OB E-ALERT: NEW GUIDANCE RELEASED ON THE COVID-19 VACCINE

As of August 9, 2021, the American College of Obstetricians and Gynecologists (ACOG), the Society for Maternal Fetal Medicine (SMFM), the Association of Women’s Health, Obstetric and Neonatal Nurses (AWHONN) and multiple other leading organizations, which represent experts in maternal care, pediatric care, and public health have recently put out a Statement of Strong Medical Consensus for Vaccination of Pregnant Individuals Against COVID-19.

As of August 9, 2021, the American College of Obstetricians and Gynecologists (ACOG), the Society for Maternal Fetal Medicine (SMFM), the Association of Women’s Health, Obstetric and Neonatal Nurses (AWHONN) and multiple other leading organizations, which represent experts in maternal care, pediatric care, and public health have recently put out a Statement of Strong Medical Consensus for Vaccination of Pregnant Individuals Against COVID-19.  All organizations according to the statement, “strongly urge all pregnant individuals-along with recently pregnant, planning to become pregnant, lactating and other eligible individuals-to be vaccinated against COVID-19.”

  • There is an increased risk of severe COVID-19 infection, including death for pregnant individuals. The best protection from potential harm from COVID-19 is vaccination.
  • The COVID-19 vaccination has been shown to be both safe and effective when administered during pregnancy based on data from tens of thousands of reporting individuals. The same data have been equally reassuring regarding infants born to vaccinated individuals.
  • COVID-19 vaccines have no impact on fertility.

What follows is a summarization of key information taken from Centers for Disease Control and Prevention, the Society for Maternal Fetal Medicine (SMFM), and American College of Obstetricians and Gynecologists (ACOG) regarding COVID-19 vaccination and counseling. Providers who choose this information, should directly verify all information with the authoritative entities mentioned above.

What You Need to Know Based on the Most Current Resources:

  • COVID-19 vaccination is recommended for all people 12 years and older, including people who are pregnant, trying to become pregnant or might become pregnant in the future, or breastfeeding.
  • Pregnant and recently pregnant people are at an increased risk for severe illness from COVID-19 compared with non-pregnant people. Severe illness includes illness that requires hospitalization, intensive care, mechanical ventilation, or special equipment to breathe, or illness that results in death.
  • Pregnant people with COVID-19 are at increased risk for preterm birth and may be at risk for other adverse pregnancy outcomes, compared with pregnant women without COVID-19.
  • No safety concerns were found in animal studies in which the animals received Moderna, Pfizer-BioNTech, or Johnson & Johnson (J&J)/Janssen COVID-19 vaccine before or during pregnancy in the pregnant animal or their babies.
  • No adverse pregnancy-related outcomes occurred in previous clinical trials that used the same vaccine platform as the J&J/Janssen COVID-19 vaccine, including a large-scale Ebola vaccination trial. No adverse pregnancy-related outcomes, including adverse outcomes affecting the baby, were associated with vaccination in these trials.
  • COVID-19 vaccines do not cause infection, including in pregnant people or their babies. None of the COVID-19 vaccines contain the live virus, so a COVID-19 vaccine cannot make anyone sick with COVID-19, including pregnant people or their babies.
  • Early data on the safety of mRNA COVID-19 vaccines during pregnancy are reassuring, including no safety concerns for pregnant people or their babies, no increased risk for miscarriage, and lowered risk of infection from the virus that causes COVID-19.
  • Vaccination of pregnant people builds antibodies that might protect the baby. Antibodies have been found in the umbilical cord blood after a pregnant person received an mRNA COVID-19 vaccine and in breastmilk, which means vaccination during pregnancy might help protect babies against COVID-19.

Counseling and Considerations for Patients:

  • Underscore the general safety of vaccines and emphasize no steps were skipped in the development and evaluation of COVID-19 vaccines and all vaccinations are currently being used under Emergency Use Authorization.
  • Safety monitoring through a variety of agencies, such as CDC’s V-SAFE, Vaccine Adverse Event Reporting System (VAERS), and Vaccines and Medications in Pregnancy Surveillance System (VAMPSS). The VAMPSS is a national surveillance system designed to monitor the use and safety of vaccines and asthma medications during pregnancy.
  • Most study participants experienced mild side effects similar to influenza-like illness symptoms following vaccination such as injection site reactions, fatigue, chills, muscle pain, joint pain, and headaches. All are considered a normal part of the body’s reaction to the vaccination and most side effects resolve within 3 days of the vaccination.
  • Most study participants experienced mild side effects similar to influenza-like illness symptoms following vaccination such as injection site reactions, fatigue, chills, muscle pain, joint pain, and headaches.
  • If fever following vaccination, acetaminophen is often used.
  • Educate patients on the importance of getting the maximum protection against COVID-19, which is two doses of the vaccine for Moderna or Pfizer, and one dose for the Johnson & Johnson vaccination.
  • COVID-19 vaccines may be administered simultaneously with other vaccines, including within 14 days of receipt of another vaccination.
  • mRNA vaccines are not live vaccines, nor do they use an adjuvant to enhance vaccine efficiency. They do not enter the nucleus and do not alter human DNA in vaccine recipients, mRNA vaccines are not reported to cause any genetic changes.
  • It takes 1-2 weeks after the second dose to be considered fully vaccinated.
  • The Johnson & Johnson vaccine has been associated with a rare severe side effect called thrombosis with thrombocytopenia syndrome (TTS), which can cause blood clots combined with low levels of platelets in patients younger than 50. Patients on hormonal birth control, who are pregnant, breastfeeding, or recently pregnant does not make them more likley to develop TTS after the Johnson & Johnson vaccination; however, health care professional should be aware of the possibility of this side effect and should counsel patients to seek medical help immediately if they develop any of the following symptoms within 3 weeks of the vaccination: severe or persistent headaches or blurred vision, shortness of breath, chest pain, leg swelling, persistent abdominal pain, or easy bruising or tiny blood spots under the skin beyond the injection site.
  • Continue to support patients who decide not to be vaccinated, share resources, and encourage the continued use of prevention measures, such as hand washing, physical distancing, and wearing a mask.
  • Ensure to document discussions about vaccination in the patient’s medical record. During subsequent office visits, address ongoing questions and concerns regarding vaccination and offer vaccination again.

Patients Who Should Not Receive the Vaccine:

  • Patients with a history of severe allergic reaction to any vaccine or injectable therapy.

Protecting yourself from the potential of litigation in the event unexpected outcomes are allegedly related to the vaccine.

Documentation regarding your efforts in patient education and consideration of the high-risk nature or susceptibility for infection for your patient population. 

Recording/being able to speak to your dependence on the guidance issued by the clinical and practice standard setting bodies as mentioned in this alert (not by MPIE we are only sharing summarized information from these authoritative entities).

Documentation of the patient’s choice to have or refuse vaccination.

Due to the rapidly evolving nature of this situation, please use the resources listed below for the most up to date information.

If you are an employed provider of a healthcare system and have questions on this subject, please consult your organizations risk management department for advisement as to system policy or protocol.

Disclaimer: This information is provided as a risk management resource and should not be construed as legal, compliance, technical or clinical advice. This information may refer to specific local regulatory or legal issues that may not be relevant to your organization.  Consult your professional advisors or legal counsel for guidance on issues specific to your organization.  Medical or clinical information presented is offered for educational and informational purposes only and does not replace independent professional judgement.  The information is intended to provide guidance to the clinician in the management of patient care and is not intended to establish a standard of care.  The clinician shall defer to applicable prevailing medical authority.  This material may not be reproduced or distributed without the express, written permission of MPIE.