Perinatal COVID-19 Vaccine Initiative

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PNQIN is receiving additional CDC funding to engage hospitals, stakeholders, and educational platforms to improve provider capacity, protocol implementation and clinical-community care linkages for equitable delivery of Covid-19 vaccines to pregnant and lactating people. 

About Our Initiative

Significance: MA and the COVID-19 Pandemic

Massachusetts (MA) was one of the first states with widespread infection from SARS-CoV-2 (COVID-19) with 655,350 total confirmed cases and 17,366 confirmed deaths as of May 14, 2021. Similar to states across the US, stark racial and ethnic inequities are reported among cases, hospitalizations and deaths from COVID-19 in MA. In response, the Commonwealth has become a national leader in COVID-19 vaccinations, with over 3.9 million people fully or partially vaccinated as of May 2021. Despite the availability of three, safe and effective FDA-approved vaccines for emergency use against SARS-CoV-2 infection, vaccine uptake has been slow and inequitably distributed. Data regarding the pregnancy status of vaccinated individuals is not available. Vaccination is being performed at a wide range of sites across the state with MA hospitals teams administering the most. MA hospitals have administered 25% of the state’s COVID-19 cumulative vaccine doses, followed by 24% at CVS and Walgreens, 22% at mass vaccination sites, and 10% at regional collaboratives and health departments. The remaining 18% of cumulative doses have been administered at community health centers, primary care practices, and other sites and pharmacies. In MA, underlying reasons for the slow vaccine rollout and uptake include national supply constraints (these have since resolved), individual factors such as mistrust of the health system and health literacy, and systemic and structural factors such as technological difficulties with the state appointment system and health system navigation barriers. Recognizing these social and structural determinants of health, the MA Department of Public Health (MDPH) has prioritized vaccination in the 20 cities and towns hardest hit by COVID-19. Even with targeting vulnerable populations early in the rollout, acceptance was lower than expected. Now, designated MDPH Community Liaisons work locally to identify and address barriers to vaccine access. This work includes robust stakeholder engagement through weekly meetings with community representatives and tailored vaccine distribution approaches. Although this approach to equitable administration is commendable, there is no existing mechanism to prioritize vaccination of pregnant or lactating people. Furthermore, there is no current MA public health campaign or coordinated education for these community liaisons that specifically target concerns regarding vaccination during pregnancy or lactation.

COVID-19 Vaccination and Pregnancy

There are limited data regarding the safety and efficacy in pregnant and lactating people of the COVID vaccines that are currently available in the US (Moderna, Pfizer BioNTech and Janssen), as pregnant and lactating individuals were excluded from the original trials. Nonetheless, data regarding immunogenicity and reactogenicity are starting to surface from cohort studies in pregnant and lactating people (predominantly healthcare workers) who have decided to receive the vaccine. In a recent study at two Boston institutions, immune response generated after mRNA vaccines was comparable in pregnant and non-pregnant individuals, and higher than in pregnant individuals after a natural COVID infection, suggesting efficacy of vaccination during pregnancy.3 Antibody titers were also detectable in umbilical cord and breastmilk, indicating that neonatal immunity may be acquired through maternal vaccination. Theoretically, the mRNA vaccines are safe during pregnancy. They do not carry live virus and therefore would not be expected to increase harm to the fetus. Vaccine safety data is limited; though based on the inadvertent pregnancies that have occurred in the main trials, there is no signal that adverse pregnancy outcomes are increased in the small number of pregnant people who have received the vaccines. Of the 35,000 pregnant people enrolled in the CDC v-safe program, 3,900 have been followed longitudinally with 827 completed pregnancies. Adverse pregnancy outcomes in this cohort were within the expected range for unexposed pregnancies. Side-effects were also similar to the non-pregnant population. Given the growing but limited evidence regarding vaccine efficacy and safety in pregnant and lactating people, guidance on vaccination counseling from professional societies is evolving. The Centers for Disease Control state that pregnant persons are eligible for and can receive the COVID vaccine. The American College of Obstetrics and Gynecology and the Society for Maternal Fetal Medicine state that vaccination should be made available during pregnancy and encourage a shared-decision making model balancing theoretical risks of the vaccine with risks of moderate or severe disease from COVID for the individual’s risk profile. Though prenatal providers are in a unique position to help guide patients through the decision-making process for the SARS-CoV-2 vaccine, one of the traditional barriers to vaccination is vaccine hesitancy, fueled by a lack of confidence in vaccine safety as well as a historical context that makes certain communities less likely to have trust in healthcare recommendations. A survey of pregnant people and parents of young children across 16 countries reported that the strongest predictors of COVID vaccine acceptance included confidence in vaccine safety and effectiveness, perceived risk of COVID disease, belief in the importance of vaccine within the cultural context and trust of public health agencies and health science.

PNQIN's Early Response to COVID-19

PNQIN, our state PQC (Perinatal Quality Collaborative), in collaboration with the Betsy Lehman Center for Patient Safety (BLC), the Massachusetts Department of Public Health (MDPH), and the Massachusetts Chapter of the Association of Women’s Health, Obstetric and Neonatal Nurses (AWHONN), developed a series of virtual town halls for maternal and neonatal health care professionals confronting the challenges of COVID-19. These collaborative meetings occurred every 1-3 weeks from April through June 2020 (with archived videos available for viewing online) and each meeting was attended by approximately 100 healthcare and public health professionals. The goal of these meetings was to support care teams during their transition to care for pregnant individuals and neonates during the early days of the pandemic and ensure safe and equitable care for families across MA. Eight obstetric and six newborn town halls focused on achieving equity and positive maternal and neonatal outcomes and experiences during implementation of new care processes during COVID-19 were hosted. Topics included evolving COVID-19 science and practice recommendations, hospital visitation policies and safe family care in the hospital, and care and discharge management of infants born to parents with COVID-19 and outpatient support. The impact of this work was demonstrable. Between April and July 2020, data collected from 11 hospital teams showed a reduction in cesarean birth among patients with COVID-19 from 58.3% to 31.3%, and increased rooming in from 11.8% to 100.0% during March-July 2020. Currently, PNQIN provides accurate, up-to-date guidance and resources for counseling and administration of the COVID-19 vaccine to pregnant and lactating people in MA. We promote COVID-19-related trainings and webinars within our provider network and have dedicated space on our websites for COVID-19 practice advisories and resources. In collaboration with BLC and the MA COVID-19 Maternal Equity Coalition, PNQIN co-hosted a community town hall on June 3rd, 2021 to highlight the experiences of people who gave birth during COVID-19 and reflect on ongoing efforts to improve the care of people who gave birth and their families during the pandemic. This town hall brought together stakeholders including providers, patients and families, and policy makers to define key considerations for care of people who gave birth moving forward. Moreover, we demonstrated our ability to be the source of best practices within our local context that are informed by robust community participation and align with the MA Secretary of Health and Human Services priorities to achieve broad uptake of COVID-19 vaccination, community engagement, and health equity. Beyond COVID-19, our commitment to equity is emphasized throughout all of our projects, including requirements that data should be stratified by age, race, ethnicity, gender identity, payor, disability status, employment status, and preferred language when possible. We are actively engaged in shifting to an equity culture in perinatal care. In our current collaboration with the Institute for Perinatal Quality Improvement, PNQIN and the MA DPH is providing SPEAK UP Champions© Implicit and Explicit Racial Bias education for nurses and other health care providers. To date, 346 providers from 35 hospitals/institutions across MA have participated in SPEAK UP trainings.

Initiative Approach: Three Primary Goals

We propose to expand our current work to develop and lead new activities for implementation of best practices for increasing SARS-CoV-2 vaccine confidence, equitable access and administration among populations disproportionately affected by COVID 19. We propose to address the following goals:

  1. Improve provider capacity for equitable delivery of SARS-CoV-2 vaccination to pregnant and lactating people and their families by:
    • Developing an educational program based on current evidence that employs principles of motivational interviewing to improve provider knowledge and to strengthen respectful patient-provider communication regarding SARS CoV-2 vaccination; and
    • Delivering the educational program to improve provider capability to address SARS-CoV-2 vaccine hesitancy.
  2. Increase the number of birth facilities with protocols for SARS-CoV-2 screening and vaccination provision for pregnant and lactating people and their families by:
    • Providing sample protocol resources, education and training on updated SARS-CoV-2 vaccination guidance;
    • Using improvement science to support and measure site protocol uptake and implementation; and
    • Engaging the 12 hospitals among the 40 that account for more than 50% of births to BNH and Hispanic residents. We will give particular attention to supporting Boston Medical Center, Lawrence General Hospital, Caritas Good Samaritan Medical Center, Cambridge Health Alliance, Caritas Holy Family Hospital and Medical Center, North Shore Medical Center, Brockton Hospital, Mercy Medical Center, Baystate Medical Center, Brigham and Women’s Hospital, Beth Israel Deaconess Medical Center, and UMass Memorial Hospital
  3. Increase the number of pregnant and lactating people with clinical-community linkages in response to SARS-CoV-2 by:
    • Partnering with MA DPH community liaisons and stakeholders in the hardest hit communities to improve SARS-CoV-2 vaccination access in communities for pregnant and lactating people and their families; and
    • Respectfully address vaccine hesitancy by providing standardized educational materials, in partnership with community stakeholders, to ensure that front line staff in community vaccination sites are adequately prepared to address frequently asked questions regarding vaccination during pregnancy and lactation in all languages.