Hey doc, who wears the pants?

65 million people worldwide have lined up for swine flu shots so far—and the data indicate that the vaccine is largely safe, according to numbers released last week from the World Health Organization and the US Centers for Disease Control and Prevention.

Researchers have been particularly watchful for signs of Guillian-Barre syndrome (GBS), a disease that afflicted approximately 1 out of every 100,000 people in the US who received vaccines for the 1976 Swine flu (the flu that never materialized.) A report from the Washington Post this weekend examines what researchers know (not much) about the trigger for the condition, which most often arises after infection with Campylobacter jejuni, a bacterium that causes food-borne illness.

In any vaccination campaign, some people will die or experience severe illness after vaccination; much of this will be coincidence. So the job of health agencies is to figure out if there is a consistent issue with safety. In the US, vaccine safety is monitored in part through, the ‘vaccine adverse event reporting system,’ which collects reports of potential reactions to vaccines from patients and doctors.

So far, ten cases of GBS have been reported in people who got the swine flu shot, according to the CDC; that number is in line with normal background rates for the illness, suggesting that vaccination is not causing a spike in GBS. The CDC says they saw no common underlying pattern in the other events reported, also consistent with their being due to chance. The WHO reports similar findings.

So, is that enough for Mehmet Oz, who bills himself as “America’s Doctor” to vaccinate his kids? In a recent interview the Oprah regular said his kids were not getting swine flu shots because at home he is “Mr. Oz, not Dr. Oz.” At least his website, although dated, seems fairly run-of-the-mill; no anti-vaccine screeds from Mrs. Oz.

image:: David Berkowitz, Wikimedia Commons https://bit.ly/5Z7Ro1

Novartis cut the ribbon on its first US flu vaccine plant yesterday. The bioreactors are still empty at the Holly Springs, North Carolina, facility, but the company eventually hopes to crank out flu vaccines made from cell cultures instead of chicken eggs.

The new plant will do little to bolster the country’s limited supply of shots against the H1N1 swine flu this year. Even so, Novartis is confident that the cell-based technology will scale up manufacturing more quickly, which will allow the company to pump out large batches of vaccine when the next pandemic ultimately strikes.

The US government is clearly banking on the approach. The Department of Health and Human Services (HHS) invested $487 million to help Novartis build the plant, which should be in production in 2011 and running at full tilt two years later, according to a Novartis press release.

Novartis’ new plant, which plans to grow flu viruses in vats of cells taken from dog kidneys, is not the only incubator of a cell-culture approach. Meriden, Connecticut-based Protein Sciences Corp. is developing a vaccine made by inserting flu genes into an insect virus that is then grown in caterpillar ovary cells. Last week, a US Food and Drug Administration advisory panel narrowly rejected the company’s application, citing safety concerns.

The HHS also doled out handsome grants to the UK’s GlaxoSmithKline and France’s Sanofi-Aventis to develop cell-based flu vaccines. GSK, however, says that the technology is a decade away from usefulness, while Sanofi maintains that the slight reduction in production time is not worth the extra cost of manufacturing. (Wall Street Journal)

It looks like we should keep counting those chickens while they hatch out our flu jabs. But if you want to hear more about the alternatives, listen to an NPR interview with Robert Belshe, director of the Center for Vaccine Development at Saint Louis University School of Medicine in Missouri, who explains the canine and caterpillar counter-options.

Image: Flickr/alvi2047 via Creative Commons

Jenny McCarthy: vaccine expert

When it comes to swine flu vaccine, US health officials seem to be fearing fear itself.

Unlike most countries, the US is not using adjuvants in its swine flu vaccine. To do so, US health authorities must approve them in the vaccine on an ‘emergency’ basis. Why haven’t they?

One reason is that officials are concerned that people will reject the vaccine. That seems clear from recent congressional testimony by Anne Schuchat, head of immunization and respiratory diseases at the US Centers for Disease Control and Prevention.

Here is an exchange at a hearing last week between Schuchat and representative Bark Stupak:

Stupak: What is the problem with the adjuvant other than we haven’t done the test here in this country? [Referring to data obtained in Europe on the safety of the swine flu adjuvant]

Schuchat: Well, you know — as you know, the public’s confidence in our vaccine system and in vaccines in this country — very, very fragile.

Schuchat voiced similar concerns in an interview with Reuters. The decision surely was not easy for Shuchat and other health officials: if they had decided to use adjuvants, which reduce the dosage needed in a flu shot, the US would probably not be facing vaccine shortages—something I have blogged about before.

Other considerations, of course, factored into the decision. For instance, Jesse Goodman, an FDA official, told congress that the bulk of the safety data for the adjuvanted vaccine has been obtained in people over age 50, “So in terms of the kind of broad experience with millions of people that’s only in the elderly who were not a focus population of this vaccine…we don’t have enough data about those at this point or at the beginning of the pandemic for them to meet the standard of FDA licensure.”

Clearly, officials have the concerns and safety of the public in mind. It is also difficult to fault US agencies for considering the concerns of a public inundated with faulty information on vaccine safety, proliferating on the internet and aired by Don Imus, the Huffington Post and Oprah. Oprah, for instance, recently signed a deal with celebrity anti-vaccine activist Jenny McCarthy. The former playboy bunny is a regular guest on her show.

I wonder if Oprah has got her flu shot yet.