Swine Flu Shots May Be Too Little, Too Late

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Swine Flu Shots May Be Too Little, Too Late to Halt Outbreaks

By Tom Randall

Aug. 19 (Bloomberg) -- Swine flu vaccines under development by drugmakers may

not provide immunity until the last week of November, too late to hold off

outbreaks triggered by infected students returning to schools in the U.S. and

Europe.

Just 45 million of 195 million doses ordered for the U.S. will be delivered by

mid-October, said health officials who lowered their estimates yesterday. The

vaccine will probably require two shots given three weeks apart, and the body

won't produce antibodies for two additional weeks, according to an Aug. 7 report

by the Department of Health and Human Services.

U.S. students go back to school this week after more than 80 outbreaks of swine

flu, also known as H1N1, were reported in summer camps, government health

officials said. U.K. classes begin Sept. 1, a week before results from the first

test of the new vaccine are set to be released by CSL Ltd., the Australian

drugmaker that makes 20 percent of the U.S. supply.

" This has been a virus that's been smoldering, particularly among children at

the many summer camp outbreaks, " said Schaffner, of the Vanderbilt

University School of Medicine. " There's no doubt it's coming, and we could see

it as early as September. Every pediatrician, internist and public health

official is cross-eyed " with worry, he said.

Swine flu infection won't protect patients from seasonal influenza, so the

coming season may be " double-barreled, " marked by successive rounds of illness,

Schaffner, chairman of the Nashville, Tennessee school's department of

preventive medicine, said in an interview.

170 Countries

H1N1 has reached more than 170 countries and territories in the four months

since being identified, the Geneva-based World Health Organization said. Swine

flu causes similar symptoms as seasonal strains. It has so far resulted in

" slightly worse " than normal flu seasons, with increased hospitalizations and

cases of severe illness, the WHO said in an Aug. 12 release.

The median age of those with the pandemic virus has been 12 to 17 years, the WHO

said on July 24, citing data from Canada, Chile, Japan, U.K. and the U.S.

Patients who have already had swine flu will be immune to it in the fall,

Schaffner said. Recovered patients shouldn't count on having immunity unless

their illness was confirmed by laboratory tests. If they weren't tested, they

should get the vaccine to ensure they're protected, he said.

Sanofi-Aventis SA, based in Paris, began vaccine trials on August 6 and needs

" two to three months " to complete them, said Donna Cary, a company spokeswoman,

in an e-mail yesterday. London-based GlaxoKline Plc and AstraZeneca Plc

both have said they began testing in the last two weeks.

Required for Licensing

The company tests are required for licensing and are separate from U.S.-funded

studies to determine dose and timing of the vaccine, said Bill Hall, a spokesman

for the U.S. Department of Health and Human Services.

The U.S. will receive 45 million vaccine doses by mid- October, and get an

additional 20 million each week until its full order of 195 million doses from

five companies has been received, Hall said.

CSL, based in Melbourne, is delaying its shipment to the U.S. to speed up shots

to people in the company's home country, Hall said in a telephone interview

yesterday. All U.S. shots are provided by companies based outside the U.S.

" I can confirm that CSL's first commitment is to Australia, " said Sheila Burke,

a spokeswoman for CSL, in an e- mail yesterday.

Rapid Outbreaks

Australia and nations in South America had rapid outbreaks early in their winter

season, and rates in those countries have begun to recede this month, the WHO

said. South Africa was the biggest exception in the hemisphere, being struck

first by seasonal flu strains that peaked in June, and only recently

experiencing a second wave dominated by H1N1, the WHO said.

Companies haven't been able to grow enough antigen, a key ingredient needed for

production, to fill vaccine orders, said , a spokeswomen from CSL,

and Kim White, a spokeswoman for Baxter International Inc. in telephone

interviews last week.

" It's apparent that the vaccine availability is going to be delayed, and that

the number of doses available is going to be less, " said A. Poland, head

of the vaccine research group at the Mayo Clinic in Rochester, Minnesota, in an

Aug. 14 telephone interview. " Right now they are getting yields of about 50

percent roughly of what they expected. "

Information about the required dose of vaccine and number of shots needed

probably won't be complete until late September, said Marie-e Kieny,

director of the WHO's initiative on vaccine research, in a telephone interview

from Washington yesterday.

Protection Priorities

Authorities want to ensure adequate supplies to protect health-care workers,

pregnant women, people at risk of developing severe complications from flu and

children, whose close contact in tightly packed schoolrooms and in other social

settings makes them the biggest spreaders of the virus.

Part of the U.S. plan to vaccinate children is to encourage state and local

health departments to set up school-based vaccine clinics. In the U.K., most

shots will be given by family doctors and nurses who provide routine health care

including seasonal flu shots, according to the Department of Health.

Schools that arrange in-house immunizations will face logistical hurdles, said

Mel Riddile, the National Association of Secondary School Principals' associate

director for high school services in the U.S. Riddile, a former principal at a

Fairfax County, Virginia, high school, said it typically took a month just for

all 2,500 students to turn in their emergency medical information forms at the

beginning of the school year.

Immunization Permissions

" It's going to be difficult getting immunization permissions, particularly with

some of the misconceptions about the effectiveness and the dangers around flu

shots, " Riddile said in an interview Aug. 7. " It certainly can be done, but it's

going to be challenging for principals to pull that off. "

Saylors, president of the National Parent Teachers Association, the

non-profit organization that helps organize parents and teachers in local PTA

groups, said that even though he has never before received a shot for seasonal

flu, he'll get one for H1N1 when it becomes available.

" I would like to see our communities, our families take this more seriously than

they normally would a regular seasonal vaccine, " Saylors said.

During the initial U.S. outbreak, hospitals saw a surge of patients that were

either seriously ill or concerned about the virus. The federal government is now

working with communities to encourage that only the sickest go to hospitals,

with the rest making appointments with doctors or clinics, the HHS's

Yeskey said.

" What we saw in the springtime was a lot of people who were referred directly to

an emergency department rather than being seen in clinics, " said Yeskey,

director of the Office of Preparedness and Emergency Operations. " That kind of

overwhelmed " the hospitals, he said. Last Updated: August 19, 2009 00:00 EDT

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