(GNB Desk): Pfizer and BioNTech on Thursday announced that the first U.S. participants have been given shots in a large-scale clinical trial to assess the safety and efficacy of their COVID-19 vaccine for pregnant women. The companies are aiming to enroll some 4,000 pregnant women in the trial around the world.
Pregnant women were not included in their first clinical trials, so, there isn’t as much data on this particular group, Pfizer’s trial will be a big help in creating more conclusive data on the subject.
“We are proud to start this study in pregnant women and continue to gather the evidence on safety and efficacy to potentially support the use of the vaccine by important subpopulations,” said William Gruber M.D., Senior Vice President of Vaccine Clinical Research and Development, Pfizer. “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. We are deeply thankful to the volunteers who are enrolling in the trial, and site investigators who are leading this work.”
Özlem Türeci, M.D., Chief Medical Officer of BioNTech said in a statement Thursday “Enabling broad access to our highly effective COVID-19 vaccine is an important goal for us. Now that we are seeing successful initial implementation of vaccine campaigns with BNT162b2 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 potentially protect both them and future generations”.
Prior to conducting their COVID-19 vaccine clinical trial in pregnant women, Pfizer and BioNTech completed a developmental and reproductive toxicity (DART) study with BNT162b2 which was required by the regulatory authorities before starting the study in pregnant women. Those studies showed no evidence of fertility or reproductive toxicity in animals, the company said in the statement.
The companies estimate this trial will wrap up by January 2023. Moderna, maker of the only other COVID-19 vaccine to receive emergency use authorization so far in the United States, has launched a registry to track pregnant women receiving the shot.
Pfizer and BioNTech said they also expect to start additional studies in children between the ages of 5 and 11 over the next couple of months, and in children younger than 5 later in 2021. Safety and efficacy in subjects 12 to 15 years of age are already being evaluated in the global Phase 3 study (C4591001) and the relevant data are planned to be submitted to the regulatory authorities in the second quarter of 2021. The Companies are also planning studies to further evaluate the vaccine in people with compromised immune.
The announcement comes a week after top scientists at the National Institutes of Health called on COVID-19 vaccine developers to ramp up their research into pregnant women, who face greater risk of severe illness from the virus and who have been frustrated by the lack of clear guidance on vaccination.
“Pregnant and lactating persons should not be protected from participating in research, but rather should be protected through research,” the federal researchers said in an article published by the Journal of the American Medical Association.
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