The U.S. Food and Drug Administration on Friday officially approved the first COVID-19 vaccine for emergency use, leading to a national campaign to vaccinate Americans enough to suppress the spread of the corona virus. But given that the Pfizer vaccine or any other vaccine awaiting FDA approval has not been tested on pregnant people or those currently breastfeeding, there are questions as to whether it is safe for those population groups to stand in line to receive the vaccine.
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So there is a Govt vaccine, but what does it mean for pregnant people?
On Saturday, the FDA said it did not recommend vaccinating pregnant women, but did not exclude them from receiving one.
“I think it’s important to consider the potential benefits and potential risks from one provider to another – what we do not know about the vaccine, what we do,” said Peter Marks, MD, Ph.D., Biology of FDA. Director of the Center for Evaluation and Research. He added: “Of course COVID-19 is not a good thing for a pregnant woman, so anyone can decide if they want to be vaccinated, but that’s not something we recommend at the moment, it’s an individual we are leaving.”
In general, the FDA recommends caution in the use of any medication or treatment that lacks explicit data on safety in pregnant women. In the case of the COVID-19 vaccine, the UK has so far advised against vaccinating pregnant people or those planning to become pregnant within three months of the first dose.
However, the fact that many experts do not have any definitive information does not mean that the vaccine is harmful to pregnant or lactating women. In fact, pregnant people already receive many vaccines, such as the flu vaccine, the diphtheria vaccine, and the hepatitis B vaccine.
“COVID-19 vaccines should not be withheld from women only on the basis of their pregnancy or lactation status, otherwise they meet the criteria for vaccination.”
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A team of experts in obstetrics and gynecology recently said that the known risks of infection with COVID-19 during pregnancy outweigh the “risks of vaccination”. The team cited recent studies showing that pregnant women with COVID were more likely to need a ventilator and die than non-pregnant women. In fact, the Centers for Disease Control and Prevention noted that although there are only mild cases of coronavirus reduction in some pregnant women, “data demonstrate the risk of severe maternal disease and preterm birth due to COVID-19 disease”.
On the recommendations of the committee, they were published American Journal of Obstetrics and Gynecology, Amanda Craig, MD, wrote, “COVID-19 vaccines should not be withheld from women solely on the basis of their pregnancy or lactation status, otherwise the criteria for vaccination must be met.” He said it was up to them to assess the risk they were exposed to and make a decision in consultation with their healthcare providers.
It is not clear whether the FDA will make additional recommendations to pregnant people as additional data is collected, but FDA Commissioner MD, Stephen Hahn, believes their study is complete and provides sufficient information to “provide as much information as the data support and to advise patients , Is also very important for patients to be aware of complications.
Over the next few days, the FDA and CDC will release more formal approvals and recommendations around vaccines that finalize Pfizer’s vaccines and tests, which will be important for those in line to receive a vaccine: namely health workers. According to the CDC, 75 percent of these workers are women and 330,000 of them “may be pregnant at the time of vaccination implementation or may have recently given birth.”
Anthony Fossie, director of the National Institute of Allergy and Infectious Diseases, said follow-up vaccine studies involving pregnant women and young children could begin in mid-January. “It’s not necessary to look at performance, but let’s look at the safety and immunity to control the performance of non – adult pregnant women,” he told a conference on Thursday.
He also believes that under so-called emergency use authorization, pregnant people will not be barred from receiving the vaccine. “[They will be] Free to make their own decision. “
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