Are the new COVID vaccines safe in pregnancy?


My email and Facebook messages are filled with the same question over and over again:

Are the new COVID vaccines safe for use in pregnancy?

I don’t know … and the truth is that no one knows.

The truth is that no one knows.

Yet the American College of Obstetrician Gynecologists (ACOG) is recommending the vaccine for pregnant persons.

They have issued the following guidance:

ACOG recommends that COVID-19 vaccines should not be withheld from pregnant individuals who meet criteria for vaccination based on ACIP-recommended priority groups.

My personal view is that ACOG has been too quick in issuing recommendations. They risk their credibility — and in a climate of active vaccine skepticism in the US — the credibility of all vaccine recommendations by getting out ahead of the data.

I’m not sure why they felt the need to make any recommendation at this time. The latest information in their own journal suggests a more cautious approach.

According to Coronavirus Disease 2019 (COVID-19) Vaccines and Pregnancy; What Obstetricians Need to Know:

Because pregnant persons were excluded from the initial phase 3 clinical trials of COVID-19 vaccines, limited data are available on their efficacy and safety during pregnancy. After developmental and reproductive toxicology studies are completed, some companies are expected to conduct clinical trials in pregnant persons. Until then, pregnant persons and their obstetricians will need to use available data to weigh the benefits and risks of COVID-19 vaccines.

There are a myriad of factors to be considered:

  • Data from animal studies (once developmental and reproductive toxicology studies become available)
  • Lack of data on pregnancies during vaccine clinical trials
  • Risks of vaccine reactogenicity, including fever; treatment with antipyretic medications (eg, acetaminophen) might reduce this risk
  • Timing of planned vaccination during pregnancy
  • Extensive evidence for safety of other vaccines during pregnancy
  • Risk of COVID-19 complications due to pregnancy (increased risk to pregnant person of severe disease and death)
  • Risk of COVID-19 complications due to underlying conditions (eg, diabetes, obesity, heart disease)
  • Risk of COVID-19 to fetus or newborn (intrauterine transmission is rare, but preterm birth appears to be increased)
  • Risk of exposure to SARS-CoV-2 and potential for mitigation with working from home, wearing masks, and physical distance

This is a uniquely difficult situation for three reasons: we don’t fully understand the disease in non-pregnant people; we don’t know whether the disease impacts the embryo or fetus; we have no experience at all with this new type of mRNA vaccine since there has never been another one like it.

Make no mistake: at the moment there is no evidence that the new vaccines are harmful to pregnant persons or their unborn babies.

The odds are high that the vaccine is safe and offers real, important protections during pregnancy. But good odds are no substitute for scientific data, and in my judgment, professional organizations should not make recommendations in the absence of data.

What does that mean for you if you are offered one of the new COVID vaccines during pregnancy?

It means — in my view — that the decision to accept or forgo the vaccine should be based on your specific circumstances, not based on a blanket recommendation.

Keep in mind that this is both a rare and a temporary situation. It’s a rare situation because the disease is relatively new, the vaccine was developed very quickly and we don’t have much data on the short and long term risks of either.

It’s temporary because going forward we will be gathering massive amounts of data on the disease, the vaccine and the impacts of both on pregnancy.

A year from now we will have a much better idea of whether pregnant people should take the vaccine. Until then, I believe we should honestly tell the public that we don’t know.