Reduced seasonal flu jab doses are safe and effective, suggests study

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Reduced seasonal flu jab doses are safe and effective, suggests study ‘Dose sparing’ could help tackle recent vaccine shortages, say researchers

Caroline White

Wednesday, 05 April 2017

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A reduced dose seasonal flu jab is not only safe, but also effective, and would help ease the recent flu vaccine shortage by boosting production capacity, suggests research* published online today in the British Journal of Clinical Pharmacology.

The currently licensed seasonal trivalent influenza vaccines contain 15 micrograms of haemagglutinin per strain for an adult, and up to 60 micrograms for elderly patients.

But prompted by recent vaccine shortages, researchers wanted to find out if immune response was governed by dose in 256 adult and elderly patients (60+).

Participants were randomly assigned in a 1:1:1:1 ratio to receive a whole virion, aluminium trivalent influenza vaccine, with the addition of adjuvant, containing 3.5, 6, 9 or 15 micrograms of hemagglutinin of seasonal A/H1N1, A/H3N2, and B influenza antigens.

Whole virion vaccines contain whole virus, not just hemagglutinin, as in most human flu vaccines. Adjuvants help to boost the immune response.

Antibody response to the virus strains was measured by the extent of hemagglutinatin inhibition.

All the vaccines were well tolerated. All four vaccines fulfilled all the licensing criteria for effectiveness for all three virus strains and in both age groups.

However, the 3.5 microgram vaccine was 28% less effective than the 15 microgram dose in terms of influenza AH3N2 among adults, which the researchers say is somewhat surprising, but suggest that it might be explained by higher exposure rates to H3N2 during the 1968 pandemic among the older participants.

But there were no significant differences in immune response for all the other doses compared with the licensed 15 microgram vaccine.

“We therefore conclude that no clear dose-response relationship exists between 6 – 15 micrograms of hemagglutinin per strain for immunogenicity for the seasonal trivalent influenza vaccine studied in the present trial in adult or elderly patients,” write the researchers.

“Our data suggest that significant dose sparing is possible with the use of whole virion vaccines and aluminium adjuvants, without compromising safety,” they say, adding that the findings could have major economic and public health implications.

“Based on our results, a new, reduced dose seasonal vaccine is being licensed in the European Union member state in Hungary, which will impact production capacities and ultimately, vaccine availability to patients,” they comment.

* Vajo Z, Balaton G, Vajo P, et al. Dose sparing and lack of dose response relationship with an influenza vaccine in adult and elderly patients - a randomised, double-blind clinical trial. British Journal of Clinical Pharmacology, 5 April 2017. DOI: 10.1111/bcp.13289

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