NEW YORK (NYTIMES) – In its emergency authorisation of the Pfizer-BioNTech vaccine on Friday (Dec 11) night, the Food and Drug Administration took an unexpected step, leaving open the possibility that pregnant and breastfeeding women may opt for immunisation against the coronavirus.
The agency authorised the vaccine for anyone 16 and older, and asked Pfizer to file regular reports on the safety of the vaccine, including its use in pregnant women.
There had been no guarantee that the agency would take this route. The vaccine was not tested in pregnant women or in those who were breastfeeding.
Regulators in Britain recommended against these women receiving the shots even while acknowledging that the evidence so far “raises no concerns for safety in pregnancy”.
The Centres for Disease Control and Prevention has not yet endorsed the vaccine for pregnant women, but an advisory committee to the agency is expected to meet this weekend to make further recommendations.
Some experts said the virus itself poses greater risks to pregnant women than the new vaccine, and noted that vaccines have been given to pregnant women for decades and have been overwhelmingly safe.
“This is a really huge step forward in recognising women’s autonomy to make decisions about their own healthcare,” said Dr Emily Miller, an obstetrician at Northwestern University and a member of the Covid-19 task force of the Society for Maternal and Fetal Medicine (SMFM).
With the first doses of the vaccine reserved for healthcare workers and residents of long-term care facilities, the FDA’s authorisation most immediately affects the estimated 330,000 pregnant and breastfeeding healthcare workers in the US.
“I am incredibly supportive of the FDA’s decision to leave the door open to Covid-19 vaccination for pregnant and lactating workers,” said bioethicist Ruth Faden at Johns Hopkins University in Baltimore.
Some healthcare workers are at high risk of Covid-19, either because their jobs bring them into intense contact with the virus – for example, cleaning the rooms of sick patients – or because they live in low-income and multigenerational homes, she said.
“We have to be able to give women the opportunity to think through this for themselves with whoever it is providing obstetrical care to them,” she said.
Healthcare organisations should also help their employees weigh the risks and accommodate women who do not feel comfortable working on the front lines, she added.
None of the vaccine clinical trials have so far included pregnant or lactating women, nor even women who are planning to get pregnant; some trials are expected to begin in January.
Still, the American College of Obstetrics and Gynecology (ACOG), the SMFM and other organisations have been calling on the FDA to allow pregnant and lactating people access to the vaccine.
At a meeting on Thursday to review Pfizer’s data for an emergency use authorisation, Dr Doran Fink, the FDA’s deputy director for vaccine development, signaled that the agency was open to the idea.
“We really have no data to speak to risks specific to the pregnant women or the fetus, but also no data that would warrant a contraindication to use in pregnancy at this time,” Dr Fink said.
“Under the EUA, they would be then free to make their own decision in conjunction with their healthcare provider.”
The EUA did not endorse the vaccine for pregnant or breastfeeding women, other than to note that Pfizer should collect long-term data on how the vaccine performs in pregnant women.
Since the 1960s, pregnant women have been urged to receive vaccines against influenza and other diseases. These women are generally cautioned against live vaccines, which contain weakened pathogens.
Even so, the benefits of live vaccines outweigh the risks in some situations, said Dr Denise Jamieson, an obstetrician at Emory University in Atlanta and a member of ACOG’s committee on Covid-19 vaccines.
“We have a long track record of giving pregnant women vaccinations, and nearly all vaccinations are very safe,” Dr Jamieson said.
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