Pfizer approved for teens, pregnant women added to Phase 1b

The Therapeutic Goods Administration (TGA) has announced its provisional approval of the use of the Pfizer COVID-19 vaccine in individuals 12 years and older. Previously, the vaccine was provisionally approved for use in individuals 16 years or older.

The TGA said provisional approval has been made following careful evaluation of the available data supporting safety and efficacy, including clinical studies with adolescents 12 to 15 years of age. Use in this age group was supported by the independent expert Advisory Committee on Vaccines.

“The Therapeutic Goods Administration (TGA) has thoroughly, and independently, assessed the domestic and international evidence before extending its approval for the Pfizer vaccine to be administered to this age group,” Minister for Health Greg Hunt said. This includes a recent study on over 2000 12- to 15-year-olds that found the vaccine had a favourable safety profile, with most participants only experiencing mild side effects and no cases of COVID-19 detected in those participants that received two injections of the vaccine 21 days apart.

Commenting on the news, Professor Fiona Russell, a Principal Research Fellow focusing on infection and immunity at the Murdoch Children’s Research Institute, noted that a rare side effect has been detected in teenage recipients in the US and Canada, in which the heart muscle (myocarditis) or lining (pericarditis) can become inflamed.

“It mostly occurs in young men and teenage boys within one week after the second dose,” Prof Russell said. “While more common than the TTS side effect seen with AstraZeneca, it is still rare and far less severe … Doctors will be on alert for symptoms in children (and young adults) who have received Pfizer, particularly after the second dose. Symptoms include chest pain and shortness of breath.”

The Australian Technical Advisory Group on Immunisation (ATAGI) will now consider the provisional approval and provide expert advice on which groups of adolescents should be prioritised for the rollout of the vaccine. The National COVID-19 Vaccines Taskforce has meanwhile been undertaking detailed planning to support the rollout of the COVID-19 vaccine for children, following an approval from the TGA and in line with the expert medical advice from ATAGI.

Meanwhile, ATAGI Co-Chair Allen Cheng has told a Senate committee that pregnant women are now included in Phase 1b of the federal government’s COVID-19 vaccine rollout.

ATAGI, together with the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG), last month recommended that pregnant women are routinely offered the Pfizer vaccine at any stage of pregnancy, as the risk of severe outcomes from COVID-19 is significantly higher for pregnant women and their unborn children. But because most Australian adults under 40 are still ineligible for Pfizer vaccination, many pregnant women remained unable to access the vaccine — until today, when they were officially added to the Phase 1b priority group.

“There have now been quite large studies that have looked at the safety of COVID vaccines in pregnancy, as well as further data about the risks of COVID to pregnant women,” said Cheng.

“That risk benefit is now more clearly on the side of getting pregnant women vaccinated. So pregnant women are now in Phase 1b.”

A bulletin explaining the inclusion of pregnant women in the phase has now been sent out to general practitioners.

Image credit: ©stock.adobe.com/au/Seventyfour

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