Revised:  26 July 2019

Committees

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:

• improved convenience for the public to obtain vaccines
• improved vaccination coverage
• easier access
• decreased strain on primary health care.

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.

You can search for data sheets of approved vaccines on the Medsafe website. The classification of a product is described in section 7 of the data sheet.

To Date

The following vaccines have been considered for reclassification:

• Oral Vibrio cholerae and enterotoxigenic Escherichia coli vaccine
• Influenza vaccine
• Diphtheria, tetanus and pertussis (acellular, component) vaccine
• Meningococcal vaccine
• Varicella (shingles) vaccine.

Vibrio cholerae and enterotoxigenic Escherichia coli vaccine

The reclassification of oral Vibrio cholerae and enterotoxigenic Escherichia coli vaccine was considered at the 46^th 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:

• prescription medicine; except in the form of an oral liquid containing inactivated Vibrio cholerae and / or its subunits when sold in a pharmacy by a registered pharmacist.

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:

• prescription medicine; except when administered to a person 18 years of age or over by a registered pharmacist who has successfully completed a vaccinator training course approved by the Ministry of Health and who is complying with the immunisation standards of the Ministry of Health.

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

Diphtheria, tetanus and pertussis (acellular, component) vaccine (Tdap) was considered for reclassification at the 48^th MCC meeting on 30 October 2012, the 49^th meeting on 17 June 2013, and the 50^th 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:

• prescription medicine; except when administered in a single dose to a person 18 years of age or over or to a pregnant woman aged 13 years and over by a registered pharmacist who has successfully completed a vaccinator training course approved by the Ministry of Health and who is complying with the immunisation standards of the Ministry of Health.

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 49^th MCC meeting on 17 June 2013 and the 50^th 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:

• prescription medicine; except when administered to a person 16 years of age or over by a registered pharmacist who has successfully completed a vaccinator training course approved by the Ministry of Health and who is complying with the immunisation standards of the Ministry of Health.

Varicella (shingles) vaccine

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

• prevention of herpes zoster (shingles)
• prevention of postherpetic neuralgia (PHN)
• the reduction of acute and chronic zoster-associated pain.

Varicella vaccine is now classified as:

• prescription medicine; except when administered for the prevention of herpes zoster (shingles) to a person 50 years of age or over by a registered pharmacist who has successfully completed a vaccinator training course approved by the Ministry of Health and who is complying with the immunisation standards of the Ministry of Health.

The classification entry for ‘varicella vaccine’ does not include vaccines that contain the substance recombinant varicella zoster virus glycoprotein E antigen. Recombinant varicella zoster virus glycoprotein E antigen was classified as a prescription medicine following recommendations from the MCC at the 60^th meeting in April 2018.