The Advisory Committee on Immuization Practices - 29 July 2009

[indigo girl]

http://afludiary.blogspot.com/2009/07/acip-committee-recommendations.html

Well done Fla Medic! Thank you for sitting thru all 7 1/2 hours of those meetings so we didn't have to!

It has been a long, but at times interesting, day of video and press conferences on the pandemic H1N1 vaccination recommendations. The bulk of today was taken up by the ACIP (Advisory Committee On Immunization Practices) conference, which ran nearly 7.5 hours.

At 4pm, Dr. Anne Schuchat held a CDC press conference which summarized some of the findings.

ACIP, which is a panel of 15 vaccine experts, usually meets three times a year to discuss and give advice to the CDC and HHS on routine vaccination matters. Today was a special session to deal with the fall pandemic vaccination program, and to decide on which groups should be targeted to receive the pandemic vaccine first.

The morning was taken up by a series of presentations, with Q&A sessions following each, and this afternoon the panel discussed . . . and eventually voted on recommendations that now go to the CDC.

The votes were not always unanimous, and there were concerns expressed by some of the panelists over the lack of data behind some of their recommendations.

Nevertheless, two major recommendations came out of the ACIP meeting, which are now forwarded for approval and action by the CDC.

These recommendations are for UNADJUVANTED Vaccines.

First, 5 high risk groups were selected to be targeted to receive the vaccine first. These groups make up nearly 160 million Americans, and consist of:

Pregnant women (4 Million)

Household contacts and caregivers of children under 6 mos (who cannot receive a vaccination themselves) (5 Million)

Health Care Workers & Medical Service Personnel (14 million)

Children and adolescents aged 6mos -24yrs (102 Million)

Persons aged 25-64 years of age with certain Medical Conditions (34 million)

Assuming that adequate supplies of vaccine are available in October or November, these five groups would all be targeted for vaccination first. If 2 shots are required, then they would need roughly 300 million doses of vaccine.

While that exceeds the amount of vaccine expected to be available in October and November, the expectation is that the uptake - or percentage of those targeted who will take the vaccine - will be far less than 100%.

As a fallback position, in the event of a major shortfall of vaccine, a smaller `subgroup' was identified who would received prioritization for the vaccine. It was roundly hoped, however, that this would not be needed:

Pregnant women (4 million)

Household contacts of Infants

Health Care Workers With Direct Patient Contact (9 Million)

Children aged 6mos - 4 yrs (18 million)

Children under 19 with chronic medical conditions (6 Million)

Only after these high risk groups have been offered a vaccine, and sufficient vaccine supplies are on hand, would healthy adults between the ages of 25 and 64 be offered the vaccine.

Those over the age of 64 would be among the last to receive the H1N1 vaccine, although they are still strongly urged to get the seasonal vaccination.

I'll have a bit more on the information we got from today's ACIP meeting in my next blog, along with some thoughts regarding the challenges that lay ahead.

[indigo girl]

Federal panel issues H1N1 vaccine guidelines

http://www.cnn.com/2009/HEALTH/07/29/CDC.H1N1.vaccine.guidelines/index.html?eref=rss_topstories

Dr. William Schaffner, a flu researcher at Vanderbilt University, which is running one of the clinical trials, played down safety concerns that have been raised because safety data are limited.

"There is no alternative" to approving the new vaccine based on the limited data, he said. Fortunately, he added, "the novel H1N1 vaccine is created exactly the same way our seasonal vaccine is created, year in and year out."

Dr. Wellington Sun of the Food and Drug Administration said data from those trials would probably be available in September.

However, Dr. Robin Robinson, director of the Biomedical Advanced Research and Development Authority at the Department of Health and Human Services, said that that even if federal regulators determine that the vaccine is safe and effective, it would take an additional four to six weeks before it could be packaged and available to the public.

About half of Americans -- 159 million -- fall into one of the five main target groups, including 102 million people aged 6 to 18.

Robinson had predicted earlier that 120 million vaccine doses would most likely be available within a month after the campaign starts.

Dr. Anthony Fiore of the Centers for Disease Control and Prevention, who led the group's deliberations, said it made sense to target such a large group because it appears that vaccine supplies will be sufficient.

Part of that estimate is based on experience with seasonal flu vaccine; Fiore said that, typically, only 20 percent to 50 percent of people in targeted groups seek out seasonal flu vaccine.

Even if two doses of the swine flu vaccine are required to confer protection -- something that will be determined in clinical trials -- suppliers would probably be able to ramp up production quickly enough to meet demand, Fiore said.

But the advisory committee approved a backup plan in case supplies are more limited. In such a case, the priority groups would be pregnant women, health care and emergency services workers with direct patient contact, household contacts of children younger than 6 months, children age 6 months to 4 years and children younger than 19 with chronic medical conditions -- a total of 42 million people.

The panel also recommended that, once sufficient supplies exist to meet the needs of all targeted groups, the vaccine should be offered to healthy adults ages 25 to 64. Once those needs are met, vaccinations would be recommended for people older than 65.

The targeted groups differ starkly from the recommendations for seasonal flu vaccine campaigns, which include people 65 and older in the highest-risk group.

The difference is based largely on data showing vastly higher infection rates among younger people; the rate of laboratory-confirmed cases in Americans 65 and older is just 0.06 per 100,000, compared with 2.6 per 100,000 for the group with the highest infection rates, children 5 to 11.

The H1N1 flu vaccination campaign would run concurrent with the usual seasonal flu campaign, which the committee recommended get under way as soon as possible.

Vanderbilt's Schaffner said patients should get the seasonal vaccine before distribution centers are swamped with demand for the pandemic vaccine.

But he also warned that the new vaccine might be of limited use. "The virus and the vaccine are in a race; the virus may win," he said.

If the pandemic strain starts spreading fast between now and October, he said, hospitals and medical personnel will be pushed to the limit.

"It's like thinking about a hurricane. You batten down the hatches. You do everything you can. But when the hurricane arrives, damage will occur. This one is going to be a doozy."

[indigo girl]

More on the ACIP Meeting

If you heard a collective sigh of relief today, it came from the 34% of the American population with a BMI (Body Mass Index) of greater than 30, which up until today had been cited as a possible risk factor for complications from the novel H1N1 virus.

...the incidence of hospitalizations among those listed as obese by their BMI was practically the same as their prevalence in society.

Roughly 34% of Americans are obese, and roughly 38% of those hospitalized met that criteria. While 6% are morbidly obese (BMI > 40), they only made up 7% of the hospitalized cases.

According to Dr. Anne Schuchat, the jury is still out on the morbidly obese, but right now there is no clear evidence that obesity – without some comorbid condition like diabetes – lends itself to a greater risk of complications from this flu.

Follow the rest of the commentary at the link below:

http://afludiary.blogspot.com/2009/07/more-on-acip-meeting.html