Part 1: The Realities of The COVID Vaccine

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:

• The vaccine candidates go through a rigorous regulatory process for approval, which includes the type of populations who should get it first and at what cost. Although the regulatory process addresses safety issues and a vaccine can be determined safe, it might not be “perfect.” Meaning: We will likely see further testing done after the initial COVID-19 vaccine is out in order to establish a more effective vaccine. This occurred with the shingles vaccines: Earlier vaccines were not as effective as the later version.
• Some researchers will maintain a perpetual stage of regular study, which will likely be the case for the novel coronavirus, since this is an atypical virus. Keep in mind, this is not a human virus; it is a virus found in the bat. As a result, we have witnessed odd symptoms, which also fluctuate in degree from mild to deadly. These assorted conditions include: Respiratory, resulting in various degrees of severity from a mild dry cough to being put on a ventilator. Multi-inflammatory syndrome in children. Circulatory: There are cases of vasculitis, resulting in strokes, heart attacks, liver, kidney, and other distal organ disease and Cytokine Storm, which is an overreaction of the immune system as seen in trauma, sepsis, & cardiac arrest.
• Production: Significant manufacturing capacity – such as infrastructure, personnel and equipment – is needed to produce large quantities of a vaccine for use. Quality control must be in place and all processes are monitored. Once licensed, policy must be developed to decide how to prioritize those who should be vaccinated; and of course in this case, distribution will be a massive undertaking since the vaccine needs to be distributed to the world (https://theconversation.com/coronavirus-vaccine-here-are-the-steps-it-will-need-to-go-through-during-development-134726).

     
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:

• November-December 2020 clinical trials in progress: There are two 30,000-participant trials with the Pfizer and Moderna vaccine candidates. Keep in mind you have two groups in a study: the experimental group (gets the vaccine) and the control group (gets the placebo or “fake” vaccine). The study approach is called a double-blind randomized clinical trial because the study groups are random in selection and the participants are unaware of which vaccine they receive. With these example studies, both happen to have a two-dose program. So after the first dose, there's a booster given a month later (end of October or beginning of November), and then it will take a few weeks (at least) before the full expected immune response occurs (in one group) and those who get sick in the other group is known.
• Early 2021 best-case scenario for the regulatory process to start: Even Moncef Slaoui, who is the head of OWS (Operation Warp Speed), thought a best-case scenario would be the end of the year, most likely the beginning of next year as the timeframe for the vaccine research to go forth with the regulatory process for approval. Dr. Offits agrees with this and thinks that's a more accurate representation (https://www.medscape.com/viewarticle/936937?src=mkm_covid_update_200910_mscpedit_&uac=64796DZ&impID=2558382&faf=1#vp_8).
• Well into 2021 before the vaccine processes are complete and production and distribution starts: The completion of the approval process will likely take us well into 2021 if we follow the full regulatory licensing process, even with OWS. Then the next stage will be the production and distribution of the vaccine (HealthLetter.MayoClinic.com- September 2020). If (and that is the key word) a vaccine is developed that is 75% effective, we will need about 2/3 of the American population immunized. With a two-dose vaccine, that totals to over 400 million doses. Realistically, even with warp-speed measures in place, we are easily looking well into 2021 for an initial vaccine roll out. Keep in mind, this is assuming that the research, approval & distribution processes have no glitches. (https://www.medscape.com/viewarticle/936937?src=mkm_covid_update_200910_mscpedit_&uac=64796DZ&impID=2558382&faf=1#vp_8).

  
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.