Pfizer and BioNTech have announced that it is launching clinical COVID-19 vaccine trials in pregnant women. At present, the companies are aiming to enroll around 4000 expectant females from around the world.
The vaccine generating company says that it aims to begin COVID-19 vaccine trials in other vulnerable populations after successful initial attempts.
“Now that we see the successful initial implementation of vaccine campaigns with BNT162b2 [the Pfizer-BioNTech vaccine] across the globe, it is time to take the next step and extend our clinical program to other vulnerable populations, such as pregnant women, to protect both them and future generations potentially,”
Pfizer hopes that they will be able to wrap up these trails by the end of January 2023. The company is also setting to launch COVID-19 vaccine trials in younger children and people with compromised immune systems.
In a recent article in the Journal of the American Medical Association, the federal researchers have said that “pregnant and lactating persons should not be protected from participating in research, but rather should be protected through research.”
Top scientists at the National Institutes of Health say that pregnant women are at greater risk of catching COVID-19 and thus have more complications during birth. But, this population lacks the necessary guidance on the use of vaccination.
Therefore, the experts want the companies to address any possible repercussions. The federal researchers wrote, “Guesswork must be removed when it comes to vaccination decisions for this important population.”
Pfizer and BioNTech say they are cautious in their trials of pregnant women. Their research has found “no evidence of fertility or reproductivity toxicity in animals” that they have tested with the vaccine.
Pregnant women during the 24 to 34 weeks of pregnancy will be vaccinated. The researchers will assess the effectiveness, tolerability, safety, and immunogenicity of the vaccine’s doses or placebo during the study.
The researchers will also evaluate the infants for about six months. They will see whether the newly borns have potentially received protective antibodies from their mothers or not.
The US Food and Drug Administration has not yet licensed the use of Pfizer-BioNTech’s COVID-19 vaccine. However, under an Emergency Use Authorization (EUA), the FDA has authorized the vaccine’s emergency use to curb the Coronavirus spread.