Posts Tagged ‘swine flu outbreak’
Peramivir Emergency Use Authorized by FDA
The U.S. Food and Drug Administration has announced recently that in response to a request from the U.S. Centers for Disease Control (CDC) and Prevention, it has issued an emergency use authorization or EUA for the investigational antiviral drug peramivir intravenous (IV) in certain adult and pediatric patients with confirmed or suspected 2009 H1N1 influenza infection who are admitted to a hospital. The CDC has developed an electronic request system that lets healthcare providers request peramivir for patients who have been admitted to their hospitals due to 2009 H1N1 influenza.
More explicitly, IV peramivir is authorized only for hospitalized adult and pediatric patients for whom therapy with an IV drug is clinically suitable, based on one or more of the
following reasons. The first is if the patient is not responding to either oral or inhaled antiviral therapy, or when drug delivery by a route other than an intravenous route like enteral which is absorbed by the intestines or inhaled is not expected to be dependable or feasible. The other is for adults only, when the health care professional deems IV therapy is appropriate due to other circumstances and t he FDA has reviewed the available scientific data and has concluded that the criteria for authorizing the emergency use of IV peramivir have been met.
There are no FDA-approved intravenously administered antivirals for the treatment of influenza. Peramivir is the only intravenously administered influenza treatment currently authorized for use under EUA for 2009 H1N1 infections. The EUA authority allows the FDA, based on the evaluation of available data, to authorize the use of unapproved or un-cleared medical products or unapproved or un-cleared uses of approved or cleared medical products following a determination and declaration of emergency, provided certain criteria are met. The authorization will end when the declaration of emergency is terminated or the authorization is revoked by the agency.
It has been reported that by the end of July, up to 5.7 million Americans which is 140 times the reported number had H1N1 swine flu. As many as 21,000 flu sufferers were hospitalized by July 23, according to CDC estimates. This suggests that the current number of H1N1 swine flu-related hospitalizations is a vast underestimate. The number is just under 22,000 from the end of August to the middle of October.
When reporting numbers of hospitalizations and deaths, CDC officials have always noted that the data is just a guide to the severity of the pandemic and not a precise tally. We still don’t really know exactly how many millions of Americans have come down with H1N1 swine flu. That question is still unanswered, but there’s been more than a fivefold increase in increasing flu-related hospitalizations and deaths since Aug. 30.
H1N1 Swine Flu in Teens and Young Adults
H1N1 Vaccine – Jury is still out
Teens and young adults continue to account for the majority of cases of H1N1 around the world, with numbers of hospitalized cases highest in very young children. One% to ten% of patients with clinical illnesses will require hospitalization. Of those hospitalized patients anywhere from 10% to 25% will need to be admitted to an intensive care unit. Of those cases, 2% to 9% end up being fatal. This information is according to the Strategic Advisory Group of Experts (SAGE) on Immunization, which advises the World Health Organization (WHO) on policies and strategies for vaccines and immunization.
A recent session of the SAGE October 27th – 29th meeting was dedicated to the discussion of pandemic influenza vaccines. The experts at SAGE reviewed the current epidemiological situation of the pandemic worldwide and considered issues and options from a public health perspective. Overall, from 7% to 10% of all hospitalized patients are pregnant women in their second or third trimester of pregnancy. Pregnant women are ten times more likely to need care in an intensive care unit when compared with the general population. Based on data and the substantially elevated risk for a severe outcome in pregnant women infected with the pandemic virus, The Strategic Advisory Group of Experts on Immunization (SAGE) recommended that any licensed vaccine can be used in pregnant women, provided no specific opposition has been identified by the regulatory authority.
The SAGE experts also advised WHO on the number of doses of vaccine needed to provide protection across all different age groups, the joint dispensing of seasonal and pandemic vaccines, and vaccines for use in pregnant women. Recommendations on the formulation of seasonal influenza vaccines for the southern hemisphere in 2010 were also provided. Other agenda items discussed included the status of vaccine availability, results from clinical trials on vaccine immunogenicity, and early results from safety monitoring in countries where dispensation of the H1N1 pandemic vaccine is currently under way.
Early results of the monitoring of people who have received pandemic vaccines were reviewed by the experts from SAGE and there were no indications of unusual adverse reactions found. Some adverse events following vaccination have been noticed, but these are well within the range of those seen with seasonal vaccines. All of which are believed to have an excellent safety profile. Although early results are encouraging, they suggested monitoring for adverse events should be continued. The group also suggested that data on immunogenicity in children older than 6 months and younger than 10 years are limited and more studies are needed. National authorities have made children a priority for early vaccination. The SAGE recommendation is that precedence be given to the allocation of one dose of vaccine to as many children as possible.
H1N1 Facts and Information
Swine flu or swine influenza or influenza A h1n1 is defined as a respiratory disease caused by influenza viruses that infect the respiratory tract of pigs and result in nasal secretions, a barking-like cough, decreased appetite, and listless behavior. Swine flu produces most of the same symptoms in pigs as human flu produces in people. Swine flu can last about one to two weeks in pigs that survive. Swine influenza virus was first isolated from pigs in 1930 in the U.S. and has been recognized by pork producers and veterinarians to cause infections in pigs worldwide.
In a number of instances, people have developed the swine flu infection when they are closely associated with pigs and likewise, pig populations have occasionally been infected with
the human flu infection. Farmers and pork processors are at the highest risk. In most instances, the cross-species infections (swine virus to man; human flu virus to pigs) have remained in local areas and have not caused national or worldwide infections in either pigs or humans.
Regrettably, this cross-species infection with influenza viruses has had the capability to transform. Researchers think the 2009 swine flu strain, first seen in Mexico, should be called novel H1N1 flu since it is predominately found infecting people and exhibits two main surface antigens, H1 (hemagglutinin type 1) and N1 (neuraminidase type1). Current research shows the eight RNA strands from novel H1N1 flu have one strand derived from human flu strains, two from avian (bird) strains, and five from swine strains.
In areas with confirmed human cases of swine influenza A (H1N1) virus infection, the possibility of infection can be lessened through a combination of actions. No single action will provide complete protection, but an approach combining the following steps can help decrease the likelihood of transmission. These steps include frequent washing hands frequently, covering coughs, and having ill persons remain at home, except to seek medical care, and minimize contact with others in the household. Additional measures that can limit transmission of a new influenza strain include voluntary home quarantine of members of households with confirmed or probable swine influenza cases, reduction of unnecessary social contacts, and avoidance whenever possible of crowded settings.
A confirmed case of swine influenza A (H1N1) virus infection is defined as a person with an acute respiratory illness with laboratory confirmed swine influenza A (H1N1) virus infection at CDC by either a real-time RT-PCR or viral culture test.
For antiviral treatment of a confirmed case of swine influenza A (H1N1) virus infection, either oseltamivir or zanamivir may be administered. The recommended length of treatment is five days. These same antivirals should be considered for treatment of cases that test positive for influenza A but test negative for seasonal influenza viruses H3 and H1.
Swine Flu Death Tracking System
Pneumonia and Influenza Hospitalization and Death Tracking system was implemented on August 30, 2009, and replaces the weekly report of laboratory confirmed 2009 H1N1-related hospitalizations and deaths that began in April 2009. Jurisdictions can now report to CDC either laboratory confirmed or pneumonia and influenza based counts of hospitalizations and deaths resulting from all types or subtypes of influenza, not just those from 2009 H1N1 influenza virus. To allow jurisdictions to implement the new case definition, counts were reset to zero on August 30, 2009. From August 30 – October 10, 2009, 4,958 laboratory-confirmed influenza associated hospitalizations, 292 laboratory-confirmed influenza associated deaths, 15,696 pneumonia and influenza syndrome-based hospitalizations, and 2,029 pneumonia and influenza syndrome-based deaths, were reported to CDC. CDC will continue to use its traditional surveillance systems to track the progress of the 2009-10 influenza season.
A flu pandemic occurs when a new influenza A virus emerges for which there is little or no immunity in the human
population. As we have seen the virus causes serious illness and spreads easily from person-to-person worldwide. On June 11, 2009, the World Health Organization (WHO) declared that a global pandemic of H1N1 flu is in progress. Nearly 5,000 people have died from swine flu infections since the A(H1N1) virus made its debut in April, the World Health Organization said on Friday. The death toll marked an increase of about 265 over the 4,735 deaths reported to the WHO a week ago. The majority of the fatal cases which number 3,539 have been recorded in North and South America, the UN health agency said in its latest update on the escalating flu pandemic.
Overseas countries like Iceland, Sudan, and Trinidad and Tobago reported their first fatal cases over the past week. Mongolia, Rwanda, and Sao Tome and Principe also recorded pandemic influenza cases for the first time, as the virus continued to spread. Perhaps some good news is the A(H1N1) influenza was declining in tropical areas of the world. That is with the exception of Cuba and Colombia. There was also no significant pandemic related activity over the past week in warmer areas of the southern hemisphere, the WHO said. At this time respiratory disease activity persists in spreading and growing in intensity in the northern hemisphere, predominately in North America. Extensive efforts are ongoing to track and monitor the spread of all flu viruses. In the U.S., epidemiologists at the Centers for Disease Control (CDC) are working diligently with the states affected to collect, compile and analyze reports of flu outbreaks. As of September 2009, the current calculations are that about 90,000 deaths will take place in the U.S. from novel H1N1 swine flu. This is the estimate set out by the president’s advisory committee. There has been no revision of these numbers by the advisory committee or the CDC as of October 2009.
Critical H1N1 Swine Flu Facts
The CDC is recommending all healthcare providers receive both the seasonal influenza vaccine every year and the 2009 H1N1 vaccine. Healthy persons including healthcare providers, who are infected with influenza virus, can transmit the virus to persons at higher risk for complications from influenza, like patients with inflammatory rheumatic disease.
Early treatment with oseltamivir or zanamivir should be contemplated for persons with flu-like symptoms, suspected or confirmed, who have an elevated risk for complications including patients with inflammatory rheumatic disease. Patients with inflammatory rheumatic disease within any of the following prioritized groups are recommended to receive the 2009 H1N1 vaccine:
- Pregnant women
- People who live with or care for children younger than 6 months of age
- Healthcare and emergency medical services personnel
- Persons between the ages of 6 months and 24 years old
- Persons between the ages of 25 and 64 years old who are at higher risk for 2009 H1N1 because of chronic health disorders or compromised immune systems (including with inflammatory rheumatic disease)
Persons age 65 or older are not included in these specific groups because recent research indicates that the chance of infection among persons age 65 or older is less than the chance for younger age groups. While not expecting a shortage of 2009 H1N1 vaccine, the CDC states that availability and demand can be unpredictable. Once the need for the vaccine among the younger groups has been taken care of, the vaccine should be offered to people age 65 or older, including people with inflammatory arthritis. Persons with inflammatory rheumatic disease who develop flu-like symptoms need to know the following:
- If you develop flu-like symptoms contact your healthcare provider.
- Avoid contact with others. Seek medical care early. You should stay home and avoid travel, including not going to work or school, until at least 24 hours after your fever is gone except to get medical care or necessities. Your fever should be gone without using fever-reducing medications.
- If you leave the house to seek medical care, wear a facemask, if available and tolerable, and cover your coughs and sneezes with a tissue.
- Do not stop taking any medicine you take for your arthritis unless told to do so by your physician.
- Seek medical attention early. Treatment is available for persons with severe disease and those at high risk for complications. Persons with inflammatory rheumatic disease are considered high risk for complications from the flu; therefore, your health care provider may choose to prescribe antiviral medications for you if you get the flu.
- If you are exposed to someone who has flu, consult your health care provider. They may prescribe medication to help prevent you from getting the flu or watch you closely to see if you develop flu symptoms.
Swine Flu Fears Spread to Gulf Coast
Overnight reports filtered in from Louisiana state government officials that confirm 62 cases of suspected N1H1 Swine Flu have been sent to the CDC for strain testing.
We will update this as the virus spreads across Texas and Louisiana.
Swine Flu Concerns Grow Worldwide
People around the world are trying to get their hands on more information about the newest crisis headlining the news, swine flu. One source, the Wikipedia site has posted the following information in regard to the swine flu outbreak touching countries around the world:
“The 2009 swine flu outbreak is the spread of a new strain of H1N1 influenza virus that was first detected by public health agencies in March 2009. Localized outbreaks of influenza-like illness were detected in three areas initially in Mexico and soon after in the United States and Canada. Following the discovery of the new strain in the United States, its presence was quickly suspected on most continents, with over 1,800 candidate cases by April 27. Because it is not possible to confirm every one of such cases as being caused by an influenza virus, the World Health Organization (WHO) refers to them collectively as influenza-like illnesses (ILI).
The new strain is derived in part from human influenza virus A (subtype H1N1), and in part from two strains of swine influenza as well as an avian influenza. In April both the WHO and the United States Centers for Disease Control and Prevention (CDC) expressed serious concerns about this novel strain, because it apparently transmits from human to human, has had a relatively high mortality rate in Mexico, and because it has the potential to become a flu pandemic.
On April 25, 2009, the WHO determined the situation to be a formal “public health emergency of international concern”, with knowledge lacking in regard to “the clinical features, epidemiology, and virology of reported cases and the appropriate responses”. Government health agencies around the world also expressed concerns over the outbreak and are monitoring the situation closely.”
Swine Flu on the Rise
Normally found in pigs, swine flu is a highly contagious acute respiratory disease. It spreads through tiny particles in the air or by direct contact. According to the World Health Organization (WHO) it has a tendency to infect large numbers of the pig population. Not every animal infected displays symptoms but the flu kills between 1 and 4 percent of those affected. Humans usually become infected through contact with pigs; though in some cases human-to-human transmission has been reported.
The recent swine flu outbreak appears to have caused fatalities in humans in Mexico as well as nonfatal cases in the United States. WHO has urged countries around the world to be alert for dubious cases of influenza. Comparisons with the 1918 epidemic are premature, but WHO Chief Margaret Chan says the global body is taking the outbreak very seriously. Serious study and monitoring is needed and preventing the spread of swine flu is key to stopping it from becoming an pandemic.
Since the swine flu outbreaks in Mexico and U.S. were first noted, the risk of a pandemic has grown. Health officials worry the swine flu might progress into a variety more easily spread among humans. Experts worry that it is more likely a pandemic strain will emerge the more the virus circulates. Though there is no way to accurately predict when and if that will happen.
Swine flu is considered widespread in the United States even though in North America pigs are routinely vaccinated for swine flu. There is no vaccine for humans at this time. The flu virus evolves quickly, making vaccines obsolete as almost as soon as developed. There is no implication that the vaccine prepared for seasonal flu will defend against swine flu according to health officials.
Good hygiene is necessary in terms of prevention. Regular hand-washing and staying a safe distance from those infected are advised. Q-Based Healthcare offers a variety of products to help with disinfecting needs. PuraCleenRx READY-TO-USE Disinfectant Spray is designed specifically as a general non-acid cleaner and disinfectant for use in homes, hospitals, nursing homes, patient rooms, operating rooms, ICU areas, schools, transportation terminals, office buildings, manufacturing facilities, lodging establishments, retail businesses, veterinary clinics, pet shops, animal life science laboratories and athlete/recreational facilities where housekeeping is of prime importance in controlling the hazard of cross contamination.
