Q. Is the Pfizer COVID-19 vaccine safe for pregnant women?

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A. Although Pfizer is conducting surveillance studies in this area, there are currently insufficient data to make conclusions about the vaccine's safety in pregnant and lactating women. According to the Pfizer/FDA Briefing Document, Pfizer studies will be submitting plans for a clinical study to assess safety and immunogenicity in pregnant women and has proposed active surveillance studies designed to monitor vaccination during pregnancy within populations expected to receive the vaccine under EUA.

 

While noting the lack of available data on the safety of COVID-19 vaccines in pregnant people, CDC states, “Observational data demonstrate that while the absolute risk is low, pregnant people with COVID-19 have an increased risk of severe illness, including illness resulting in ICU admission, mechanical ventilation, or death. Additionally, they might be at an increased risk of adverse pregnancy outcomes, such as preterm birth.”

 

Given that, however, CDC notes that if a pregnant woman is among a group recommended for the vaccine (e.g., healthcare personnel), she may choose to be vaccinated. While a conversation with their healthcare provider could be helpful, it is not required prior to vaccination. In making the decision, the following considerations are recommended: the level of COVID-19 community transmission, the patient’s personal risk of contracting COVID-19, the risks of COVID-19 to the patient and potential risks to the fetus, the efficacy of the vaccine, the side effects of the vaccine and the lack of data about the vaccine during pregnancy.

 

Q. If a person who has received the COVID-19 vaccine begins showing symptoms of the virus, should they be allowed to work, under the assumption that the symptoms are simply a reaction to the vaccine? Or should they be excluded?

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A. If a person who has been vaccinated shows symptoms, TAG recommends that they be excluded from work. There is overlap between post-vaccination symptoms and those of the virus, so the two cannot be differentiated. It also is possible that the person could have been infected just prior to being vaccinated, so would have the virus and be infectious to others.

 

TAG recommends that any symptomatic persons be tested, as only the virus itself, not the vaccine, would cause a positive result. As stated by CDC, “Vaccines currently in clinical trials in the United States won’t cause you to test positive on viral tests, which are used to see if you have a current infection.” However, this is not true of antibody tests (which indicate you had a previous infection), as the immunities developed in the body through the vaccine may result in a positive.

 

The most common reaction to the Pfizer vaccine has been injection site reactions (84.1%), with other generally mild to moderate symptoms including: were fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%). Severe adverse reactions occurred in 0.0% to 4.6% of participants, were more frequent after Dose 2 than after Dose 1, and were generally less frequent in adults ≥55 years of age (≤2.8%) as compared to younger participants (≤4.6%).

 

Among adverse events of particular interest, which could be possibly related to the vaccine, lymphadenopathy was reported in 64 participants (0.3%): 54 (0.5%) in the younger (16 to 55 years) age group; 10 (0.1%) in the older (>55 years) age group; and 6 in the placebo group. The average duration of these events was approximately 10 days, with 11 events ongoing at the time of the data cutoff.