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Excluding pregnant women from the COVID-19 vaccine trial puts their health at risk




In one study, pregnant women with COVID-19 were 1.5 times more likely to be admitted to the intensive care unit and 1.7 times more likely to use a ventilator than infected non-pregnant women. Photo: Petr Kratochvil / Wikimedia Commons

The development of a safe and effective vaccine for COVID-19 is a top priority due to the lack of effective treatments and limited treatment options. Vaccines reduce the spread of the virus to the community by protecting individuals from infection and blocking transmission routes.

Once a safe and effective vaccine for COVID-19 is available, the challenge is to ensure fair distribution in and out of the country. In addition to global fair access, fair priorities must be set within the jurisdiction. Immediate priority groups may include healthcare professionals, personal care attendants, first responders, adults 65 years and older, and other high-risk adults in existing health conditions. But then the groups that need to be considered include pregnant women.

COVID-19 during pregnancy

Although data on the prevalence and severity of COVID-19 in pregnant women are limited, it is believed that there is a risk of serious complications from COVID-19. A study in the United States found that infected pregnant women were 1.5 times more likely to be admitted to the intensive care unit and 1.7 times more likely to use a ventilator than infected non-pregnant women.

A systematic review and meta-analysis, including 17 studies (2,567 pregnancies), required admission to the intensive care unit in 7% of cases, while the admission rate for infected non-pregnant women was 4.2. %was. This review also confirmed the increased risk of preterm birth and childbirth due to caesarean section.

These facts, and the potential for restricted access of pregnant women to COVID-19 drug therapy (as is the case with most drug therapies during pregnancy), are that pregnant women are the target population for COVID-19 vaccine research. Suggests that it should be. .. Nevertheless, the default position for both drug and vaccine studies is to exclude pregnant women from study participation because of the risk to them and their offspring.

Two major tragedy, thalidomide prescribed in the 1950s and diethylstilbestrol (DES) prescribed to prevent miscarriage in the 1940s and 1970s, are vulnerable to pregnant women and their offspring, due to research risk. I have solidified the view that it should be protected. Ironically, both of these cases were associated with the harm caused in the clinical setting due to the lack of appropriate prior clinical research, resulting in systematic removal of pregnant women from clinical trials. It was decided to exclude it.

Risk of exclusion

The lack of evidence that the vaccine is safe and can provoke an immune response in pregnant women undermines the effective decision-making of both clinicians and pregnant women, leading to the use of unsafe vaccines. There is a possibility of connecting. Without studies, pregnant women and their offspring are at unavoidable risk of off-label and compassionate use of non-evidence-based vaccination.

Exclusions from the study do not avoid the risk of unproven vaccination. It simply shifts this risk from carefully monitored clinical trials to clinic privacy. Excluding pregnant women from vaccine research is unfair and rude from a public health standpoint.

Last year, the Pregnancy Research Ethics (PREVENT) Working Group for Vaccines, Epidemics, and New Technologies published guidance on pregnant women and vaccines against new epidemic threats: Ethics Guidance for Preparation, Research, and Response. This guidance is based on the belief that pregnant women cannot be ignored as the scientific and biomedical communities continue to innovate and develop new medicines and tools to improve health. .. It provides a general “roadmap for including ethically responsible, socially fair and respectful inclusion of pregnant women’s interests in the development and deployment of vaccines against emerging pathogens”.

COVID-19 vaccine test

The 44 candidate vaccines for COVID-19 are currently in human clinical trials. 29 in Phase 1, 14 in Phase 2, and 11 in Phase 3. Phase 1 trials focus on safety and dosage and typically recruit a small number of study participants. Phase 2 trials continue to collect information about adverse events and immune responses, typically involving hundreds of people.

Tens of thousands of healthy volunteers participated in Phase 3 randomized controlled trials, some immunized with the candidate vaccine and others receiving placebo. The goal is to determine if the vaccinated person is protected from infection. If the candidate vaccine proves to be safe and effective, it can be approved for use in the general population.

To date, Johnson & Johnson, Moderna, and Pfizer have all begun Phase 3 clinical trials, and are reported to be interested in future vaccine trials in pregnant women, probably in early 2021. I am. In Moderna or Pfizer trials, the vaccine uses unproven gene-based technology.

To minimize the risk of harm to pregnant women and their offspring, the vaccines tested in this population should use more established techniques. The Johnson & Johnson COVID-19 vaccine uses the same technology as the Ebola vaccine given to pregnant women.

Include pregnant women in the exam

Moving from the general to the concrete, there are at least two scientifically valid options for including pregnant women in vaccine trials. One option is a stand-alone Phase 1 trial in pregnant women that begins after Phase 1 and 2 studies in the general population have been successfully completed and Phase 3 studies have begun in this population.

This approach includes only pregnant women and allows specific endpoints to be defined for pregnant women and their offspring, resulting in clearer study design and safety monitoring during clinical trials. It will be easier. Pregnancy-specific trials may increase the likelihood of effective pregnancy-related risk counseling and informed consent processes, involvement of researchers with relevant expertise, and effective follow-up.

Alternatively, a Phase 1 vaccine trial in pregnant women can be incorporated into a general population Phase 3 trial. This approach reduces upfront costs compared to initiating individual trials, as key testing protocols, infrastructure, staff, monitoring arrangements, and regulatory approvals have already been established.

Pregnant women and their offspring should not be left behind in the competition to develop a safe and effective vaccine for COVID-19.conversation

This article will be republished from conversation Under a Creative Commons license.Read Original work..

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