Alana Hippensteele

, the authors discussed the critical nature of the comprehensive safety testing conducted in preclinical and clinical trials. The history of vaccine development has paved the way for ensuring a coronavirus disease 2019 (COVID-19) vaccine is both safe and effective, according to the authors.

Regardless of the urgent need for COVID-19 vaccines, the perspective said researchers must remain focused on ensuring safety and public confidence in vaccines by following the established clinical safety testing protocols throughout vaccine development, which includes the stages before and after the deployment of COVID-19 vaccines.

The authors noted that if regulatory agencies maintain the well-documented safety testing protocols that have been developed over the years, COVID-19 vaccines will be safe and trustworthy. These protocols include practices such as testing all batches of vaccines for safety before vaccine deployment.

It is also important that developers understand the mechanism of action and immune correlates of protection in relation to the vaccine, according to the authors. This is critical to ensuring that vaccines are able to induce the optimal immune response for protection while not creating nonproductive or counterproductive immune responses.

The authors also explained an important lesson from past vaccine development research, which taught development researchers that if serious adverse events (AEs) are detected during a clinical trial, it is critical that the researchers begin additional clinical testing before progressing things further.

In current regulatory practice, it is necessary to monitor rare AEs before and after vaccine licensure. Upon the detection of serious AEs, the authors said the trial or the use of the vaccine should be put on pause. During current COVID-19 vaccine research, occurrences of such safety pauses have occurred, demonstrating the value of extensive regulatory safety protocols, which should be neither rushed or undermined.

“There is an urgent need for COVID-19 vaccines and exciting progress to that end, but there remains a critical public health obligation to conduct rigorous evaluation to ensure safety as well as efficacy,” the authors wrote in the study. “Vaccines remain one of the most successful biomedical tools for prevention of disease. The urgent need for COVID-19 vaccines must be balanced with the imperative of ensuring safety and public confidence in vaccines by following the established clinical safety testing protocols throughout vaccine development, including both pre- and postdeployment.”

Knipe DM, Levy O, Fitzgerald KA, et al. Ensuring vaccine safety. 

. 2020:eabf0357. doi: 10.1126/science.abf0357.

Comprehensive safety testing of COVID-19 vaccines based on experience with prior vaccines. American Association for the Advancement of Science; November 17, 2020. eurekalert.org/pub_releases/2020-11/aaft-cst111720.php. Accessed November 20, 2020.

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The authors noted that if regulatory agencies maintain the well-documented safety testing protocols that have been developed over the years, COVID-19 vaccines will be safe and trustworthy.

Following Regulatory Safety Protocols Is Critical to Ensuring Safety and Public Confidence in COVID-19 Vaccines

Individuals with a higher risk of cardiovascular disease (CVD) demonstrate an increase in cognitive decline, including a rise in the typical markers of Alzheimer disease, according to the results of a recent study.

Furthermore, monitoring and controlling for CVD may be critical to maintaining and improving cognitive health later in life.

 The study results showed that a higher CVD risk burden was associated with an increased rate of decline in episodic memory, perceptual speed, and working memory.

“In the absence of effective treatments for dementia, we need to monitor and control cardiovascular risk burden as a way to maintain patients’ cognitive health as they age,” Weili Xu, PhD, Department of Epidemiology and Biostatistics, School of Public Health, Tianjin Medical University, Tianjin, China, said in a statement. “Given the progressive increase in the number of dementia cases worldwide, our findings have both clinical and public health relevance.”

Song R, Xu H, Dintica CS, et al. Associations between cardiovascular risk, structural brain changes, and cognitive decline. 

. 2020;75(20):2525-2534. doi:10.1016/j.jacc.2020.03.053

Maintaining heart health may protect against cognitive decline. ScienceDaily. May 18, 2020. Accessed July 23, 2020. sciencedaily.com/releases/2020/05/200518144842.htm

Risk of Cardiovascular Disease Is Associated with Cognitive Decline Later in Life

In the first nationwide study assessing the rate of cancer-related deaths following the adoption of the Affordable Care Act (ACA) of 2010, researchers found that states that adopted ACA’s Medicaid expansion saw greater decreases in cancer mortality rates than states that did not.

The researchers observed trends for age-adjusted cancer mortality in the United States between the years of 1999 and 2017. The data from these years demonstrated that in the states where Medicaid was expanded following the adoption of the ACA, there was a 29% decline in mortality, falling from 65.1 to 46.3 per 100,000 individuals during that period.

However, in states that did not adopt the Medicaid expansion, the mortality rates dropped by 25%, from 69.5 to 52.3 per 100,000 individuals.

Based on the data, in 2017 alone, there was an estimated 785 fewer cancer deaths in states that adopted Medicaid expansion.

"This is the first study to show the benefit of Medicaid expansion on cancer death rates on a national scale,” said study lead author Anna Lee, MD, MPH, a radiation oncology fellow at Memorial Sloan Kettering Cancer Center, in a press release. “We now have evidence that Medicaid expansion has saved the lives of many people with cancer across the United States.”

Although the ACA granted states permission to expand Medicaid coverage to more people, Medicaid is administered by individual states, so it needs to be adopted state-by-state. Medicaid offers health care coverage to individuals with disability or low income.

In January 2014, many states formally adopted the ACA’s Medicaid expansion. Upon its adoption, these states saw an increase in Medicaid enrollment, with people enrolling who had incomes near the poverty level but were not previously eligible, as well as others who had been eligible but did not yet enroll. By 2017, 27 states plus the District of Columbia had adopted Medicaid expansion, while 23 states had not.

The researchers used data for all US residents from the National Center for Health Statistics. By establishing baseline trends between 1999 and 2017, the researchers compared the age-adjusted rates prior to full state expansion (before 2014) and following the expansion (after 2014) in the states that adopted Medicaid expansion and those that did not.

However, patients age 65 or older who died from cancer were not included in the researchers’ analysis, as those patients would be eligible for Medicare and would not be enrolled in Medicaid.

The researchers also analyzed the data of sub-populations, including patients who were black or Hispanic. Despite large mortality gains during the study period for patients who were black, there was no observed additional mortality reduction in this population in states where Medicaid was expanded. Furthermore, age-adjusted cancer mortality overall was worse for black patients in states that did not expand Medicaid in comparison with states that did (58.5 vs 63.4 per 100,000 for the expansion and non-expansion states respectively).

However, among Hispanic patients, there was a significant change in cancer mortality rates between expansion and non-expansion states. Yet, there was also a significant variation observed between the year-to-year mortality rate in this population.

“There is a greater Hispanic population in states that have adopted Medicaid expansion, and they have almost 3 times the un-insurance rate as white adults,” said senior author Fumiko Chino, MD, a radiation oncologist at MSK, in a press release. “Our research shows that Hispanic patients with cancer may have benefited the most because they had the most to gain.”

When approaching the analysis, the researchers used the difference-in-differences statistical technique. This technique required the calculation of the difference in mortality rates between the periods for the expansion and non-expansion states, and then additionally the calculation of the difference between these values. The researchers used this technique in order to mitigate baseline population differences and other differences in access at the state level.

The study’s findings will be presented by the researchers at the virtual 2020 American Society of Clinical Oncology (ASCO) Annual Meeting.

“This study provides needed data to understand the effects of Medicaid expansion on cancer care,” said Richard L. Schilsky, MD, FACP, FSCT, FASCO, chief medical officer and executive vice president of ASCO, in a press release. “Better access to quality cancer care, in this case through state expansion of Medicaid, leads to fewer cancer deaths.”

Lee A, Shah K, Chino JP, et al. Changes in cancer mortality rates after the adoption of the Affordable Care Act [ASCO abstr 2003]. 

. 2020;38(suppl). doi: 10.1200/JCO.2020.38.15_suppl.2003.

Greater Decline in Cancer-Related Deaths Seen in Medicaid Expansion States in First Nationwide Study [news release]. Alexandria, VA: ASCO; May 13, 2020. asco.org/about-asco/press-center/news-releases/greater-decline-cancer-related-deaths-seen-medicaid-expansion. Accessed May 29, 2020.

In 2017 alone, there was an estimated 785 fewer cancer deaths in states that adopted Medicaid expansion.