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The COVID-19 vaccine is safe and effective for pregnant people, says the NIH director

 


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(New York) — Pfizer and Modern COVID-19 vaccines are “totally safe” and effective for pregnant people, according to Dr. Francis Collins, director of the National Institutes of Health (NIH). Two new studies show.

Collins writes: Blog post On Tuesday, Pfizer and Modana vaccines, both using mRNA technology, were found to provide pregnant people with the levels of antibodies and immune cells needed to protect them from COVID-19.

According to Collins, the vaccine is likely to have a protective effect on babies born to vaccinated people.

“Overall, both studies show that the COVID-19 mRNA vaccine is safe and effective during pregnancy and may benefit both mother and child,” he wrote. The best way for pregnant and lactating women to protect themselves and their families from COVID-19 is to roll up their sleeves to get one of the mRNA vaccines currently approved for emergency use. Evidence is increasing.

Here’s what pregnant and lactating people want to know about the COVID-19 vaccine to make informed decisions.

1. When can pregnant women be vaccinated with COVID-19?

According to the US Centers for Disease Control and Prevention (CDC), anyone over the age of 12 is currently eligible for COVID-19 vaccination, including pregnant people.

Pregnant people can be vaccinated with the COVID-19 vaccine at any time during their pregnancy and do not need to be vaccinated at intervals from other vaccines, such as influenza vaccination or Tdap booster vaccination.

2. What is the science behind the COVID-19 vaccine?

Both Pfizer and Modana vaccines use mRNA technology that does not enter the nucleus of cells and alter human DNA. Instead, it sends genetic instructions that encourage cells to make proteins that look like viruses, and develops ways for the body to learn and develop defenses against future infections.

These are the first mRNA vaccines that are theoretically safe during pregnancy because they do not contain live viruses.

The Johnson & Johnson vaccine uses the inactivated adenovirus vector Ad26, which cannot replicate. The Ad26 vector carries a piece of DNA that contains instructions for making the SARS-CoV-2 spike protein that triggers an immune response.

This same type of vaccine has been approved for Ebola and has been extensively studied for its effects on other illnesses and pregnant or lactating women.

After reviewing more than 200 pages of data provided by the company and the US Food and Drug Administration (FDA), the CDC concluded that pregnant people could receive the Johnson End Johnson one-shot vaccine.

Vaccine experts interviewed by ABC News recommend that pregnant women should not be vaccinated because live attenuated vaccines such as measles, mumps and rubella can pose a theoretical risk of transmission to the fetus. However, Johnson & Johnson vaccines need to be safe because they do not contain live viruses.

3. Are there any studies on pregnant women and the COVID-19 vaccine?

One study, quoted by Collins in a blog post, was led by a researcher at Northwestern University who studied people who were completely vaccinated during pregnancy.

A study published in the journal on May 11 Obstetrics and gynecologyAccording to the university, it is believed to be the first person to investigate the effects of the COVID-19 vaccine on the placenta. Researchers have found that the vaccine does not affect pregnancy and does not affect fertility, menstruation, or puberty.

The second study, cited by Collins, was led by researchers at the Beth Israel Deacones Medical Center and Harvard Medical School, and examined more than 100 women who chose either the Pfizer or Moderna vaccine. Researchers have found that antibodies to COVID-19 in women after complete vaccination are also present in infant umbilical cord blood and breast milk.

Previous studies published in American Journal of Obstetrics & Gynecology In March, Pfizer and Moderna vaccines were found to be safe and effective for pregnant and lactating people, who can pass protective antibodies to newborns.

The researchers surveyed a group of 131 reproductive-age women vaccinated with Pfizer or Moderna, including 84 pregnant, 31 lactating, and 16 non-pregnant women. We found that antibody levels were similar in all groups. There were no significant differences in the side effects of the vaccine between pregnant and non-pregnant study participants.

This study had some limitations. It was small and the participants were primarily white medical workers in a single city. On the other hand, this is the largest study in the group excluded from the first vaccine trial.

4. What do health organizations say about the COVID-19 vaccine?

The World Health Organization (WHO) states that pregnant people at high risk of exposure to COVID-19 and those at risk of serious illness should be vaccinated.

“Women are at increased risk of COVID-19 when they become pregnant, but there are few data to assess the safety of vaccines during pregnancy,” the WHO said in a statement. “Still, about this type of vaccine. Based on what we know, there is no specific reason to believe that there is a specific risk that outweighs the benefits of vaccination for pregnant women. Therefore, the risk of exposure to SARS-CoV-2 is high. Pregnant women (such as health care workers) or pregnant women with comorbidities that increase the risk of serious illness can be vaccinated in consultation with their health care provider.

The CDC said that pregnant and lactating people “can choose to be vaccinated” and should be discussed with their healthcare provider, while breastfeeding is an important consideration, but “vaccine safety”. There are few concerns about this. “

The Society of Obstetrics and Gynecology (ACOG) is a professional membership organization of OB-GYN and the Advisory Committee on Immunization Implementation of the CDC (ACIP).

Similarly, the Maternal-Fetal Medicine Association (SMFM) recommends that pregnant people have access to the vaccine, and pregnant people “engage in shared decisions” with their doctors about the vaccine. It states that it is necessary.

“In general, SMFM engages in making pregnant women accessible to the COVID-19 vaccine at all stages of future vaccine campaigns, and for her and her healthcare professionals to make common decisions regarding vaccine receipt. It is highly recommended that … the mRNA vaccine, which is likely to be the first vaccine available, does not contain live viruses, but rather induces humoral and cellular immune responses through the use of viral mRNAs. ” “Healthcare professionals also need to advise patients that the theoretical risk of harm to the fetus from the mRNA vaccine is very low,” the Society said in a statement. “

5. What are the clinical trials for pregnant people?

The company announced in a press release that Pfizer’s Phase 2/3 trial enrolled approximately 4,000 women within 24-34 weeks of gestation.

Half receive the vaccine and half receive the placebo.

This study includes healthy pregnant women over the age of 18 in the United States, Canada, Argentina, Brazil, Chile, Mozambique, South Africa, the United Kingdom and Spain.

Vaccine group participants receive two doses every 21 days. Each woman is followed for at least 7-10 months to continuously assess the safety of both participants and babies.

Infants are evaluated for the transfer of protective antibodies from vaccinated mothers up to 6 months of age.

Women who participate in the study will be aware of the status of the vaccine shortly after giving birth and will be able to receive the vaccine while the first woman receiving the placebo is participating in the study.

6. Why did early clinical trials not include pregnant women?

According to Dr. Ruth Faden, founder of the Johns Hopkins Berman Institute for Bioethics and a bioethicist who studies pregnancy and vaccine ethics, not recruiting parents for clinical trials or medical research is about to begin. That’s not the case.

“For a very long time, pregnant women have not participated in biomedical research evaluation activities or clinical trials. Manufacturers and pharmaceutical companies,” Faden told ABC. Good morning, America last month. “There is a big gap between what we know about the safety and efficacy of new drugs or vaccines and what we know about those that are specific to pregnancy.”

For the COVID-19 vaccine, health professionals have only one of three sources of evidence used to assess safety and efficacy during pregnancy. According to Faden, data on non-pregnant people enrolled in clinical trials. ..

From there, health professionals can try to find out what side effects occur in pregnant people, but that’s not an accurate science.

However, many argue that it is typical and ethically appropriate to first study an unknown substance in healthy adults and then gradually study it in a wider and wider population. It is believed to be. Pregnant people and children are often tested later because of the potential for long-term harm.

Some volunteers from previous COVID-19 vaccine trials who did not involve pregnant women directly may still become pregnant during the trial. This also gives researchers insight into the safety of this group of vaccines.

7. What are the risk factors that pregnant people should consider?

At this time, the CDC recommends that pregnant women prioritize vaccination and encourages them to consult their doctor about the risks and benefits of vaccination.

The question of whether pregnant parents should be vaccinated with COVID-19 is ultimately the whole pregnancy, the risk factors for COVID-19, the ability to stay socially distant in lifestyle and profession, and from doctors. We end up with many factors, such as guidance. Recommendations from federal and state officials and their own doctors, according to experts.

Similar to influenza vaccines that were not tested in pregnant people in clinical trials, medical professionals can use continuously entered data to make decisions about the safety of the COVID-19 vaccine during pregnancy. Must depend.

Pregnant people “should not be unnecessarily vigilant,” said Fadden, who said the authorities are doing the same for the general public, given the rate at which the COVID-19 vaccine was developed. “.

You can get the COVID-19 vaccine in any semester. Because other vaccines are recommended during pregnancy, the CDC currently recommends that you make a few weeks to book your vaccine, if possible.

8. Is COVID-19 more dangerous for pregnant women?

More than a year after the outbreak of the coronavirus pandemic in the United States, there are still some questions about how pregnant women will be affected by COVID-19.

The CDC shows that pregnant people infected with COVID-19 are at higher risk of “entrance to the intensive care unit, invasive ventilation, extracorporeal oxygenation, and death” than non-pregnant people. We are sharing data that indicates.

Health experts say that pregnant people, with or without vaccines, need to remain alert for COVID-19 according to safety protocols such as wearing face masks, social distance, and hand washing. Stated.

Copyright © 2021, ABC Audio. all rights reserved.

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