The American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) have recommended that COVID-19 vaccines “not be withheld” from pregnant or lactating patients if they are at high risk of complications from COVID. These organizations oppose barriers including a required consultation with a clinical care team. They also recommend against requiring pregnancy or COVID tests.
The Association of American Physicians and Surgeons (AAPS) advises that information to patients who are (or might be) pregnant include the following:
- Women who were pregnant or who might become pregnant were excluded from clinical trials—as is customary to protect the fetus.
- Pfizer is now looking for 4,000 pregnant women between 24 and 34 weeks gestation to enroll in a trial. This of course will not reveal whether birth defects could be caused during the first trimester.
- So far, with an estimated 20,000 pregnant patients having received the mRNA products, 28 miscarriages have been reported to the Vaccine Adverse Events Reporting System (VAERS) after the Pfizer and 7 after the Moderna injections.
- For perspective, about 10 to 20 percent of confirmed pregnancies end in miscarriage, 80 percent during the first trimester. Since reporting to VAERS is far from complete, it is not clear whether the mRNA products increase the risk.
- The Pfizer and Moderna products are experimental biologic agents. Biologics, including vaccines, are much more complex than drugs and have different regulatory requirements. Most biologics have not been adequately tested in pregnant or breastfeeding patients.
- Unlike true vaccines, the mRNA products contain genetic material designed to cause the vaccinated person’s own cells to manufacture the antigen intended to produce the antibody response. This is a new concept in humans.
- It is too early to see long-term effects.
AAPS also recommends informing patients that early treatment is an option if a patient gets COVID-19. For example, hydroxychloroquine, also widely used in lupus and rheumatoid arthritis, has for decades been considered safe in pregnancy.
The Association of American Physicians and Surgeons (AAPS) is a national organization representing physicians in all specialties since 1943.