COVID-19 has led to almost 14 million cases and over 270,000 deaths in the US alone (1, 2) as of publication.  While hand hygiene, contact-related measures and masking are currently the best available protection against community spread (3), a number of vaccines are under development.  Vaccination is the ultimate goal to arrest the pandemic (3, 4). 

A large number of vaccines are undergoing safety testing worldwide.  Traditionally, pregnant women have been excluded from these trials. One of the preeminent specialty organizations involved in care of pregnant women, the Society of Maternal-Fetal Medicine (SMFM), has released a statement advocating for inclusion of pregnant women in ongoing studies, as well as vaccination of pregnant and lactating people when a vaccine (or vaccines) have completed Phase III trials (link here).  We at the Society of OBGYN Hospitalists endorse this practice.

Vaccinations are structured in a variety of ways; one of the most common is through utilization of an inactive form of the virus’ mRNA to induce an immune response in the host. Theoretically, this could also provide some degree of passive immunization in the neonate, a tremendous benefit during the current surge.  Another delivery method in current trials utilizes a viral vector; this method was used successfully in creation of an Ebola virus trial and was unintentionally administered to pregnant women without any clear evidence of harm to the pregnancy or the offspring (5).  In general, vaccines other than those that are live have been used in pregnancy to prevent a wide range of illness.  Data suggest that, much like influenza, pregnant women have more severe disease when infected with COVID-19, thus vaccination is even more important to offset serious morbidity.

Frontline healthcare workers, including OBGYN hospitalists, should be high priority for vaccination, and should continue to adhere to hospital safety protocols including hand hygiene, masking, and physical distancing.  In addition to providing immunity, vaccination may support public perception and acceptance.
For more information and frequent updates to this statement and to care guidelines, please visit https://www.smfm.org/covidclinical or https://www.acog.org/en/Topics/COVID-19.

REFERENCES

1. JHU CSSE COVID-19 Data, accessed at https://github.com/CSSEGISandData/COVID-19 on 12/2/2020.
2. Dong E, Du H, Gardner L. An interactive web-based dashboard to track COVID-19 in real time. Lancet Inf Dis. 20(5):533-534. doi: 10.1016/S1473-3099(20)30120-1
3. Lerner AM, Folkers GK, Fauci AS. Preventing the Spread of SARS-CoV-2 with Masks and Other “Low-tech” Interventions. JAMA. 2020;20892:10–1.
4. Lyu W, Wehby GL. Community Use Of Face Masks And COVID-19: Evidence From A Natural Experiment Of State Mandates In The US. Health Aff (Millwood), 2020 Aug;39(8):1419–25.
5. Legardy-Williams J, Carter R, Goldstein S, Jarrett O, Szefer E, Fombah A, et al. Pregnancy Outcomes among Women Receiving rVSVΔ-ZEBOV-GP Ebola Vaccine during the Sierra Leone Trial to Introduce a Vaccine against Ebola. Emerg Infect Dis. 2020;26(3):541.

Vaccination is the Key to Preventing New Infections

January 13, 2021 – During the COVID-19 pandemic, public health measures such as physical distancing, masking, hand hygiene, and appropriate personal protective equipment for healthcare personnel have proven critical in minimizing the spread of existing COVID-19 infection. Vaccination is the key to preventing new infections and is an important next step to combatting the COVID-19 pandemic and saving lives.

“Frontline health workers are encouraged to be vaccinated, to learn the safety profile of approved vaccines, and to inspire vaccine confidence among their communities,” said Judette Louis, MD, MPH, President of the Society for Maternal-Fetal Medicine. “In addition to affording significant individual-level protection, keeping healthcare workers safe protects the workforce so we can continue to provide care to those who are sick with COVID-19 or other illnesses. By preventing the COVID-19 infections, vaccination also helps prevent healthcare workers from spreading COVID-19 infection to patients and other healthcare workers.”

Vaccinations Are Safe and Effective

The vaccines that are currently approved for the prevention of COVID-19 (Pfizer and Moderna) in the United States are mRNA vaccines, which help the body create antibodies to fight future infection. The vaccines do not contain live COVID-19 virus. Data suggest that mRNA is rapidly degraded in the body by normal cellular processes in about 10 to 20 days.

The Pfizer vaccine study included 43,448 people who received two doses of the vaccine 21 days apart. The efficacy of preventing COVID-19 after the second dose was 95%.1 The Moderna vaccine study included 30,350 people who received two doses of the vaccine 28 days apart. The efficacy of preventing COVID-19 after the second dose was 94.1%.2 Common side effects of both vaccines include mild to moderate fever, headache, and muscle aches.
These side effects suggest that the immune system is working.1,2

“After an explicit, evidence-based review of all available data, the Advisory Committee on Immunization Practices (ACIP) has issued recommendations for use of these vaccines, as both have been demonstrated safe and effective in preventing COVID-19 infection, and thereby increasing community immunity against the virus,” said Cyndy Krening, MS, RN, President of the Association of Women’s Health, Obstetric and Neonatal Nurses.

“The Centers for Disease Control and Prevention (CDC) are tracking vaccine side effects through a smartphone- based tool called V-Safe,” said Diana Drake, DNP, WHNP, FAAN, President of the Nurse Practitioners in Women’s Health. “Vaccine recipients are encouraged to register for the no-cost program for personalized health check-ins and to report any side effects.”

The Impact of Vaccinations on Future Fertility, Pregnancy, and Lactation

In the United States, 75% of healthcare workers are women, and the Centers for Disease Control and Prevention (CDC) estimates that 330,000 healthcare workers are pregnant or have recently given birth. The approved vaccines are available to pregnant and lactating people.

“Pregnant people should discuss the benefits and risks of COVID vaccination with their healthcare provider,” said Jennifer Butler, MD, President of the Society of ObGyn Hospitalists. “Frontline health workers are more likely to be exposed to COVID-19 and, if pregnant, more likely to be admitted to the ICU, need advanced life support and a breathing tube, and even die.”

While pregnant people were not allowed to take part in the clinical trials for the COVID-19 vaccines, many healthcare workers who are pregnant or lactating have received the vaccine and have registered for a COVID-19 vaccine registry so that scientists can better understand the impacts of COVID-19 vaccination on pregnancy.

“There is no data to suggest that vaccination impacts future fertility,” said Hugh Taylor, MD, President of the American Society for Reproductive Medicine. “Because the approved COVID-19 vaccines do not use a live virus, they are not thought to cause an increased risk of infertility, first- or second-trimester loss, stillbirth, or congenital abnormalities.”

Vaccines Should Be Distributed Equitably

ACIP recommended that healthcare personnel and long-term care facility residents be offered COVID-19 vaccination first (Phase 1a).3 Healthcare personnel include all those who come into contact with patients including, but not limited to: transport personnel, environmental services (cleaning and maintenance staff), nutrition service staff, physical and occupational therapists, phlebotomists, pharmacists, technicians, unit secretaries, nurses, nursing assistants, and physicians.

“The vaccine should be offered to individuals in all of these roles in an equitable and transparent manner,” said Cathy Collins-Fulea, CNM, DNP, FACNM, President of the American College if Nurse-Midwives. “Priority should be given to those with the most patient contact and should include trainees.”

"Health care professionals, including obstetrician-gynecologists, have the opportunity to demonstrate to their patients and their communities the value of COVID-19 vaccination by leading by example and receiving the vaccine themselves," said Eva Chalas, MD, FACOG, FACS, President of the American College of Obstetricians and Gynecologists. "We also have a responsibility to counsel patients, including our pregnant colleagues in the health care workforce, about their risk of severe complications associated with COVID-19 infection, the available evidence regarding the safety of vaccination, and their own individual values and priorities."

As data emerge regarding COVID-19 and vaccination, additional information will be shared on the following websites:

• SMFM.org/covid19
• www.awhonn.org/novel-coronavirus-covid-19
• www.asrm.org/news-and-publications/covid-19/
• www.midwife.org/monitoring-covid-19
• www.npwh.org/pages/covid19
• www.societyofobgynhospitalists.org/portfolio/covid-19-education-and-resources/
• www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2020/12/vaccinating-pregnant-and- lactating-patients-against-covid-19

References

• Polack FP, Thomas SJ, Kitchin N, et al. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. 2020;383(27):2603-2615.

• FDA Briefing Document: Moderna COVID-19 Vaccine. Vaccines and Related Biological Products Advisory Committee Meeting, Dec 17, 2020. https://www.fda.gov/media/144434/download. Accessed Jan 6, 2021.

• Dooling K, Marin M, Wallace M, et al. The Advisory Committee on Immunization Practices’ Updated Interim Recommendation for Allocation of COVID-19 Vaccine – United States, December 2020. MMWR Morb Mortal Wkly Rep. 2021;69(5152):1657-1660.