I worked in a flu lab for a year and was part of the team trying to understand the genetic nature of the flu virus. How did it change it’s genetic makeup so quickly each year that we needed to update our flu vaccination annually. Little did I expect to have to deal with questions on what to do about egg allergy. You see, until recently, all flu vaccines were prepared in eggs. Now, there are some brands available that are not made in eggs. Should a child or adult with egg allergy try to brave the flu season naturally or should they protect themselves by taking a vaccine until recently only made in eggs.

If you have never had the flu, chances are you may never get the flu. You may want to get expert advice on whether you need any protection at all. If you or your child has gotten the flu in the past, chances are that you and/or your child will get the flu again, and it may be best to get advice on the safest vaccination options if egg allergy is an issue. There is an excellent article in the British Medical Journal in 2009 by Lajeunesse and colleagues on egg allergy and flu vaccines.

Egg free vaccines have recently been researched and produced using a new technique in a mammalian cell line instead of eggs. Surface antigen, split virion, subunit, split flu, and inactivated flu vaccines are grown in hens’ eggs and do contain residual egg proteins. During the 2008 flu season, some but not all flu vaccines reported maximum egg protein content above 1.2 ug/ml with levels up to 2ug/ml. The proposed safety egg content is less than 1.2ug/ml (0.6ug per dose). Some vaccines often have much less residual egg protein, although still grown in egg cultures, such as virosomal vaccines, which are highly purified.

The youngest and the oldest are most at risk from succumbing to the flu. Certain elderly are recommended a much higher dose of flu vaccine to be effectively protected. It is important to note that egg-free mammalian culture based flu vaccines are now available or under clinical trials and should be given preferentially under expert advise to individuals allergic to egg. If an egg-free vaccine is unavailable, then check the maximum egg content of the vaccine and ensure that it is below 1.2ug/ml. The vaccination should be done in a center experienced in management of anaphylaxis if the doctor advises so. A single dose protocol is effective for individuals with less severe allergy. A 2 dose split protocol is recommended for asthma prone or anaphylaxis prone individuals.

Flugen is under clinical trial and showing promise. Celvapran (Baxter) a pandemic vaccine for A/H1N1 and Optiflu (Novartis) a seasonal flu vaccine have good safety records for egg allergy.

It is predicted that the H1N1 will return in 2010 fall around the same time as it did in 2009. The spring flu may have been displaced by the fall flu. If so, then it may be a race against time to vaccinate our kids safely and effectively before the fall H1N1 flu season descends upon us. Take advise, be cautious, and make a wise decision.

As for eating naturally to prevent the flu, there are oranges, providing vitamin C, there is garlic reputed to keep a family save through many recipes and always ginger, against inflammation. Gargling with salt daily in flu season is very helpful.

(AP Photo/Evan Vucci)

It’s flu-shot season already, and for the first time health authorities are urging nearly everyone to get vaccinated. There is even a new high-dose version for people 65 or older. Continue Reading

The meeting of the CDC’s Advisory Committee on Immunization Practices (ACIP) just updated the 2009 recommendations regarding the use of influenza vaccine for the prevention and control of influenza.  These 2010 influenza recommendations include new and updated information.

The Advisory Committee on Immunization Practices (ACIP) consists of 15 experts in fields associated with immunization, who have been selected by the Secretary of HHS to provide advice and guidance to HHS and the CDC on the control of vaccine-preventable diseases. The role of the ACIP is to provide advice that will lead to a reduction in the incidence of vaccine preventable diseases in the United States, and an increase in the safe use of vaccines and related biological products.

Highlights of the 2010 revisions include:

1. Recommendation that annual vaccination be administered to all persons over 6 months of age for the 2010–11 influenza season
2. Recommendation that children aged 6 months–8 years should receive 2 doses of the 2010–11 seasonal influenza vaccine (minimum interval: 4 weeks) during the 2010–11 season if they meet the following criteria:
   • Vaccination status is unknown OR
   • Have never received seasonal influenza vaccine before (or who received seasonal vaccine for the first time in 2009–2010 but received only 1 dose in their first year of vaccination)
   • Children who did not receive at least 1 dose of an influenza A (H1N1) 2009 monovalent vaccine regardless of previous influenza vaccine history
3. Recommendation that vaccines contain the 2010–11 trivalent vaccine virus strains:
   • A/California/7/2009 (H1N1)-like (the same strain as was used for 2009 H1N1 monovalent vaccines)
   • A/Perth/16/2009 (H3N2)-like
   • B/Brisbane/60/2008-like antigens be used
4. Information about Fluzone High-Dose, a newly approved vaccine for persons aged ≥65 years
5. Information about other standard-dose newly approved influenza vaccines and previously approved vaccines with expanded age indications. Vaccination efforts should begin as soon as the 2010–11 seasonal influenza vaccine is available and continue through the influenza season.

These recommendations also include a summary of safety data for U.S.-licensed influenza vaccines. These recommendations and other information are available at CDC’s influenza website (http://www.cdc.gov/flu); any updates or supplements that might be required during the 2010-2011 influenza season also will be available at this website.

http://www.cdc.gov/mmwr/preview/mmwrhtml/rr59e0729a1.htm?s_cid=rr59e0729a1_e

As the supply of H1N1 vaccine for the adult population increases, recent evidence suggests that a new vaccine formulation from an Australian manufacturer may require only one dose for effectiveness in infants and children.  CSL, Ltd, of Australia, announced that their 15 mcg antigen formulation (twice the antigen amount in use in the United States at present) resulted in effective antibody levels (immunity) in over 90% of infants and children immunized.  Many officials remain concerned about new waves of H1N1 as the winter progresses in the northern hemisphere and then begins later in 2010 in the southern hemisphere.  Next  year’s routine seasonal flu shots are already scheduled to contain variants of this  years H1N1 strain, barring any major mutations in the virus.  These modifications are already scheduled to be incorporated into seasonal flu vaccines which will be administered south of the equator beginning in March, April and May.  Here in the U.S., concerns about vaccine safety have kept many parents on the sidelines.  To be sure, there are always concerns with vaccines, but to date, the H1N1 vaccines appear to have no greater side effect profiles than the seasonal flu vaccines.  Health officials are still urging general vaccination of children.  Parents of children with special health needs and concerns have been strongly advised to have the receive the vaccine.  Parents should discuss this decision with their pediatrician if there are concerns . . . ben kazie md

Australian vaccine maker CSL Ltd (CSL.AX) said on Monday its pandemic H1N1 swine flu vaccine delivered a strong immune response after just one dose in children as young as 6 months. Global health authorities recommend children get two swine flu shots for full protection, but the CSL vaccine showed strong response with just one shot. Australian researchers find that more than 90% of those in study had effective immunity after a single dose, but the 15-microgram dose of antigen is twice that used in the United States.

Study shows one dose of H1N1 vaccine may be enough for children – http://www.latimes.com/features/health/la-sci-swine-flu-vaccine22-2009dec22,0,7581593.story

Will One Dose of H1N1 Vaccine Be Enough for Kids? – http://www.time.com/time/health/article/0,8599,1949187,00.html

UPDATE 1-CSL says its H1N1 vaccine effective with 1 dose – http://www.reuters.com/article/idUSN2125173820091221

One Dose of H1N1 Vaccine Enough for Young – http://www.cbsnews.com/stories/2009/12/21/health/main6005618.shtml?tag=cbsnewsLeadStoriesAreaMain;cbsnewsLeadStoriesHeadlines

Immunogenicity of a Monovalent 2009 Influenza A(H1N1) Vaccine in Infants and Children:… Nolan et al. JAMA.2009; 0: 20091911-10.

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The Pediatric Insider

© 2009 Roy Benaroch, MD

While no one is ready to call it over, H1N1 season seems to winding down in most parts of The United States. In my practice, we’ve seen only a handful of cases in the last few weeks. We’re also getting far fewer panicked phone calls for Tamiflu (the wonder-drug, as in “I wonder why so many people think this stuff works so well?”) The vast majority of children and adults who had H1N1 (or “Swine”) flu recovered after four or so days of fever and misery.

Whew.

There are definitely some sobering statistics. About 1 in 6 Americans probably came down with this flu by mid-November, an astonishing number that reflects just how rapidly and thoroughly a new virus can spread. There have been far too many deaths among children: about 212 at last count, a number that is certain to rise as further reports are processed. Obese adults and pregnant women also turned out to be particularly vulnerable.

The vaccine turned out to be both safe and effective, but probably didn’t reach a “critical mass” of widespread availability until a little too late for most people. Cases of H1N1 are waning just as the vaccine is becoming easy-to-find, and it’s difficult to know for certain just how big an impact the vaccine has had on the epidemic. The Swine Flu of 2009 illustrated some important lessons for dealing with an epidemic: it takes too long to make influenza vaccines using current technology, and it’s difficult to distribute millions of doses of vaccines through 50 states and thousands of health departments. Hopefully lessons from this pandemic can spur development of improved vaccine technologies and public health infrastructure to support a massive delivery of vaccines, medicines, and  other stuff needed to keep a country healthy.

Some dosing issues for the H1N1 vaccine were confusing. Early studies showed that a single dose was effective in adults, but that two doses were needed in children. Because of poor availability and quirks in the FDA licensing, getting two doses into children proved quite challenging, and I’m doubtful that even now most families have gotten both doses for their kids. A more recent study from Australia trumpeted in the headlines just this week announced that a single dose is effective for most children—but that formulation used twice as much influenza antigen in each dose, so the results really don’t apply to the H1N1 vaccines available in the United States.

At this point, I still recommend that children who haven’t yet reached their ninth birthday get two doses of the H1N1 flu vaccine. Though the epidemic is winding down, in some years flu comes back when the coldest part of winter hits, after children return to school in January. Also, H1N1 is not going to disappear after this year—you can bet it will be part of next year’s flu season. Getting two doses this year means that your child is primed for good immunity next year (when presumably H1N1 will be included in the ordinary seasonal flu vaccine.)

There was also a recent recall of some lots of children’s H1N1 vaccine, about 800,000 doses in total. These lots were found to be a little less potent than they were supposed to be, by about 10-12%. The affected lots were only designed for children less than three, who all are supposed to get a second dose. Even if your child got one of these sub-par doses, as long as you get that second dose of vaccine your child will be well-protected.

So: yes, H1N1 was pretty bad—many people got sick, and some died. But it wasn’t a huge catastrophe. Hopefully, the worst is behind us. Keep washing your hands and using that hand sanitizer, and if you haven’t been immunized yet, it’s still a good idea. Children less than 9 still ought to get two doses of H1N1 vaccine, which has been remarkably free of serious side effects.

Not that anyone wants to hear about this, but there’s the “regular” flu season, still to come! Just because H1N1 has overshadowed other causes of flu so far, don’t expect that we’ll get to skip the ordinary flu season. That’ll be here, probably in January. Did I mention you ought to keep washing your hands?

I know the kids are delighted to have to get two kinds of flu vaccines this year, for both H1N1 and for ordinary seasonal flu—so plan to stop by QuikTrip for a tasty chocolate-mint milkshake on the way home. Or pick up a box (or three*) of Trader Joe’s Candy Cane Joe-Joes. Either one will put a smile back on a child who had to get a shot. Heck, they’re probably more effective than Tamiflu for a child who ends up getting the flu.

*One for child, one for you, one to mail to me!

N Engl J of Medicine  Dec.17, 2009  V.361  N.25  p.2405-2413

Michael E. Greenberg, M.D., M.P.H., Michael H. Lai, B.Med.Sc., M.B., B.S., M.Med.Sc., Gunter F. Hartel, M.S., Ph.D., Christine H. Wichems, Ph.D., Charmaine Gittleson, B.Sc., M.B., B.Ch., Jillian Bennet, M.Sc., M.P.H., Gail Dawson, B.Pharm., Wilson Hu, M.D., M.B.A., Connie Leggio, B.Sc., Diane Washington, M.D., and Russell L. Basser, M.B., B.S., M.D., F.R.A.C.P.

Background A novel 2009 influenza A (H1N1) virus is responsible for the first influenza pandemic in 41 years. A safe and effective vaccine is needed. A randomized, observer-blind, parallel-group trial evaluating two doses of an inactivated, split-virus 2009 H1N1 vaccine in healthy adults between the ages of 18 and 64 years is ongoing at a single site in Australia.

Methods We evaluated the immunogenicity and safety of the vaccine after each of two scheduled doses, administered 21 days apart. A total of 240 subjects, equally divided into two age groups (<50 years and 50 years), were enrolled and underwent randomization to receive either 15 µg or 30 µg of hemagglutinin antigen by intramuscular injection. We measured antibody titers using hemagglutination-inhibition and microneutralization assays at baseline and 21 days after vaccination. The coprimary immunogenicity end points were the proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition assay, the proportion of subjects with either seroconversion or a significant increase in antibody titer, and the factor increase in the geometric mean titer.

Results By day 21 after the first dose, antibody titers of 1:40 or more were observed in 114 of 120 subjects (95.0%) who received the 15-µg dose and in 106 of 119 subjects (89.1%) who received the 30-µg dose. A similar result was observed after the second dose of vaccine. No deaths, serious adverse events, or adverse events of special interest were reported. Local discomfort (e.g., injection-site tenderness or pain) was reported by 56.3% of subjects, and systemic symptoms (e.g., headache) by 53.8% of subjects after each dose. Nearly all events were mild to moderate in intensity.

Conclusions A single 15-µg dose of 2009 H1N1 vaccine was immunogenic in adults, with mild-to-moderate vaccine-associated reactions.

abstract

http://content.nejm.org/cgi/content/full/361/25/2405?query=TOC

PDF

http://content.nejm.org/cgi/reprint/361/25/2405.pdf

N Engl J of Medicine  Dec.17, 2009  V.361  N.25  p.2414-2423

Feng-Cai Zhu, M.D., Hua Wang, M.D., Han-Hua Fang, M.D., Jian Guo Yang, M.D., Xiao Jun Lin, M.D., Xiao-Feng Liang, M.D., Xue-Feng Zhang, M.D., Hong-Xing Pan, M.D., Fan-Yue Meng, M.D., Yue Mei Hu, M.D., Wen-Dong Liu, M.D., Chang-Gui Li, M.D., Wei Li, M.D., Xiang Zhang, M.D., Jin Mei Hu, M.D., Wei Bing Peng, M.D., Bao Ping Yang, M.D., Pei Xi, M.D., Hua-Qing Wang, M.D., and Jing-Shan Zheng, M.D.

Background There is an urgent need for a vaccine that is effective against the 2009 pandemic influenza A (H1N1) virus.

Methods A split-virus, inactivated candidate vaccine against the 2009 H1N1 virus was manufactured, and we evaluated its safety and immunogenicity in a randomized clinical trial. Subjects were between 3 and 77 years of age, stratified into four age groups. The immunization schedule consisted of two vaccinations, 21 days apart. Subjects were injected with placebo or with vaccine, with or without alum adjuvant, at doses of 7.5 µg, 15 µg, or 30 µg. Serologic analysis was performed at baseline and on days 21 and 35.

Results A total of 2200 subjects received one dose, and 2103 (95.6%) received the second dose, of vaccine or placebo. No severe adverse side effects associated with the vaccine were noted. In the nonadjuvanted-vaccine groups, injection-site or systemic reactions, most mild in nature, were noted in 5.5 to 15.9% of subjects. Among the subjects receiving 15 µg of nonadjuvanted vaccine, a hemagglutination-inhibition titer of 1:40 or more was achieved by day 21 in 74.5% of subjects between 3 and 11 years of age, 97.1% of subjects between 12 and 17 years, 97.1% of subjects between 18 and 60 years, and 79.1% of subjects 61 years of age or older; by day 35, the titer had been achieved in 98.1%, 100%, 97.1%, and 93.3% of subjects, respectively. The proportion with a titer of 1:40 or more was generally highest among the subjects receiving 30 µg of vaccine, with or without adjuvant. Vaccine without adjuvant was associated with fewer local reactions and greater immune responses than was vaccine with adjuvant.

Conclusions These data suggest that a single dose of 15 µg of hemagglutinin antigen without alum adjuvant induces a typically protective immune response in the majority of subjects between 12 and 60 years of age. Lesser immune responses were seen after a single dose of vaccine in younger and older subjects.

Abstract

http://content.nejm.org/cgi/content/full/361/25/2414?query=TOC

PDF

http://content.nejm.org/cgi/reprint/361/25/2414.pdf

N Engl J of Medicine  Dec.17, 2009  V.361  N.25  p.2424-2435

Tristan W. Clark, M.R.C.P., Manish Pareek, M.R.C.P., Katja Hoschler, Ph.D., Helen Dillon, M.R.C.P., Karl G. Nicholson, M.D., F.R.C.P., Nicola Groth, M.D., and Iain Stephenson, M.D., F.R.C.P.

Background The 2009 pandemic influenza A (H1N1) virus has emerged to cause the first pandemic of the 21st century. Development of effective vaccines is a public health priority.

Methods We conducted a single-center study, involving 176 adults, 18 to 50 years of age, to test the monovalent influenza A/California/2009 (H1N1) surface-antigen vaccine, in both MF59-adjuvanted and nonadjuvanted forms. Subjects were randomly assigned to receive two intramuscular injections of vaccine containing 7.5 µg of hemagglutinin on day 0 in each arm or one injection on day 0 and the other on day 7, 14, or 21; or two 3.75-µg doses of MF59-adjuvanted vaccine, or 7.5 or 15 µg of nonadjuvanted vaccine, administered 21 days apart. Antibody responses were measured by means of hemagglutination-inhibition assay and a microneutralization assay on days 0, 14, 21, and 42 after injection of the first dose.

Results The most frequent local and systemic reactions were pain at the injection site and muscle aches, noted in 70% and 42% of subjects, respectively; reactions were more common with the MF59-adjuvanted vaccine than with nonadjuvanted vaccine. Three subjects reported fever, with a temperature of 38°C or higher, after either dose. Antibody titers, expressed as geometric means, were higher at day 21 among subjects who had received one dose of MF59-adjuvanted vaccine than among those who had received one dose of nonadjuvanted vaccine (P<0.001 by the microneutralization assay). By day 21, hemagglutination-inhibition and microneutralization antibody titers of 1:40 or more were seen in 77 to 96% and 92 to 100% of subjects receiving MF59-adjuvanted vaccine, respectively, and in 63 to 72% and 67 to 76% of those receiving nonadjuvanted vaccine, respectively. By day 42, after two doses of vaccine, hemagglutination-inhibition and microneutralization antibody titers of 1:40 or more were seen in 92 to 100% and 100% of recipients of MF59-adjuvanted vaccine, respectively, and in 74 to 79% and 78 to 83% of recipients of nonadjuvanted vaccine, respectively.

Conclusions Monovalent 2009 influenza A (H1N1) MF59-adjuvanted vaccine generates antibody responses likely to be associated with protection after a single dose is administered.

abstract

http://content.nejm.org/cgi/content/full/361/25/2424?query=TOC

PDF

http://content.nejm.org/cgi/reprint/361/25/2424.pdf