Pfizer Inc and BioNTech have joined hands to initiate an international study involving 4000 volunteers to assess the efficacy and safety of their coronavirus vaccines for pregnant women.
As per international reports, pregnant women are at higher risk of developing severe COVID-related complications, due to which several health officials recommend women with a baby bump to get vaccine shots even without proof of their safety.
However, Pfizer is hopeful that their vaccine will prove fruitful for pregnant women. Dr. William Gruber, senior vice president of vaccine clinical research and development for Pfizer expects to have results by the fourth quarter of 2021.
The data available so far suggests that pregnant women with COVID-19 have higher rates of severe disease. They also have higher rates of pregnancy complications, such as premature birth, compared with pregnant women not infected by the coronavirus.
“This is why US regulators and public health advisers are interested in doing this in the first place – so people can be fully informed about the safety profile,” he said.
Taking the hint from it, the US National Institutes of Health last week called for greater inclusion of pregnant and lactating women in COVID-19 vaccine research.
Despite the calls from bioethicists, vaccine and maternal health experts that pregnant women should be included early in trials of pandemic vaccines, they excluded from the large US trials.
Drug-makers have said they first need to make sure the vaccines are safe and effective more generally.
The companies said in a statement that some pregnant women in the US have already received their first doses. The new study will test pregnant women aged 18 and older in the United States, Canada, Argentina, Brazil, Chile, Mozambique, South Africa, the UK, and Spain.
As per the trial schedule, women will be given the shots during weeks 24-34 of gestation, getting two shots 21 days apart – the same regimen used in the larger clinical trial.
The participants will be checked for placebo shortly after giving birth and will have a chance to get the actual vaccine.
The trial will also assess whether vaccinated pregnant women transfer protective antibodies to their babies.
Thanks for sharing this. It’s really an important info for many especially who are expecting