What is Pandemrix?

What is Pandemrix?
Pandemrix is a vaccine that is given by injection. It contains parts of influenza (flu) viruses that have been inactivated (killed). Pandemrix contains a flu strain called A/California/7/2009 (H1N1) v-like strain (X-179A).
What is Pandemrix used for?
Pandemrix is a vaccine to protect against ‘pandemic’ flu. It should only be used for the Influenza A (H1N1) flu pandemic that was officially declared by the World Health Organization on 11 June 2009. A flu pandemic happens when a new strain of flu virus appears that can spread easily from person to person because people have no immunity (protection) against it. A pandemic can affect most countries and regions around the world. Pandemrix is given according to official recommendations.
The vaccine can only be obtained with a prescription.
How is Pandemrix used?
Pandemrix is given by injection into the shoulder muscle preferably as two single doses at least three weeks apart.
How does Pandemrix work?
Pandemrix is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. Pandemrix contains small amounts of haemagglutinins (proteins from the surface) of a virus called A(H1N1)v that is causing the current pandemic. The virus has first been inactivated so that it does not cause any disease.
When a person is given the vaccine, the immune system recognises the virus as ‘foreign’ and makes antibodies against it. The immune system will then be able to produce antibodies more quickly when it is exposed to the virus again. This will help to protect against the disease caused by the virus.
Before use, the vaccine will be made up by mixing together a suspension that contains the virus particles with a solvent. The resulting ‘emulsion’ will then be injected. The solvent contains an ‘adjuvant’ (a compound containing oil) to stimulate a better response.
How has Pandemrix been studied?
Pandemrix was first developed as a ‘mock-up’ vaccine, using a H5N1 strain of the flu virus called A/Vietnam/1194/2004. The company studied the ability of this mock-up vaccine to trigger the production of antibodies (‘immunogenicity’) against this strain of flu virus in advance of the pandemic.
Following the start of the H1N1 pandemic, the company replaced the virus strain in Pandemrix with the H1N1 strain causing the pandemic, and presented data relating to this change to the Committee for Medicinal Products for Human Use (CHMP).
What benefit has Pandemrix shown during the studies?
The mock-up vaccine was shown to bring about protective levels of antibodies in at least 70% of people in which it was studied. In line with the criteria laid down by the CHMP, this demonstrated that the vaccine brought about an appropriate level of protection.The CHMP was also satisfied that the change of strain to the H1N1 strain did not affect the characteristics of the vaccine.
What is the risk associated with Pandemrix?
The most common side effects with Pandemrix (seen with more than 1 in 10 doses of the vaccine) are headache, arthralgia (joint pain), myalgia (muscle pain), reactions at the site of the injection (hardening, swelling, pain and redness), fever and fatigue (tiredness). For the full list of all side effects reported with Pandemrix, see the Package Leaflet.
Pandemrix should not be given to people who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, or to any of the substances found at very low levels in the vaccine, such as egg or chicken protein, ovalbumin (a protein in egg white), formaldehyde, gentamicin sulphate (an antibiotic) and sodium deoxycholate.
However, it may be appropriate to give the vaccine to these patients during a pandemic, as long as facilities for resuscitation are available.
Why has Pandemrix been approved?
The CHMP decided that, based on the information obtained with the mock-up vaccine and the information provided on the strain change, the benefits of Pandemrix are greater than its risks for the prophylaxis of influenza in the officially declared H1N1 pandemic situation. The Committee recommended that Pandemrix be given marketing authorisation.
Pandemrix has been authorised under ‘Exceptional Circumstances’. This means that it has not been possible to obtain full information about the pandemic vaccine. Every year, the European Medicines Agency will review any new information that may become available and this summary will be updated as necessary.
What information is still awaited for Pandemrix?
The company that makes Pandemrix will collect information on the safety and effectiveness of the vaccine, and submit this to the CHMP for evaluation.
Which measures are being taken to ensure the safe use of Pandemrix?
The company that makes Pandemrix will collect information on the safety of the vaccine while it is being used. This will include information on its side effects and its safety in the elderly, pregnant women, patients with severe conditions and people who have problems with their immune systems.
Other information about Pandemrix:
The European Commission granted a marketing authorisation valid throughout the EU for the H5N1 mock-up vaccine for Pandemrix to GlaxoSmithKline Biologicals s.a. on 20 May 2008.
The change to the marketing authorisation for the H1N1 virus was authorised by the European Commission on 29 September 2009.

What is Focetria?

What is Focetria?
Focetria is a vaccine. It is a suspension for injection that contains parts (‘surface antigens’) of the influenza (flu) virus. It contains a flu strain called A/California/7/2009 (H1N1)v like strain (X-179A).

What is Focetria used for?
Focetria is a vaccine to protect against ‘pandemic’ flu. It should only be used for the influenza A (H1N1) pandemic that was officially declared by the World Health Organization on 11 June 2009. A flu pandemic happens when a new strain of flu virus emerges that can spread easily from person to person because people have no immunity (protection) against it. A pandemic can affect most countries and regions around the world. Focetria is given according to official recommendations.
The vaccine can only be obtained with a prescription.
How is Focetria used?
Focetria is given in two doses, at least three weeks apart. It is given by injection into the upper arm muscle.
How does Focetria work?
Focetria is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. When a person is given the vaccine, the immune system recognises the virus as ‘foreign’ and makes antibodies against it. The immune system will then be able to produce antibodies more quickly when it is exposed to the virus again. This helps to protect against the disease.
Focetria contains small amounts of ‘surface antigens’ (proteins on the outer membrane of the virus that the body recognises as foreign) of a virus called A(H1N1)v that is causing the current pandemic. The virus has been first inactivated so that it does not cause any disease. The outer membranes that contain the surface antigens have then been extracted and purified. The vaccine also contains an ‘adjuvant’ (a compound containing oil) to stimulate a better response.
How has Focetria been studied?
Focetria was first developed as a ‘mock-up’ vaccine that contained an H5N1 strain of the flu virus called A/Vietnam/1194/2004. The company studied the ability of this mock-up vaccine to trigger the production of antibodies (immunogenicity) against this strain of flu virus in advance of the pandemic.
Following the start of the H1N1 pandemic, the company replaced the virus strain in Focetria with the H1N1 strain causing the pandemic, and presented data relating to this change to the Committee for Medicinal Products for Human Use (CHMP).
What benefit has Focetria shown during the studies?
The mock-up vaccine was shown to bring about protective levels of antibodies in at least 70% of people in which it was studied. In line with the criteria laid down by the CHMP, this demonstrated that the vaccine brought about an appropriate level of protection.
The CHMP was also satisfied that the change of strain did not affect the characteristics of the vaccine.

What is the risk associated with Focetria?
The most common side effects with Focetria (seen in between 1 and 10 people in 100) are headache, sweating, arthralgia (joint pain), myalgia (muscle pain), reactions at the site of the injection (redness, swelling, hardening, bruising and pain), fever, malaise (feeling unwell), fatigue (tiredness) and shivering. For the full list of all side effects reported with Focetria, see the Package Leaflet.
Focetria should not be given to patients who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, or to any substances found at trace levels in the vaccine, such as egg or chicken protein, ovalbumin (a protein in egg white), kanamycin or neomycin sulphate (antibiotics), formaldehyde, cetyltrimethylammonium bromide and polysorbate 80. However, it may be appropriate to give the vaccine to these patients during a pandemic, as long as facilities for resuscitation are available.
Why has Focetria been approved?
The CHMP decided that, based on the information obtained with the mock-up vaccine and the information provided on the strain change, the benefits of Focetria are greater than its risks for the prophylaxis of influenza in the officially declared H1N1 pandemic situation. The Committee recommended that Focetria be given marketing authorisation.
Focetria has been authorised under ‘Exceptional Circumstances’. This means that it has not yet been possible to obtain full information about the pandemic vaccine. Every year, the European Medicines Agency will review any new information that may become available and this summary will be updated as necessary.
What information is still awaited for Focetria?
The company that makes Focetria will collect information on the safety and effectiveness of the vaccine, and submit this to the CHMP for evaluation.
Which measures are being taken to ensure the safe use of Focetria?
The company that makes Focetria will collect information on the safety of the vaccine while it is being used. This will include information on its side effects and its safety in children, pregnant women, patients with severe conditions and people who have problems with their immune systems.
Other information about Focetria:
The European Commission granted a marketing authorisation valid throughout the European Union for the H5N1 mock-up vaccine for Focetria to Novartis Vaccines and Diagnostics S.r.l. on 2 May 2007.
The change to the marketing authorisation for the H1N1 virus was authorised by the European Commission on 29 September 2009.

What is Celvapan?

What is Celvapan?
Celvapan is a vaccine that is given by injection. It contains influenza (flu) viruses that have been inactivated (killed). Celvapan contains a flu strain called A/California/07/2009 (H1N1)v.

What is Celvapan used for?
Celvapan is a vaccine to protect against ‘pandemic’ flu. It should only be used for the influenza A (H1N1) pandemic that was officially declared by the World Health Organization on 11 June 2009. A flu pandemic happens when a new strain of flu virus appears that can spread easily from person to person because people have no immunity (protection) against it. A pandemic can affect most countries and regions around the world. Celvapan is given according to official recommendations.
The vaccine can only be obtained with a prescription.

How is Celvapan used?
Celvapan is given by injection into the shoulder muscle in two doses, at least three weeks apart.
How does Celvapan work?
Celvapan is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. Celvapan contains a virus called A(H1N1)v that is causing the current pandemic. The virus has been inactivated so that it does not cause any disease.
When a person is given the vaccine, the immune system recognises the inactivated virus as ‘foreign’ and makes antibodies against it. The immune system will then be able to produce antibodies more quickly when it is exposed to the virus again. This helps to protect against the disease.
The viruses used in Celvapan are grown in mammal cells (‘vero cells’), unlike those in some other flu vaccines, which are grown in hen’s eggs.

How has Celvapan been studied?
Celvapan was first developed as a ‘mock-up’ vaccine that contained an H5N1 strain of the flu virus called A/Vietnam/1203/2004. The company studied the ability of this mock-up vaccine to trigger the production of antibodies (‘immunogenicity’) against this strain of flu virus in advance of the pandemic.
Following the start of the current pandemic, the company replaced the virus strain in Celvapan with the H1N1 strain causing the pandemic, and presented data relating to this change to the Committee for Medicinal Products for Human Use (CHMP).
What benefit has Celvapan shown during the studies?
The mock-up vaccine was shown to bring about protective levels of antibodies in at least 70% of the people in which it was studied. In line with the criteria laid down by the CHMP, this demonstrated that the vaccine brought about an appropriate level of protection.
The CHMP was also satisfied that the change of strain to the H1N1 strain did not affect the characteristics of the vaccine.
What is the risk associated with Celvapan?
The most common side effect with Celvapan (seen in more than 1 people vaccinated in 10) is pain at the site of the injection. For the full list of all side effects reported with Celvapan, see the Package Leaflet.
Celvapan should not be given to people who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, or to any of the substances found at trace (very low) levels in the vaccine, such as formaldehyde, benzonase or sucrose.
However, it may be appropriate to give the vaccine to these patients during a pandemic, as long as facilities for resuscitation are available.

Why has Celvapan been approved?
The CHMP decided that, based on the information obtained with the mock-up vaccine and the information provided on the strain change, the benefits of Celvapan are greater than its risks for the prophylaxis of influenza in the officially declared H1N1 pandemic situation. The Committee recommended that Celvapan be given marketing authorisation.
Celvapan has been authorised under ‘Exceptional Circumstances’. This means that it has not yet been possible to obtain full information about the pandemic vaccine. Every year, the European Medicines Agency will review any new information that may become available and this summary will be updated as necessary.

What information is still awaited for Celvapan?
The company that makes Celvapan will collect information on the safety and effectiveness of the vaccine, and submit this to the CHMP for evaluation.

Which measures are being taken to ensure the safe use of Celvapan?
The company that makes Celvapan will collect information on the safety of the vaccine while it is being used. This will include information on its side effects and its safety in children, the elderly, pregnant women, patients with severe conditions and people who have problems with their immune systems.

Other information about Celvapan:
The European Commission granted a marketing authorisation valid throughout the EU for the H5N1 mock‑up vaccine for Celvapan to Baxter AG on 4 March 2009. The change to the marketing authorisation for the H1N1 virus was authorised by the European Commission on 6 October 2009. The full assessment report will be published shortly.

What is Swine Influenza?

Swine Influenza (swine flu) is a respiratory disease of pigs caused by type A influenza virus that regularly causes outbreaks of influenza in pigs. Swine flu viruses cause high levels of illness and low death rates in pigs. Swine influenza viruses may circulate among swine throughout the year, but most outbreaks occur during the late fall and winter months similar to outbreaks in humans. The classical swine flu virus (an influenza type A H1N1 virus) was first isolated from a pig in 1930.

What is H1N1 Influenza? - (Swine Flu)

What is H1N1 Influenza?

(Swine Flu)

Should You Worry About Swine Flu?
The news coverage about H1N1 (swine) flu might have you worried, but there's no reason to panic. You should definitely take precautions, like washing your hands a lot. But although this flu virus has been affecting teens more than other flu viruses, most teens don't get seriously ill from it.

What Is H1N1?
The H1N1 flu that many people call "swine flu" is a recent strain of flu virus. This strain contains a combination of flu viruses that affect pigs, birds, and humans. Because of the human component, the virus can spread from person to person more easily.

How Do People Get It?
H1N1 influenza spreads the same way that other flu viruses do — through the air when a person who has the virus sneezes, coughs, or speaks. People also can catch the virus after touching an object that someone with the virus sneezed or coughed on. As with other flu viruses, people who have the virus can be contagious a day or so before their symptoms start, so they can pass it on before they even know they're sick. You might have heard that flu epidemics often start in schools. If health authorities in your state become concerned that a flu outbreak is possible, they may close schools as a precaution to help slow the spread of the infection.

What Are the Signs and Symptoms?
Symptoms of swine flu are similar to other flu symptoms. A person with swine flu may notice:

• fever
• cough
• sore throat
• runny nose
• body aches
• headaches
• tiredness

Some people with swine flu also might have diarrhea or vomiting.

What If I Think I Have the Flu?
If you think you have the flu, call your doctor. It's especially important to see a doctor if you have trouble breathing, or your flu symptoms seem to get better, then return.
Other things you should do are:

• Drink lots of liquids, especially if you're throwing up or have diarrhea.
• Stay home from school as long as your doctor recommends.
• Limit contact with other people to help prevent the spread of illness.
• Cough or sneeze into tissues instead of your hands.
• If you have asthma, make sure you follow your asthma management plan to keep it under control.
• Medicines used to treat seasonal flu may help make swine flu symptoms milder and help people feel better sooner.

What's a Pandemic?
You've probably heard people talk about a swine flu "pandemic." A pandemic doesn't mean a disease causes severe illness in most people who get it. When health experts say a disease is pandemic, this means it has spread widely around the world so lots of people could become infected.
Health officials declare a pandemic as a way to put medical services on alert. That way, they're prepared with enough staff and medication in case large numbers of people need care at the same time.
In the past, some pandemics have caused lots of people to get seriously ill, while others have not. It's too early to tell how dangerous this outbreak of H1N1 flu might be.

Can I Eat Pork?
Because the flu virus isn't transmitted through food, the CDC and U.S. Department of Agriculture (USDA) say it's safe to eat pork. Of course, pork should be well cooked to avoid any illness. Cooking pork to a temperature of 160° or higher will kill all viruses (check the internal temperature of meats when cooking by using a meat thermometer). There's no evidence that touching raw pork will transmit the virus — although it's always a good idea to wash your hands and all surfaces after touching any raw meat.

Take Care, But Don't Panic
Most people who've had swine flu in the United States got better on their own without needing medicines. The best way to protect yourself is by washing your hands frequently during the day and getting the flu shots this fall. If you're worried about the virus, it can help to remember that the last flu pandemic serious enough to kill a lot of people happened almost a century ago — before people had access to the medical knowledge, care, and medications that we have today.

How Can I Protect Myself?
The Centers for Disease Control and Prevention (CDC) recommends that teens take the following precautions against swine flu:

• Wash your hands often with soap and water or use hand sanitizer — particularly before eating.
• Avoid touching your eyes and mouth.
• Avoid being around people who are sick and be sure to wash your hands if you touch anything someone who seems sick might have touched.
• Get the H1N1 flu vaccine when it becomes available this fall.
• Of course, people sneeze and cough for reasons other than swine flu — like if they have allergies, for example. Try not to worry. The best thing you can do is take the precautions above. If you're concerned about a flu outbreak at school, talk to teachers or your school nurse.

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Teenshealth