As
the nation girds for a possible swine flu pandemic, one of the big weapons may
come from an unexpected source — a vaccine squirted or dropped into the nose.
MedImmune, which already makes the nasal spray vaccine FluMist for seasonal flu
viruses, says it is on track to produce about five times as much swine flu
vaccine as it had expected — so much, in fact, that it will run out of nasal
spray devices and is looking to administer the vaccines with droppers instead.
A nasal spray vaccine could be a strong weapon against swine flu because makers
of conventional flu shots have reported problems producing their vaccines.
If nasal spray vaccines emerge as a central player against swine flu, it would
represent a reversal of fortune for MedImmune’s efforts in the field. As a
vaccine for seasonal influenza, its FluMist has been a flop from a marketing
standpoint, accounting for only a few percent of the inoculations Americans
receive each year.
But it appears to have a manufacturing edge. Because its vaccine uses a live but
weakened virus, MedImmune uses a different viral strain than the makers of flu
shots, which contain an inactivated virus.
Each approach uses chicken eggs as the culture for growing its virus strain, but
flu shot makers say the strain of swine flu virus they are using is growing more
slowly than expected. MedImmune’s strain, meanwhile, is growing faster than
expected.
As a result, MedImmune, a subsidiary of AstraZeneca, says it can make 200
million doses by next March, about five times what it had expected.
Robin Robinson, who heads procurement of the pandemic vaccine for the Department
of Health and Human Services, said MedImmune alone accounted for 12 million of
the 20 million doses already produced by the five companies under contract to
the government.
Dr. Robinson said that the other drug makers were resolving their production
problems and would catch up. He said 120 million doses should be available by
October, without counting on any extra production from MedImmune. But if the
extra nasal spray doses can be used, Dr. Robinson said, “our supply could
possibly increase by a very large amount.”
The problem for MedImmune is that the unexpected production surge left the
company short of the sprayers used to squirt the vaccine into the nose. It can
supply only about 40 million doses in sprayers by March.
“We now are sitting on a surplus of potentially 150 million bulk doses,”
Bernardus N. M. Machielse, executive vice president for operations, said in an
interview.
BD, supplier of the sprayers, said Thursday that it was running its sprayer
factory in Columbus, Neb., round the clock to increase annual capacity to 70
million sprayers — up from 20 million.
But even that will not be enough. So MedImmune wants to use droppers in addition
to sprayers. Some early clinical trials of the vaccine were conducted with
droppers, so the company hopes to win approval from the Food and Drug
Administration to use them.
Pandemic vaccines could bolster the total sales of AstraZeneca, the
pharmaceutical giant based in London that acquired MedImmune, a Maryland
biotechnology company, for $15.6 billion in 2007.
The government has ordered 12.8 million doses of pandemic vaccine from MedImmune
for $151 million, Dr. Robinson said. AstraZeneca might get many hundreds of
millions more in sales if the government buys the rest of the 40 million or so
doses in sprayers and potentially the some 150 million doses in droppers.
Simon Lowth, AstraZeneca’s chief financial officer, told analysts on Thursday
that FluMist had a lower-than-average profit margin and that the pandemic
vaccine, being sold under government contract, had margins that are “lower
still.”
The pandemic might also allow AstraZeneca to achieve a foothold outside the
United States, the only country that has approved FluMist. The company is
applying for approval in other countries and is talking to the World Health
Organization about supplying some pandemic vaccine to poorer countries, David
Brennan, its chief executive, said Thursday.
When MedImmune agreed to buy Aviron, the developer of FluMist, in 2001,
executives predicted sales would grow to more than $1 billion a year. But in
2008, the best year yet for FluMist, sales reached only $104 million.
Several missteps nullified any appeal a needle-less vaccine might have. When it
was initially sold in 2003, FluMist was priced at about $50, two to six times as
much as a flu shot. And FluMist had to be frozen, a problem for some doctors’
offices.
Because of safety concerns FluMist was approved only for healthy people 5 to 49
years old. But those are not typically the people who get flu vaccines.
FluMist is now approved for children as young as 2, it can be refrigerated
instead of frozen and the wholesale price is down to $18.95.
