Author: GMDP Academy Editorial Board

Safety of mRNA COVID-19 Vaccines During Pregnancy

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The use of any drug during pregnancy may be the source of significant anxiety and myriad discussions regarding safety of such. This continued to be the case during the COVID-19 pandemic, where pregnant people were at increased risk of severe illness and death, and there was concern about the safety of the vaccines for pregnant people. Additionally, COVID-19 during pregnancy is associated with increased risk for adverse pregnancy outcomes, such as preterm birth and stillbirth. When mRNA COVID-19 vaccines first became available in December 2020, safety data in pregnancy were limited because pregnant people were excluded from pre-authorisation clinical trials. Lack of data and safety concerns contributed to initially low uptake among pregnant people, which continues to be lower than uptake among non-pregnant females of reproductive age. To address this issue, public health researchers from across the globe have assessed the safety and effectiveness of COVID-19 vaccines during pregnancy.

Community Spotlight Series: Florin Draica on What He Values About the Academy/King’s College London Professional Certification Program

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We love hearing from our learning community. We extend our gratitude to Florin Drain, US Senior Medical Director for the Pfizer PAXLOVID team for sharing what he valued most about his participation in the Professional Certification in Medical Affairs in Medicines Development from the Academy and King’s College London. Continue reading to hear what Florin has to say.

Gene therapy in China: past, present, and future

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Rapid advancements in gene therapy have contributed significantly to the treatments and cures for genetic disorders. In China, there are approximately 200,000 newborn babies each year with genetic disorders, 22% of which are caused by monogenic mutations. Birth defects, endocrine or metabolic diseases, nervous system diseases, and blood system diseases are the four most common genetic disorders. Additionally, gene therapies such as chimeric antigen receptor (CAR) T-cell immunotherapy have been increasingly reported as effective treatments for diseases such as cancer and HIV infection. Globally, China has registered the third most clinical trials for gene therapy.

FDA investigating risk of severe hypocalcemia in patients on dialysis receiving osteoporosis medicine Prolia (denosumab)

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RWE studies are performed when any drug is on the market with two main objectives. The first objective is to confirm the efficacy and safety in the normal population of patients, without exclusion criteria seen in Phase II and III trials. The second objective is to collect safety data from a much larger patient population for the possible identification of immediately rare or very rare adverse reactions. Below is a good example of the identification of a rare adverse event thanks to RWE studies. Of note, this rare adverse event was not identified during the pre-NDA clinical trials.

News from the EMA: Drug Withdrawal from the Market

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Obesity is a relevant worldwide medical issue. As such, many pharmaceutical companies have devoted efforts to research medicines which prevent or reduce obesity and/or weight gain.  There are currently two pharmaceutical avenues in the treatment and/or prevention of obesity: Drugs which act in the gut and inhibit fat absorption, and drugs which act at the CNS level to suppress appetite. In past years, many drugs were developed to suppress appetites. However, RWE studies underlined the risk of the latter group, as they were often administered for several months and caused severe adverse reactions.

Covid-19: Universal and Individual Masking Impacts

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Nearly 3 years into the Covid-19 pandemic, the United States leads high-income nations in Covid-19–related mortality. Millions of persons now have long-term neurologic, cardiopulmonary, and other disabling conditions. Essential workers continue to face high workplace exposure to Covid-19 with few protections. To prevent Covid-19 transmission, 40 states and Washington DC implemented universal indoor masking policies in 2020. Most maintained these policies until May 2021, when the Centers for Disease Control and Prevention (CDC) replaced guidance that everyone wear masks with guidance according to vaccination status. Understanding the effects of universal masking policies as compared with individual masking is critical to minimizing the inequitable harms caused by Covid-19 and maximizing our ability to learn, work, and socialize during the pandemic.

Why is Strep-A Surging, and How Worried Are Scientists?

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British pediatricians each spring know what to expect: an increase in group A streptococcal infections that should be tail off by the summer. But an off-season outbreak of the bacterial infections this year has jumbled expectations, made scores of people ill and killed 13 children under the age of 15 in England since September.

News from the EMA: Public Consultation for Viral Safety of Biotechnology Products

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The European Medicines Agency has published for public consultation a ICH Guideline Q5A(R2) on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin.

This guideline concerns the testing and evaluation of the viral safety of biotechnology products, and it outlines what data should be submitted in marketing application and registration packages for those products. Biotechnology products include biotherapeutics and certain biological products derived from cell cultures initiated from characterized cell banks of human or animal origin (e.g., mammalian, avian, insect).

Prescribing Opioids for Pain- The New CDC Clinical Practice Guideline

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One of the biggest challenges in medical practice is the treatment of chronic pain. Pain affects the lives of millions of Americans and potentially reduces their level of function, mental health, and quality of life. Yet limited access to pain treatments and lack of clarity regarding the evidence supporting pain treatments prevent many people with pain from accessing the full range of potentially helpful therapies. Furthermore, there are persistent disparities in pain management according to race or ethnic group, gender, socioeconomic status, and population density, among other factors. Opioids continue to be commonly used to treat pain, despite evidence that their short-term benefits are small and despite limited evidence of long-term benefits.

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