Pfizer and BioNTech announced Thursday that they are launching clinical trials of their anti-Covid vaccine on pregnant women, these are the first such tests to be performed, NBC reports, according to news.ro.
Pharmaceutical companies are considering enrolling about 4,000 pregnant women for these studies, which will include participants from the United States, Argentina, Canada, Chile, Mozambique, South Africa, Spain and the United Kingdom.
Women over the age of 18 who are 24 to 34 weeks pregnant are eligible.
The first doses will be given in the United States, Pfizer said.
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Dr. Brenna Hughes, a specialist at Duke Health in Durham, North Carolina, said she “applauded” this study by Pfizer.
“There is a desperate need for all the data that will help us reassure pregnant women that the vaccine is safe for them,” said Hughes, a member of the American College of Obstetricians and Gynecologists.
Dr. William Gruber, Vice President of Vaccine Clinical Research at Pfizer, said in a statement: “We are proud to begin this study in pregnant women and continue to gather evidence on safety and efficacy to reduce the use of the vaccine in subpopulations. support. ”.
Some of the women enrolled in the study will receive real serum, others placebo. They will not know what was given to them until they were born. At that time, women who received placebo would receive the vaccine.
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Researchers will check for adverse effects, including pregnancy loss. There are some preliminary data on the safety of the vaccine during pregnancy, as some women who participated in the first vaccine tests became pregnant during the study.
“Of everything I’ve seen so far in pregnant women who have received the vaccine, there are no warning signs,” said Stacey Stewart, president of the March of Dimes.
However, there is evidence that Covid-19 disease affects pregnant women. From existing data, those infected with SARS-CoV-2 have a higher risk of complications, including premature birth.
The Pfizer study will also monitor children for six weeks to find out if the mother’s antibodies have been transferred to the baby.