No COVID-19 vaccine tested on pregnant women, gynaecologists say

Angela Onwuzoo

Obstetricians and gynaecologists in the United States under the umbrella of American College of Obstetricians and Gynaecologists have said that despite their persistent advocacy for the inclusion of pregnant individuals in COVID-19 vaccine trials, none of the COVID-19 vaccines approved under the Emergency Use Authorisation by the US Food and Drug Administration has been tested on pregnant individuals.

The US FDA had, on December 11, 2020 issued an EUA for the Pfizer-BioNtech mRNA vaccine for use in individuals age 16 years and older as a two-dose regimen given three weeks apart.

The vaccine, according to the manufacturer, has been shown to be 95 per cent effective at preventing COVID-19 illness after the second dose.

The concern of the gynaecologists was published on the college’s website in their latest practice advisory titled, ‘Vaccinating pregnant and lactating patients against COVID-19.’

They said, “Despite ACOG’s persistent advocacy for the inclusion of pregnant individuals in COVID-19 vaccine trials, none of the COVID-19 vaccines approved under EUA have been tested in pregnant individuals. However, studies in pregnant women are planned.

“Data from Developmental and Reproductive Toxicity studies for the Pfizer-BioNtech COVID-19 vaccine are anticipated in mid-December, according to the manufacturer.

“From what has been communicated so far regarding these forthcoming data, there have not been any major safety signals identified. These animal model studies provide the first safety data to help inform the future of clinical trials in pregnancy. “

Pointing out that the development and use of mRNA vaccines is relatively new, the gynaecologists, however, said, “Based on the mechanism of action of these vaccines and the demonstrated safety and efficacy in Phase II and Phase III clinical trials, it is expected that the safety and efficacy profile of the vaccine for pregnant individuals would be similar to that observed in non-pregnant individuals.

“That said, there are no safety data specific to mRNA vaccine use in pregnant or lactating individuals and the potential risks to a pregnant individual and the fetus are unknown.”

The gynaecologists had in July called for the inclusion of pregnant patients with COVID-19 in the clinical trials for a vaccine for the viral infection.

Commenting on the side effects, the maternal health experts said, “Expected side effects should be explained as part of counseling patients, including that they are a normal part of the body’s reaction to the vaccine and developing antibodies to protect against COVID-19 illness.

“Clinicians should review the available data on risks and benefits of vaccination with pregnant patients, including the risks of not getting vaccinated in the context of the individual patient’s current health status, and risk of exposure, including the possibility for exposure at work or home and the possibility for exposing high-risk household members.”

On whether pregnant and lactating mothers could take the COVID-19 vaccine, the gynaecologist said, “ACOG recommends that COVID-19 vaccines should not be withheld from pregnant individuals who meet criteria for vaccination based on Advisory Committee on Immunization Practices-recommended priority groups.

“While safety data on the use of COVID-19 vaccines in pregnancy are not currently available, there are also no data to indicate that the vaccines should be contraindicated, and no safety signals generated from DART studies for the Pfizer-BioNtech vaccine.

“Therefore, in the interest of allowing pregnant individuals who would otherwise be considered a priority population for a vaccine approved for use under EUA, make their own decisions regarding their health, ACOG recommends that pregnant individuals should be free to make their own decision in conjunction with their clinical care team.

“Individuals considering a COVID-19 vaccine should have access to available information about the safety and efficacy of the vaccine, including information about data that are not available.

“A conversation between the patient and their clinical team may assist with decisions regarding the use of vaccines approved under EUA for the prevention of COVID-19 by pregnant patients.”

“ACOG recommends COVID-19 vaccines be offered to lactating individuals similar to non-lactating individuals when they meet criteria for receipt of the vaccine based on prioritization groups outlined by the ACIP. While lactating individuals were not included in most clinical trials, COVID-19 vaccines should not be withheld from lactating individuals who otherwise meet criteria for vaccination”, they added.

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