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Published: 14 January 2016

Reclassification of vaccines

Background

Since 2011, several vaccines have been considered by the Medicines Classification Committee (MCC), and reclassified from prescription medicines to restricted medicines when administered by a registered Pharmacist who has successfully completed a vaccinator training course approved by the Ministry of Health, and is complying with the immunisation standards of the Ministry of Health.

Pharmacist vaccination has several benefits:

Pharmacist vaccination offers an opportunity for pharmacists to develop new skills and practice at the top of their scope.

Increasing Pharmacist administration of vaccines is an international trend. Pharmacist vaccinations take place in the United States, the United Kingdom, Ireland, Canada, and Portugal.

Pharmacist vaccinators will be required to successfully complete a Ministry of Health approved vaccinator’s course and meet the requirements in standards set by the Ministry of Health. Vaccinator training, available through the Immunisation Advisory Centre, is comprehensive, and involves a choice of a two-day course or a flexible learning course, requiring 12 hours self-guided study followed by a four hour face-to-face clinical tutorial. To become authorised, the person must complete the training, achieve a pass mark of 80% on an open book test, and be clinically assessed on a minimum of two vaccinations relevant to their clinical area. Updates for trained vaccinators can be either four hours face-to-face or conducted on-line every two years. Alternatively, Pharmacists wishing to administer influenza vaccines only can attend a one-day influenza only course and clinical assessment.

Not all vaccine products referred to in this article will be available in pharmacies. Some sponsors may need to modify the indications of their product to align with the permissions, and some sponsors may not distribute the medicines to New Zealand pharmacies.

To Date

The following vaccines have been considered for reclassification:

Vibrio cholerae and enterotoxigenic Escherichia coli vaccine

The reclassification of oral Vibrio cholerae and enterotoxigenic Escherichia coli vaccine was considered at the 46th MCC meeting on 15 November 2011.

The oral Vibrio cholerae and enterotoxigenic Escherichia coli vaccine provides active cholera immunisation for adults and children from two years of age. The application sought to reclassify oral Vibrio cholerae and enterotoxigenic Escherichia coli vaccine from prescription medicine to restricted medicine to increase access to the vaccine, particularly for foreign aid workers and others intending to visit or spend an extended period of time in areas in which cholera infection is a risk.

The MCC recommended that oral Vibrio cholerae and enterotoxigenic Escherichia coli vaccine should be reclassified dependant on appropriate educational material being produced and a campaign for pharmacists being established, which it since has.

Cholera vaccine is now classified as:

An example of a Medsafe approved oral Vibrio cholerae and enterotoxigenic Escherichia coli vaccine is Dukoral. Further information about Dukoral can be found on the company datasheet (pdf 37KB).

Influenza vaccine

The reclassification of Influenza vaccine was considered at the 47th MCC meeting on 1 May 2012 and the 48th meeting on 30 October 2012. The primary aim of the reclassification was to increase the access and convenience of obtaining an influenza vaccination, in order to increase uptake by the general population and reduce the healthcare burden of influenza.

The Committee recommended that Influenza vaccine be reclassified for the prophylaxis against influenza in adults. Influenza vaccine is now classified as:

Examples of approved influenza vaccines are shown below. Information about these vaccines can be found on the company datasheets.

Influvac Suspension for injection (pdf 35KB)

Intanza Suspension for injection (pdf 259KB)

Fluarix Suspension for injection (pdf 75KB)

Fluvax vaccine Suspension for injection (pdf 84KB)

Vaxigrip vaccine Solution for injection (pdf 91KB) 

Diphtheria, tetanus and pertussis (acellular, component) vaccine (Tdap)

Diphtheria, tetanus and pertussis (acellular, component) vaccine (Tdap) was considered for reclassification at the 48th MCC meeting on 30 October 2012, the 49th meeting on 17 June 2013, and the 50th meeting on 12 and 13 November 2013. Tdap is for the prophylaxis against whooping cough, tetanus and diphtheria in people 16 years of age or older as a booster vaccine (not for primary vaccination).

The primary aim of the reclassification was to increase the access and convenience of Tdap booster vaccination in order to increase uptake by adults in close contact with infants. This includes parents, grandparents, health workers, and caregivers, to reduce the risk of whooping cough in infants in their first year of life, which is the most vulnerable age group for this disease.

Diphtheria, tetanus and pertussis (acellular, component) vaccine is now classified as:

Examples of approved Tdap vaccines are Adacel, Boostrix and Tdap-Boostrix. Information on these vaccines can be found on the company datasheets.

Adacel Suspension for injection (pdf 138 KB)

Boostrix Suspension for injection (pdf 98 KB)

Tdap-Boostrix Suspension for injection (pdf 179  KB)

Note: The reclassification does not apply to paediatric vaccines (containing the same antigens but at increased levels) that are indicated for primary immunisation of infants eg, Infanrix and Tripacel. These vaccines remain prescription-only, and should not be administered to adults.

Meningococcal vaccine

An application for the reclassification of Meningococcal vaccine was considered at the 49th MCC meeting on 17 June 2013 and the 50th meeting on 12 and 13 November 2013, for the prevention of invasive meningococcal disease in people aged 16 years and older.

The primary aim of this reclassification was to reduce the incidence, morbidity, and mortality from meningococcal invasive disease, primarily in at-risk adolescents, by increasing access to the vaccine.

Meningococcal vaccine is now classified as:

Examples of meningococcal vaccines are shown below. Further information about these vaccines can be found on the company datasheets.

Menactra Solution for injection (pdf 210KB)

Mencevax ACWY vaccine Suspension for injection (pdf 113KB)

Meningitec Suspension for injection (pdf 221KB)

Menomune ACYW-135 vaccine Injection with diluent (pdf 88KB)

NeisVac-C vaccine Suspension for injection (pdf 140KB)

Varicella (shingles) vaccine

Varicella (shingles) vaccine was considered for reclassification at the 50th MCC meeting on 12 and 13 November 2013 for the following in individuals 50 years of age and over:

Varicella vaccine is now classified as:

An example of an approved varicella vaccine for this indication is Zostavax.

Further information about Zostavax can be found on the company datasheet (pdf 78KB).

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