Dr. Omar P. Haqqani
Dr. Omar P. Haqqani
Dr. Omar P. Haqqani
Dr. Omar P. Haqqani
About 30,000 people who have never had COVID-19 will participate in Phase III testing of a vaccine. Protocol established by the Centers for Disease Control and Prevention requires any vaccine to be tested in several phases before it can be used. The stages of the testing process include exploratory testing, pre-clinical and clinical development, regulatory review, manufacturing and quality control.
Phase I involves a small number of people and initial results are evaluated. In Phase II, the vaccine is given to a larger group with specific conditions relating to an individual virus. In Phase III, the efficiency and safety of the vaccine is evaluated. CDC also has a fourth phase that allows for more formal and ongoing studies after a vaccine is approved and licensed.
The coronavirus vaccine being tested is designated mRNA-1273. It was co-developed by biotechnology company Moderna Inc., and the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. The trial is to be conducted at United States clinical research sites and is being conducted by The NIH Coronavirus Prevention Network. To accelerate the development, manufacturing and distribution of medical countermeasures for COVID-19, the vaccine efficacy trial for mRNA-1273 is the first to be implemented under Operation Warp Speed, a multi-agency collaboration led by the U.S. Department of Human Services.
Researchers have several specific areas for which the vaccine will be evaluated. Among them are safety and the ability of the vaccine to prevent symptomatic COVID-19 after two doses. The goal of NIH is to have an effective vaccine available by the end of 2020.
The higher risk of COVID-19 for pregnant women
As efforts to develop a virus move forward, it is still imperative to remember that there are many active cases and the number fluctuates daily. In addition to the previously acknowledged groups at high risk for infection, CDC released information in June confirming the increased risk for pregnant women. Between January and June, it was estimated that 31.5% of pregnant women diagnosed with COVID-19 were admitted to a hospital, compared to only 5.8% of non-pregnant women. Those pregnant are also more likely to be admitted to intensive care units (ICU) and to require a ventilator. The probability of certain difficulties, including pre-term birth, also exists if the mother contracts the virus.
COVID-19 may also have a more critical impact on pregnancy in minorities, according to CDC. Hospitalization rates are higher for certain ethnic groups. The American College of Obstetricians and Gynecologists reports that severe illness and the need for ICU admission appears higher in African American, Hispanic or Asian patients. The increased risk is not due to biological differences but to social and economic disparities.
Newborns may also become infected
Newborn children may also contract the coronavirus if they are near someone who is infected. As more time has passed to study the impact of COVID-19 on new mothers and babies, it has been established that some children test positive for the virus shortly after birth. It is difficult to determine if they had the virus before, during or after they were born. While some cases of COVID-19 in newborns were considered severe, most revealed either no symptoms or very mild symptoms and a high rate of recovery.
Safe practices during pregnancy
The well-known preventative measures of COVID-19 including social distancing, hand washing and wearing masks should be observed during pregnancy. All prenatal appointments should be kept and updates, including any health changes, should be reported. Keeping medical supplies and a thirty-day supply of medicines is recommended to reduce out-of-house trips and the possibility of exposure.
Ask Dr. Haqqani
If you have questions about your cardiovascular health, including heart, blood pressure, stroke lifestyle and other issues, we want to answer them. Please submit your questions to Dr. Haqqani by e-mail at [email protected].
Dr. Omar P. Haqqani is the chief of Vascular and Endovascular Surgery at Vascular Health Clinics in Midland: www.vascularhealthclinics.org