TGA approves Pfizer vaccine in under-fives

The Therapeutic Goods Administration (TGA) this week provisionally approved a paediatric dose of Pfizer’s COVID-19 vaccine, COMIRNATY (tozinameran), for children aged six months to less than five years. As seen with older age groups, it is expected that vaccines for younger children will provide protection from the most severe COVID-19 outcomes, such as hospitalisation and death.

The TGA’s decision follows provisional approval for the use of COMIRNATY for immunisation as a primary course to prevent COVID-19 in individuals five years and older on 3 December 2021, and as a booster dose in individuals five years and older on 20 September 2022. The paediatric vaccine is made in the same way as the vaccines for older persons but contains a lower amount of active ingredient.

In making this regulatory decision, the TGA carefully considered data from an ongoing clinical study conducted in the United States. The study, which included over 4500 participants aged six months to five years, demonstrated that the immune response to the vaccine was similar to that seen in children aged five to 12 years. The study also showed that the safety profile in children was similar to that seen in adults with observed side effects being mild. The vaccine’s approval was also informed by expert advice from the Advisory Committee on Vaccines, an independent committee with expertise in scientific, medical and clinical fields including consumer representation.

As with all COVID-19 vaccines, the federal government’s decision on the use of this vaccine in this age group will be informed by advice from the Australian Technical Advisory Group on Immunisation (ATAGI), which will be forthcoming; ATAGI is also yet to approve COMIRNATY as a booster in children five and over. That said, ATAGI did recently issue a recommendation that children who are aged six months to under five years should get vaccinated against COVID-19 if they have certain health conditions or disability which increase their risk of getting very sick from COVID-19. Moderna’s Spikevax vaccine is already approved for young children with the following or similar conditions:

• severe primary or secondary immunodeficiency, including those undergoing treatment for cancer, or on immunosuppressive treatments as listed in the ATAGI advice on third primary doses of COVID-19 vaccine in individuals who are severely immunocompromised
• bone marrow or stem cell transplant, or chimeric antigen T-cell (CAR-T) therapy
• complex congenital cardiac disease
• structural airway anomalies or chronic lung disease
• Type 1 diabetes mellitus
• chronic neurological or neuromuscular conditions, or
• a disability that requires frequent assistance with activities of daily living, such as severe cerebral palsy or Down syndrome (Trisomy 21).
   

ATAGI also recently approved Moderna’s new bivalent booster as an option in people aged 18 years and older for the first or second booster dose (ie, the third or fourth dose for most people), along with the other registered COVID-19 vaccines. This is the first bivalent COVID-19 vaccine approved for use in Australia, triggering an immune response against two different COVID-19 variants — the original virus and the BA.1 Omicron variant — and is anticipated to induce a broad immune response to current SARS-CoV-2 variants. ATAGI says that any person who has not yet received their recommended first or second COVID-19 booster should address this soon, using either the Moderna bivalent booster or an alternative original vaccine.

Image credit: iStock.com/mixetto

Please follow us and share on Twitter and Facebook. You can also subscribe for FREE to our weekly newsletters and bimonthly magazine.