City commission, public updated on COVID-19 vaccine
An educational presentation about the COVID-19 vaccine was given by Evan Wilson, pharmacy director of Western Plains Medical Complex, via Zoom and attended by members of the Dodge City Commission on Jan. 15.
The presentation was originally meant to better inform city employees on the COVID-19 vaccine, but as there were city commissioners attending, the presentation was open to the public.
Wilson gave general background on COVID-19 activity in Kansas and the rest of the U.S.
Records for daily cases are increasing and more than 400,000 Americans have died of COVID-19, with the death total in Kansas at 502 as of Jan. 15, according to Wilson.
He said the data for both the Pfizer and Moderna vaccines have proved promising and that both have been granted Emergency Use Authorization by the Federal Drug Administration.
Wilson said the vaccine process starts with targeting what is to be inoculated before moving into preclinical testing on animal models, cell models, and test tube models to form the vaccine into a receptive drug-admissible state in the human population.
Next comes the manufacturing development, which for COVID-19 was different.
Usually, a vaccine must have regulatory approval before being manufactured by drug companies, but since the federal government and other national entities so heavily funded the creation of the COVID-19 vaccine, companies were able to manufacture the vaccine during Phase 1 and 2 clinical trials.
This is largely thanks to the government’s Operation Warp Speed that allows the increased and prompt development of a COVID-19 vaccine.
Phase 1 of clinical trials looks at the side affects of a potential vaccine as well as what constitutes a safe, appropriate dose and is tested on about 10 to 100 people.
Phase 2 covers more safety and immunogenicity, monitoring whether the expected results of the vaccine are yielded, and is tested on about 100 to 1,000s of people.
Phase 3 is the final large scale clinical trial that determines how effective the drug is.
Phase 3 of clinical trials for the Pfizer vaccine included 40,000 people, while for the Moderna vaccine that was 30,000 people, before either was brought to the FDA for review.
Vaccine development typically ends with a regulatory review and both COVID-19 vaccines available have already moved past the stage.
A third vaccine, according to Wilson, may be going before the FDA before the end of January.
Wilson describes the mRNA vaccine as a new type of vaccine with research dating back to 1989.
The mRNA vaccine instructs the body’s cells to make a “spike protein,” the same kind of protein that COVID-19 uses to enter the body’s cells.
The mRNA vaccine does not reach the nucleus, nor does it cause alterations to the DNA, and once the spike proteins are made and presented to the body’s immunity response, like other infectious processes like the flu, those cells break down, getting rid of the mRNA instructions.
It is important to note that the mRNA vaccine cannot give someone COVID-19.
Wilson said that Ford County is starting to move onto Phase 2 of the overall vaccination plan, which under the Kansas Department of Health and Environment prioritizes people older than 65, congregate settings, high-contact critical workers and unvaccinated persons who were prioritized in Phase 1.
The state of Kansas defines high-contact critical workers as fire, police and correctional personnel and other first responders; people in grocery or other food services; K-12 educators and other child care specialists, including support staff such as secretaries, principals and custodians; food processing facilities, such as meatpacking plants; bus services, retail workers, and agricultural producers; and people working for the United States Postal Service and Department of Motor Vehicles.
While KDHE is expecting to officially begin Phase 3 in March, difficulties providing the vaccine at federal and state levels reduces that timeline to an estimate.
Phase 3 of the Vaccination Plan includes people between the ages of 16 and 64 with severe high medical risks, including cancer, kidney disease, COPD, Down syndrome, cardiomyopathy, anyone who is immunocompromised following a surgical transplant, type-2 diabetes, sickle cell disease and pregnancy.
Other critical workers include manufacturing and utility workers, government workers, other logistics and delivery services, construction, finance and information technology and telecommunications.
Phase 4, projected to begin in late April or mid-May, includes people between the ages of 16 and 64 with other medical risks that tend to be less severe in people who do contract COVID-19.
Phase 5, projected to begin in June, is expected to see the COVID-19 vaccine available to the rest of the population, including children.
“So, with these ages 16 to 64, currently the Pfizer vaccine is the only one that does have the EUA documentation to support use between ages 16 and 18, the Moderna is only for ages 18 plus,” Wilson said. “So that tells me they’re going to continue distributing the Pfizer even though it’s significantly logistically challenging.”
Wilson described five main safety checkpoints for vaccines.
The first checkpoint is an independent safety board, and the second checkpoint is a manufacturer independent safety board, where more research determines whether the vaccine yields the proper results to be presented to the FDA as part of the third checkpoint for review.
The fourth checkpoint is handled by a completely different team of non-government physicians that make up an FDA Advisory Committee.
The fifth checkpoint sees the FDA authorize the vaccine for Emergency Use Authorization.
“So, one thing you got to know is all vaccines are going to cause side effects, that’s how you know the vaccine is working,” said Wilson. “You’re basically tricking your body into thinking that you’re sick so you can mount the immune response like you were sick.”
Having administered both the Pfizer and Moderna vaccine at their facility, Western Plains Medical Complex lists the side effects for both.
The Pfizer vaccine side effects according to Western Plains data include fever, chills, myalgia, nausea and headache.
Moderna side effects, according to Western Plains data, include chills, headache, myalgia and fatigue.
“The Pfizer was very well tolerated on that first dose, the second dose we had a bit more which is to be expected because you already have some level of an immune response built,” said Wilson. “We had person report they had a pretty high fever, other than that no real significant side effects.
"With the Moderna, we’ve only given the first dose of that and nobody has had any severe side effects with that yet. But I will say with the Pfizer, it is pretty much one hundred percent you do get some of that arm pain and it’s usually fairly mild.”
Wilson reassured that both vaccines are safe and likely effective, with the most common side effect among 100% of people being pain at the injection site.
The FDA looks for 50% efficacy in a vaccine before approving. Both Pfizer and Moderna vaccines showed 94% efficacy during Phase 3 clinical trials, according to Wilson.