By Tara Gibson - October 13, 2020
The globe has been anxiously waiting for news about the COVID-19 vaccine, when it will be ready, and how it will be distributed. As of this writing there have been over 7.5 million cases of the virus in the United States alone, with over 210,000 deaths, proving the necessity of getting the vaccine ready to go. Although there are more unknowns than knowns, experts have been working around the clock to get the coronavirus vaccine approved and ready to be distributed across the country.
Creating a vaccine is no easy feat and typically require years of extensive research and testing before reaching healthcare facilities for distribution. With the coronavirus having completely taken hold over the United States, and other countries across the world, scientists have been racing to produce a safe and effective vaccine by next year.
With 44 vaccines currently being tested in clinical trials, many are hopeful that there will be at least one proven to be successful. Back in January of this year, work began to decipher the SARS-CoV-2 genome. Shortly after, in March, the first vaccine safety trials in humans began, according to the New York Times Vaccine Tracker. It’s apparent that some trials will fail, and others will bring unclear results, but there is hope that a few will stimulate the immune system to produce effective antibodies against COVID-19.
As mentioned above, rolling out a brand-new vaccine is extremely challenging. The FDA explains that vaccine clinical development follows the same general pathway as for drugs and other biologics. Sponsors who wish to begin a clinical trial must submit an Investigation New Drug application (IND) to the FDA, including an in-depth description of the proposed vaccine, the method of manufacture, information about the vaccine’s safety and ability to produce protective immune response, quality control tests for release, and proposed clinical protocol for studies in humans.
Phase 1 are the initial human studies in which safety and immunogenicity studies are performed in a small number of closely monitored subjects.
Once approved, sponsors can move to phase 2. These studies are dose-ranging studies that may enroll hundreds of subjects.
When moving into phase 3, these trials typically enroll thousands of individuals and provide the critical documentation of effectiveness as well as important safety data required for licensing.
If at any stage during the clinical studies the data raises significant concerns about either the safety or effectiveness, the FDA may request additional information or may halt ongoing clinical studies. On the other hand, if successful throughout all three phases of clinical development, sponsors can submit a Biologics License Application. Following the FDA’s review of this application, the sponsor and the FDA may present their findings to FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC).
The FDA explains that, “Vaccine approval also requires the provision of adequate product labeling to allow health care providers to understand the vaccine's proper use, including its potential benefits and risks, to communicate with patients and parents, and to safely deliver the vaccine to the public.”
After approval, the FDA will continue overseeing the production of the vaccine and ensure continuing safety. Many vaccines will then undergo Phase 4 studies, which are formal studies on a vaccine once it is on the market.
There are lots of rumors and thoughts circulating about the coronavirus vaccine, but one thing is certain; healthcare organizations have to have a great understanding of the vaccine - when it’s available - and be able to relay the important information to patients and colleagues alike.
With a mass notification solution, healthcare facilities can quickly and efficiently get pertinent and frequent news updates about the vaccine out to employees across multiple locations with just a few clicks. This could include proposed timelines, crucial vaccine information, and availability options for the public.
For those who may have questions, two-way communications can be hugely helpful, as employees can initiate a conversation with administrators and get the answers they are seeking. With a healthcare employee safety app an available resource library containing critical vaccine information available to workers can also be a useful reference and prevent confusion among the workforce.
It's likely that it’ll be a crazy time for healthcare organizations, and with staffing shortages already apparent, having a tool to assist with shift management will be beneficial. By sending out a polling link to employees, employers can solicit responses on whether workers can fill upcoming shifts. After the shift has been filled, the poll will automatically end. This short video below covers automated shift management:
When the vaccine is ready to go, healthcare facilities are bound to be inundated with calls and questions, which is why ensuring healthcare employees have all the correct information is paramount. Leverage mass notification technology to streamline internal communications, fill open shifts, and provide important resources and information to all healthcare employees.
Tara is a Marketing Coordinator on the Rave Mobile Safety marketing team. She loves writing about all things K-12, State & Local, Higher Ed, Corporate, and Healthcare, and manages the Rave social media channels. When she's not working, she's taking care of her smiley, shoe eating, Instagram-famous fur baby, Enzo!
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