The European Medicines Agency (EMEA) has approved GlaxoSmithKline's "Pandemrix" and Novartis' "Focetria" H1N1 vaccines for use for adults and children from 6 months up as well as pregnant women. The current product characteristics can be downloaded through the EMEA, here (Pandemrix) and here (Focetria). The Committee is recommending a two shot series, three weeks apart for all vaccinees, although clinical trials of other H1N1 vaccines have recently shown one shot to be effective in most vaccinees older than 10 years.
The UK has made provisions to acquire 132 million doses of the GSK vaccine. The following 2 vaccines have been approved by the EMEA
Description: Pandemrix is a suspension and emulsion for injection, meaning fluid from 2 vials must be mixed to form a multidose container that stays usable for 24 hours.
After mixing, 1 dose (0.5 ml) contains: Split influenza virus, inactivated, containing 3.75 µg A/California/7/2009 (H1N1)v-like strain (X-179A) (haemagglutinin ) (propagated in eggs). AS03 adjuvant composed of squalene (10.69 mg), DL-α-tocopherol (11.86 mg) and polysorbate 80 (4.86 mg). The suspension (2.5ml) and emulsion (2.5ml) vials once mixed form a multidose container (10 doses) containing 5 micrograms thiomersal (0.5 µg per dose). There does not seem to be a single dose container planned for Pandemrix at this time.
Indications and Usage: H1N1 Pandemrix is indicated for the active immunisation of individuals 18 years and up against influenza disease caused by pandemic (H1N1) 2009 virus. Adults aged 18-60 years of age, one dose can be given although 2 doses are recommended at an interval of 3 weeks between the first and second doses. Adults >60 years old should receive 2 doses, 3 weeks apart.
Children 6 months to 17 years may receive this vaccine if medically indicated: Children and adolescents aged 10-17 years: If vaccination is considered to be necessary, consideration may be given to dosing in accordance with the recommendations for adults. However, the choice of dose for this age group should take into account the available data on safety and immunogenicity in adults and in children aged from 3-9 years. See sections 4.8 and 5.1.
Children aged 3-9 years: If vaccination is considered to be necessary, the available data suggest that administration of 0.25 ml of vaccine (i.e. half of the adult dose) at an elected date and a second dose administered at least three weeks later may be sufficient.
There are very limited safety and immunogenicity data available on the administration of AS03-adjuvanted vaccine containing 3.75 μg HA derived from A/Vietnam/1194/2004 (H5N1) and on administration of half a dose of the same vaccine (i.e. 1.875 μg HA and half the amount of AS03 adjuvant in 0.25 ml ) at 0 and 21 days in this age group.
See sections 4.8 and 5.1.
Children aged from 6 months to 3 years: If vaccination is considered to be necessary, consideration may be given to dosing in accordance with the recommendation in children aged 3-9 years.
Contraindications: History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues (egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate and sodium deoxycholate) of this vaccine. If vaccination is considered to be necessary, facilities for resuscitation should be immediately available in case of need. Please consult the full package insert for other warnings and precautions.
Clinical Trials: There are numerous phase II and III trials listed here although it is unclear the antigen concentrations and adjuvanted or non-adjuvanted vaccines used.
Safety and Efficacy: Clinical data from trials are not yet available.
Description: Focetria comes as a suspension for injection in pre-filled syringes. It is an H1N1 pandemic influenza vaccine (surface antigen, inactivated, adjuvanted) containing (per 0.5ml dose) haemagglutinin and neuraminidase 7.5 µg (expressed in µg haemagglutinin) from A/California/7/2009 (H1N1)v like strain (X-179A) virus propagated in eggs. The adjuvant MF59C.1 contains 9.75 mg squalene, 1.175 mg polysorbate 80, and 1.175 mg sorbitan trioleate. Other excipients include: sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, sodium citrate, citric acid and water. The single dose vial comes in a thimerosal free formulations of pre-filled syringes.
Indications and Usage: Novartis H1N1 monovalent vaccine is indicated for adults 18 years and older with 2 doses given at a ≥ 3 week interval. Children between the ages of 6 months and 17 years can also receive this vaccine with 2 doses given at a ≥ 3 week interval.
Contraindications: History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues (egg and chicken proteins, ovalbumin, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB)) of this vaccine. If vaccination is considered to be necessary, facilities for resuscitation should be immediately available in case of need. Please consult the full package insert for other warnings and precautions.
Clinical Trials: Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children (3 to less than 9 years old) is a randomized, single blind, dose comparison, single group assignment, safety/efficacy study. The anticipated primary outcome date is November, 2009. Immunogenicity, safety and tolerability of 2 doses of adjuvanted and non-adjuvanted swine origin A/H1N1 Monovalent Influenza Vaccine (egg-derived) in healthy subjects from 6 months to 17 years of age is a randomized, single blind, uncontrolled, parallel assignment, safety/efficacy study. The anticipated study completion date is April, 2011, but the primary outcome data will be completed in November, 2009. More trials can be found here.
Safety and Efficacy: Titers of the hemagglutination-inhibition antibody exceeded 1:32 in 88% of subjects who had received one vaccine dose by this time and in 92 to 100% of subjects who had received both doses (Figure 2A). All subjects had microneutralization antibody at a titer exceeding 1:40 by day 21 (Figure 2B).
Edited 30 November 2009