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.

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 27^th – 29^th 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.

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.

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.

CDC continues to take aggressive action to respond to an expanding outbreak caused by novel H1N1 flu.

CDC’s response goals are to:

1. Reduce transmission and illness severity, and
2. Provide information to help health care providers, public health officials and the public address the challenges posed by this emergency.

CDC is issuing updated interim guidance daily in response to the rapidly evolving situation. This includes updated interim guidance for clinicians on how to identify and care for people who are sick with novel H1N1 flu now that more widespread illness has been detected in the United States. CDC recommends that testing and antiviral treatment be prioritized for those with severe respiratory illness and those at highest risk of complications from seasonal influenza. This includes children younger than 5 years old, pregnant women, people with chronic medical conditions and weakened immune systems, and people 65 years and older. In addition, CDC has provided information for the public on what to do if they develop flu-like symptoms.

CDC has completed deployment of 25 percent of the supplies in the Strategic National Stockpile (SNS) to all states in the continental United States. These supplies and medicines will help states and U.S. territories respond to the outbreak. In addition, the Federal Government and manufacturers have begun the process of developing a vaccine against the novel H1N1 flu virus.

Response actions are aggressive, but they may vary across states and communities depending on local circumstances. Communities, businesses, places of worship, schools and individuals can all take action to slow the spread of this outbreak. People who are sick are urged to stay home from work or school and to avoid contact with others, except to seek medical care. This action can avoid spreading illness further.

Don’t Just Rush to the Emergency Room

Joe Raedle / Getty

Since this global swine flu issue is taking off in the media and by word of mouth nearly everywhere you turn, there’s no wondering why so many people may easily panic and overact to even the smallest sign that they feel ill right now. Because of this terror instilled in people, some are going so far as to pour into emergency rooms in many states across our country; they fear they have this horrifying disease. It is strongly urged that people DO NOT rush to the emergency room if they start feeling the tiniest inkling that they have contracted swine flu. Like, “oh, my throat hurts…”, or “I feel more tired than i usually do”, or “what’s with my coughing and sniffling?, that can’t be good!”

It also burdens hospitals, the more that “just paranoid” people that start rushing to ER.  Having to examine people who aren’t really sick puts a toll on the already strained/stressed hospitals that are trying to prepare for a pandemic. Additionally, going to an emergency room without just cause may even put you further in harms way and risk your health. In past outbreaks, including SARS in 2003, hospitals were actually breeding grounds of infections — all those sick people in close proximity — and the same could be true of swine flu.

“If you actually have flu-like symptoms — a fever above 100° F, headache, sore throat, body aches, chills or fatigue — and you live in an area where there have been confirmed swine flu cases, by all means report to your doctor. Otherwise, leave the hospital to the sick people.”

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