Intranasal and Novartis H1N1 vaccines still not for egg-sensitive people
Scott McPherson
in Politics and government, Popular Culture, influenza and infectious diseases
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5 Comments
Recently, I was sitting in my dentist's chair when an assistant remarked she could not receive flu vaccine due to her allergy to eggs and egg products.
I listened intently and replied,
"Cauuuuuuggggggwwwwwllllllhhhhhh. MMmmmugggggggwwwaaaaaawwwwaaahhh."
After the assistant removed all the stuff in my mouth, I then translated: I would check this out and get back to her.
Well, I happened upon the insert to the monovalent H1N1v vaccine manufactured by Medimmune. Medimmune manufactures a live virus, intranasal vaccine principally for youth, and they are one of the four FDA-approved pandemic vaccines.
But I noticed this entry:
4 CONTRAINDICATIONS
4.1 Hypersensitivity
Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal is contraindicated in individuals with a history of hypersensitivity, especially anaphylactic reactions, to eggs, egg proteins, gentamicin, gelatin, or arginine or with life-threatening reactions to previous influenza vaccinations.
Likewise, I also saw this factoid:
------------------------------DRUG INTERACTIONS-------------------------------
• Antiviral agents active against influenza A and/or B: Do not administer Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal until 48 hours after antiviral cessation. Antiviral agents should not be administered until 2 weeks after Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal administration unless medically necessary.
(7.2)
So, you have to be off Tamiflu and Relenza for at least two days prior to accepting this vaccine into your schnozz. Probably because FluMist is live virus, and the antivirals might kill the virus before it helps you.
Finally, immunocompromised persons should not receive the vaccine intranasally.
5.4 Altered Immunocompetence
Administration of Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal, or FluMist live virus vaccine, to immunocompromised persons should be based on careful consideration of potential benefits and risks. Although FluMist was studied in 57 asymptomatic or mildly symptomatic adults with HIV infection [see Clinical Studies (14.3)], data supporting the safety and effectiveness of FluMist administration in immunocompromised individuals are limited.
I had never realized that FluMist was not for persons with sensitivity to eggs. So in the event others thought as I did (or did not), this is offered as a helpful; and potentially lifesaving reminder.
Buit wait, you say! Wasn't there word Novartis was making a vaccine from cells, rather than eggs, and they had whipped up a whopping ten liters of vaccine?
That's what the media ballyhooed. But again, directly from the Novartis package insert:
CONTRAINDICATIONS
•
History of systemic hypersensitivity reactions to egg proteins, or any other component of Influenza A (H1N1) 2009 Monovalent Vaccine, or life-threatening reactions to previous influenza vaccinations. (4, 11)
So there you go. None of the four vaccines can be taken by persons sensitive to eggs. I am unsure how much of the US population falls into that category, but I am betting it is a significant number. Better save the antivirals for them! Easpecially persons with egg allergies and under age 50.
Scott
PS. I will try to blog from the CIDRAP Summit in Minneapolis. Mostly, I hope FLA_MEDIC and I get around to some used book and comic stores! FLA_MEDIC should be quite the celebrity after this is all said and done! He is appearing with Robert Bazell of NBC News, one of my favorite correspondents, and Katie Couric's producer. The print editors are no slouches, either.
I think I will tell Mike some Katie Couric stories when she was a cub reporter at Channel 4 in Miami and I ws running for office......
Reader Comments (5)
Scott,
I don't know if the Novartis and Medimmune vaccines are any more risky for egg-sensitive people than those of other manufacturers. However, I would recommend that the dentist's assistant check with an allergist about getting vaccinated. My 21-month-old daughter has egg allergies. Her pediatrician will not give her a flu vaccine, but my understanding is that some allergists will do so because they have better expertise to watch for and evaluate adverse reactions and a better ability to respond to them. We plan to call her allergist this week.
In some recent Googling, I read about some studies in which seasonal flu vaccines were administered to a few hundred kids with egg allergies. In the study I came across, some of the subjects had minor skin reactions at the injection site, a few broke out in hives, and none experienced anaphylaxis.
Thanks for the continuing coverage Mr. McPherson! First came accross your blog/column on ComputerWorld (I think it was the Miami fire -> blackout event).
Anyway, I used to love checking out the book stores/comic stores when I went back to the twin cities to visit family/friends. Don't get out as often when I am back these days, but I fondly recall a few treasures discovered over the years.
I guess I didn't have the time and money to enjoy them when I lived there.
A few highlights...
Uncle Hugo/Edgar if they are still around is a must.
Some Shinders locations have a good selections.
There was a comic shop in Falcon Heights, right on Snelling and Larpenter (The Source) that had the best shopability - they had sliding drawers instead of just shelves filled with heavy, overstuffed long boxes.
All of the vaccines currently LICENSED in the US for seasonal or H1N1 are manufactured by growing the virus in eggs. Therefore, the contraindication for those allergic to eggs.
Tim, I would be very cautious about any doctor that would administer contrary to the prescribing information provided by the manufacturer. Trust me, if the mfg had clinical trial data to allow them to remove the contraindication, they would. The allergist would be going "off label" and administering the vaccine contrary to the FDA approved use of the vaccine...never a good idea unless absolutely necessary.
Novartis is working on a mfg process for influenza using cells instead of eggs, but that process has not yet been licensed in the US. They have received $487 million to build a facility in NC to do this, but it is still some years away.
I was desperate for an over-the-counter product that would help relieve this nasty tickle in the back of my throat that caused an even nastier non-productive cough. A pharmacist recommended Flonase over the counter spray. Couldn't find it at a retail store, so I ended up finding it at "kiwi drug" news. And I must say for anyone who is haing to suffer from allergies or a cold this helps. Humm I wonder if it helps with this H1N1 virus too?
Thanks nittanylions! Go JoePa!