Dr. Nidhi Singh, MD (Obstetrics and Gynecology).
COVID-19 Vaccine and Pregnancy: FAQs.
Background: The SARS-COV 2 or COVID-19 pandemic has taken over the world and our lives since December 2019 causing disease, death and misery in a manner never known or seen before. However, we humans have come a long way since the first wave of the disease hit. From hardly knowing anything about this novel virus to manufacturing vaccines in less than a year (the shortest known time in the history of vaccine development).
Vaccination started globally with frontline workers and those above 45 years of age being prioritized. The myths and fears around the vaccine have been palpable. Fortunately, the results have been promising in the population vaccinated so far. The fatalities and severity of the disease were drastically reduced when vaccinated persons got infected.
In India the second wave of the pandemic (started early to mid-March 2021) has been a nightmare that almost crushed the healthcare infrastructure. An enhanced vaccination drive is the need of the hour to mellow down the impact of the next wave. Pregnant women are a specially vulnerable group. With the next wave around the corner inclusion of pregnant women for vaccination becomes an important issue that needs focused action.
1. How does COVID-19 effect Pregnant women?
COVID-19 infection may be more dangerous during pregnancy as opposed to those not pregnant. Studies have shown that hospital admission and severe illness may be more common in pregnant women compared to those not pregnant. Women in their third trimester are at higher risk because there are more chances of premature birth if COVID-19 infection occurs. Pregnant women with underlying medical conditions (like diabetes, hypertension, renal disease etc.) are also at higher risk of severe illness.
2. What is a vaccine and how does it work?
Vaccines are basically small doses of the pathogen i.e., the disease-causing organism (e.g. bacteria, viruses). It can be a protein from the pathogen, a live but weakened whole pathogen or the dead pathogen. Vaccines do not cause disease. They just put the immune system to work to make specific antibodies (proteins that kill pathogen if infection occurs). Vaccines are usually given in two or more doses at specified intervals.
3. How are vaccines tested for safety?
After being formulated in the laboratories, vaccines are first tested on experimental animals following which they go into human trials. The human volunteers are recruited and divided into groups. One group receives the vaccine and the other a placebo (something which looks like a drug but is not a drug e.g., a saline injection). Only after specified rounds of trials, a vaccine is approved for mass distribution. Pregnant women are excluded from vaccine trials.
4. What does one need to know to get vaccinated in pregnancy?
Trials testing the vaccine in pregnant and breastfeeding women have not yet taken place. Whether to get the vaccine in pregnancy or not is completely a personal choice. The two options are (a) either to get vaccinated after knowing all the information available so far or (b) wait for more information regarding safety and efficacy of vaccine in pregnancy.
5. Should COVID-19 vaccine be given to pregnant women?
Though COVID-19 vaccine trials did not include pregnant women, a few women accidentally got vaccinated during the trials. This happened either because they were unaware of their pregnancies or got pregnant during or after the vaccination period. So far, all these pregnancies are ongoing with no major adverse effects being reported. However, the numbers are not enough to say anything authoritatively.
Given the risk that the COVID-19 infection poses to the mother and the unborn baby during pregnancy, the medical community is recommending COVID-19 vaccination for pregnant women. Their argument is based on the following facts:
(i) Pregnant women are at risk of developing more severe symptoms if infected and therefore must be vaccinated. (ii) The small number of pregnant women who got vaccinated accidentally did not show any major adverse effects. (iii) The benefits that a vaccine can provide seemingly outweighs the theoretical risk that the vaccine can pose.
In the UK and USA, the vaccine is being offered to all pregnant women after educating them with the information available and with the disclaimer that there have been no trials on pregnant women so far.
It is the pregnant woman’s choice to take the vaccine or wait until more information regarding vaccination in pregnancy is available.
Some pregnant women are more vulnerable than others such as those with high risk pre-existing medical conditions, health care workers, women who develop diabetes during pregnancy and those who are obese are all potential candidates for vaccination.
6. What are the benefits of vaccination for pregnant women?
Vaccination will prevent severe disease in pregnant women especially those in their third trimester Pregnant women who have underlying medical problems and who work in high-risk areas (i.e., those that are more exposed to the virus) are also protected from getting severely unwell if infection occurs. It also prevents premature childbirth. Hence vaccination can help ensure safety of mother and baby.
7. Can vaccination cause infection during pregnancy?
One cannot get COVID-19 infection from vaccination because the COVID-19 vaccines do NOT contain the “live coronavirus”. Vaccines also do NOT contain any additional ingredients that are harmful to pregnant women or their babies
Other non-live vaccines (whooping cough, influenza) are also considered to be safe for pregnant women and their unborn babies. It is likely that the COVID-19 vaccine is safe in pregnancy though we have limited data as of now.
8. What are the risks of vaccination in pregnant women?
The COVID-19 vaccines have not yet been tested specifically in pregnant women. COVID-19 vaccines have been given to large numbers of people ensuring that stringent standards of effectiveness and safety are met. However, there isn’t statistically significant evidence available in pregnant women. The data generated in the United States, where more than 100,000 pregnant women have received a COVID-19 vaccine (using Pfizer, BioNTech or Moderna vaccines), has not raised any safety concerns. More information may come from studies in the future.
Side effects from the vaccine are common. These do not affect pregnancy, but may include: Injection site reactions (sore arm), fatigue, headache, muscle pain, fever and chills and joint pain.
Extremely rare but serious side effects involving thrombosis (blood clots) have been reported for the AstraZeneca vaccine (Covishield).
9. What does the Royal College of Obstetricians and Gynecologists (RCOG) & the American Association of Obstetrician and Gynecologists (ACOG) say?
Both have advised that the COVID-19 vaccines should be offered to pregnant women at the same time as the rest of the population, based on their age and clinical risk group. Women should discuss the benefits and risks of taking the vaccine with their healthcare professional and reach a joint decision based on individual circumstances.
Breastfeeding women need not stop breastfeeding if vaccinated or to be vaccinated against COVID -19. Women trying to become pregnant need not avoid pregnancy after vaccination and there is no evidence to suggest that COVID-19 vaccines will affect fertility.
10. What is the status of COVID-19 vaccines in India?
In India Covishield (AstraZeneca) and Covaxin (Bharat Biotech) were approved in the initial rounds which excluded pregnant women. The Government of India has still not approved any vaccine for pregnant women.
However, key medical associations like the IMA (Indian Medical Association) and FOGSI (Federation of Obstetricians and Gynecologists of India) are in favor of vaccinating pregnant women and making efforts to get it approved by the government. In India Covaxin can be offered to pregnant women.
Conclusion: To sum up, the medical community globally is in favor of vaccinating pregnant women to prevent severe symptoms and/or death. Due to the limited data available, the advice goes with caution. Informed choice is being recommended. Your doctor will fully support your decision whether you choose to be vaccinated or wait for further information. Pregnant women who have medical issues should seriously consider vaccination.
If a person thinks that he or she may be eligible for COVID-19 vaccination, it should be discussed with their doctor and accurate information must be obtained. If a pregnant woman decides to get a COVID-19 vaccine, vaccination team must be informed for the record.
Even after vaccination one must continue the practices of regular hand washing, wearing masks and social distancing. With careful, well informed, vigilant and responsible action we shall be able to tide over this pandemic and bring in a healthy future for all.
Dr. Nidhi Singh, MD (Obstetrics and Gynecology), King George’s Medical College, Lucknow, Uttar Pradesh, India.
June 19, 2021