I want to share with you some updates I’ve provided to the various organizations and agencies I advise regarding novel H1N1 flu, commonly known as swine flu. Keep in mind that this is an evolving situation and what we know now may change.

1) Federal supervision of the novel H1N1 vaccine will be administered by public health departments to ensure strict oversight of the vaccine and its possible side effects. During a recent White House Summit, there was an announcement from the Centers for Disease Control and Prevention (CDC) about using other facilities, like health clinics, community centers, and schools as vaccination sites. Essentially, schools will try to stay open. The decision to close schools will take place at a local level where officials can weigh all the factors, including how many students and teachers are ill or whether or not certain schools have special issues, like a large population of students with special health needs. Private providers and clinics will be able to administer the vaccine so long as the clinics sign and comply with the provider pre-registration process/agreements, ensuring that the vaccine will be stored properly and administered according to standards and priorities. The VARS -- an electronic system monitored by the CDC and state public health departments which tracks side effects -- will be used. Additionally, there will be an electronic registry to monitor doses given. It is estimated that schools may get the H1N1 vaccine for their students by the end of September.

2) The CDC will be conducting prospective studies to evaluate post-vaccine side effects and efficacy. For example, four sites around the nation will do comprehensive review, including evaluating at least 900 pregnant women and their use of over-the-counter medicines.

3) There are new treatment and prevention guidelines for pregnant women, who are four times more likely to have complications from H1N1 infection compared to the general population. It is recommended that Tamiflu (5 days) be given for treatment or Relenza (10 days) be used preventatively to treat expectant moms. Relenza is inhaled and results in decreased systemic absorption, which may have a lesser impact on the fetus. (For those with asthma, caution is necessary when taking Relenza.)

4) If one presents with flu-like symptoms during the summer season, it is assumed to be novel H1N1 infection and should be treated. It is unusual for the seasonal flu to appear during the summer, but the H1N1 virus has done just that throughout the world. Studies now show that the rapid detection tests used to diagnose H1N1 infection are not accurate. The nasopharyngeal swabs using PCR-Polymerase Chain Reaction technology are recommended if there is concern about diagnosing and treating the infection.

5) New studies coming out of the United Kingdom indicate that children may experience more side effects to Tamiflu than adults, including vomiting, nausea, diarrhea, dehydration, and neuropsychiatric complications (nightmares, insomnia, and poor concentration). These side effects may outweigh the benefits, so more investigation is needed.

6) It is highly recommended that health clinics use separate rooms to isolate those suspected with H1N1 infection. Many believe it may even be wise to have patients with flu-like symptoms call in advance of arriving at health facilities, so steps can be taken to limit their exposure to non-infected patients. Those suspected to be infected with novel H1N1 should wear facemasks to prevent spread to others. Emergency rooms and even clinics may end up being the new incubators of this disease.

7) There is much debate over the strategy of removing pregnant women from working with suspected or infected patients. There are challenges to this approach, including an already limited workforce supply and the fact that some women don't even know when they are pregnant. Some have even suggested that this tactic may also be appropriate for other high risk groups, such as those who are obese. This is not a very practical solution, but the need for it should be considered over time.

8) Seasonal flu vaccines are being shipped to the U.S. market and novel H1N1 studies are now ongoing at eight sites. I have some concerns about the H1N1 vaccines and their impact on the immune system. Some of my concerns, which may not be fully evaluated during these studies due to a lack of time, include:

• Impact of one’s sex on response to the vaccine, as well as the use of adjuvant therapies on dosage. It’s believed that the female immune and inflammatory response may be more robust, so perhaps women may need a smaller dosage. Might a smaller dosage decrease the side effects that some women experienced when vaccinated? 
  
• Is there a higher risk for complications if one receives the seasonal flu vaccine and then is exposed to pandemic flu or given the first shot of pandemic flu vaccine? Will there be a cytokine storm (a serious immune reaction), since there is some cross over in the antigenic determinants and the immune and inflammatory systems will be activated? 
  
• Is there a higher risk for complications due to cytokine storm if one gets the pandemic flu vaccine and then is exposed to seasonal flu or the seasonal flu vaccine?
  
• Will there be populations were the pandemic flu vaccine may not be effective?
  
• Will there be any impact if one gets one pandemic flu vaccine from one drug maker than another -- such as those who travel overseas and get vaccinated?

Tight surveillance for side effects and efficacy will be essential as the immunization effort gets underway. Public service announcements have been funded and will appear now and throughout the year to help educate the public.

While the novel H1N1 presents serious concerns, it’s good to keep in mind that the U.S. has developed a robust public health system over the years, which will help to protect our health and wellbeing. For most of us, what’s key to remember is that if you do not feel well and have flu-like symptoms, stay home! There is simply no need to risk infecting others or to worsen your own recovery. A tincture of time, rest, and fluids is often the best medicine. If you’re not doing well, call your doctor immediately. Keep in mind that your local emergency room may not necessarily be the best place to spend time.

Always stay informed and never hesitate to ask questions!