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.

Flu Myths and Realities

Flu Myths and Realities

“The federal government is running a mandatory vaccination campaign.”
The federal government’s vaccination program for H1N1 flu is VOLUNTARY. Some hospitals and localities are requiring that health care workers get vaccinated for the flu, but that is a local decision. HHS and the CDC have included health care workers as one of our top priority groups to receive the vaccine, and several places across the country began offering H1N1 vaccination to health care workers this week.
The petition on a few selected internet sites protesting the federal government’s “mandatory” vaccination campaign is simply false in its claims. Vaccination is highly recommended as a protective measure against the flu, but is absolutely voluntary.

“It costs too much money to get an H1N1 vaccine.”
The federal government has purchased the H1N1 vaccine and is providing it to the states free of charge. This is different in many places from the seasonal flu vaccine.
Public vaccination clinics (sponsored by local health departments at schools or other places) will offer vaccine at no charge. Some private providers may charge a small fee to administer the vaccine, but cost should not be a barrier to getting immunized. Many, many people and businesses have stepped up to the public health challenge we all face and are working together for the overall public good to make this vaccine free – or at least affordable – for all those who want it.

“You need to get two doses of the H1N1 vaccine, and it takes a month between each dose.”
There is really good news that has come out of our clinical trials being run by the National Institutes of Health and the flu vaccine manufacturers. The H1N1 vaccine is a really good match with the H1N1 virus currently circulating across the country, and healthy adults and children 10 and older will need only one dose of vaccine.
Though scientists initially thought that two doses might be required, information from clinical trials has since demonstrated the H1N1 vaccine works faster than we expected and works well against the H1N1 virus, which is making millions of Americans sick.
It’s also fine to get the seasonal flu shot and the H1N1 shot at the same time. It is true that if you get the nasal spray form of the vaccine, you need to wait three to four weeks before getting another nasal spray vaccine.

“This new vaccine is not safe and is untested.”
Clinical trials conducted by the National Institutes of Health and the vaccine manufacturers have shown that the new H1N1 vaccine is both safe and effective. The FDA has licensed it. There have been no safety shortcuts.
It is produced exactly the same way the seasonal flu vaccine is produced every year. It is simply a new virus strain. In fact, had H1N1 struck this country earlier than this spring, the H1N1 strain probably would have been included as part of this year’s seasonal flu shot.
Millions of Americans get the seasonal flu vaccine each year without any problems. Still, understanding that some Americans have concerns about “new” vaccines, the National Institutes of Health and the vaccine manufacturers have conducted more rigorous tests on the H1N1 vaccine than they do on other flu vaccines, and there have been no red flags from these clinical trials.
Also, CDC has stepped up surveillance efforts to track the H1N1 vaccine and any possible adverse events. Since it is so closely related to the seasonal flu vaccine, we do not expect to see serious side effects. But we are taking all the necessary steps to promote and monitor safety.
Our top doctors and scientists believe the risk of the flu, especially for pregnant women, children, and people with underlying health conditions, is higher than any risk that might come from the H1N1 vaccine.

“I got an email that tells the story of someone who got a flu shot and had a miscarriage two days later.”
Tragically, every day in the U.S., people suffer from heart attacks, miscarriages, strokes, and other health-related events. Some result in serious illness, even death. For example, there are approximately 8,700 deaths from heart attack, 140 cases of Guillain-Barre, and 14,000 miscarriages in the U.S. every week. These events are no more common among people who have received seasonal flu vaccine than in people who have not.
The CDC has received no reports of serious adverse events from people who have received the H1N1 vaccine to date in the clinical trials or in the few places across the country where vaccinations have begun. We have created a strong new surveillance system that will allow us to track adverse reactions and quickly analyze whether there is a link to the vaccine.

“You can get infected with H1N1 virus from eating pork.”
False. The 2009-H1N1 virus is not spread by food. Eating properly handled and cooked pork products is safe.

“A 14-year old girl in the United Kingdom died after being vaccinated with the HPV vaccine.”
British scientists report this particular event was unrelated to the HPV vaccine and definitely unrelated to the H1N1 flu vaccine.
Public health officials in the UK have said the safety of the HPV vaccine was not in question, and no link can currently be made between the girl’s death and the vaccine. According to the Medicines and Healthcare Products Regulatory Agency—their counterpart to the FDA—the girl had a rare serious underlying medical condition that was likely to have caused her death.
Licensed seasonal flu vaccines have a long track record of safety based on use in hundreds of millions of people. H1N1 vaccines are being manufactured by the same methods as the seasonal flu vaccines administered every year.

“You can get flu from drinking water or swimming pools.”
Chlorinated tap water and swimming pool water does not put you at risk for flu. To date, we don’t know of anyone who has acquired flu from drinking water or from a swimming pool.

“The H1N1 vaccine includes adjuvants, such as squalene.”
None of the H1N1 vaccines currently distributed by the U.S. government contain adjuvants.
All H1N1 vaccines used in the United States are licensed by the FDA and are made in the same way as seasonal influenza vaccines are made. Currently, seasonal flu vaccines in the United States are also made without adjuvants.
If needed, an adjuvant is a component that can be incorporated into a vaccine to help to generate a stronger immune response to the vaccine and help prevent disease. Squalene is a compound found in many natural sources, such as olive oil, that can act as an adjuvant and is used as an adjuvant in vaccines in many countries.
The evaluation of any vaccine by the Food and Drug Administration considers the safety, effectiveness, and the immune response and includes consideration of all components of the vaccine.

China produce primeras dosis de la vacuna contra AH1N1

Noticas Uno-Las autoridades chinas presupuestaron 725 millones de dólares, para combatir la propagación de la gripa AH1N1.Un grupo de 11 empresas farmacéuticas chinas produjo el primer lote de 90 mil dosis de la vacuna contra el virus de tipo A, que se someterá a pruebas clínicas de 40 a 50 días.La medicina será enviada a hospitales a mediados de septiembre, con el propósito de vacunar a todas las personas que figuran en los grupos de alto riesgo. Además, se prevé la producción de 360 millones de dosis al año.La Organización Mundial de la Salud, OMS, informó que hay 52.160 casos confirmados del virus, y 231 fallecimientos.

OMS alista todo para fabricar vacuna contra gripe AH1N1

13:20: martes, 19 de mayo de 2009. Confirmado.net / El Universo.

La Organización Mundial de la Salud (OMS) informó hoy en el marco de su reunión anual que estima que se pueden fabricar en un año 5.000 millones de vacunas contra la gripe AH1N1, de la que se confirmaron 1.000 nuevos casos en las últimas 24 horas, en México y Estados Unidos.Sobre este tema se centró la atención de todos los delegados de la OMS, que explicaron a través de su directora, Margaret Chan, que la fabricación de la vacuna se haría en producción de 94,3 millones de dosis por semana.

Esta producción se llevaría a cabo según un documento presentado este martes por grupos farmacéuticos como Sanofi, Solvay, GSK y Novartis, solo se espera la orden de la OMS para lanzar la producción de vacunas, aseguró la última farmacéutica nombrada.
"Recibimos el virus y nuestros investigadores están modificándolo para empezar a producir una vacuna", precisó un portavoz del laboratorio, añadiendo que se necesitarán entre tres y cuatro semanas para empezar la producción efectiva.
En la reunión de más de una hora se discutieron temas como el costo de la vacuna y disponibilidad en los países pobres más vulnerables, cuestión que aún no está resuelta.
La OMS sigue calculando de momento el riesgo que implicaría interrumpir la producción de esta vacuna para liberar la capacidad de los laboratorios para la nueva vacuna contra la gripe porcina, si el virus logra controlarse.
La presión en la OMS es mayor cuando se han confirmado 1000 casos más de contagio en las últimas 24 horas, por lo que este organismo ha alertado sobre la posibilidad de aumentar de categoría 5 a 6 por la rápida propagación del virus.
Japón es uno de los países asiáticos más afectados pues en este país la detección de 15 nuevos casos de gripe porcina, ha hecho que más de 4.000 colegios y guarderías en la región de Kobe y Osaka (oeste), región por la que la enfermedad se propagó rápidamente desde el sábado se cierren.