key: cord-0877659-wuawku5p
authors: Magon, Navneet; Prasad, Shail; Mahato, Chandrashekhar; Sharma, Jai Bhagwan
title: COVID-19 vaccine and pregnancy: A Safety weapon against pandemic
date: 2022-02-10
journal: Taiwan J Obstet Gynecol
DOI: 10.1016/j.tjog.2022.02.005
sha: cadc7458d895ed60447368a1675a7daf86792a9d
doc_id: 877659
cord_uid: wuawku5p

The ongoing COVID-19 pandemic is raising great concern all over the world. The recent introduction of vaccines has offered reason for optimism, however, new issues have arisen, such as vaccine reluctance. The safety of vaccines for pregnant women is one of the most serious of these concerns. The purpose of this review article is to provide updated international vaccine recommendations, results of ongoing studies and clinical trials, and the role of gynecologists in counseling the women to understand the risks versus benefits as well as form an informed decision towards vaccine acceptance for COVID-19. Although COVID-19 infection increases the risk of severe morbidity and mortality in pregnant women, pregnant women were not included in the initial vaccine trials. As a result, safety information is scarce. Nations have differing recommendations, though many have recently approved the COVID-19 immunization in pregnancy following a risk-benefit analysis. The Joint Committee on Vaccination and Immunization (JCVI) of the United Kingdom recently approved an mRNA vaccination for pregnant women. Vaccination is recommended by the CDC, ACOG, ARFM, and WHO. India recently took a stand, with the ICMR and the Ministry of Health and Family Welfare recommending vaccination during pregnancy and lactation.

These vaccines are made up of messenger RNA (mRNA) that has been encapsulated in a lipid nanoparticle (LNP) for delivery into the host cells. These vaccines use the body's cells to produce coronavirus spike protein (the relevant antigens), which induces immune cells to produce antibodies against COVID-19, much like all other vaccinations.

These vaccines do not enter the nucleus and do not cause any changes to the human DNA of vaccine recipients. As a result, mRNA vaccinations are incapable of causing genetic alterations.

The Pfizer-BioNtech COVID-19 vaccine was 91.3% vaccine efficacy observed against COVID-19, measured seven days through up to six months after the second dose. 15 The Moderna vaccine was 94.1 % effective in preventing laboratory-confirmed COVID-19 infection in persons who received two doses and had no signs of being previously infected, as per clinical study results. 16 In a study, 17 the BNT162b2 mRNA COVID-19 vaccine is projected to be as efficacious for pregnant women as previously reported for the general population at the same time period in this study: Effectiveness against confirmed infection is 96 percent, while effectiveness against symptomatic infection is 97 percent. 7-56 days after receiving the second dose of vaccination.

In a cohort study, 18 serum antibodies were found in all of the women in the group after vaccination administration.

Vaccination with mRNA vaccines produced spike antigen-specific IgA in a non-infected population with comparable kinetics of induction as IgG, however, spike antigen-specific IgA levels declined considerably with time. After the second dose, it was observed that there was a considerable rise in IgG response. The IgA response, on the other hand, diminished following the second dose.

In another study, 19 people 16 years and older, a two-dose regimen of BNT162b2 provided 95 percent protection against COVID-19. The safety of the vaccination was comparable to that of other viral vaccines after a median of two months.

The COVID-19 vaccine (Ad26.COV2.S) from Janssen (Johnson & Johnson) is a monovalent vaccine based on the AdVac technology platform. It is made up of a recombinant, replication-incompetent human adenovirus type 26 (Ad26) vector that encodes a stabilized form of the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) spike protein. Based on data from ongoing and completed clinical trials using Ad26-vectored vaccines for COVID-19, HIV, and Ebola in pregnant women, Ad26-based vaccinations have an acceptable safety and reactogenicity profile, with no notable safety concerns reported so far. 20 The vaccine developed by Oxford-AstraZeneca is based on the virus's genetic instructions for constructing the spike protein. The Oxford vaccine, unlike the Pfizer-BioNTech and Moderna vaccines, stores the instructions in doublestranded DNA rather than single-stranded RNA. The Oxford-AstraZeneca team utilized ChAdOx1, a modified variant of a chimp adenovirus. It can enter cells but not multiply within them. To prime the immune system to fight the coronavirus, the Oxford-AstraZeneca vaccine requires two doses, four weeks apart.

Phase 3 data of Janssen Biotech Inc. demonstrated the vaccine was 85% effective in preventing severe disease across all regions of the study, and showed protection against COVID-19 related hospitalization and death, starting from 28 days after vaccination. 21 The data from the Serum Institute of India for the Covishield vaccine was reported to be of 78.29% efficacy after completing the second vaccination dosage at more than 12 weeks apart. Increased immunogenicity was linked to a longer dose interval in exploratory investigations. 22 23 J o u r n a l P r e -p r o o f As inactivated vaccines do not multiply, therefore are unlikely to revert and cause disease. They include dead viruses that are unable to infect humans but activate the immune system to develop a defensive response against the infection. COVAXIN contains immune-potentiators, commonly known as vaccine adjuvants that are added to vaccines to augment their immunogenicity.

The vaccine has an efficacy rate of 81%, from the preliminary data from its phase 3 trial. 24 14 FDA received a combined developmental, perinatal/postnatal reproductive toxicity (DART) study of Moderna's mRNA-1273 in rats on December 4, 2020. According to an FDA review of this study, mRNA1273 given at a dose of 100 µg before mating and during gestation periods had no adverse effects on female reproduction, fetal/embryonal development, or postnatal developmental outcomes, except for skeletal variations, which are common and typically resolve postnatal without intervention (FDA 2021). 14 reported pregnancy-related adverse event among 29 participants; however, the reported miscarriage figures reflect background rates.

Recently India took a stand to support COVID-19 vaccination in Pregnant and Lactating Women. MoHFW issued guidelines on 02 nd July 2021 on the restricted use in an emergency and stated that vaccines like Covishield, Sputnik V, and Covaxin were safe in pregnancy. 27 Pre-existing co-morbidities in pregnant women such as Diabetes mellitus, Asthma, advanced maternal age, obesity, Organ transplant recipients, immunosuppression therapy, chronic kidney disease or on dialysis, sickle cell disease, presence of heart disease are all risk factors for developing severe COVID -19 infection during pregnancy. COVID-19 infection is more likely in health care workers or frontline workers, communities with a high or increasing rate of COVID-19 infections, and people who live in crowded conditions. 27,37

Special focus is given to the manpower development and training of the healthcare workers to provide seamless vaccine services to pregnant women. The role of household visits, antenatal check-ups have been encouraged to provide counseling and help the women understand the risks, benefits, and side effects of the vaccine. The role of obstetricians and pediatricians has been recognized for sensitization and management of an Adverse Event Following Immunization (AEFI). 24 Table 3 : Worldwide updated recommendations from government and professional organizations.

As Obstetrician and gynecologists, we are facing three groups of patients in our clinical practice: 1) Pregnant women 2) plan to become pregnant 3) Breastfeeding or plan to do so Professional ethics in obstetrics and gynecology provide practical tools for counseling eligible patients.

J o u r n a l P r e -p r o o f . The informed consent procedure embodies the ethical premise of respect for autonomy, which requires the obstetrician-gynecologist to equip patients with the knowledge they need to make informed decisions. When the informed consent procedure is based on the patient's values and beliefs, the patient is empowered to make informed decisions. 38 Patients should be informed about available information and advised not to make decisions purely based on speculative danger. As a result, the risk of complications should be weighed against the enormous benefit of preventing infection, asymptomatic infections, and potential transmission of infection to others, as well as serious sickness, long-term repercussions, and death. 38

Some individuals who are anticipating a pregnancy may be apprehensive to get vaccinated. Vaccine apprehension results from several factors that differ from person to person and community to community. An obstetrician should inform a patient who is planning to become pregnant that there is no evidence that the vaccine impacts current or future fertility, and the ASRM recommends that all eligible patients who are planning to become pregnant be vaccinated. 38

The safety of COVID-19 vaccines in lactating people, the effects of vaccination on the breastfed baby, and the effects on milk supply or excretion should all be discussed with an obstetrician. 39 Figure 1 : depicting our views on the process of counseling and guidance of expecting women.

The most efficient strategy to combat the present COVID-19 pandemic is to vaccinate everyone. Although we don't have adequate clinical data on long-term adverse effects, we can expect vaccines to end the pandemic because the number of new cases, critically ill patients, and mortality in many countries has reduced.

In the instance of COVID-19, pregnant women having high-risk factors such as diabetes, cardiovascular disease, hypertension, advanced maternal age, and obesity were associated with serious consequences of COVID-19 infection.

In our expert opinion, a comprehensive risk-benefit discussion regarding the lack of safety data before COVID-19 vaccine administration in pregnant women is recommended, with a preference for pregnant women at the highest risk of more severe infection-related diseases until the safety and efficacy of these novel COVID-19 vaccines are established. vomiting; rashes; allergic reaction to the components of the vaccine. 

The National Academy of Medicine advises to consider pregnancy as a serious risk factor in the event of SARS-CoV-2 infection, and to protect each pregnant woman from any potential source of contamination; to vaccinate any professionally or family-exposed pregnant woman, or pregnant woman with comorbidity (age >35 years, BMI >25, hypertension, diabetes); not to postpone or terminate a pregnancy due to vaccination; to encourage women who have been infected with SARS-CoV2 or vaccinated during their pregnancy to continue breastfeeding, as antibodies delivered through breast milk protect the newborn. recommendations are met and a risk assessment dictates that the benefits outweigh the potential risks for the individual and the fetus, the pregnant woman can undergo vaccination. 52

Vaccination is advised for all pregnant women in their second or third trimester. It is also suggested that breastfeeding mothers, as well as those contemplating pregnancy or undergoing reproductive treatments, receive the two vaccine doses before the start of the pregnancy. 53 Table 3 : Worldwide updated recommendations from government and professional organizations.

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severe allergic reactions; non-severe allergic reactions such as rash, itching, hives, or swelling of the face

pericarditis (inflammation of the lining outside the heart)

tiredness; headache; muscle pain; chills; joint pain; fever; injection site swelling

injection site redness; nausea; feeling unwell; swollen lymph nodes (lymphadenopathy); diarrhea; vomiting

Injection site reactions-pain, tenderness and swelling of the lymph nodes in the same arm of the injection, swelling (hardness), and redness

General side effects-fatigue, headache, muscle pain, joint pain, chills, nausea and vomiting, and fever

Severe allergic reactions; myocarditis (inflammation of the heart muscle)

Vaccine 33

Known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine; injection site pain; headache; fatigue; myalgia; nausea; fever

injection site erythema and injection site swelling; thrombosis with thrombocytopenia

ChAdOx1 nCoV