Obstetricians and gynaecologists in the United States under the umbrella of American College of Obstetricians and Gynaecologists say that individuals — including pregnant women — considering a COVID-19 vaccine should have access to available information about the safety and efficacy of the vaccine.
The maternal health experts said COVID-19 vaccines should not be withheld from pregnant individuals, though none of the COVID-19 vaccines approved under the Emergency Use Authorisation by the US Food and Drug Administration was tested on pregnant individuals.
This is even as renowned professor of virology and former Vice-Chancellor of the Redeemer’s University Nigeria, Oyewole Tomori, called for caution, saying pregnant women were exempted from the trial based on the spectrum of the virus.
The FDA issued an Emergency Use Authorisation for both the Moderna and Pfizer-BioNtech vaccines.
The Pfizer-BioNtech mRNA vaccine is approved for use in individuals age 16 years and older as a two-dose regimen given three weeks (21 days) apart.
Moderna mRNA-1273 vaccine is approved for use in individuals age 18 and older as a two-dose regimen given one month (28 days) apart.
The gynaecologists in their latest update on COVID-19 vaccines and guidance for their use in pregnant individuals published on ACOG website, said that COVID-19 vaccine development and regulatory approval are rapidly progressing.
They stated that pregnant individuals who meet criteria for vaccination based on
Advisory Committee on Immunisation Practices recommended priority group should have access to the vaccine.
Those under ACIP recommended priority group include healthcare workers, persons aged 75 years and frontline essential workers, persons aged 16-64 years with high-risk medical conditions (including pregnancy), and other essential workers.
The gynaecologists explained, “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.
“Important considerations include: the level of activity of the virus in the community, the potential efficacy of the vaccine, the risk and potential severity of maternal disease, including the effects of disease on the foetus and newborn. The safety of the vaccine for the pregnant patient and the foetus.
“While a conversation with a clinician may be helpful, it should not be required prior to vaccination, as this may cause unnecessary barriers to access.
“Vaccines currently available under EUA have not been tested in pregnant women. Therefore, there are no safety data specific to use in pregnancy.”
The maternal health experts pointed out that pregnancy testing should not be a requirement prior to receiving any EUA-approved COVID-19 vaccine.
“Pregnant patients who decline vaccination should be supported in their decision.
“Regardless of their decision to receive or not receive the vaccine, these conversations provide an opportunity to remind patients about the importance of other prevention measures such as hand washing, physical distancing, and wearing a mask.
“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.
“The mRNA vaccines are not live virus vaccines, nor do they use an adjuvant to enhance vaccine efficacy.
“These vaccines do not enter the nucleus and do not alter human DNA in vaccine recipients. As a result, mRNA vaccines cannot cause any genetic changes”,they said .
The gynaecologists argued that available data suggest that symptomatic pregnant patients with COVID-19 are at increased risk of more severe illness compared with nonpregnant peers.
“Pregnant patients with comorbidities such as obesity and diabetes may be at an even higher risk of severe illness consistent with the general population with similar comorbidities”, they noted.
A renowned professor of virology and former Vice-Chancellor of the Redeemer’s University Nigeria, Oyewole Tomori, called for caution, saying pregnant women were exempted from the trial based on the spectrum of the virus.
“It is hard to tell how they will react, hence the need to look at the spectrum of the infection – those who are affected and age groups. On the strength of that, children and pregnant women are not usually included.
“It is only when it works in other age groups that we can subsequently begin to look at them. We have to be very careful because the virus is something new and we don’t know what may happen.
“We always want to take extra precaution to be sure the foetus is not affected. The same applies to children,” Tomori said.
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