AbleChild’s Statement on Informed Consent as it Relates to Covid and Consumer Safety

AbleChild has worked diligently throughout the years on informing the public on the importance of Informed Consent and an individual’s right to be given all necessary information (full disclosures on diagnosis, benefits, risks, alternatives) regarding psychiatric drugs and children.  Informed Consent is no less important as it overlaps many different issues and comes back to overall public safety.

One prominent issue dominating our news outlets daily are the Covid Vaccines which are being openly marketed to the public. AbleChild feels compelled to offer its position on this subject as it relates to informed consent and adverse reporting.  Too many stories are airing focusing solely on Covid deaths and symptom related issues, falling short on providing necessary adverse effects or genuine risk information on the vaccine itself.  In fact there seems to be a deafening silence regarding any possible cons associated with the vaccine or the fact that there is a voluntary reporting system in place, VAERS, created in 1990, in response to the National Childhood Vaccine Injury Act and co-managed by the FDA and CDC, where people can and should be reporting adverse side effects.

News outlets, the pharmaceutical manufacturers, the CDC, and other health organizations and even many health professionals who are screaming from the rooftops about the deaths associated with COVID all seem to be challenged on giving out the other side of the coin, the much-needed information, which are the guidelines where and how to report adverse side effects.  Yes, since these vaccines are new there is limited information on safety, however, this does not discount the need to publicly promote the importance of reporting adverse side effects for monitoring and tracking purposes.  The public, as consumers, should also be advised that the emergency rollout of these vaccines null the pharmaceutical manufacturer’s liability.

AbleChild has throughout the years informed the public on the importance of MedWatch, a similar program to VAERS, which was set up by the FDA to monitor and track adverse drug reactions.  Both programs rely on voluntary reporting, meaning the consumer needs to know that they are responsible for reporting any adverse effects and how to.  Each program can assess the data collected to ultimately safeguard public health.  Both programs are underutilized as they are rarely advertised publicly.

• From the VAERS site itself we know that the number of VAERS reports submitted varies each year. In 2019, VAERS received over 48,000 reports.
• One site, Vaccine Impact, notes that less than 1% of adverse reporting occurs.
• Similarly, the MedWatch program logged approximately 85,000 voluntary reports, mostly from health professionals, in the first five years of its current form.(1993-1998).^[1]
• FDA Adverse Events Reporting System establishes that MedWatch is still significantly underused.

AbleChild continues to educate the public on issues surrounding health and we affirm our position on informed consent and the consumers right to vital information to make educated decisions regarding their health and safety. See more from us on MedWatch.