Pregnant Women Should Not Use Moderna's COVID-19 Vaccine, Says WHO
Pregnant women shouldn't use Moderna's COVID-19 vaccine, with special exceptions, according to a recent review of the biotech firm's vaccine shared on the World Health Organization's official website.
The exceptions include pregnant women who are also health workers or have pre-existing medical conditions placing them at heightened risk from the virus.
Pregnant women shouldn't use Moderna's COVID-19 vaccine
The WHO's Strategic Advisory Group of Experts on Immunization — called SAGE — announced several recommendations on Moderna weeks after issuing previous guidance on Moderna's rival vaccine, from Pfizer and BioNTech.
UPDATE Jan. 26, 12:03 PM EST: Moderna vaccine clinical trials for women needed
However, research explaining this recommendation has yet to be seen — for either Moderna's or Pfizer's vaccines.
"While pregnancy puts women at a higher risk of severe COVID-19, the use of [the Moderna] vaccine is currently not recommended, unless they are at high risk of high exposure (e.g. health workers)," read a statement on WHO's blog post.
Kate O'Brien — WHO's director of immunization — said clinical trials for the Moderna vaccine are needed for pregnant women. "There is no reason to think there could be a problem in pregnancy, we are just acknowledging the data is not there at the moment," said O'Brien.
UPDATE Jan. 26, 12:22 PM EST: Lacking evidence to inform treatment decisions on pregnant women
As of writing, the WHO is working with Moderna to evaluate data submitted as part of the firm's application for emergency use listing — which aims to make a decision soon, added O'Brien.
However, without evidence to guide doctors in administering COVID-19 vaccines and related health care to pregnant women, it can be difficult to make decisions at crucial junctures. "We've been denied that evidence," said the Chair of Obstetrics and Gynecology Judette Louis of the University of South Florida, in an NPR report.
UPDATE Jan. 26, 12:45 PM EST: COVID-19 vaccine trials will start soon, says Fauci
While it's true COVID-19 vaccines have yet to see full testing on pregnant people, the problem is more general: "There are very few vaccines that have [been tested on pregnant people]," said Louis, to NPR.
Anthony Fauci — director of the National Institute of Allergy and Infectious Diseases — said during a Columbia University talk in December 2020 that phase 1 and 2 clinical trials testing for safety and immunogenicity of COVID-19 vaccines for both young children and pregnant women had yet to start.
However, they will soon. "Those studies will probably start in mid- to late January," said Fauci during the Columbia University talk.
UPDATE Jan. 26, 1:10 PM EST: Pregnant women represent 'blind spot' of health care system
Until then, the lack of research of medical treatments on pregnant women remains a general, "overarching problem," said Louis — who is also president of the Society of Maternal-Fetal Medicine. "COVID is just the most recent example — because now you have a pandemic and a condition that has been demonstrated to be more severe in pregnant women," she added.
"And so the issue is just more urgent now," said Loius.
With multiple COVID-19 vaccines already moving through the populations of several nations, it's tempting to think full vaccination and herd immunity is only a matter of time. But the bureaucracies of big pharma and government regulating agencies can and have left vast sections and groups of humans out of focus. Until we understand how we can immunize everyone — including pregnant women and young children — our health care system has substantial blind spots to address.