Pfizer and BioNTech say the first US participants were given shots in a large clinical trial to evaluate their safety and efficacy COVID-19 (new coronavirus infection) (# If there is no character limit, add parentheses when it first appears For pregnant women. The two companies aim to enroll approximately 4,000 pregnant women worldwide in the study.
“Currently, the initial implementation of a vaccine campaign using BNT162b2 has been successful. [the Pfizer-BioNTech vaccine] Dr. Ozremtilech, Chief Medical Officer at BioNTech, has taken the next step around the world, extending clinical programs to other vulnerable people such as pregnant women, potentially both them and future generations. It’s time to protect. “ In the statement Thursday.
Estimates of both companies This trial It will end by January 2023. Moderna, the only other COVID-19 vaccine maker to date with an emergency use authorization in the United States, Launched the registry To track pregnant women who have been shot.
Pfizer and BioNTech also said they are aiming to launch new studies in young children in the coming months. Exams recently started in adolescence.. Studies are also planned to assess doses in people with a weakened immune system.
The announcement reinforces research on pregnant women who are dissatisfied with COVID-19 vaccine developers at high risk of serious viral illness and lack of clarity by top scientists at the National Institutes of Health. It will be done a week after you ask. Guidance on vaccination.
“Pregnant and lactating people should not be protected from participating in research, but rather through research,” said federal researchers. Said in the article Published by the Journal of the American Medical Association.
“When it comes to vaccination decisions for this important population, speculation needs to be removed,” they write.
Pregnant women were excluded from the first trial of COVID-19 shots of Moderna and Pfizer. This is a common method in such studies.The Food and Drug Administration recommended vaccine developers to include pregnant women, but regulators Also needed them First complete additional investigations to check for potential warning signs.
Pfizer and BioNTech state that their study “has no evidence of animal fertility or toxicity” tested with the vaccine.
Some participants in the Moderna and Pfizer trials in the United States will become pregnant and no vaccine-related issues have been reported.
After analyzing the data from these trials, the American College of Obstetrics and Gynecology Ends in December The shot “should not be withheld from pregnant individuals.”Centers for Disease Control and Prevention Technology says What is used to create mRNA vaccines like Pfizer and Moderna is that “it is unlikely to pose a particular risk to pregnant people.”
Both groups are advised to consult a doctor if a pregnant woman has questions about firing.Limited data Guided some pregnant women Hesitate about whether to get the vaccine.
But without the vaccine, studies suggest pregnant women High risk Percentage of hospitalizations and deaths due to COVID-19. A study published in January found that pregnant women had a 13-fold higher COVID-19 mortality rate than other patients of similar age.
“This is an important group that is usually very vulnerable to influenza but excluded from the COVID-19 vaccine trial,” said Dr. Christina Adams Waldorf, lead author of the University of Washington study. Stated. Said in a press release Details of their study.
“Pregnant patients should have been given the option to enroll in vaccine trials to better understand the risks and benefits of vaccines.”
But even before the new data came out, many doctors say the benefits of vaccines are already clear.
“We strongly recommend that all pregnant women be vaccinated from the first discovery of pregnancy to maturity,” said Dr. Bob Rahita, a professor of medicine at New York Medical College and director of medicine at St. Joseph’s University Hospital. It was. Interview with CBSN last week. He said there was “no evidence” that the vaccine “has any effect on the placenta, foetation, or mother.” Unless you are infected, infected with COVID and pregnant, you are at great risk. I’m very ill. “
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