systemic reactions, including mild fever, were slightly more pronounced in older children receiving the adjuvanted vaccine, but were generally of short duration.

 

 

The conclusion, as expressed in the abstract reads:

 

Influenza vaccine with the MF59 adjuvant is efficacious against PCR-confirmed influenza in infants and young children. (Funded by Novartis Vaccines and Diagnostics; ClinicalTrials.gov number, NCT00644059.)

 

 

While studies continue to show it to be both safe and efficacious, the use of squalene is not without some controversy. There have been attempts to link its use to everything from Gulf War Syndrome to Lupus, although no convincing evidence of such links has ever been established. 

 

The World Health Organization has this to say about Squalene adjuvants.

 

Squalene-based adjuvants in vaccines

What is squalene?

• Squalene is a naturally occurring substance found in plants, animals, and humans. It is manufactured in the liver of every human body and circulates in our bloodstream.
• Squalene is also found in a variety of foods, cosmetics, over-the-counter medications, and health supplements.
• Squalene is commercially extracted from fish oil, and in particular shark liver oil. Squalene used in pharmaceutical products and vaccines is purified from this source.

Is there squalene in vaccines?

• Since 1997, an influenza vaccine (FLUAD, Chiron) which contains about 10 mg of squalene per dose, has been approved in health agencies in several European countries. Squalene is present in the form of an emulsion and is added to make the vaccine more immunogenic.
• Squalene is being added to improve the efficacy of several experimental vaccines including pandemic flu and malaria vaccines which are being developed.

Why is squalene added to vaccines?

• Squalene is a component of some adjuvants that are added to vaccines to enhance the immune response.
• MF59, an adjuvant produced by Novartis and added to the FLUAD flu vaccine, is such an example.
• Squalene by itself is not an adjuvant, but emulsions of squalene with surfactants do enhance the immune response.

What is known about the safety of squalene in vaccines?

• Twenty two million doses of Chiron's influenza vaccine (FLUAD) have been administered safely since 1997. This vaccine contains about 10mg of squalene per dose. No severe adverse events have been associated with the vaccine. Some mild local reactogenicity has been observed.
• Clinical studies on squalene-containing vaccines have been done in infants and neonates without evidence of safety concerns.

Why do some people think squalene in vaccines carries a risk?

• A few people have tried to link the health problems of Gulf War veterans to the possible presence of squalene in the vaccines these soldiers received.
• One published report suggested that some veterans who received anthrax vaccines developed anti-squalene antibodies and these antibodies caused disabilities.
• It is now known that squalene was not added to the vaccines administered to these veterans, and technical deficiencies in the report suggesting an association have been published.

 

 

This study was conducted before the emergence of the 2009 H1N1 vaccine, and was done during a time when the H3N2 virus was the dominant strain. This makes it difficult to draw any firm conclusions on how well this adjuvanted vaccine would work against other strains of influenza, such as H1N1 and influenza B.

 

And a final note, more than 150 million doses of MF59 adjuvanted vaccines have been deployed since 1997 (100 million during the pandemic), and thus far, no evidence of safety concerns has emerged.  

»» Read More

Pediatrics: Effectiveness Of A Single Adjuvanted Pandemic Flu Shot In Children

 

# 5890

 

 

The recommendation by the CDC for young children receiving the (unadjuvanted) flu vaccine is that:

 

Children less than nine years of age being vaccinated for the first time should receive two doses of influenza vaccine, spaced at least 4 weeks apart in the initial year.

 

The assumption has also been that during a pandemic, even previously immunized children would require 2-doses of vaccine against any emerging novel virus. 

 

A 1-dose vaccination schedule would be highly desirable, provide savings in both time-to-immunity and resources.

 

We’ve a study that appeared yesterday in the journal Pediatrics that looks at the effectiveness of a single adjuvanted flu shot given to children during the fall of 2009 for the H1N1 pandemic (my thanks to loyal reader Anne who forwarded this link to me).

 

What they found was that a single dose of the AS03-adjuvanted vaccine conferred significant protection against influenza-related hospitalization in children aged 6 months to 9 years of age.

 

 

Effectiveness of Pandemic H1N1 Vaccine Against Influenza-Related Hospitalization in Children

Rodica Gilca, MD, PhDGeneviève Deceuninck, MD, MSc, Gaston De Serres, MD, PhD, Nicole Boulianne, MSc, Chantal Sauvageau, MD, MSc, FRCPC, Caroline Quach, MD, MSc, FRCPC, François D. Boucher, MD, FRCPC, Danuta M. Skowronski, MD, MHSc

Abstract

<SNIP>

Results: The overall effectiveness of a single pediatric dose of vaccine administered ≥14 days before illness onset was 85% (95% confidence interval [CI]: 61% to 94%), varying according to age category but with wide and overlapping CIs: 92% (95% CI: 51% to 99%) in 6–23 month-old children, 89% (95% CI: 34% to 98%) in 2–4 year-olds, and 79% (95% CI: −31% to 96%) in 5–9 year-olds. Overall vaccine effectiveness for immunization ≥10 days before illness onset was slightly lower at 80% (95% CI: 60% to 90%), with similar variation according to age.

 

Conclusion: In children aged 6 months to 9 years, a single pediatric dose of the AS03-adjuvanted pH1N1 vaccine was highly protective against hospitalization beginning at 10 and 14 days after vaccination.

 

 

Adjuvants such as AS03 are additives that are used to increase the immune response to a vaccine. While they have been used in Europe and in Canada, adjuvanted flu vaccines have not been licensed for use in the United States. 

 

With tens of millions of adjuvanted flu vaccines deployed since the pandemic of 2009, we are getting more data on their impact.

 

In February of this year, in BMJ: Effectiveness of AS03 adjuvanted pandemic H1N1 vaccine researchers found the vaccine to be 93% effective, at least in recipients under the age of 50.

 

In December of 2010, in Lancet: Immunogenicity and safety Of Adjuvanted Flu Vaccines, researchers compared the safety and immunogenicity of GSK’s adjuvanted (AS03_A) H1N1 pandemic vaccine and Baxter’s non-adjuvanted 2-Dose pandemic vaccine.

 

They found the adjuvanted split-virus vaccine achieved a stronger and faster immune response than the whole-virus non-adjuvanted vaccine.

 

They also found that a single antigen-dose sparing adjuvanted vaccination mounted a sufficient immune response in adults and adolescents, although the elderly might require a second shot.

 

Safety of the two vaccines was comparable, although recipients of the adjuvanted vaccine were more likely to report injection site soreness, and general complaints (malaise, fever, headaches) than did those who received the non-adjuvanted vaccine.

 

And in May of 2010 we saw a comparison study (see BMJ: Immunogenicity Of Adjuvanted vs. Unadjuvanted H1N1 Vaccines) between GSK’s Pandemrix, containing the adjuvant AS03, verses Baxter’s unadjuvanted Celvapan in British children.

 

Although the adjuvanted Pandemrix vaccine was associated with a higher rate of (usually mild) side effects (fever, injection site soreness), it produced a superior immune response.  

 

One unresolved question regarding the safety of adjuvants stems from the increase in narcolepsy seen among recipients of the 2009 Pandemrix vaccine in Finland (see Finland: Task Force Report On Pandemrix-Narcolepsy Link).

 

This report found:

 

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.

 

Whether these antibodies are in any way connected to these rare cases of narcolepsy – or in any way affects the health of the vaccine recipients – has yet to be determined.

 

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 the influenza virus itself.

 

Even if the adjuvant is eventually linked to these cases (and the jury on that is still out), Finland’s Narcolepsy taskforce found that the use of the vaccine probably saved lives and that `overall benefit-risk balance remains positive.’

 

Despite a few nagging questions over the safety of adjuvants in some quarters, studies over the past couple of years continue to reassure in terms of both safety and efficacy.

»» Read More

BMJ: Effectiveness of AS03 adjuvanted pandemic H1N1 vaccine

 

 

 

# 5287

 

We’ve another study – this time from the BMJ – that indicates that the 2009 H1N1 AS03 adjuvanted vaccine – used in Canada and much of Europe - was very effective in preventing the pandemic flu.

 

Researchers looked at 552 patients consulting their GP’s between Nov 8th and Dec. 5th, 2009 across 4 Canadian provinces and found that the H1N1 virus was detected in 209 of them.  

 

Of those, 2 (1%) had received the pandemic jab at least two weeks earlier, while 58 (17%) patients who had received the shot tested negative.

 

The researchers found the vaccine to be 93% effective, at least in recipients under the age of 50.

 

Only 20% of those in the study were over the age of 50, and so further research on the vaccine’s effectiveness in that age group is needed.

 

First the abstract, then I’ll return with a little more.

 

 

• BMJ 2011; 2011; 342:c7297

Effectiveness of AS03 adjuvanted pandemic H1N1 vaccine: case-control evaluation based on sentinel surveillance system in Canada, autumn 2009

Danuta M Skowronski, Naveed Z Janjua, Gaston De Serres, Travis S Hottes, James A Dickinson, Natasha Crowcroft, Trijntje L Kwindt, Patrick Tang, Hugues Charest, Kevin Fonseca, Jonathan B Gubbay, Nathalie Bastien, Yan Li, Martin Petric, clinical virologist

Accepted 22 November 2010

Abstract

Objective To assess the effectiveness of the pandemic influenza A/H1N1 vaccine used in Canada during autumn 2009.

 

Design Test negative incident case-control study based on sentinel physician surveillance system.

 

Setting Community based clinics contributing to sentinel networks in British Columbia, Alberta, Ontario, and Quebec, Canada.

 

Participants 552 patients who presented to a sentinel site within seven days of onset of influenza-like illness during the primary analysis period between 8 November and 5 December 2009; participants were mostly (>80%) children and adults under 50 years old.

 

Interventions Monovalent AS03 adjuvanted pandemic influenza A/H1N1 vaccine as the predominant formulation (>95%) distributed in Canada.

 

Main outcome measures Vaccine effectiveness calculated as 1−(odds ratio for influenza in vaccinated (received pandemic H1N1 vaccine at least two weeks before onset of influenza-like illness) versus unvaccinated participants), with adjustment for age, comorbidity, province, timeliness of specimen collection, and week of illness onset. Sensitivity analyses explored the influence of varying analysis periods between 1 November and 31 December, receipt of trivalent seasonal influenza vaccine, and restriction to participants without comorbidity.

 

Results During the primary analysis period, pandemic H1N1 was detected by reverse transcription polymerase chain reaction in 209/552 (38%) participants; rates were highest in children and young adults (40%) and lowest in people aged 65 or over (9%). Among the 209 cases, 35 (17%) reported comorbidity compared with 80/343 (23%) controls. Two (1%) cases had received pandemic H1N1 vaccine at least two weeks before the onset of illness, compared with 58/343 (17%) controls, all single dose. Adjusted vaccine effectiveness overall was 93% (95% confidence interval 69% to 98%). High estimates of vaccine protection—generally at least 90%—were maintained across most sensitivity analyses.

 

Conclusions Although limited by a small number of vaccine failures, this study suggests that the monovalent AS03 adjuvanted vaccine used in Canada during autumn 2009 was highly effective in preventing medically attended, laboratory confirmed pandemic H1N1 illness, with reference in particular to a single dose in children and young adults.

 

 

While limited by its relatively small size, this study adds to the weight of evidence showing that the 2009 pandemic vaccine was very effective in preventing the flu.

 

Last month we saw two studies released showing that the unadjuvanted vaccine provided an adjusted vaccine effectiveness for adults under 65 of about 72%.

Eurosurveillance: Another Pandemic Vaccine Effectiveness Study

PLoS Medicine: Effectiveness Of The 2009 Pandemic Vaccine

 

In May of 2010 we saw a comparison study (see BMJ: Immunogenicity Of Adjuvanted vs. Unadjuvanted H1N1 Vaccines) between GSK’s Pandemrix, containing the adjuvant AS03, verses Baxter’s unadjuvanted Celvapan in British children.

 

Although the adjuvanted Pandemrix vaccine was associated with a higher rate of (usually mild) side effects (fever, injection site soreness), it produced a superior immune response.  

 

While there remain some open questions regarding the  Pandemrix vaccine and reports of narcolepsy in adolescents and children in some Scandinavian countries, except for a handful of suspected adverse events under investigation, the safety profile of the adjuvanted vaccine has been excellent.

 

Lancet: Immunogenicity and safety Of Adjuvanted Flu Vaccines

 

While admittedly not 100% perfect, the adjuvanted and unadjuvanted 2009 H1N1 pandemic vaccines have proven themselves to have been very safe, and very effective.

 

Given the short time in which scientists, manufacturers, and public health agencies had to identify, isolate, grow, test, and distribute a pandemic vaccine - despite some bumps along the way – it is hard not to view this emergency vaccination program as a remarkable success.

»» Read More

Lancet: Immunogenicity and safety Of Adjuvanted Flu Vaccines

 

# 5154

 

 

Should the next pandemic prove deadlier than the last, the ability to rapidly produce and distribute a safe and effective vaccine could prove invaluable in the saving of countless lives.

 

The time it takes from the identification of a novel virus to having the first doses of vaccine ready to go into people’s arms is measured in months. And then it may take 3 or 4 more weeks, and a second (booster) shot, before a vaccine recipient can mount a good antibody response.

 

A fast moving pandemic virus could easily spread around the world before a vaccine could be made widely available.

 

While there are new, faster vaccine manufacturing techniques on the horizon, right now the use of adjuvants to stretch limited antigen supplies – and to invoke a stronger immune response from a single shot – are viewed by many health officials as our best option to reduce this logistical nightmare.

 

Adjuvants are proprietary additives put into vaccines that increase the immune response, and thereby reduce the amount of precious antigen required for each shot.

 

They were widely used during the 2009 pandemic in Europe and Canada, although they were not utilized in American and Australian vaccines – partly because of public resistance to the idea.

 

Today The Lancet has a study that looked at, and compared, the safety and immunogenicity of GSK’s adjuvanted (AS03_A) H1N1 pandemic vaccine and Baxter’s non-adjuvanted 2-Dose pandemic vaccine.

 

The bottom line: 

 

Researchers found that the adjuvanted split-virus vaccine achieved a stronger and faster immune response than the whole-virus non-adjuvanted vaccine.

 

They also found that a single antigen-dose sparing adjuvanted vaccination mounted a sufficient immune response in adults and adolescents, although the elderly might require a second shot.

 

Safety of the two vaccines was comparable, although recipients of the adjuvanted vaccine were more likely to report injection site soreness, and general complaints (malaise, fever, headaches) than did those who received the non-adjuvanted vaccine.

 

 

It is worth noting that the use of laboratory antibody titers to gauge a vaccine’s effectiveness in preventing infection isn’t an exact science.  It just happens to be the best yardstick we have, short of exposing vaccinated individuals to a virus and seeing how many get sick.

 

 

Although registration is required, you can read the abstract at the link below:

 

The Lancet Infectious Diseases - 17 December 2010
DOI: 10.1016/S1473-3099(10)70296-6

Immunogenicity and safety of a two-dose schedule of whole-virion and AS03A-adjuvanted 2009 influenza A (H1N1) vaccines: a randomised, multicentre, age-stratified, head-to-head trial

Prof Karl G Nicholson FRCP,Prof Keith R Abrams PhD,Sally Batham BA,Tristan W Clark MRCP,Katja Hoschler PhD,Wei Shen Lim FRCP,Marie-Jo Medina MS,Jonathan S Nguyen-Van-Tam FFPH,Robert C Read FRCP,Fiona C Warren PhD,Maria Zambon PhD

 

While  a good deal of concern was expressed last year over the use of adjuvanted vaccines in Europe – and those concerns likely influenced many people’s decision not to take the pandemic jab – thus far, there has been no evidence to indicate that these adjuvants posed any sort of increased health risk.

 

As we get more reassuring studies, and more experience with these adjuvants, the public’s comfort level with them will hopefully improve.   

 

For now, the idea of incorporating adjuvants into flu vaccines  . . . at least here in the United States . . .  remains a tough sell.

»» Read More

BMJ: Immunogenicity Of Adjuvanted vs. Unadjuvanted H1N1 Vaccines

 

 

 

# 4602

 

 

Last year, as many of you will recall, there was a huge debate over the inclusion of adjuvants in the pandemic vaccine – additives that help boost the immune response and lower the amount of antigen needed for each shot.

 

By using adjuvants, the limited supply of antigen could be used to make more flu shots, and immunize more people.

 

Another plus to  using adjuvants is that they can induce a wider range of cross-protection, meaning that as a virus `drifts’ antigenically over time, an adjuvanted vaccine is more likely to remain protective. 

 

Although some adjuvants have been used for years (alum and aluminum salts are incorporated into some diphtheria, tetanus and pertussis vaccines), their use in flu vaccines had been limited.

 

 

Unfortunately that meant we had limited data on their safety and effectiveness, particularly in children and pregnant women.  And that lack of data gave a lot of people pause.

 

So much so, that the decision here in the United States was to go with an unadjuvanted vaccine.  Authorities feared that the incorporation of an adjuvant would deter some people from taking the vaccine.    

 

And in fact, one of the reasons cited for the low uptake of pandemic vaccine in Europe was public concern over the inclusion of adjuvants in the vaccine.

 

Now that millions of doses of adjuvanted vaccine have been administered to people of all ages, we are starting to get research papers on their safety and effectiveness.   

 

Today, we get a head-to-head comparison of GSK’s Pandemrix, containing the adjuvant AS03, verses Baxter’s unadjuvanted Celvapan in British children.

 

Although the adjuvanted Pandemrix vaccine was associated with a higher rate of (usually mild) side effects (fever, injection site soreness), it produced a superior immune response.  

 

Children under the age of three receiving Pandemrix showed an impressive  98.2 % immune response rate, compared to just over 80% with the unadjuvanted Celvapan.

 

For older children, the difference was less pronounced, with 99.1% after 2 doses of Pandemrix verses 95.9% for Celvapan.

 

Excerpts from the BMJ research article follow.  The entire study is available for free.

 

Cite this as: BMJ 2010;340:c2649

Research

Safety and immunogenicity of AS03B adjuvanted split virion versus non-adjuvanted whole virion H1N1 influenza vaccine in UK children aged 6 months-12 years: open label, randomised, parallel group, multicentre study

Claire S Waddington, clinical research fellow, et al.

Abstract

Objectives To compare the safety, reactogenicity, and immunogenicity of an adjuvanted split virion H1N1 vaccine and a non-adjuvanted whole virion vaccine used in the pandemic immunisation programme in the United Kingdom.

 

Design Open label, randomised, parallel group, phase II study.
Setting Five UK centres (Oxford, Southampton, Bristol, Exeter, and London).

 

Participants Children aged 6 months to less than 13 years for whom a parent or guardian had provided written informed consent and who were able to comply with study procedures were eligible. Those with laboratory confirmed pandemic H1N1 influenza or clinically diagnosed disease meriting antiviral treatment, allergy to egg or any other vaccine components, or coagulation defects, or who were severely immunocompromised or had recently received blood products were excluded. Children were grouped by age: 6 months-<3 years (younger group) and 3-<13 years (older group). Recruitment was by media advertising and direct mailing. Recruitment visits were attended by 949 participants, of whom 943 were enrolled and 937 included in the per protocol analysis.

 

<SNIP>

 

Conclusions In this first direct comparison of an AS03B adjuvanted split virion versus whole virion non-adjuvanted H1N1 vaccine, the adjuvanted vaccine, while more reactogenic, was more immunogenic and, importantly, achieved high seroconversion rates in children aged less than 3 years. This indicates the potential for improved immunogenicity of influenza vaccines in this age group.

»» Read More

Novartis To Open Next Generation Vaccine Plant In NC

 

# 4068

 

The bottleneck in producing ample pandemic vaccine for the US, and the world, was caused in large part because we rely on the 50-year-old technology of growing antigen in chicken eggs.  

There are newer cell-based technologies on the horizon, but production facilities must be built, manufacturing problems solved, and these novel vaccines approved for use by the FDA.

Maggie Fox, Health & Science Editor for Reuters brings us word of a new factory in Holly Springs, North Carolina, that in a few years will hopefully be capable of producing as much as 150 million doses of adjuvanted cell-based vaccine within 6 months of a pandemic virus being isolated. 

 

The problems aren’t all technical or logistical, however.  

 

This cell technology is new, unfamiliar to most Americans, and the use of adjuvants in this country is currently viewed with suspicion.

 

The hope is, that we’ll come out of this pandemic season with a lot more safety data on the use of adjuvants.

 

Tens of millions of adjuvanted vaccines have already been delivered to the arms of people in Canada and Europe without apparent problems, and by the time this factory is ready to produce, it is hoped Americans may be more inclined to accept the product.

 

 

 

Next-generation flu vaccine plant to open in U.S.

Mon Nov 23, 2009 11:53am EST

 

* New factory first in U.S. to use cells to make flu shots

* Novartis hopes U.S. market will accept boosted vaccines

* First dose won't come before 2011

 

By Maggie Fox, Health and Science Editor

 

WASHINGTON, Nov 23 (Reuters) - Novartis (NOVN.VX) will officially open the first next-generation flu vaccine plant in the United States on Tuesday, but it will be years before it makes its first vaccine.

 

The factory in Holly Springs, North Carolina, will use batches of dog cells to grow influenza vaccine, instead of the chicken eggs widely used now. While the cell method is only slightly faster, it can be scaled up more quickly.

 

Federal advisers to the U.S. Food and Drug Administration last week asked for more safety data on another cell-based vaccine, one made by privately held Protein Sciences Corp. But U.S. officials said the new Novartis shot is not as experimental.

 

"I see them as totally different. The whole point of pushing on cell culture was increasing capacity and surge capacity," Dr. Bruce Gellin, head of the U.S. Health and Human Services Department's National Vaccine Program Office, said in an interview.

 

HHS spent $487 million helping Novartis build the plant, which was planned before the current pandemic of H1N1 swine flu.

 

(Continue . . .)

»» Read More

Referral: Fergus Walsh Pandemrix Vaccine Q&A

 

 

 

# 4029

 

Fergus Walsh, medical correspondent for the BBC, brings us an in depth interview with Dr Thomas Breuer, who is Senior Vice President Global Clinical R&D and Chief Medical Officer at GSK, the makers of the Pandemrix vaccine.

 

While this interview has more direct implications for people living in the UK, Canada, and most of Europe  . . . I’m sure many Americans are curious about the production and safety of adjuvanted vaccines as well.

 

To be clear: The US vaccine does not contain an adjuvant or squalene.

 

Rather than try to lift a quote or two from the interview, I’ll simply post the link for you to follow.

 

 

Vaccine: Questions and answers

Fergus Walsh | 09:43 UK time, Tuesday, 17 November 2009

 

»» Read More

SAGE Advice

 

# 3915

 

 

SAGE, the Strategic Advisory Group of Experts on Immunizations, advises the WHO (World Health Organization) on policies and strategies for vaccination around the world.  

 

Earlier today, the WHO released a vaccination Briefing note based on SAGE’s latest recommendations.  (see WHO Briefing Note # 14: Vaccine Policies And Strategies)

 

Helen Branswell, ace medical reporter for The Canadian Press, untangles some of the complexities of this SAGE advice, including a reversal of an earlier recommendation that unadjuvanted vaccines be provided to pregnant women whenever possible.

 

As always with a Branswell report, it’s worth taking the time to read the whole thing.

 

 

Single H1N1 shot sufficient, pregnant women can use adjuvanted vaccine: WHO

 

By Helen Branswell Medical Reporter (CP) 

A single dose of H1N1 vaccine should be adequate for all age groups, even very young children, and pregnant women should feel free to use vaccine containing adjuvant, an expert committee that advises the World Health Organization on vaccine issues reported Friday.

 

The group, known by the acronym SAGE, said vaccines containing boosting additives called adjuvants and vaccines that are adjuvant-free appear to be equally safe and there is no need to recommend pregnant women get the latter on a preferential basis.

 

"This is based on the fact that the safety profiles of adjuvanted vaccine and the non-adjuvanted vaccine are very similar, and the fact that the non-adjuvanted vaccine has been recommended for pregnant women for many, many years," Dr. Marie-Paule Kieny, director of the WHO's initiative for vaccine research, said in reporting on the recommendations of the panel.

 

"So there is no reason, in SAGE's view, to distinguish between both types of vaccines."

 

(Continue . . . )

»» Read More

Canada Purchases Unadjuvanted Vaccine From CSL

 

# 3894

 

 

The Canadian government has purchased 200,000 doses of adjuvant-free vaccine from Australian vaccine producer CSL, to offer to pregnant women starting next week.

While adjuvants are generally assumed to be safe, there is scant scientific data on their use among pregnant women, and so the WHO has urged nations to try to provide unadjuvanted vaccines for them whenever feasible.

 

Helen Branswell of the Canadian Press brings us the details.

 

 

Adjuvant-free vaccine coming

200,000 interim doses in response to concerns from pregnant women

By HELEN BRANSWELL The Canadian Press
Tue. Oct 27 - 4:46 AM

TORONTO — Canada is importing adjuvant-free H1N1 vaccine from Australia for pregnant women, hoping to be able to offer that product sooner than if it waits for unadjuvanted vaccine from Canada to make it through the licensing process.

 

Health Minister Leona Aglukkaq announced Monday she signed an interim order that will allow 200,000 doses of adjuvant-free vaccine from CSL Ltd. to be used in this country.

 

The CSL vaccine should be available starting next week, said Dr. David Butler-Jones, head of the Public Health Agency of Canada.

 

"We have heard the concerns about pregnant women about having to wait for an unadjuvanted vaccine and we have been working very hard on providing it earlier, given they have always been considered a priority group," Aglukkaq said at a news conference in Ottawa.

(Continue . . . )

»» Read More

Helen Branswell’s Q&A On Adjuvants

 

 

# 3892

 

 

Adjuvants are additives to vaccines, designed to enhance the body’s immune response, and reduce the amount of antigen needed per shot. 

 

While they are not used in any of the flu vaccines offered in the United States right now, they are part of the vaccine mix for Canada, the UK, Europe, and much of the rest of the world. 

 

Helen Branswell, ace medical reporter for The Canadian Press, gives us a Q&A session on vaccine adjuvants today.  One that will hopefully dispel some of the myths, rumors, and concerns that surround them.

 

This report from the Toronto Sun.

 

Flu vaccine additive helps immune system

By Helen Branswell, THE CANADIAN PRESS

Last Updated: 26th October 2009, 3:07pmSix months ago, most Canadians probably didn’t know what a vaccine adjuvant was.

 

But now, as Canadians and many Europeans mull over whether to line up for an H1N1 flu shot that includes an adjuvant, many have Googled this addition to their vocabularies. And lots are wondering whether they are comfortable with the idea of having vaccine mixed with one of these additives injected into their arms.

(Continue. . . ) 

Ms. Branswell asks, and answers the following questions for her readers:

 

Q: What is an adjuvant?

 

Q: Why is Canada buying adjuvanted vaccine?

 

Q: So we’re using vaccine with adjuvant to benefit someone else?

 

Q: But what’s this about adjuvanted flu shots hurting more?

 

Q: What is the safety record for adjuvants?

 

Q: What are adjuvants made from?

 

Q: Isn’t squalene dangerous? Didn’t it cause Gulf War Syndrome?

 

Q: What’s that about autoimmune disease?

 

Q: Squalene used commercially is sourced from shark’s liver. Does that mean people with fish allergies should avoid this vaccine?

»» Read More

Branswell Reports On Canada’s Unadjuvanted Vaccine Purchase

 

# 3867

 

 

Helen Branswell, ace medical reporter for the Canadian Press, brings us details on Canada’s purchase of 1.8 million doses of unadjuvanted vaccine, and the hopes of officials that pregnant women and children don’t wait for it to become available next month.

 

 

Canada buying H1N1 vaccine without adjuvant, hoping people don't wait for it

By Helen Branswell Medical Reporter (CP) 

TORONTO — Canada is buying 1.8 million doses of H1N1 vaccine it hopes people won't want and won't wait for.

 

The Public Health Agency of Canada urged pregnant women who are 20 weeks or more into their pregnancy and parents of children under three on Wednesday to take or to give their kids a swine flu shot containing an adjuvant, an additive that boosts the body's response to the vaccine.

 

The agency has purchased 1.8 million doses of vaccine made without an adjuvant, but it won't be licensed until some time in early November. The main vaccination effort, involving vaccine containing an adjuvant, should start next week in many provinces and territories.

 

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David Dobbs Examines The Adjuvant Controversy

 

 

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David Dobbs, who writes the Neuron Culture blog, is the author of several books (including Reef Madness & The Great Gulf), and writes with some regularity for the New York Times Magazine, Slate, Audubon, and Scientific American Mind, where he is a contributing editor.

 

Today he examines, in an article in Slate Magazine, the seldom discussed global ramifications of the United State’s decision to go with an unadjuvanted swine flu vaccine.  

 

Whether you favor of the use of adjuvants or not, it is important to understand how our decision not to use them impacts the rest of the world.  

 

David does a terrific job explaining the global costs of that decision, along with political realities of trying to `sell’ an adjuvanted vaccine to the American public.

 

 

To Boost or Not To Boost

The United States' swine flu vaccines will leave millions worldwide unprotected.

By David Dobbs Posted Thursday, Sept. 17, 2009, at 3:36 PM ET

 

David also has a blog post on Neuron Culture about this subject.  Both are highly recommended.

 

To boost or not to boost, or how our H1N1 vaccines will leave millions naked

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Branswell: Feds Between Rock & Hard Place On Vaccines

 

 

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Helen Branswell of the Canadian Press tonight brings us some deep background on what can only be described as a `no-win situation’ facing public health regulators when it comes to the pandemic vaccine.   

 

This is something we’ve discussed before: The decision to use (or not use) adjuvants in the vaccine.   A few recent blogs on this subject include:

 

Canada To Offer Unadjuvanted Vaccine To Pregnant Women

CAMJ Editorial: The H1N1 Vaccine Race

Running Into A Public Relations Buzz Saw

More On The Adjuvant Controversy

Branswell On The Adjuvant Controversy

 

Ms. Branswell demonstrates, once again, why she is so highly regarded as a science reporter as she outlines the complexities of this issue.

 

Follow the link to read it in its entirety.

 

 

Feds between a rock and a hard place juggling speed, safety of pandemic vaccine

Published Sunday September 6th, 2009

 

Helen Branswell, THE CANADIAN PRESS--

TORONTO - In the race to get pandemic vaccine into Canadian arms, public health and vaccine regulatory authorities in this country find themselves the reluctant filling in a rock-and-a-hard-place sandwich, knowledgeable observers say.

 

Doctors who've seen how desperately sick some swine flu patients become are pressing authorities to further fast-track vaccine approval. But a large portion of the public appears reluctant to take the vaccine, a situation that could worsen if fast-tracking deepens suspicions about the product's safety.

 

Individuals and organizations concerned about global equity are urging countries with vaccine contracts to stretch supplies by using boosting compounds called adjuvants so developing countries can also get some serum. But the decision to use an adjuvant is being blamed - unfairly, federal officials say - for the fact Canada may not start vaccinating until a month after the U.S. and Britain.

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Canada To Offer Unadjuvanted Vaccine To Pregnant Women

 

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While the United States has put any decision to use adjuvants – chemical additives to a vaccine designed to increase the recipient’s immune response – on hold, in Canada and Europe plans are to use these compounds to stretch the vaccine supply.

 

It now appears that adjuvanted vaccines may provide significant immunity with just one shot, as opposed to the two shots anticipated for an unadjuvanted vaccine.  And that not only increases the number of people who can be vaccinated, it also means the recipient gains immunity several weeks sooner as well.

 

And if that was all there was to it, everyone would want an adjuvanted vaccine.   And maybe someday, they will . . .

 

But right now, there is precious little data on the long term effects of adjuvanted flu vaccines when used on children, young adults, and pregnant women in particular.   No serious problems have been detected over years of use in Europe, but it has been used primarily on the elderly, to provoke a better immune response.

 

After the swine flu vaccination problems in 1976 (see Deja Flu, All Over Again), scientists and officials in the United States would just as soon not add the `complication’ of a largely untested, and as yet unapproved, additive to a pandemic vaccine.

 

This has led to a good deal of International criticism, since other nations see this as the United States using more of the global vaccine supply than they would have to if they embraced  the use of adjuvants.

 

Today, Canada has announced their intention to purchase 1.2 million doses of an unadjuvanted vaccine, to be offered to pregnant women. 

 

Helen Branswell brings us the details of this decision, along with some good background on adjuvants, and the general reluctance of pregnant women to accept flu vaccines.

 

 

Canada to buy unadjuvanted vaccine for pregnant women, health officer says

Friday, 04 September 2009

 

TORONTO - Canada will purchase supplies of unadjuvanted swine flu vaccine to offer to pregnant women who might otherwise choose not to be vaccinated, the country's chief public health officer has revealed.

 

Dr. David Butler-Jones told The Canadian Press that Canada will buy 1.2 million doses of unadjuvanted pandemic vaccine which will be reserved for pregnant women, who are at significantly greater risk of becoming severely ill and dying if they contract the virus.

 

"I'm anticipating for pregnant women we will have an option," he said in an interview.

 

The vaccine will be supplied by GlaxoSmithKline, Canada's pandemic vaccine manufacturer, and is expected to be available at the same time as the country's other supplies of vaccine.

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