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Daniel More, MD

New Egg-Free Flu Vaccine Available

By June 22, 2013

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Influenza is a potentially life-threatening viral respiratory infection that is particularly dangerous for people with chronic underlying medical conditions, such as asthma, diabetes and heart disease, as well as for young children and the elderly. The seasonal influenza vaccine is recommended to prevent, or to reduce the severity of, infection with the influenza virus. Unfortunately, the influenza vaccine is made in chicken eggs, and therefore contains a small amount of egg protein. For this reason, the influenza vaccine has traditionally not been given to people with an allergy to eggs. While newer information suggests that the influenza vaccine can be safely given under medical supervision by a physician skilled in the treatment of allergic reactions, many people with egg allergy still don't receive the seasonal influenza vaccine.

Flublok, a new seasonal influenza vaccine, has been developed for the 2013-2014 influenza season. It does not contain any egg protein, as it is made in an "insect cell line". The current FDA approval of Flublok is for adults 18-49 years of age -- which is disappointing -- as most people outgrow their egg allergy by their teenage years. Therefore, it is somewhat surprising to me that the manufacturer, Protein Sciences Corporation, is even bothering with Flublok. It's likely to be far more expensive than traditional egg-based influenza vaccines, and can only be used for adults -- of whom egg allergy is not common. Go figure.

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Comments
June 25, 2013 at 12:31 pm
(1) Rachael Felberbaum, PhD says:

Part 1 of 2:

Dr. More:

You are correct that influenza vaccination is very important and until now, vaccination of people who have or believe they have allergies to egg proteins has been a challenge. We are proud to offer Flublok Influenza Vaccine for many reasons, only one of which is that it is 100% egg-free and the first flu vaccine that is highly purified and made without a live influenza virus, antibiotics or formaldehyde. It also contains three times more of the active ingredients than the standard influenza vaccine.

The vaccine is approved for adults 18-49 years old and the ACIP, which is a panel of experts that advises the CDC, just issued a unanimous recommendation last week that people 18-49 with egg allergies of any severity be vaccinated with Flublok (please see http://www.cdc.gov/media/releases/2013/a0620-FluBlok.html). Note that the ACIP stated that Flublok should always be used if there is a suspicion of egg allergies and other vaccines can be used if Flublok is not available but the patient has to be observed for 90 minutes. Thus, not only for safety reasons but also for patient convenience Flublok is an important product.

[continued in next comment...]

June 25, 2013 at 12:32 pm
(2) Rachael Felberbaum, PhD says:

Part 2 of 2 [continued from previous comment]:

Receiving FDA approval of a new vaccine in children is a long process and it was our intent to make Flublok available to the adult population while studies to expand the approved age range are underway. A study to support approval of Flublok in all people over 18 has been completed and will be filed with the FDA in the next few months. A pediatric trial is scheduled to commence this fall.

I encourage you to learn more about Flublok at our website (www.Flublok.com), which includes product and safety information. In regard to the cost of the vaccine, it will be associated with unique insurance billing codes and will be covered by insurance. I expect that this addresses your concerns.

Safety Information

Flublok is approved for people 18-49 years old to prevent influenza disease. The most common side effect from Flublok is pain at the site of injection. Other side effects may occur and include fatigue, headache and muscle aches. Flublok should not be administered to anyone with a severe allergic reaction (e.g., anaphylaxis) to any vaccine component. Flublok does not contain any preservatives (e.g., thimerosal, a mercury derivative), antibiotics, egg proteins or latex. Tell the doctor if you have ever experienced Guillain-Barré syndrome (severe muscle weakness) within 6 weeks of receipt of a previous dose of influenza vaccine. If you notice any other problems or symptoms following vaccination, please contact your healthcare professional immediately. Vaccination with Flublok may not protect all individuals. Please see the complete Package Insert available at http://www.Flublok.com for more information.

Rachael Felberbaum, PhD
Scientific Communications
Protein Sciences Corporation

August 13, 2013 at 11:01 am
(3) Dina says:

I’m not so certain that egg allergy is that rare for adults. I never realized I was allergic until I was tested. Because I didn’t have an anaphylactic reaction, I didn’t realize the headaches, chronic fatigue and eczema were being caused by eggs. After I was tested my friend was tested and she also is positive for a strong egg allergy. Later my sister was tested and she too is allergic, although not as bad as me. So you see, I think there may be a lot more adults who have egg allergies but they just don’t know it. Either I live in a very small world, or it’s not as rare as some think.

October 23, 2013 at 3:07 pm
(4) Diana says:

When I first heard of Flublok I went right to the company website and asked questions. I was surprised that within the hour, a very nice lady called me to answer my questions personally. Their trials were broken down into three groups. The 18 to 49 group has been approved already and is available for use now. The under 18 and the over 49 trials are going on as I write this. The company hopes that both those groups will be approved by next flu season for use.
Incidentally, I am 62 years old and allergic to eggs. if I take the regular flu shot, I would run the risk of going into anaphylactic shock. I was told that since all the data on my age group is not in yet, I could talk with my doctor about taking the current Flublok. I am pretty sure that my doctor would recommend waiting until all information is gathered.

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