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Pfizer and BioNTech say early U.S. participants injected in large-scale clinical trial to assess safety and effectiveness of their COVID-19 vaccine for pregnant women. The companies aim to enroll some 4,000 pregnant women for the trial around the world.
“Now that we are witnessing a successful initial implementation of vaccination campaigns with BNT162b2 [the Pfizer-BioNTech vaccine] across the world, it is time to take the next step and expand our clinical program to other vulnerable populations, such as pregnant women, to protect them and future generations, ”said Thursday the Chief Medical Officer of BioNTech, Dr Özlem Türeci.
The companies estimate that this trial will be completed by January 2023. Moderna, maker of the only other COVID-19 vaccine to have received emergency use authorization so far in the United States, has launched a registry for monitor pregnant women receiving the vaccine.
Pfizer and BioNTech said they also aim to start new studies in young children in the coming months, and recently started trials in adolescents. Research is also planned to assess doses in people with weakened immune systems.
The announcement comes a week after top scientists at the National Institutes of Health called on COVID-19 vaccine developers to step up their research on pregnant women, who are at greater risk of serious illness from the virus and who have been frustrated with the lack of vaccination advice.
“Pregnant and breastfeeding people should not be protected from participating in research, but should instead be protected by research,” federal researchers said in an article published by the Journal of the American Medical Association.
“We need to remove the guesswork when it comes to vaccination decisions for this important population,” they wrote.
Pregnant women have been excluded from the original trials of Moderna and Pfizer’s COVID-19 injections, a common practice in such studies. Although the Food and Drug Administration has encouraged vaccine developers to include pregnant women, the regulator has also asked them to start by doing additional research to check for potential red flags.
Pfizer and BioNTech say their research has found “no evidence of toxicity to fertility or reproduction in animals” tested with the vaccine.
Some participants in the US Moderna and Pfizer trials ended up getting pregnant, and no vaccine-related issues were reported.
After analyzing the data from these trials, the American College of Obstetricians and Gynecologists concluded in December that injections “should not be refused to pregnant women.” The Centers for Disease Control and Prevention say the technology used to create mRNA vaccines like Pfizer and Moderna is “unlikely to pose a specific risk to pregnant women.”
Both groups recommend that pregnant women see their doctor to ask questions about the vaccine. The limited data has led some pregnant women to express hesitation about whether to get the vaccine.
However, without the vaccine, research suggests pregnant women are at a higher risk of hospitalization and death from COVID-19. A study published in January found a death rate from COVID-19 in pregnant women 13 times higher than in other patients of the same age.
“Here is a large group that is generally very vulnerable to influenza infections and yet they have been excluded from COVID-19 vaccine trials,” said Dr. Kristina Adams Waldorf, lead author of the University of Washington study. , in a press release detailing their research.
“Pregnant patients should have been given the opportunity to enroll in vaccine trials so that we could better understand the risks and benefits of the vaccine for them.”
But even before this new data arrives, many doctors say the benefits of vaccines are already clear.
“I strongly recommend that all pregnant women be vaccinated, from the initial discovery of pregnancy to term,” said Dr. Bob Lahita, professor of medicine at New York Medical College and chair of the Department of Medicine at St. CBSN last week. He said there was “no evidence” that the vaccine “has any effect on the placenta, on the fetus, on the mother. Unless you get the infection, COVID, and you are pregnant, you run the risk of getting very, very sick. “
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