Operational Guidance for COVID-19 Vaccination of Pregnant Women

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COVID-19 infection during pregnancy may result in rapid deterioration of health of pregnant women and could also affect the fetus. Experts are of the view that the benefits of vaccination to the pregnant women outweigh its potential risks. Based on the recommendations from National Technical Advisory Group on Immunization (NTAGI), MoHFW has approved vaccination of pregnant women against COVID-19 with the condition that the pregnant women may be informed about the risks of exposure to COVID-19 infection along with the risks and benefits associated with the COVID-19 vaccines available in the country. Based on the information provided, a pregnant woman will have the choice to take the vaccination.

The COVID-19 vaccination has been expanded to include all citizens from 18 years of age onwards, making more than 69% of population eligible, of which nearly half (48%) are women. Pregnant women who develop COVID-19 are more likely to require intensive care than their non-pregnant counterparts. COVID-19 infection during pregnancy may result in rapid deterioration of health of pregnant women and might affect the fetus also.

Information related to COVID-19, the impact of the disease on pregnancy and data related to COVID-19 vaccines are rapidly evolving. In the context of current situation of the SARS-CoV-2 pandemic,
experts have suggested that the COVID-19 vaccine may be offered to the pregnant women if no contraindications exist. The intent is to weigh risk versus benefit on individualized basis, so that a pregnant woman can take an informed decision. This decision is based on the woman’s
understanding that the risk of infection and/or morbidity from COVID-19 outweighs the undescribed risk of being vaccinated during pregnancy.

In India, at present three vaccines have received approval for restricted use in emergency situation. One of them is an inactivated vaccine (Covaxin) and other two are based on non-replicating viral vector platform (Covishield and Sputnik V).
A pregnant woman who opts for vaccination, could be vaccinated at any time of the pregnancy. To help pregnant women make an informed decision to be vaccinated, they should be provided with information about the risks of COVID-19 infection in pregnancy, the benefits
of vaccination, along with the likely side effects of vaccination.

1. Why is COVID 19 vaccine being recommended for pregnant women?
– Pregnancy does not increase the risk to COVID-19 infection, but current evidence
indicate that pregnant women are at an increased risk for severe illness from COVID-19 compared to non-pregnant women in case they get infected.

– Additionally, pregnant women with COVID-19 are at increased risk for preterm birth and might have an increased risk of other adverse pregnancy outcomes1
including higher chances of neonatal morbidity2

– Most pregnant women will be asymptomatic or have mild disease, BUT their health may deteriorate rapidly and that might affect the foetal outcome.

– It is important that they take all precautions to protect themselves from acquiring COVID-19, including taking vaccination against COVID-19.

– WHO recommends vaccination in pregnant women when the benefits of vaccination to the pregnant woman outweigh the potential risks, such as pregnant women at high risk of exposure to COVID-19andpregnant women with comorbidities that place them in a
high-risk group for severe COVID-19 disease.

– It is therefore advised that a pregnant woman should take COVID-19 vaccine.

2. Who are at Higher Risk of getting infected with COVID-19?
– Someone who is a health care worker or a frontline worker.

– Community having high or increasing rate of COVID-19 infections.

– Frequently exposed to people outside the household.

– Difficulty in complying with social distancing if living in a crowded household.

3. How does COVID 19 affect the health of the pregnant woman?
– Although most (>90 percent) infected pregnant women recover without need for
hospitalization, rapid deterioration in health may occur in a few.

– Symptomatic pregnant women appear to be at increased risk of severe disease & death.

– Compared with pregnant women without COVID-19, those with symptomatic COVID-
19 are at increased risk of adverse pregnancy outcomes, including admission to the ICU, iatrogenic preterm birth, pre-eclampsia-like symptoms, Caesarean section and death 3

4. How does COVID 19 infection of pregnant women affect the baby?
– Most (over 95 percent) of newborns of COVID-19 positive mothers have been in good condition at birth.

– However, Covid-19 in pregnancy increases the chances of preterm birth, increasing the possibility of hospitalization for the neonate and in some cases even death.

5. Which pregnant women are at higher risk of developing complication after COVID 19 infection?
Risk factors for developing complication after COVID 19 infection during pregnancy are:

– Pre-existing co-morbidities, advanced maternal age, and high body mass index are risk factors for severe COVID -19 in pregnancy4

– Pregnant women with certain high-risk conditions have greater risk of severe illness from COVID-19 such as

  • Pre-existing medical conditions e.g. Diabetes
  • Organ transplant recipients
  • Chronic respiratory conditions like COPD, Asthma, Cystic Fibrosis
  • Homozygous sickle cell disease

6. If a pregnant woman has already had COVID-19, when should she be vaccinated?
– In case a woman has been infected with COVID-19 infection during the current
pregnancy, then she should be vaccinated soon after the delivery.

7. Are there any side effects of the COVID 19 vaccines that can either harm the pregnant women or her foetus?
– COVID 19 vaccines available are safe and vaccination protects pregnant women against COVID 19 illness/disease like other individuals.

– Based on current knowledge, experts believe that COVID -19 vaccines are unlikely to pose a risk to the pregnant person or foetus5

– Like any medicine a vaccine may have side effects which are normally mild. After getting the vaccine, she can get mild fever, pain at injection site, or feel un-well for 1-3 days.

– The long-term adverse effects and safety of vaccine for foetus and child is not
established yet.

– Very rarely, (one in 1-5 lakh persons) the beneficiary may after COVID 19 vaccination, experience some of the following symptoms within 20 days after getting the injection which may need immediate attention

Symptoms occurring within 20 days after receiving any COVID 19 vaccine
– Shortness of breath (difficulty in breathing)
– Chest Pain
– Pain in limbs / pain on pressing the limbs or swelling in the limbs (arm or calf)
– Small pinpoint haemorrhages (petechial) or bruising of the skin beyond the vaccination site
– Persistent abdominal pain with or without vomiting
– Seizures in the absence of previous history of seizures with or without vomiting
– Severe and persistent headaches with or without vomiting (in the absence of previous history of migraine or chronic headache)
– Weakness/paralysis of limbs or any particular side of the body
– Persistent vomiting without any obvious reason
– Blurred vision/ pain in eyes

8. Are there any specific contraindications for vaccination in Pregnancy?
As for the general population, pregnant women should avoid vaccination in the following conditions:

  • Anaphylactic or allergic reaction to the previous dose of COVID-19 vaccine
  • Anaphylaxis or allergic reaction to vaccines or injectable therapies, pharmaceutical products, food-items etc.
  • Vaccine is temporarily contraindicated in the following conditions:
    o Diagnosed COVID-19 infection – defer for 12 weeks from infection or 4 to 8
    weeks from recovery
    o Active COVID-19 infection
    o COVID-19 infection treated with anti-COVID-19 monoclonal antibodies or
    convalescent plasma

9. What are the global recommendations and practices on vaccination of pregnancy women in other countries?
Given the potential benefits and risks of the vaccine, International professional bodies have taken a positive stand on the COVID-19 vaccine in pregnancy. These bodies acknowledged lack of data in pregnancy.

– WHO recommends use of recombinant vaccine in pregnant women, provided the
benefits of vaccination outweigh the potential risk. Pregnant women may also be exposed to COVID-19 vaccine before the woman knows she is pregnant.

– WHO does not recommend pregnancy testing prior to vaccination and delaying
pregnancy or terminating pregnancy because of vaccination.

– International Federation of Gynecology and Obstetrics (FIGO) believes that risk-based approach to immunization might be of disadvantage to the pregnant woman.

– The Royal College of Obstetricians and Gynecologists (RCOG) states that pregnant women should be offered the vaccine as the general population6

– The American College of Obstetricians and Gynecologists (ACOG) states that pregnancy testing should not be required prior to receiving vaccine and vaccine may be administered to the people who may consider future pregnancy. Women under age 50 including pregnant women can receive any COVID-19 vaccine. However, they should be aware of the rare risk of thrombosis with thrombocytopenia syndrome after receipt of mRNA vaccines.

– Countries such as Australia, Canada, Israel, Singapore, United Kingdom and United State of America are vaccinating pregnant women with COVID-19 vaccines.

For additional information please contact: Medical Officer of nearest Health Centre

1. Why is COVID-19 vaccine being recommended for pregnant women?
– Pregnancy does not increase the risk to COVID-19 infection
– Most pregnant women will be asymptomatic or have mild disease, BUT their health may deteriorate rapidly and that might affect the foetus too.
– It is important that they take all precautions to protect themselves from acquiring COVID-19, including taking vaccination against COVID-19.
– It is therefore advised that a pregnant woman should take COVID-19 vaccines.

2. Who are at higher risk of getting infected with COIVD-19?
– Someone who is a health care worker or a frontline worker
– Community having high or increasing rate of COVID-19 infections
– Frequently exposed to people outside the household
– Difficulty in complying with social distance if living in a crowded household

3. How does COVID-19 affect the health of the pregnant woman?
– Although most (>90 percent) infected pregnant women recover without need for
hospitalization, rapid deterioration in health may occur in a few.

Symptomatic pregnant women appear to be at increased risk of severe disease and
death. In severe disease, like all other patients, pregnant women may also need
hospitalization.

– Pregnant women with underlying medical conditions e.g., high blood pressure,
diabetes, obesity, age over 35 years are at higher risk of severe illness due to COVID-
19.

4. How does COVID-19 infection of pregnant women affect the baby?
– Most (over 95 percent) of newborns of COVID-19 positive mothers have been in good condition at birth.
– In some cases, COVID-19 infections in pregnancy may increase the possibility of pre- mature delivery, baby’s weight might be less than 2.5 KG and in rare situations, baby might die before birth.

5. Which pregnant women are at higher risk of developing complication after COVID-19 infection?
– Pregnant women who are:

  • Older than 35 years of age
  •  Obese
  • Have an underlying medical conditions such as diabetes or high blood pressure
  • Have a history of clotting in the limbs

6. If a pregnant woman has already had COVID, when should she be vaccinated?
– In case a woman has been infected with COVID during the current pregnancy, then she should be vaccinated soon after the delivery.

7. Are there any side effects of the COVID-19 vaccines that can either harm the pregnant women or her foetus?
– COVID-19 vaccines available are safe and vaccination protects pregnant women
against COVID 19 illness/disease like other individuals.

– Like any medicine a vaccine may have side effects which are normally mild After
getting the vaccine injection, she can get mild fever, pain at injection site, or feel un-
well for 1-3 days

The long-term adverse effects and safety of vaccine for foetus and child is not
established yet.

– Very rarely, (one in 1 to 5 lakh persons) the beneficiary may afterCOVID19 vaccination, experience some of the following symptoms within 20 days after getting the injection which may need immediate attention.

Symptoms occurring within 20 days after receiving any COVID 19 vaccine
– Shortness of breath (difficulty in breathing)
– Chest Pain
– Pain in limbs / pain on pressing the limbs or swelling in the limbs (arm or calf)
– Small pinpoint haemorrhages (petechial) or bruising of the skin beyond the vaccination site
– Persistent abdominal pain with or without vomiting
– Seizures in the absence of previous history of seizures with or without vomiting
– Severe and persistent headaches with or without vomiting (in the absence of previous history of migraine or chronic headache)
– Weakness/paralysis of limbs or any particular side of the body
– Persistent vomiting without any obvious reason
– Blurred vision/ pain in eyes

Any other symptom or health condition which is of concern to the recipient or the family

8. When should the vaccine be given to the pregnant woman?
– The COVID-19 vaccination schedule can be started anytime during pregnancy.

9. What other precautions need to be advised to the pregnant woman after vaccination?
– You must counsel the pregnant woman and her family members to continue to
practice COVID appropriate behaviour: wearing double mask, frequent handwashing, maintaining physical distance, and avoiding crowded areas, to protect themselves and those around from spreading the COVID-19 infection.

10. How does a pregnant woman register herself for Covid-19 vaccination?
– All pregnant women need to register themselves on Co-WIN portal or may get
themselves registered on-site at the COVID-19 vaccination centre. The process of registration for pregnant women remains same as of the general population and as per the latest guidance provided by MoHFW from time to time.

Hence, You cannot get COVID-19 infection from vaccination.

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