Pandemic (H1N1) 2009 influenza FAQ

Vaccine development
Vaccine clinical trials
Vaccine components and supply
Vaccine policy and distribution
Relenza
Actiprotect

Vaccine development

How quickly will pandemic (H1N1) 2009 influenza vaccines be available for use?

The first doses of the candidate pandemic (H1N1) 2009 influenza adjuvanted vaccine are anticipated to be available for delivery to Governments starting in September. In the meantime governments are already evaluating and determining their vaccination policy within their specific country.
Regulatory agencies will need to approve the vaccine before it can be used.

Why is a pandemic different from the seasonal influenza?

The current pandemic is a result of a new strain of the influenza virus appearing. Because this strain is new and completely foreign to most people’s immune system, it is suspected that those who come in contact with it will have little or no natural immunity. As a result the virus has a higher chance of causing infections.
Seasonal influenza strains also change over time (known as a virus ‘drifting’) and this is why a new influenza vaccination is needed every year. However, the changes in the seasonal influenza strains are generally less significant and therefore not completely foreign to most people’s immune system. The seasonal influenza vaccination therefore boosts the body’s ability to recognize and protect against these drifted seasonal viruses. The seasonal influenza vaccination is not expected to help the body’s ability to recognize and protect against the new pandemic virus.

What is the process for developing a pandemic vaccine?

View a diagrammatic overview of the process. (PDF 442Kb)
The GSK vaccine for the pandemic (H1N1) 2009 influenza virus will be produced the same way as the annual seasonal vaccine production, by growing the vaccine viruses in eggs.
The process starts with the identification of the virus by the WHO. The WHO produces what is known as a ‘seed strain’. A seed strain is a version of the virus that has been changed so that it is no longer capable of causing disease. The seed strain is used by manufacturers as a starting point in their production process.
Manufacturers will optimise the seed strain to their specific manufacturing process and develop their own ‘seed bank’. This ensures that the manufacturer will be able to maintain the quality of the vaccine being produced.
As with annual seasonal vaccine production, eggs, used to grow the new virus, are inoculated. After a number of days, the virus is collected from the eggs and a process of purification and standardisation takes place. This process breaks down the virus to separate out the antigen; the part required for the vaccine.
The vaccine is then filled into the appropriate vials and labelled accordingly.
These processes are designed to conform to all the regulatory requirements that apply to vaccine production and registration
The vaccine is then tested in clinical trials to determine it is safe and produces an appropriate immunologic response.
Regulatory agencies will need to approve the vaccine before it can be used.

What are the timelines for development of the vaccine?

In June, GSK started production of its candidate pandemic (H1N1) 2009 influenza adjuvanted vaccine following receipt of the seed strain. The vaccine is currently being produced at GSK’s influenza vaccine manufacturing sites in Canada and Germany.
The clinical trial programme started in August. In the meantime, governments are already evaluating and determining their vaccination policy within their specific country.
The first doses of the candidate pandemic (H1N1) 2009 influenza adjuvanted vaccine are anticipated to be available for delivery to governments in September. However, regulatory agencies will need to approve the vaccine before it can be used.

Will there be enough pandemic (H1N1) 2009 vaccine for everyone?

When pandemic vaccine first becomes available, it is anticipated that the demand will be greater than the supply. This gap may narrow as more vaccine becomes available over time. In the meantime governments are already evaluating and determining their vaccination policy and target groups within their specific country.

Vaccine clinical trials

What clinical trials will be conducted in the Global Development Plan?

GSK plans to conduct 16 clinical trials in either healthy adults, the elderly or children including infants. The first trial started in August.
Details of the clinical trials will be posted on www.clinicaltrials.gov

Will there be clinical trial data available before the vaccine is used?

GSK is working closely with the regulatory agencies to ensure they receive the clinical trial data as quickly as possible. In the meantime, governments are already evaluating and determining their vaccination policy within their specific country.

What data is required for approval of the vaccine in each major region (ie: US, Europe, UK etc)?

Each regulatory agency either has or is in the process of defining their requirements for approval of the vaccine.
GSK is working closely with these agencies to ensure that the vaccine will be made available as quickly as possible while meeting the individual regulatory agency’s requirements.

What is the quantity of the antigen in the vaccine and the dosing schedule?

GSK expects the amount of antigen and dosing to be similar to its H5N1 pandemic influenza vaccine, based on the experience gained in the H5N1 pandemic influenza vaccine Global Development Plan. However the final dose will be discussed and agreed to with the regulatory agencies based on the initial clinical data from the H1N1 trials.
Over 12,000 adults above 18 years old of age have been given a 2 dose course of the H5N1 pandemic vaccine. Also over 300 children (age 3 to 9 years) have received two doses of the H5N1 vaccine. The H5N1 adjuvanted pandemic influenza vaccine is generally well tolerated and has an acceptable safety profile.

Will clinical trials be conducted in children?

Yes, clinical trials will also be conducted in children.
GSK has previously conducted clinical trials in children using our H5N1 adjuvanted pandemic influenza vaccine which provides additional information for regulators because it is produced in the same way as the H1N1 adjuvanted pandemic influenza vaccine.

How long will the clinical trials take?

Clinical trials have been designed to follow the subjects for up to 1 year to monitor the safety of the vaccine.
The immune response and safety of individuals toward the vaccine will be measured at several time points and all data will be reported to the appropriate regulatory agencies.

Is GSK conducting trials in pregnant women?

GSK will run initial trials in a healthy population but not in pregnant women. GSK will discuss the need for specific trials in vaccination target groups with the appropriate regulatory authorities. This part of the plan will be further developed based on the result of these discussions.

Vaccine components and supply

What is an adjuvant?

Adjuvants are added to vaccines to improve the quality of the immune response. The word “adjuvant” comes from the Latin adjuvare, which means “to help.” Vaccine adjuvants have been used for over 80 years, and help to enhance the body’s own specific immune response against a disease.

What adjuvant will the candidate H1N1 adjuvanted vaccine contain?

GSK’s candidate H1N1 adjuvanted influenza vaccine is formulated with the Company’s proprietary AS03 Adjuvant System. Over the years, GSK has developed a unique expertise in combining different components to develop Adjuvant Systems designed to increase the immune response to a specific antigen.
AS03 is an oil-in-water emulsion based Adjuvant System which contains tocopherol (vitamin E). As in the H5N1 adjuvanted pandemic influenza vaccine, it has been used in the A(H1N1) pandemic adjuvanted vaccine to address three important challenges posed by the pandemic strain:
Make the most vaccine doses available in a short time – this is achieved as a result of ‘antigen-sparing’ whereby less antigen per vaccine dose is needed to enable the required immune response

To allow for broader protection known as ‘cross-protection’ – just as with the seasonal strain, the pandemic strain is expected to change slightly over time (drift). In a pandemic situation a vaccine could be needed that enables the body to better respond to these potential drifted strains.
Afford flexibility in dosing –pandemic vaccines are usually given in 2 doses usually 21 days apart. Being able to vary the timing between the doses gives governments greater flexibility with their vaccination programmes.

Will you also supply the adjuvant system separately and what volume of adjuvant system can you supply?

GSK is committed to working with all Governments and health authorities to develop appropriate options to respond to the emergence of this new influenza strain. This may include use of our adjuvant system.

Has the AS03 adjuvant system been tested in other vaccines?

GSK’s pandemic programme started in the late 1990s. GSK has studied and produced significant clinical data for pandemic vaccines using various influenza strains, including H5N1, and the company’s adjuvant (AS03).
In clinical trials, 39,000 people have been vaccinated with AS03-adjuvanted vaccines, some of which are pandemic influenza vaccines, and available data show these vaccines to be generally well tolerated with acceptable safety profiles.
GSK has received approval from regulators for both Prepandrix™ (GSK’s pre-pandemic vaccine) and Pandemrix (GSK’s pandemic vaccine) in the EU and some countries in Asia.

What is your expected total volume capacity for pandemic influenza vaccine vaccine?

Volume capacity will depend on a series of factors such as the manufacturing yield that can be achieved from the strain (ie: the amount of virus that can be grown in each egg) and the production time required.
In addition, the manufacturing process with this strain will be stringently evaluated and improved where possible. The total capacity will be determined as a result of these ongoing efforts.

Vaccine policy and distribution

How do I know if my government has bought GSK vaccine?

Over the past few years governments have worked to establish their own pandemic preparedness plans. Some of these plans have included the purchase of vaccine. It is, of course, a government’s decision as to how and when they will communicate these plans.

When will my government have their vaccine?

GSK is committed to producing large volumes of a vaccine aimed at providing protection against H1N1 and being generally well tolerated with an acceptable safety profile. Deliveries to individual governments are confidential.

Will GSK sell its pandemic vaccine to corporations or individuals?

GSK will only provide the candidate pandemic (H1N1) 2009 influenza adjuvanted vaccine to individual governments and supranational organizations like the WHO which will help to deliver pandemic vaccine to the developing world.
Governments will determine what the most appropriate vaccination policy will be for their country.

How will GSK provide the pandemic (H1N1) 2009 pandemic adjuvanted vaccine to developing countries?

GSK has allocated 20% of capacity at its Canadian manufacturing site for developing countries. Included within this capacity is the intended donation of 50 million doses of candidate pandemic (H1N1) 2009 influenza adjuvanted vaccine to the WHO.
GSK will operate a tiered-pricing policy for the candidate pandemic (H1N1) 2009 adjuvanted influenza vaccine. The tiered pricing policy is based on World Bank classifications and GAVI eligibility.

Relenza

What is Relenza?

Relenza contains zanamivir, which belongs to a group of medicines called antivirals.
Relenza is used to treat flu (influenza virus infection). It reduces the symptoms of flu, and helps you recover more quickly.
Relenza is also used to help prevent you from getting flu, during a flu outbreak.

When should Relenza be used?

Antiviral drugs can be given to treat those who become ill. These antiviral drugs are prescription medicines (capsules or liquid for oral administration or dry powder for administration via an inhaler) which have been shown to be active against influenza viruses, including Pandemic H1N1 (2009).
There are two influenza antiviral medications that are recommended for use against Pandemic H1N1; one of which is Relenza (zanamivir)
Relenza should be taken within 48 hours of the onset of flu symptoms in order to be effective (within 36 hours for children).

Can I purchase Relenza or is this only being sold to the government, like GSK’s vaccine?

Relenza is a prescription-only medicine which is being prioritised to government supply in the current pandemic. As GSK's production capacity expands, this may be reviewed.

How can I get Relenza?

Relenza is a prescription-only medicine which is available via your healthcare professional or via country-specific arrangements for access to anti-viral medication.

Can Relenza be used by children?

In most countries Relenza is approved for use in children five years and older.

Can Relenza be used by women who are pregnant or breast feeding?

Pregnancy: The safe use of Relenza during pregnancy has not been established. The potential risk for humans is unknown. Relenza should not be used in pregnancy unless the expected benefit to the mother is thought to outweigh any possible risk to the foetus.
Lactation: There is no information on secretion into breast milk in humans. The use of Relenza is not recommended in mothers who are breast feeding.
Pregnant women and their unborn babies may be at increased risk of serious outcomes from pandemic influenza and additional guidance regarding the use of antivirals among pregnant women with confirmed or suspected pandemic influenza has been released by the World Health Organization (WHO), the United States Centers for Disease Prevention and Control (CDC) as well as the European Medicines Agency (EMEA) and other health authorities. Clinicians may refer to this guidance for further information. The prescribing decision ultimately lies with the patient and their treating physician and is based on the patient’s individual risks versus benefits.

Can I use Relenza if I have asthma?

There are special precautions for patients with asthma and chronic lung conditions. Your physician is best placed to advise you on whether Relenza would be suitable for you.

Are there any significant differences between Tamiflu and Relenza in terms of side-effect profile or adverse events?

Tamiflu is an orally-administered medicine. The most common side-effects are nausea, vomiting, diarrhoea, stomach ache and headache.
Relenza is an inhaled medicine. Some patients have experienced bronchospasm (wheezing or tightness of the throat or chest) after using Relenza.

Is there any evidence of resistance to Relenza?

Resistance to Relenza is extremely rare. There have been no reports of resistance to Relenza in treated patients with influenza A, the influenza virus subtype which causes influenza pandemics.

Where is Relenza manufactured?

Relenza is manufactured in three locations around the world: Evreux, France; Zebulon, North Carolina, USA; and Boronia, Australia.

What is your manufacturing capacity for Relenza?

As a result of recent investments made, GSK has increased its annual production capacity of Relenza to 190 million treatment courses per year. This represents a threefold increase to the previously estimated maximum capacity of 60 million treatment courses.
This new capacity has been achieved by increasing production capacity of Relenza Diskhaler from 60 to 90 million treatment courses per year and building new capacity to produce 100 million treatment courses per year of Relenza Rotacaps (a different device for delivery of the inhaled medicine).

How will you price Relenza?

GSK operates a tiered-pricing policy for Relenza.
GSK offers Relenza at not-for-profit prices to the world’s 50 Least Developed Countries (LDCs) and provides Relenza at highly preferential prices to developing countries.
The tiered pricing policy is based on offering a single price per group of countries using World Bank classifications.

Will GSK provide Relenza to developing countries?

GSK has allocated 10% of its new Relenza production capacity for developing countries. Included within this capacity is an intended donation of 2 million courses of Relenza to the World Health Organization (WHO).
GSK is also operating a tiered-pricing policy for Relenza, again based on World Bank classification of countries.
GSK remains committed to engaging in voluntary license arrangements with companies willing to manufacture and supply a zanamivir-based product for use in developing countries. In China, GSK is working with Simcere Pharmaceuticals as a further option to raise production levels of zanamivir. GSK granted a voluntary licence to Simcere in 2006 to manufacture and sell products containing zanamivir, in China and a number of other countries, including all 50 of the world's Least Developed Countries

What is the shelf-life for Relenza?

The current Relenza shelf life is seven years.

Actiprotect®

What is Actiprotect?

The Actiprotect antiviral respirator mask is an innovative new respirator mask specifically designed to help protect individuals from pandemic influenza.
Actiprotect antiviral respirator masks have a unique antiviral coating on the outer surface of the mask and help to protect the wearer from inhaling airborne influenza virus. In a laboratory study no influenza virus could be detected passing through the Actiprotect antiviral mask whereas a standard uncoated FFP2/N95 respirator mask was shown to allow significant amounts of influenza virus to pass through.

How does Actiprotect work?

Actiprotect antiviral respirator masks are coated with Virucoat which rapidly inactivates all influenza viruses tested and continues to work at 24 hours.

How can I purchase Actiprotect?

Actiprotect antiviral respirator mask production is being prioritised to government supply in the current pandemic. GSK is exploring the feasibility of making Actiprotect available directly to the general public.

Find out how to protect yourself from the flu

"Protect Yourself from the Flu" learning module

Quick links