WASHINGTON – The Food and Drug Administration says it has approved Pfizer Inc.‘s best-selling Prevnar 13 vaccine for use in preventing pneumococcal disease in adults age 50 and older.
The agency’s move on Friday was widely anticipated, coming a little over a month after a panel of federal health experts voted overwhelmingly to recommend the use of Prevnar 13 as a safe and effective vaccine for preventing the bacterial infection in adults.
Pneumococcal disease causes meningitis, pneumonia and ear infection.
Prevnar 13 protects against 13 strains of the disease. It’s already a standard vaccination for infants and young children.
By Mark Lennihan, AP–good job on this article!
Two key late-stage studies of Pfizer’s blockbuster pneumococcal vaccine for children show it works at least as well as a rival in adults, a big market the drugmaker wants to tap.
What does this mean for you?
If you have chronic sinus infections or pneumonias, I will check antibody levels to see how well you fight infection. If low, you will usually be immunized with Pneumovax™–0.50ml in adults, 0.25ml in children.
Now, I have a choice: use Prevnar 13 or Pneumovax. Which one is better? You would have to ask!
Studies haven’t been done with immunodeficient patients comparing the two vaccines, but the FDA now considers Prevnar 13 as effective in normal adults as Pneumovax.
How about the cost? You guessed it….the Prevnar 13 is ~twice as expensive as Pneumovax™
Unfortunately, all influenza vaccines carry the admonition that egg allergic individuals may react to their administration. STOP….before reading any further, make sure you have a true egg allergy before you worry about the influenza vaccine. Many patients have a positive TEST to eggs, but eat them just fine without any symptoms. This isn’t an allergy and you have no need to worry about avoiding sunny side up for breakfast. You do need to still get your flu shot!
There are no exceptions to this since all such vaccines are grown on media which may contain egg allergen. As always, there are clearly alternatives that are available to, in the vast majority of instances, allow the administration of influenza vaccine to egg allergic individuals. In fact, new guidelines recommend giving the Flu vaccine even if you are allergic to egg….it’s tolerated very well and allergic reactions are quite rare (see below).
If you’re concerned, such patients can be tested to egg and influenza vaccine; testing & desensitization is usually highly successful in allowing the safe administration of influenza vaccine under these circumstances.
Listed below are clinical studies demonstrating that patients with egg allergy can safely receive the influenza vaccine: J Allergy Clin ImmunolVolume 121, Issue 2, Supplement 1, Page S240 (February 2008).
Zeiger RS. Current issues with influenza vaccination in egg allergy. JACI 2002;110:830-40
Soooo….how about some history of influenza vaccine? The original injectable influenza vaccine was developed at the University of Michigan in the mid-1940s. The vaccine was made by taking influenza virus, injecting it into embryonated hen’s eggs (see picture), and letting the virus grow in the chorioallantoic cells that surrounded the yolk sac. They harvest the egg, purify the virus, and kill the virus with formaldehyde. I’m sure this is more than anyone wants to know, but since the vaccine was made in eggs, a certain amount of contaminating egg protein, specifically, ovalbumin was always still present.
What do we do, then, about children and adults who are severely allergic to egg proteins?
1. During the last 15 years, we have gotten much better at protein purification, protein chemistry, and being able to purify the inactivated virus or the live attenuated virus without using ovalbumin. Thus, there is much, much less ovalbumin in current vaccines. (The quantity of egg protein in vaccine is expressed as the concentration of ovalbumin per dose or unit volume. Check the package insert to find out if ovalbumin is < 1.4μg/mL; reaction rates are much less below this threshold)
2. Children with egg allergy can receive the vaccine, but the Advisory Committee on Immunization Practices does recommend that, as a precaution for those who have more severe allergic manifestations like hives (or worse), those children should be given the vaccine in the presence of an allergist or someone who knows what to do should there be an anaphylactic reaction. I think that’s a good idea.
3. Ultimately, we will probably give the influenza vaccine much as we give the measles vaccine to children who are egg allergic now. Carefully, but most tolerate both vaccinations just fine.
Want more information–>check out the following resources:
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