I will start with the ending: If the full regulatory licensing process is carried out (even with Operation Warp Speed in place), a COVID vaccine will likely be available for mass distribution later into 2021. But the vaccine will not be a magic bullet that will put an end to wearing masks and practicing physical distancing. These practices will have to continue, and it will take until 2022 before we see some “normalcy” again. Recovery from a world-wide pandemic takes time; here’s why.
One of my sources was an excellent interviewee, who addressed the COVID-19 vaccine. His credentials are impressive: Paul A. Offit, MD, is the director of the Vaccine Education Center at Children's Hospital of Philadelphia (CHOP), and he serves as the *Maurice R. Hilleman Professor of Vaccinology at the Perelman School of Medicine at the University of Pennsylvania. An internationally recognized expert in virology and immunology, he has published more than 150 papers in medical and scientific journals. *(Maurice R. Hillman is considered the “father of modern vaccines” and is credited with saving more lives than any other medical scientist of the 20th century (https://www.medscape.com/viewarticle/936937?src=mkm_covid_update_200910_mscpedit_&uac=64796DZ&impID=2558382&faf=1#vp_8).
General information about the vaccine for coronavirus:
Vaccines do not cure a disease; they prevent a person from getting it by activating our immune system to build antibodies against – in this case– the coronavirus. The antibodies of our immune system have “memory” and the next time the virus enters our body, the antibodies prevent the virus from attacking our system and we do not get sick. In the case of the COVID-19 vaccine research taking place, some vaccine candidates are utilizing dead or weakened coronaviruses, others are using fragments of the viruses, some will take the proteins of the virus and transfer them to viruses that don’t cause disease (you could say that the proteins of the coronavirus are piggybacking) and finally, other vaccines are employing the virus’s genetic materials (mRNA). Per Dr. Offit’s interview in addressing the use of genetic material for vaccines, he concludes: “I think when you have no commercial experience with a vaccine strategy and you're using that as a way to try to stop a new virus, there will be something of a learning curve “ (https://www.medscape.com/viewarticle/936937?src=mkm_covid_update_200910_mscpedit_&uac=64796DZ&impID=2558382&faf=1#vp_8).
Some vaccines provide protection long-term or even over a lifetime (polio, measles); others require boosters (tetanus) and some are seasonal (flu). Interesting that it appears that the MMR vaccine is helping to protect against and reduce the severity of COVID-19 (https://www.iadvanceseniorcare.com/covid-19-and-the-elderly-could-mmr-vaccination-slow-the-pandemic/). We have yet to discover how the COVID-19 vaccine will work and how long it will last. Some current research strategists are seeing the need for two-dose vaccines, taken a few weeks apart (https://www.nationalgeographic.com/science/health-and-human-body/human-diseases/coronavirus-vaccine-tracker-how-they-work-latest-developments-cvd/).
What are the phases and steps in development of this vaccine?
To get a vaccine to market can take at least a decade or more; the vaccine for mumps was considered fast (1960) and that took four years. Due to the fact that this virus is infecting and affecting the entire world, the U.S. has created Operation Warp Speed (OWS) in order to fast track the development of a vaccine (https://www.hhs.gov/coronavirus/explaining-operation-warp-speed/index.html).
Phases and Steps to produce a vaccine:
Phase 1: After studying and identifying the virus, potential vaccine candidates are identified.
Phase 2: Pre- Clinical Testing of these vaccine candidates is carried out with animals to determine if the vaccine safely triggers an immune response.
Phase 3: Clinical Trials with human populations
A) Clinical Trial occurs when the testing pool is widened to include humans – groups of people who may have the disease or will be more likely to catch it, in order to gauge the vaccine’s effectiveness
B) The testing pool expands to the thousands to make sure the vaccine is safe and effective among a wider array of people, given that immune response can vary by age, ethnicity, or by underlying health conditions.
The next steps after the phases of the clinical trials include:
Why Do Vaccine Trials Take Time?
The reason for the length of time is that the researchers have to wait to see how the testing pools (animals or humans) respond, then evaluate the responses, and finally, tally and measure the outcome. It takes time for the virus to activate in the body and for the immune system to respond. Obviously, this is the part of the development that the researchers cannot speed up. The testing groups start out small (for safety purposes) and are gradually increased once the vaccine presents itself to be effective. The research is in progress and changing almost daily, so when this article was written, the following was in place: Out of the 169 COVID-19 vaccine potentials worldwide, 26 of these are in the human trial phases with eight companies being in the midst of phase 3B (large clinical trials with thousands in the testing pool) as noted above (https://www.who.int/emergencies/diseases/novel-coronavirus-2019/covid-19-vaccines).
A sample timeline of vaccine candidates:
Could we see a vaccine come out at an earlier date? See next month’s column: Part II
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Charlotte Michos is a clinical nurse specialist who values personal-centered care and serves as a Healthcare Consultant in helping others make informed decisions. For more information, email her or call (845) 548-5980.
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