The developers of Comirnaty, the first approved vaccine against COVID-19, have kicked off a global Phase II/III trial to test the product in pregnant women.
New York’s Pfizer and Mainz, Germany-based BioNTech have already conducted preclinical work which shows no evidence of fertility or reproductive toxicity in animals.
The firms said they expect to start additional studies in children between the ages of five and 11 over the next couple of months, and in children younger than five later in 2021.
Pfizer’s senior VP of vaccine R&D, William Gruber, said: “Pregnant women have an increased risk of complications and developing severe COVID-19, which is why it is critical that we develop a vaccine that is safe and effective for this population.”
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