COVID-19 VACCINES | TERIS agent: 6816

TERIS Summary
TERIS Agent Number: 6816 Bibliographic Search Date:  04/2021
Agent Name:

COVID-19 VACCINES

   

 

COVID-19 vaccines provide protection against the COVID-19 virus, SARS-CoV-2, and are administered by injection. Several different COVID-19 vaccines have been developed. Below is a list of those currently approved or that have received Emergency Use Authorization in various jurisdictions throughout the world.

1) Messenger ribonucleic acid (mRNA) vaccines: these vaccines use mRNA as the minimal genetic vector to encode a spike protein of SARS-CoV-2, the protein found on the surface of the virus, to trigger an immune response. The mRNA does not enter the nucleus and therefore does not integrate into the DNA. The mRNA is degraded into the cell cytoplasm within hours to days after injection.

2) Viral vector vaccines: these contain viruses engineered to deliver the spike protein of SARS-CoV-2 into the cell. Common vectors include non-replicating adenovirus or adeno-associated virus.

3) Protein-based vaccines: these vaccines contain whole or fractionated SARS CoV-2 protein without the genetic material.

4) Inactivated or attenuated whole-virus vaccines: these vaccines consist of whole or fractionated inactivated or weakened SARS-CoV-2 virus.



Magnitude of Teratogenic Risk to Child Born After Exposure During Gestation:
 
UNDETERMINED

Quality and Quantity of Data on Which Risk Estimate is Based:
 
NONE

Comments:   

A SMALL RISK CANNOT BE EXCLUDED, BUT A HIGH RISK OF CONGENITAL ANOMALIES IN THE CHILDREN OF WOMEN VACCINATED WITH COVID-19 VACCINES DURING PREGNANCY IS UNLIKELY.

Summary of Teratology Studies:

MAJOR CONGENITAL ANOMALIES

No epidemiological studies of congenital anomalies among infants born to women who received any type of COVID-19 vaccine during pregnancy have been reported.

PREGNANCY AND NEONATAL OUTCOMES

The rate of spontaneous abortion (12.6%) reported among 827 pregnant women in the v-safe pregnancy registry who received an mRNA COVID-19 vaccine in the first trimester was similar to that expected in the general population (Shimabukuro et al., 2021). In the same preliminary study, no neonatal deaths were reported among 724 liveborn infants of mothers who received an mRNA COVID-19 vaccine in the third trimester of pregnancy, and rates for preterm birth (9.4%), small for gestational age (3.2%), and stillbirth (0.1%) were similar to background population rates.

SARS-CoV-2 IgG antibodies were detectable in the cord blood of 25 out of 28 infants whose mothers were vaccinated with an mRNA vaccine in the third trimester of pregnancy in a prospective case-series (Mithal et al., 2021).

ANIMAL TERATOLOGY STUDIES

Animal teratology studies of COVID-19 vaccines conducted by the manufacturer have not been published in the peer-reviewed literature.

Selected References:
(Each paper is classified as a review [R], human case report [C], human epidemiological study [E], human clinical series [S], animal study [A], or other [O].)

Mithal LB, Otero S, Shanes ED, Goldstein JA, Miller ES: Cord blood antibodies following maternal coronavirus disease 2019 vaccination during pregnancy. Am J Obstet Gynecol 2021 Apr 1 (published online ahead of print). [S]

Shimabukuro TT, Kim SY, Myers TR, Moro PL, Oduyebo T, Panagiotakopoulos L, Marquez PL, Olson CK, Liu R, Chang KT, Ellington SR, Burkel VK, Smoots AN, Green CJ, Licata C, Zhang BC, Alimchandani M, Mba-Jonas A, Martin SW, Gee JM, Meaney-Delman DM: Preliminary findings of mRNA Covid-19 vaccine safety in pregnant persons. N Engl J Med 2021 Apr 21 (published online ahead of print). [E]

 

COVID-19 VACCINE PREGNANCY REGISTRIES

Healthcare providers are encouraged to enroll their patients, whether they have been given the vaccine or not, to the following registries:

V-SAFE

A registry collecting health information from people who received COVID-19 vaccinations in the periconception period or during pregnancy is being maintained by the Centers for Disease Control. The registry attempts to assist individuals and healthcare providers to make informed decisions about COVID-19 vaccination.

Pregnant people who would like to participate must be enrolled in v-safe (a smartphone-based tool that uses text messaging and web surveys to provide personalized health check-ins after you receive a COVID-19 vaccine. People who enroll in v-safe and report that they were pregnant at the time of vaccination or after vaccination, may be contacted by the registry staff for additional details.

COVID-PRICE (COVID-19 Pregnancy Related Immunological, Clinical, and Epidemiological Factors and Perinatal Outcomes)

A registry collecting health and exposure information from women who were diagnosed with COVID-19 or have received vaccinations against COVID-19 during pregnancy or while breastfeeding. The registry is maintained by Thomas Jefferson University in Philadelphia, Penn. It is a prospective cohort study of pregnant patients followed up to six weeks postpartum.

Healthcare providers may find more information about this registry here.

C-VIPER (COVID-19 Vaccines International Pregnancy Exposure Registry)

A registry collecting information from pregnant women who were vaccinated against COVID-19 during pregnancy and is maintained by Pregistry in Los Angeles, Calif. This registry evaluates obstetric, neonatal, and infant outcomes among women vaccinated during pregnancy to prevent COVID-19.

Healthcare providers may find additional information about this study here.