This note is not part of the order, but is intended to indicate its general effect.

This order is made under the Epidemic Preparedness Act 2006. It comes into force on 3 February 2022 and is revoked when the Epidemic Preparedness (COVID-19) Notice 2020 expires or is revoked. It revokes and replaces the Epidemic Preparedness (Medicines Act 1981—COVID-19) Immediate Modification Order 2021 (the 2021 Modification Order) and modifies the requirements imposed by the Medicines Act 1981 (the Act) to enable the effective management of COVID-19 or its effects (or both).

The modifications to section 25 of the Act facilitate the administration by persons other than authorised prescribers of a third dose of the Pfizer/BioNTech (Comirnaty, Tozinameran, BNT162b2) (the COVID-19 Pfizer vaccine) at a dose interval of 3 months, rather than the current approved period of 4 months (as currently modified by the 2021 Modification Order). This is to ensure that third doses of the COVID-19 Pfizer vaccine are more accessible to the public and to continue the 2021 Modification Order’s intention that these doses can be provided by a wider vaccinator workforce in order to mitigate the public health risk posed by COVID-19.

Clause 4 modifies the requirement in section 25 of the Act that only an authorised prescriber may administer or procure the administration of medicines (in this case, the COVID-19 Pfizer vaccine). New section 25(4) provides that the Director-General of Health may, by written notice, authorise a person or class of persons (vaccinators) to administer the COVID-19 Pfizer vaccine to a person who is aged 18 years or older, and who received their second dose of the COVID-19 Pfizer vaccine at least 3 months before the date on which the third dose is administered to that person. New section 25(5) clarifies that a vaccinator does not require a prescription in order to administer or procure a third dose. New section 25(7) provides that, to avoid doubt, a third dose of the COVID-19 Pfizer vaccine administered or procured in accordance with new section 25(4) is not to be considered a new medicine for the purposes of its administration or procurement by a vaccinator.