Posts Tagged ‘epidemic’
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.
Prevent Swine Flu Tip 1
The CDC says that a good way to prevent any flu disease is to avoid exposure to the virus. This is done by frequent hand washing, not touching your hands to your face. Be especially careful to avoid the nose and mouth and avoiding any close proximity to or touching any person who may have flu symptoms. Since the virus can remain live and infectious for about 48 hours on many surfaces it is essential to practice good hygiene like cleaning with soap and water or alcohol-based hand disinfectants. Some physicians say face masks may help prevent getting airborne flu viruses from a cough or sneeze but others think it would be better for the people who actually have symptoms and sneeze or cough to wear the masks.
The use of Tamiflu or Relenza may help prevent the flu if taken before symptoms develop or reduce symptoms if taken within about 48 hours after symptoms develop. The vaccine recommendations as of October 2009 from the CDC say the following groups should get the vaccine as soon as it is available:
* people who live with or provide care for children younger than 6 months of age,
* pregnant women,
* health-care and emergency medical services personnel,
* people between 6 months and 24 years of age, and
* people from the ages of 25 through 64 who are at higher risk because of chronic health disorders such as asthma, diabetes, or a weakened immune system.
Generally speaking, about 90%-95% of people who get the disease feel dreadful but eventually bounce back with no problems. This has been seen in patients in both Mexico and the U.S. Caution is still crucial as the swine flu (H1N1) is still spreading and has become a pandemic. So far, young adults been hit hardest, and in Mexico, this group currently has the highest mortality rate. This data however is constantly changing.
At this time the CDC is stating that people ages 10 and above are likely to need only one vaccine shot to provide protection against novel H1N1 swine flu and further suggest that these shots will be effective in about 76% of people who obtain the vaccine. One type of vaccine (currently named Influenza A [H1N1] 2009 Monovalent Vaccine Live, Intranasal) has been made available during the first week in October 2009. It is a live attenuated novel H1N1 flu vaccine that contains no thimerosal. This vaccine is produced by MedImmune, LLC, and is administered by spraying it into the nostrils. This vaccine is only for healthy people 2-49 years of age. Children 2-9 years of age should receive two doses (0.1 ml in each nostril; total equals 0.2 ml per dose) and the second dose should be given the same way about one month after the first dose. Children, adolescents and adults, 10-49 years of age should receive one dose (0.1 ml in each nostril; total equals 0.2 ml per dose).
Swine Flu and Seasonal Flu
Flu activity in the U.S. is reported to now be widespread in 41 states. Across the nation visits to doctors for influenza-like-illness continued to be on the rise and are now about equal to or higher than what is seen at the height of most normal flu seasons. Flu-related hospitalizations and deaths are also continuing to mount and are above expectations for this time of year.
The CDC continues to remind health providers and the public of the need to continue hand and cough hygiene measures for the period of any influenza symptoms, even while taking antiviral medications in order to combat the spread of antiviral resistant virus strains. The influenza activity reported by both state and territorial epidemiologists shows geographic spread of both seasonal influenza and 2009 influenza A (H1N1) viruses.
Each week CDC evaluates information collected about influenza disease activity in the United States and issues findings of key flu indicators in a report called FluView. A review of the key indictors found that during the week of October 4-10, 2009 influenza activity continued to increase in the United States from the previous week. Below is a summary of the latest significant indicators:
· Visits to doctors for influenza-like illness (ILI) continued to increase in the United States, and overall, are higher than what is expected for this time of the year. ILI activity now is equal to or higher than what is seen at the peak of many regular flu seasons.
· Total influenza hospitalization rates for laboratory-confirmed flu are climbing and are higher than expected for this time of year.
· The proportion of deaths attributed to pneumonia and influenza (P&I) based on the 122 Cities Report has increased and exceeds what is normally expected at this time of year. In addition, 11 flu-related pediatric deaths were reported this week; 10 of these deaths were confirmed 2009 H1N1, and one was influenza A virus, but unsubtyped. Since April 2009, there have been 86 confirmed pediatric 2009 H1N1 deaths; 39 of these have been reported to CDC since August 30, 2009.
· Forty-one states are reporting widespread influenza activity at this time. They are: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Texas, Tennessee, Utah, Virginia, Washington, West Virginia, Wisconsin, and Wyoming. This many reports of widespread activity are unprecedented during seasonal flu.
· Almost all of the influenza viruses identified so far is 2009 H1N1 influenza A viruses. These viruses remain similar to the virus chosen for the 2009 H1N1 vaccine, and remain susceptible to the antiviral drugs oseltamivir and zanamivir with rare exception.
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.”
