Key points
- The TGA has approved the Pfizer-BioNTech COVID-19 vaccine for use in Australia.
- There are some concerns due to a lack of data on the vaccine's effects on pregnancy.
- The government says it expects the advice from ATAGI on vaccine safety for pregnancy to be available before inoculations begin.
Erica Romano is half-way through her pregnancy, and after doing her own research, she has decided against receiving the COVID-19 vaccine.
“I am not confident enough tests have been carried out to understand the effects the vaccine on pregnant women and unborn babies," she says.
Amy Lombardo is also pregnant and desperate for more information on the vaccine.
"My doctor did not give me any advice,” she tells SBS Italian. "I feel like I have been left in the dark without clear information helping me making a decision; therefore, I will not get vaccinated."
Because the COVID-19 vaccines weren’t tested on pregnant women in clinical trials, there’s insufficient information about the vaccines’ effects on pregnant women and foetuses.
Australia’s chief medical officer Dr Paul Kelly said more information would likely become available from other countries later this year.
“Pregnant women are the key question for our regulator, the TGA to look at. We know that most of the time with clinical trials, they exclude women who are pregnant or breastfeeding. But some of that information will come from the rollouts of these vaccines, in their millions, right now across the world. So, we'll have that data, but probably later in the year,” he said at a recent media conference.
The Therapeutic Goods Administration on Monday has approved the Pfizer-BioNTech vaccine for use in Australia. The federal government aims to start the national vaccination program in late February with 10 million doses of the Pfizer vaccine for the priority group.
The World Health Organisation, earlier this month, said it did not recommend the Pfizer-BioNTech vaccine for pregnant women due to “insufficient data”.
Source: Courtesy of Martina Maver
In the UK, the Joint Committee on Vaccination and Immunisation says though the available data do not indicate any safety concern for pregnancy, there is insufficient evidence to recommend routine use of COVID-19 vaccines during pregnancy.
The JCVI advises that Pfizer or AstraZeneca COVID-19 vaccines in pregnancy should be considered only if the risk of contracting COVID-19 is high and cannot be avoided or in case of underlying conditions that may result in serious complications of COVID-19.
Health Department Secretary Prof Brendan Murphy said on Monday that the government is waiting for advice on the vaccine's safety for pregnancy.
"Theoretically, the risk of this vaccine - Pfizer - or AstraZeneca, on pregnancy is very low. You know that the UK and the US have different recommendations about pregnancy, we will be getting advice from ATAGI (Australian Technical Advisory Group on Immunisation) - advice that's just going to be based on the best guess of what the risks are at the moment, and that's coming very shortly before the vaccine is administered.
Besides the ten million Pfizer doses, Australia has secured 54 million doses of Oxford-AstraZeneca COVID-19 vaccine, neither of which has been tested on pregnant women.
Despite the uncertainty about safety, some women are supportive of the vaccine.
Martina Maver, a Sydney mother who recently gave birth to her first daughter, is among them.
Source: Courtesy of Erica Romano
“I believe in medicine. If I were still pregnant and the vaccine was made available, I would choose to receive it. In my view, being vaccinated protects my daughter and my elderly parents,” she told SBS Italian.
“I will get the vaccine as soon as the government starts rolling it out in Australia, even if I’m still breastfeeding.”
Another pregnant woman Marta Fossati has made her mind to get vaccinated after speaking to a doctor in Italy.
“Unable to find clear information, I asked my doctor in Italy, Professor Augusto Enrico Semprini. He is a specialist in obstetrics and gynaecology, clinical immunology and allergy. He provided clear information which convinced me about the vaccine," she said.
Professor Semprini says a doctor should give clear advice so that the patient can make a decision.
“Statements such as 'I'll tell you then you decide' is contrary to the responsibility I feel I have towards pregnant women who have entrusted me with the protection of their health and their unborn child,” he said.
To the many women who have asked Prof Semprini if it was safe for them to receive COVID-19 vaccine during pregnancy, he responded in a resounding 'yes'.
Source: Courtesy of Marta Fossati
"Yes, because this infection exposes young people, like pregnant women, to a demanding clinical course that can endanger the patient's life," he told SBS Italian.
On the other hand, Dr Luis Izzo, gynaecologist and obstetrician at Royal Prince Alfred Hospital, sounds a word of caution, not just for women who are pregnant but also for those who may be planning to conceive.
"Since there is not enough information about the safety of the vaccines for pregnant women, they are excluded from vaccination at the moment," he says. “To be absolutely sure, even someone who is planning a pregnancy should wait at least two months after receiving the jab before trying to conceive.”
