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H1N1 Vaccine Hits the Market


Pharmaceutical Executive

Pharmaceutical ExecutivePharmaceutical Executive-10-08-2009
Volume 0
Issue 0

Pulling off an incredibly fast turnaround, the pharma industry has released a vaccine for the H1N1 virus, bolstering its bottom line with a second flu vaccine and potentially helping millions of people. So why is there such an uproar over whether it's safe?

This week saw the release of the first batches of the new H1N1 vaccine, and with it came the usual fears that there won’t be enough treatments to go around, or that the vaccine will cause more harm than good.

According to the CDC, those rumors are unfounded.

“Each Friday, we'll provide information on the amount of vaccine available to each state and the amount of vaccine each state has ordered,” said Thomas Frieden, director of the Center for Disease Control and Prevention.” “That's a little complicated, because what we have decided to do is make vaccine available as soon as it comes off the production line. That means it's coming available in lots, and states learn each day of additional vaccine available to them. It's a little bit of a messy process, and we expect it to be somewhat bumpy in the first few weeks.”

First out the gate is the nasal version of the vaccine, which is being distributed to healthcare workers and infants this week. The traditional injectible vaccine will follow with a million doses being delivered every week starting in late October.

On Tuesday, GlaxoSmithKline announced that it has received 22 government orders for 149 million doses, bumping the total does in production to 440 million, with treatments being made available through early 2010. GSK stands to make upwards of $3.5 billion from the H1N1 vaccine, according to reports by Reuters.

Novartis also announced that it had shipped the first batch of its H1N1 vaccine, as well as 27 million doses of its seasonal vaccine. Novartis received contracts worth $979 million for its H1N1 vaccine.

“The early shipment is the first of an accelerated effort to provide as much H1N1 vaccine as soon as possible, despite the low yield seen with the initial production seed strain provided by the World Health Organization,” Novartis stated in a release. Production has switched to a higher yielding seed strain, which will allow deliveries of higher volumes later in the year.”

But there are people choosing not get the H1N1 vaccine because they feel that it hasn’t been tested enough. There’s an underlying concern that because this particular flu shot is new, it is physiologically different from the seasonal flu shot released each year.

“We have cut no corners,” Frieden said in a conference call. “This flu vaccine is made the same way the flu vaccine is made each year-by the same companies, in the same production facilities, with the same procedures, and with the same safeguards. We have had literally hundreds of millions of people vaccinated with flu vaccines made in this way.”

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