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Dr. Saralyn Mark's Remarks at the 8/11/2009 H1N1 Influenza OCHMO ViTS
Federal oversight of the novel H1N1 vaccine will be administered at this point by public health departments to ensure strict oversight of the vaccine and possible symptoms. During the White House Summit, there was some discussion about using other facilities such occupational health clinics, community centers, schools as sites. (Schools will try to stay open but it will be the judgment at the local level-for example, if many students and teachers are ill or if schools have special issues such as many students with special health needs, there may be closings.) CDC will be conducting prospective studies to evaluate post vaccine side effects/efficacy. For example, four sites around the nation will do comprehensive review even including use of OTC meds evaluating at least 900 pregnant women.

In regard to pregnant women (they have the highest mortality - 4 fold higher than the rest of the population), there are new guidelines for treatment and prevention. It is recommended that Tamiflu for 5 days be used for treatment and Relenza (it is inhaled so caution is necessary for those with asthma) for 10 days as prophylaxis -selected because of decreased systemic absorption and potentially less impact on the fetus.

New studies out of the UK are suggesting that children may have more side effects to Tamiflu such as gastrointestinal and dehydration and neuropsych complications that is may be more harmful to use the drug - this will be explored more.

Highly recommend that clinics use separate rooms to isolate suspected infected from non-infected. Perhaps even having patients call before coming may be useful. Suspected cases should wear facemasks to prevent spread to others. ERs will be the new incubators and perhaps even clinics.

There is much debate about removing pregnant women from working with suspected or infected patients. Challenges to this include workforce supply may be limited, some women don't know they are pregnant. Others state that this may apply to other high risk groups such as those who are obese. This is not very practical but will need to be followed.

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

  1. Impact of sex as well as the use of adjuvants on dosage - we believe that the female immune and inflammatory response may be more robust so perhaps women may need smaller dosage. Could this also decrease the side effects that some women get when vaccinated?
  2. Is there a higher risk for complications if one receives 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 since there is some cross over in the antigenic determinants and the immune and inflammatory systems will be activated?
  3. Is there a higher risk for complications due to cytokine storm if one get the pandemic flu shot and then is exposed to seasonal flu or the vaccine?
  4. Will there be populations were the pandemic vaccine may not be effective?
  5. Will there be any impact if one gets one pandemic 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 and the occupational health clinics may help to play a role in this.