By Marsha Mullings, MPH
USA13million cases, 266,887 deaths
Florida992,660 cases, 54,706 total hospitalizations, 18,500 deaths
Broward 105,632 cases, 6,713 total hospitalizations, 1,659 deaths
*There were 54,246 new coronavirus cases in Florida last week.
*There was an average of 7,700 daily new cases over the last week.
Vaccines are coming. Some important points to understand.
As December approaches, we move closer to the availability of at least two COVID-19 vaccines. The speed of vaccine development has been remarkable. If they are effective and offer long-term immunity, then we will have ushered in a remarkable innovation in vaccine development that will have ramifications on the development of therapeutics for many other diseases. Safety, of course, is on everyone’s mind given the speed of development and the urgency of managing this pandemic. These vaccine candidates have gone through the same rigorous development process as all others in the past, although at a more rapid pace. The development process consists of several well defined steps:
*The first stage is scientific research and discovery. Scientists conduct research and study the disease and the infectious agent. They then try to assess whether a vaccine is feasible and how a potential vaccine will work on the disease agent. Animal studies may begin in this stage. If a vaccine is feasible, the next stage begins.
*The preclinical stage of development begins upon the determination of vaccine feasibility. In this stage, additional laboratory research and animal testing occurs. The goal here is to assess the safety of the vaccine in animals before administration in humans.
*If the vaccine candidate shows no adverse events in animal testing, clinical testing in humans follows. They occur in three or more phases.
*Phase 1 trials involve administering the vaccine to 20-100 healthy volunteers and monitoring them for dose response and adverse effects. This phase also provides an early indication of the body’s immune response to the vaccine
*If there are no adverse responses to the vaccine from phase 1, phase 2 trial proceeds with hundreds more volunteers. An attempt is made to enroll people from all demographic groups, and with varying levels of health. Vaccine is administered at different dosages to test the body’s response to each dose. Trial is randomized between two groups. One group is given the vaccine, the other a placebo. Groups are compared to assess the difference in immune response between the groups. This phase provides initial information on the vaccine’s effectiveness at preventing disease (efficacy).
*Phase 3 involves thousands of volunteers. More in-depth information on vaccine safety and efficacy is collected in this phase. Less common adverse events, if present, are identified here. In the presence of a public health emergency such as the current pandemic, the vaccine developer may request an emergency use authorization (EUA) from the FDA to facilitate the use of the vaccine candidate in selected vulnerable populations, considering that all safety protocols have been met.
*If all safety and efficacy criteria are met in the clinical phases, then the manufacturer submits a biologics license application to the FDA to start the process of manufacturing and distributing the vaccine.
Three vaccine candidates are at the end of phase 3 clinical trials and their development companies have reported their efficacy rate and safety of the vaccine. Pfizer/BioNTech and Moderna pharmaceuticals have applied for emergency use authorization and if approved, will begin the process of shipping and distributing the vaccines as needed. Other manufacturers will announce their efficacy rates and will most likely go through the same process of applying for emergency use. The public now awaits the availability of vaccines to fight this pandemic.
In the meantime, disease control efforts must continue as before. Social distancing, wearing a mask when out in public, and good hand hygiene are critical steps. Most importantly, avoiding crowded indoor locations is critical.
For more information on coronavirus (COVID-19) prevention, visit www.FloridaHealth.org; coronavirus.jhu.edu; FDA.gov/vaccines
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