Dr. Narendra Kumar Arora, a paediatric gastroenterologist and a senior member of the National COVID-19 Task Force while explaining why and how the regulators approved vaccines for pregnant women says that though pregnancy and childbirth do not increase the risk of acquiring SARS-CoV-2 infection, they worsen the clinical course of the pandemic compared to other women in the same age group.
Why is COVID-19 vaccine important for pregnant women?
Though pregnancy and childbirth do not increase the risk of acquiring SARS-CoV-2 infection, it worsens the clinical course of COVID-19 compared to other women in the same age group.
During the second wave, the country witnessed a surge in COVID-19 cases, and with that a sudden surge in the absolute number of cases in pregnant women. It was found that 22% of pregnant women who tested positive for COVID-19 had premature deliveries, and 48% had to undergo a caesarean delivery. Besides, the rate of admission to the ICU among pregnant women with COVID-19 was also higher than those of non-pregnant women.
COVID-19 during pregnancy can lead to pre-eclampsia or eclampsia, which is an increase in the blood pressure of mother, and the risk of cardiopulmonary arrest increases, especially if the infection occurs during the third trimester.
Since the vaccine significantly reduces the severity and mortality due to COVID-19, the government took the decision to provide vaccination to pregnant mothers.
What kind of safety studies were conducted before prescribing COVID-19 vaccines for pregnant women?
The common perception has been to avoid any drug or new interventions during pregnancy because two lives are affected — the mother-to-be and the embryo growing in her womb. Developmental and Reproductive Toxicology (DART) studies have been conducted for the m-RNA based COVID-19 vaccines. These reproductive tract toxicity studies are done on pregnant animals e.g., mice. In several countries across the world, there are cases of young frontline workers, who were unknowingly pregnant at the time of vaccination, also indicated that the vaccine is safe for both the mother and the foetus. On the basis of the above two findings, the World Health Organisation has recommended the use of vaccines for pregnant women.
Killed virus vaccines such as Covaxin have been used before the current pandemic in pregnancy without side-effects. In view of these scientific rationales, the continuing intense SARS COV-2 virus transmission in our country and the increased mortality observed among hospitalised pregnant women during the second wave, the experts strongly felt that the benefits of administering the vaccine outweigh the remote risk associated with Covishield, Sputnik-V, and other similar COVID-19 vaccines. The government guidelines specifically instruct the vaccinators that every pregnant women should be informed in a simple and comprehensible manner about the benefits as well as the minor risks of taking COVID-19 vaccines.
Is there any specific phase of pregnancy when a woman should take this vaccine?
The vaccine can be taken anytime during pregnancy, including in the first trimester.
If a pregnant woman acquires COVID-19 disease during pregnancy, when is the vaccine to be given?
If the pregnant woman gets COVID-19 infection, no vaccine doses are required till she gives birth, even if she had already taken the first dose. She can take the second dose post childbirth.
Pregnant women receive Tetanus-Diptheria (TD) vaccine. Can the COVID-19 vaccine be given together with this?
The COVID-19 vaccine should be given as soon as possible so that if a woman catches infection during pregnancy, the chances of her developing severe disease and related complications could be minimised. Yes, the two vaccines can be given together with TD vaccine on the same day.
Which of the three vaccines availablein India — Covaxin or Covishield or Sputnik V — would you recommend for pregnant women?
I emphasise that all the vaccines in the national programme are equally effective and safe as per the currently available national data. The minor side-effects too are similar, mostly mild and stay for 1-3 days post vaccination. These include slight pain at the injection site, mild fever, fatigue, etc.
Is there a plan to study the long-term impact of vaccination on women and children?
Active maternal immunisation safety surveillance network for COVID-19 vaccines is being established to identify any known or unknown side-effects of the vaccines. The aim is to assemble a big group of pregnant women who have received at least the first dose of any COVID-19 vaccine during pregnancy and they are then followed up till parturition/culmination of pregnancy. This will also document fetal outcome and follow up the neonate for 28 days after the delivery. The network is planned to cover the whole country. It will comprise tertiary care hospitals across India, and equipped with NICU facility.
What about adverse events following immunisation?
There are strict guidelines on how to prioritise reporting of adverse events following immunisation (AEFIs) in vaccinated pregnant women. The National and State AEFI Committees have inducted obstetricians, paediatricians, and neonatologists who have been oriented towards identifying and addressing adverse events post vaccination. Vaccinators, ANMs, ASHAs, AWWs, and other health workers, medical officers, private practitioners can report the adverse events on CoWIN platform.
All pregnant women receiving any of the COVID-19 vaccines are also advised to report back to the vaccination centre any time till four weeks after receiving any dose if they are hospitalised, experience unusually severe headache or abdominal pain with or without vomiting, or breathing difficulty. This helps in identifying even the rare side-effect of vaccines quickly, which can be managed in the hospital.
All such cases must be referred to the nearest AEFI management centre or secondary or tertiary healthcare facility. The health system across the country has now the capacity to reliably capture, diagnose and manage AEFIs/AESIs.
