Ethicist worried about rushed swine flu vaccine
Updated Sun. Aug. 16 2009 11:56 PM ET News Staff

The race is on to create a vaccine for swine flu,
as many infectious disease experts warn that the
northern hemisphere could face a "second wave" of
H1N1. But some worry the fast-tracked vaccine may
be more dangerous than the virus itself.

Across Europe, Asia and the U.S., vaccine
manufacturers have begun testing the first
batches of the vaccines, with volunteers rolling
up their sleeves to try the new formulations for
safety and effectiveness. They will be testing
different dosages, looking to see if any trigger
immune reactions or other possible side effects.

But in his office in Winnipeg, University of
Manitoba medical ethicist Dr. Arthur Schafer is worried.

"We're rushing the vaccines, there isn't time for
them to be properly tested for effectiveness;
there won't be time for them to be properly
tested for safety," he tells CTV News.

The vaccine is being touted as our best weapon
against the virus, and hailed as a sort of "magic
bullet." But Schafer notes that the first
scientific data will only provide information on
the correct dosage and immediate reactions from
the shot. Long-term safety data won't be
available when vaccination programs begin in the fall.

"So the claim that we know it to be safe and
effective just isn't levelling with the Canadian
public. No one knows that," says Schafer.

Many remember the ill-advised mass vaccination
program in the U.S. in 1976, when millions of
Americans and some Canadians got a vaccine for a
virus that quickly fizzled out. About 4,000
people became ill after getting immunized,
including about 500 who came down with
Guillain-Barré syndrome, a paralyzing though
generally temporary neuromuscular disorder.

When anger over the vaccine program reached a
crescendo, the program was quickly withdrawn and
the U.S. government was left with a $3-billion lawsuit.

The World Health Organization has acknowledged
safety issues "will inevitably arise during a
pandemic when vaccine is administered on a
massive scale. For example, adverse events too
rare to show up even in a large clinical trial
may become apparent when very large numbers of
people receive a pandemic vaccine."

Still, Schafer says he's not comfortable with the
plan to encourage every Canadian to get the
vaccine. He recently let his feelings be known in
an interview with the Winnipeg Free Press and
says his comments seemed to hit a nerve.

"I've had a lot of feedback from scientists
around the country who have emailed or phoned to
say they are relieved someone is flagging these concerns," he says.

Shafer says the evidence from the southern
hemisphere suggests swine flu is no more lethal
than the seasonal flu. So he wonders why a mass
vaccination program is being considered.

"There are serious public health issues and
issues of ethics as to whether we should be
distributing (vaccines) massively to healthy
people, including children and pregnant women,
when there are really big question marks about
their effectiveness and their safety."

But Toronto vaccine specialist Dr. Allison McGeer
says speeding the vaccine through production and testing is necessary.

She says as the safety data comes in, in the
coming weeks, and a clearer picture of swine
flu's effects in the southern hemisphere emerges,
decisions will be made about who needs it.

"The order is insurance," she said, referring to the vaccine.

McGeer agrees that open public discussion is
needed. She points out that there are risks to
any influenza, including swine flu. The vaccine
is designed to protect those at risk.

"The recommendation is based on a very careful
assessment of what the risks of influenza are,
and what the benefits (and risks) of the vaccine are."

With a report from CTV Medical Specialist Avis Favaro