(This story was first published in The Times of India on December 13, 2020)
- The United States will begin mass vaccinations on Monday after becoming the sixth country to pass the
vaccinedeveloped by Pfizer and BioNtech. India is expected to approve one or more vaccines in the coming weeks: Pfizer, the Serum Institute of India (Oxford vaccine) and Bharat Biotech have applied for emergency approval.
- In India, 10 million healthcare workers, 20 million frontline workers and 270 million people over the age of 50 and minor people with comorbidities should get the doses first. But should
pregnant women– Who can overlap with the aforementioned groups – also get the vaccine?
- While pregnant women are considered a high-risk group and therefore must be online to receive the vaccine, no vaccine has been studied in them. For example, none of the 44,000 participants in the Pfizer late-stage trial were pregnant.
- Denise Jamieson, from Emory University School of Medicine, Atlanta, says researchers avoid pregnant women in trials for the simple reason that it is easier to do so. “There are actually very few drugs, for example, that are approved during pregnancy because, basically, it’s easier. It is easier to exclude pregnant women because when you include pregnant women, you have to be concerned about both the health of the woman and the development of the fetus and baby, ”she tells NPR.
- The flip side of this cautious approach is that we don’t know if a vaccine has any safety concerns for pregnant women. In Britain, regulators have advised against offering the vaccine to pregnant or lactating people. British authorities also warn that “women of childbearing age should be advised to avoid pregnancy for at least 2 months after their second dose.” Canada says pregnant women should speak to their doctor before receiving a vaccine, but it does not exclude them as a policy.
- The US FDA has licensed the Pfizer vaccine for anyone 16 years of age and older, and has asked Pfizer to provide periodic reports on the safety of the vaccine, including its use in pregnant women. The CDC has not yet endorsed the vaccine for pregnant women, reports the New York Times, but an agency advisory committee is expected to make further recommendations.
- The American College of Obstetricians and Gynecologists has urged the CDC not to exclude pregnant and lactating people, as they are identified as a risk group.
- In the absence of test data, Indian regulators will closely follow the steps their colleagues are taking elsewhere.