Who is Monitoring COVID-19 Vaccine Adverse Events of Seniors?
The Center for Biologics Evaluation and Research (CBER) at the U.S. FDA confirmed on February 9, 2021, it is monitoring the safety of authorized COVID-19 vaccines through both passive and active safety surveillance systems.
The CBER is doing so in collaboration with the Centers for Disease Control and Prevention (CDC), the Center for Medicare and Medicaid Services (CMS), the Department of Veterans Affairs (VA), and other academic and large non-government healthcare data systems.
CBER stated it ‘had worked over the past several years with CMS to develop capabilities for routine and time-sensitive assessments of the safety of vaccines for people 65 years of age and older using the Medicare Claims database.’
‘Because it was already in place, this system was immediately put into use for COVID-19 vaccine surveillance to monitor for adverse events.’
During the current COVID-19 pandemic, the FDA, CMS, and CDC have already used the Medicare data to publish a study in December 2020, showing that frailty, comorbidities, and race/ethnicity were strong risk factors of COVID-19 hospitalization and death among the U.S. elderly.
In summary, ‘the CBER has assembled passive and active surveillance systems that can detect and refine safety findings with the recently authorized COVID-19 vaccines in a relatively rapid manner. These systems can also potentially be leveraged to assess safety in specific subpopulations and to assess vaccine effectiveness, including against emerging variants.’
The SARS-CoV-2 betacoronavirus is changing through mutation, and new variants of the virus are expected to occur over time. Sometimes new variants emerge and disappear. Other times, new variants appear and start infecting people, says the CDC.
The initial coronavirus strain, detected in Wuhan, China, in December 2019, was the L virus strain. The virus then mutated into the S strain at the beginning of 2020.
As of February 11, 2021, the CDC reported the following number of variant cases in the USA: UK B.1.1.7 = 981; South Africa B.1.351 = 13; Brazil P.1 = 3.
These virus variant’s impact on experimental COVID-19 vaccines is being evaluated. A listing of authorized COVID-19 vaccines can be found on this webpage.
The U.S. FDA has issued two emergency authorizations of COVID-19 vaccines.
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