6 AUGUST 2009 | GENEVA -- WHO is aware of some media reports that have expressed concern about the safety of vaccines for pandemic influenza. The public needs to be reassured that regulatory procedures in place for the licensing of pandemic vaccines, including procedures for expediting regulatory approval, are rigorous and do not compromise safety or quality controls.
Vaccines are among the most important medical interventions for reducing illness and deaths during a pandemic. However, to have the greatest impact, pandemic vaccines need to be available quickly and in large quantities.
During the 1957 and 1968 pandemics, vaccines arrived too late to be used as an effective mitigation tool during the more severe phases of the pandemics. Influenza vaccines had not yet been developed when the 1918 pandemic swept around the world, eventually killing an estimated 50 million people.
In 2007, as part of preparedness for an influenza pandemic, WHO worked together with health officials, regulatory authorities, and vaccine manufacturers to explore a broad range of issues surrounding the regulatory approval of pandemic vaccines. [1]
Ways were sought to shorten the time between the emergence of a pandemic virus and the availability of safe and effective vaccines. Different regulatory pathways were assessed, and precautions needed to ensure quality, safety, and effectiveness were set out in detail.
Fast-track procedures for approval
Regulatory authorities have shown great flexibility in developing procedures for fast-tracking the approval and licensing of pandemic vaccines.
In some cases, pandemic vaccines are not regarded by regulatory authorities as entirely “new” vaccines, as they build on the technology used to produce vaccines for seasonal influenza, established procedures for testing and regulatory control, and an extensive body of safety data.
In such cases, approval procedures are similar to those applied to “strain changes” made each year when seasonal vaccines are modified to match circulating viruses in the Northern and Southern Hemispheres.
Specific regulatory procedures have been devised to expedite the approval of pandemic vaccines. In the USA, for example, fewer data are required when the manufacturer already has a licensed influenza vaccine and intends to use the same manufacturing process for its pandemic vaccine.
In the European Union, the European Medicines Agency uses a rolling review procedure whereby manufacturers can submit sets of data for regulatory review as they become available, without having to wait until all data can be submitted together in a single formal application.
Also in Europe, some manufacturers have conducted advance studies using a so-called “mock-up” vaccine. Mock-up vaccines contain an active ingredient for an influenza virus that has not circulated recently in human populations and thus mimics the novelty of a pandemic virus. Such advance studies can greatly expedite regulatory approval.
Special safety concerns
Influenza vaccines have been used for more than 60 years and have an established record of safety in all age groups. While some serious adverse events have been reported, these have been rare.
Nonetheless, special safety issues will inevitably arise during a pandemic when vaccine is administered on a massive scale. For example, adverse events too rare to show up even in a large clinical trial may become apparent when very large numbers of people receive a pandemic vaccine.
Some adverse events will be coincidental – that is, associated in time with vaccine administration, yet not directly caused by the vaccine. Genuine adverse events directly caused by the vaccine may also occur, but cannot be predicted in advance. Given the safety record of seasonal vaccines, such events are expected to be rare.
Time constraints mean that clinical data at the time when pandemic vaccines are first administered will inevitably be limited. Further testing of safety and effectiveness will need to take place after administration of the vaccine has begun.
For these reasons, WHO advises all countries administering pandemic vaccines to conduct intensive monitoring for safety and efficacy, and many countries have plans in place for doing so. On the positive side, mass vaccination campaigns can generate significant safety data within a few weeks.
International sharing of data from such post-marketing surveillance will be vital in guiding risk-benefit assessments and determining whether changes in vaccination policies are needed. WHO has developed standardized protocols for data collection and reporting in real-time, and will communicate findings to the international community via its web site.
Fonte: WHO
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quinta-feira, agosto 06, 2009
segunda-feira, agosto 03, 2009
Two Billion People
World Health Officials Say Two Billion People May Contract Swine Flu
By Melinda Smith
Washington
28 July 2009
The World Health Organization predicts the H1N1 Swine Flu virus will infect two billion people, or one out of every three persons, over the next two years. While this flu has already killed 800, the WHO says thousands more could die unless an effective vaccine is developed soon.
his year's pandemic spread around the globe with record-breaking speed. It has taken less than two months for the H1N1 swine flu to spread, while previous pandemics took six months or longer.
Yet Dr. Keiji Fukuda of the World Health Organization warns this global outbreak is still in the early stages. "We have a very large global population, and it is quite clear that we'll continue to see spread of this virus through countries, and then among countries," he said.
Most of the patients have been teenagers, between 12 and 17 years old. But the virus is spreading more deeply into many communities and the WHO says the average age of patients now appears to be getting slightly older.
While young people and pregnant women are still at higher risk for contracting the H1N1 virus, health officials also caution that patients with cardiovascular disease, respiratory illness, diabetes, cancer, and obesity are just as vulnerable.
Some clinical trials of potential vaccines are underway, others will start soon.
The European Medicines Agency says large scale clinical trials will be bypassed in order to get vaccines into the general population as soon as possible.
Health officials in Britain, Greece, France and Sweden have announced they will begin inoculations among the public possibly within weeks.
The WHO's Dr. Fukuda has not criticized that decision, but expressed concern about rushing vaccine production too soon. "There are certain things which cannot be compromised," he explains. "And one of the things which cannot be compromised is the safety of vaccines. There can't be any questions whether the vaccine is safe or not."
Meanwhile, the World Health Organization says countries with widespread infections have switched from reporting individual testing of all patients, to monitoring and reporting trends in the population.
According to the WHO, testing of patients has strained the laboratory capacity of many countries.
Dr. Fukuda believes health officials can still accurately predict the pandemic's size. "We know that the total number of laboratory confirmed cases is really only a subset of the total number of cases," he asserts.
Recently, the international health organization said it would no longer publish global tables reporting the number of new cases for all countries.
FONTE: Voice of America
By Melinda Smith
Washington
28 July 2009
The World Health Organization predicts the H1N1 Swine Flu virus will infect two billion people, or one out of every three persons, over the next two years. While this flu has already killed 800, the WHO says thousands more could die unless an effective vaccine is developed soon.
his year's pandemic spread around the globe with record-breaking speed. It has taken less than two months for the H1N1 swine flu to spread, while previous pandemics took six months or longer.
Yet Dr. Keiji Fukuda of the World Health Organization warns this global outbreak is still in the early stages. "We have a very large global population, and it is quite clear that we'll continue to see spread of this virus through countries, and then among countries," he said.
Most of the patients have been teenagers, between 12 and 17 years old. But the virus is spreading more deeply into many communities and the WHO says the average age of patients now appears to be getting slightly older.
While young people and pregnant women are still at higher risk for contracting the H1N1 virus, health officials also caution that patients with cardiovascular disease, respiratory illness, diabetes, cancer, and obesity are just as vulnerable.
Some clinical trials of potential vaccines are underway, others will start soon.
The European Medicines Agency says large scale clinical trials will be bypassed in order to get vaccines into the general population as soon as possible.
Health officials in Britain, Greece, France and Sweden have announced they will begin inoculations among the public possibly within weeks.
The WHO's Dr. Fukuda has not criticized that decision, but expressed concern about rushing vaccine production too soon. "There are certain things which cannot be compromised," he explains. "And one of the things which cannot be compromised is the safety of vaccines. There can't be any questions whether the vaccine is safe or not."
Meanwhile, the World Health Organization says countries with widespread infections have switched from reporting individual testing of all patients, to monitoring and reporting trends in the population.
According to the WHO, testing of patients has strained the laboratory capacity of many countries.
Dr. Fukuda believes health officials can still accurately predict the pandemic's size. "We know that the total number of laboratory confirmed cases is really only a subset of the total number of cases," he asserts.
Recently, the international health organization said it would no longer publish global tables reporting the number of new cases for all countries.
FONTE: Voice of America
sexta-feira, julho 31, 2009
Pandemic (H1N1) 2009 - briefing note 5
31 JULY 2009 | GENEVA -- Research conducted in the USA and published 29 July in The Lancet [1] has drawn attention to an increased risk of severe or fatal illness in pregnant women when infected with the H1N1 pandemic virus.
Several other countries experiencing widespread transmission of the pandemic virus have similarly reported an increased risk in pregnant women, particularly during the second and third trimesters of pregnancy. An increased risk of fetal death or spontaneous abortions in infected women has also been reported.
Increased risk for pregnant women
Evidence from previous pandemics further supports the conclusion that pregnant women are at heightened risk.
While pregnant women are also at increased risk during epidemics of seasonal influenza, the risk takes on added importance in the current pandemic, which continues to affect a younger age group than that seen during seasonal epidemics.
WHO strongly recommends that, in areas where infection with the H1N1 virus is widespread, pregnant women, and the clinicians treating them, be alert to symptoms of influenza-like illness.
WHO recommendations for treatment
Treatment with the antiviral drug oseltamivir should be administered as soon as possible after symptom onset. As the benefits of oseltamivir are greatest when administered within 48 hours after symptom onset, clinicians should initiate treatment immediately and not wait for the results of laboratory tests.
While treatment within 48 hours of symptom onset brings the greatest benefits, later initiation of treatment may also be beneficial. Clinical benefits associated with oseltamivir treatment include a reduced risk of pneumonia (one of the most frequently reported causes of death in infected people) and a reduced need for hospitalization.
WHO has further recommended that, when pandemic vaccines become available, health authorities should consider making pregnant women a priority group for immunization.
Danger signs in all patients
Worldwide, the majority of patients infected with the pandemic virus continue to experience mild symptoms and recover fully within a week, even in the absence of any medical treatment. Monitoring of viruses from multiple outbreaks has detected no evidence of change in the ability of the virus to spread or to cause severe illness.
In addition to the enhanced risk documented in pregnant women, groups at increased risk of severe or fatal illness include people with underlying medical conditions, most notably chronic lung disease (including asthma), cardiovascular disease, diabetes, and immunosuppression. Some preliminary studies suggest that obesity, and especially extreme obesity, may be a risk factor for more severe disease.
Within this largely reassuring picture, a small number of otherwise healthy people, usually under the age of 50 years, experience very rapid progression to severe and often fatal illness, characterized by severe pneumonia that destroys the lung tissue, and the failure of multiple organs. No factors that can predict this pattern of severe disease have yet been identified, though studies are under way.
Clinicians, patients, and those providing home-based care need to be alert to danger signs that can signal progression to more severe disease. As progression can be very rapid, medical attention should be sought when any of the following danger signs appear in a person with confirmed or suspected H1N1 infection:
* shortness of breath, either during physical activity or while resting
* difficulty in breathing
* turning blue
* bloody or coloured sputum
* chest pain
* altered mental status
* high fever that persists beyond 3 days
* low blood pressure.
In children, danger signs include fast or difficult breathing, lack of alertness, difficulty in waking up, and little or no desire to play.
Fonte: OMS
Several other countries experiencing widespread transmission of the pandemic virus have similarly reported an increased risk in pregnant women, particularly during the second and third trimesters of pregnancy. An increased risk of fetal death or spontaneous abortions in infected women has also been reported.
Increased risk for pregnant women
Evidence from previous pandemics further supports the conclusion that pregnant women are at heightened risk.
While pregnant women are also at increased risk during epidemics of seasonal influenza, the risk takes on added importance in the current pandemic, which continues to affect a younger age group than that seen during seasonal epidemics.
WHO strongly recommends that, in areas where infection with the H1N1 virus is widespread, pregnant women, and the clinicians treating them, be alert to symptoms of influenza-like illness.
WHO recommendations for treatment
Treatment with the antiviral drug oseltamivir should be administered as soon as possible after symptom onset. As the benefits of oseltamivir are greatest when administered within 48 hours after symptom onset, clinicians should initiate treatment immediately and not wait for the results of laboratory tests.
While treatment within 48 hours of symptom onset brings the greatest benefits, later initiation of treatment may also be beneficial. Clinical benefits associated with oseltamivir treatment include a reduced risk of pneumonia (one of the most frequently reported causes of death in infected people) and a reduced need for hospitalization.
WHO has further recommended that, when pandemic vaccines become available, health authorities should consider making pregnant women a priority group for immunization.
Danger signs in all patients
Worldwide, the majority of patients infected with the pandemic virus continue to experience mild symptoms and recover fully within a week, even in the absence of any medical treatment. Monitoring of viruses from multiple outbreaks has detected no evidence of change in the ability of the virus to spread or to cause severe illness.
In addition to the enhanced risk documented in pregnant women, groups at increased risk of severe or fatal illness include people with underlying medical conditions, most notably chronic lung disease (including asthma), cardiovascular disease, diabetes, and immunosuppression. Some preliminary studies suggest that obesity, and especially extreme obesity, may be a risk factor for more severe disease.
Within this largely reassuring picture, a small number of otherwise healthy people, usually under the age of 50 years, experience very rapid progression to severe and often fatal illness, characterized by severe pneumonia that destroys the lung tissue, and the failure of multiple organs. No factors that can predict this pattern of severe disease have yet been identified, though studies are under way.
Clinicians, patients, and those providing home-based care need to be alert to danger signs that can signal progression to more severe disease. As progression can be very rapid, medical attention should be sought when any of the following danger signs appear in a person with confirmed or suspected H1N1 infection:
* shortness of breath, either during physical activity or while resting
* difficulty in breathing
* turning blue
* bloody or coloured sputum
* chest pain
* altered mental status
* high fever that persists beyond 3 days
* low blood pressure.
In children, danger signs include fast or difficult breathing, lack of alertness, difficulty in waking up, and little or no desire to play.
Fonte: OMS
Novel H1N1 Vaccination Recommendations
With the new H1N1 virus continuing to cause illness, hospitalizations and deaths in the US during the normally flu-free summer months and some uncertainty about what the upcoming flu season might bring, CDC's Advisory Committee on Immunization Practices has taken an important step in preparations for a voluntary novel H1N1 vaccination effort to counter a possibly severe upcoming flu season. On July 29, ACIP met to consider who should receive novel H1N1 vaccine when it becomes available.
Novel H1N1 Vaccine
Every flu season has the potential to cause a lot of illness, doctor’s visits, hospitalizations and deaths. CDC is concerned that the new H1N1 flu virus could result in a particularly severe flu season this year. Vaccines are the best tool we have to prevent influenza. CDC hopes that people will start to go out and get vaccinated against seasonal influenza as soon as vaccines become available at their doctor’s offices and in their communities (this may be as early as August for some). The seasonal flu vaccine is unlikely to provide protection against novel H1N1 influenza. However a novel H1N1 vaccine is currently in production and may be ready for the public in the fall. The novel H1N1 vaccine is not intended to replace the seasonal flu vaccine – it is intended to be used along-side seasonal flu vaccine.
CDC’s Advisory Committee on Immunization Practices (ACIP), a panel made up of medical and public health experts, met July 29, 2009, to make recommendations on who should receive the new H1N1 vaccine when it becomes available. While some issues are still unknown, such as how severe the virus will be during the fall and winter months, the ACIP considered several factors, including current disease patterns, populations most at-risk for severe illness based on current trends in illness, hospitalizations and deaths, how much vaccine is expected to be available, and the timing of vaccine availability.
The groups recommended to receive the novel H1N1 influenza vaccine include:
* Pregnant women because they are at higher risk of complications and can potentially provide protection to infants who cannot be vaccinated;
* Household contacts and caregivers for children younger than 6 months of age because younger infants are at higher risk of influenza-related complications and cannot be vaccinated. Vaccination of those in close contact with infants less than 6 months old might help protect infants by “cocooning” them from the virus;
* Healthcare and emergency medical services personnel because infections among healthcare workers have been reported and this can be a potential source of infection for vulnerable patients. Also, increased absenteeism in this population could reduce healthcare system capacity;
* All people from 6 months through 24 years of age
o Children from 6 months through 18 years of age because we have seen many cases of novel H1N1 influenza in children and they are in close contact with each other in school and day care settings, which increases the likelihood of disease spread, and
o Young adults 19 through 24 years of age because we have seen many cases of novel H1N1 influenza in these healthy young adults and they often live, work, and study in close proximity, and they are a frequently mobile population; and,
* Persons aged 25 through 64 years who have health conditions associated with higher risk of medical complications from influenza.
We do not expect that there will be a shortage of novel H1N1 vaccine, but flu vaccine availability and demand can be unpredictable and there is some possibility that initially, the vaccine will be available in limited quantities. So, the ACIP also made recommendations regarding which people within the groups listed above should be prioritized if the vaccine is initially available in extremely limited quantities. For more information see the CDC press release CDC Advisors Make Recommendations for Use of Vaccine Against Novel H1N1.
Once the demand for vaccine for the prioritized groups has been met at the local level, programs and providers should also begin vaccinating everyone from the ages of 25 through 64 years. Current studies indicate that the risk for infection among persons age 65 or older is less than the risk for younger age groups. However, once vaccine demand among younger age groups has been met, programs and providers should offer vaccination to people 65 or older.
Fonte: CDC
Novel H1N1 Vaccine
Every flu season has the potential to cause a lot of illness, doctor’s visits, hospitalizations and deaths. CDC is concerned that the new H1N1 flu virus could result in a particularly severe flu season this year. Vaccines are the best tool we have to prevent influenza. CDC hopes that people will start to go out and get vaccinated against seasonal influenza as soon as vaccines become available at their doctor’s offices and in their communities (this may be as early as August for some). The seasonal flu vaccine is unlikely to provide protection against novel H1N1 influenza. However a novel H1N1 vaccine is currently in production and may be ready for the public in the fall. The novel H1N1 vaccine is not intended to replace the seasonal flu vaccine – it is intended to be used along-side seasonal flu vaccine.
CDC’s Advisory Committee on Immunization Practices (ACIP), a panel made up of medical and public health experts, met July 29, 2009, to make recommendations on who should receive the new H1N1 vaccine when it becomes available. While some issues are still unknown, such as how severe the virus will be during the fall and winter months, the ACIP considered several factors, including current disease patterns, populations most at-risk for severe illness based on current trends in illness, hospitalizations and deaths, how much vaccine is expected to be available, and the timing of vaccine availability.
The groups recommended to receive the novel H1N1 influenza vaccine include:
* Pregnant women because they are at higher risk of complications and can potentially provide protection to infants who cannot be vaccinated;
* Household contacts and caregivers for children younger than 6 months of age because younger infants are at higher risk of influenza-related complications and cannot be vaccinated. Vaccination of those in close contact with infants less than 6 months old might help protect infants by “cocooning” them from the virus;
* Healthcare and emergency medical services personnel because infections among healthcare workers have been reported and this can be a potential source of infection for vulnerable patients. Also, increased absenteeism in this population could reduce healthcare system capacity;
* All people from 6 months through 24 years of age
o Children from 6 months through 18 years of age because we have seen many cases of novel H1N1 influenza in children and they are in close contact with each other in school and day care settings, which increases the likelihood of disease spread, and
o Young adults 19 through 24 years of age because we have seen many cases of novel H1N1 influenza in these healthy young adults and they often live, work, and study in close proximity, and they are a frequently mobile population; and,
* Persons aged 25 through 64 years who have health conditions associated with higher risk of medical complications from influenza.
We do not expect that there will be a shortage of novel H1N1 vaccine, but flu vaccine availability and demand can be unpredictable and there is some possibility that initially, the vaccine will be available in limited quantities. So, the ACIP also made recommendations regarding which people within the groups listed above should be prioritized if the vaccine is initially available in extremely limited quantities. For more information see the CDC press release CDC Advisors Make Recommendations for Use of Vaccine Against Novel H1N1.
Once the demand for vaccine for the prioritized groups has been met at the local level, programs and providers should also begin vaccinating everyone from the ages of 25 through 64 years. Current studies indicate that the risk for infection among persons age 65 or older is less than the risk for younger age groups. However, once vaccine demand among younger age groups has been met, programs and providers should offer vaccination to people 65 or older.
Fonte: CDC
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