Long awaited COVID-19 vaccine release may be near, but the wait continues for most

Recent developments by companies and organizations around the world have been showing promising signs of finalizing a long-awaited vaccine for COVID-19 as early as this month. Pharmaceutical and biotechnology companies are developing the vaccines with pre-clinical and clinical data at the forefront of all decision-making, but it’s uncommon for a vaccine to be developed with such speed. This, unfortunately, is by no means the end, but it is a small twinkle of light at the end of the tunnel.

“There are several companies involved in vaccinations such as AstraZeneca, Moderna, Johnson & Johnson, Pfizer, BioNtech, and more,” senior Jaxson Villeneuve said. “Vaccine companies are based in pretty much all first world countries.”

Senior Leah Fannin worries that the vast majority of people are still vulnerable to COVID-19, and that the importance of a vaccine cannot be overstated.

“Nobody is taking it seriously, and I think that people don't realize that it affects everyone, not just elders and people with health conditions,” she said. “Perfectly healthy 30 year-olds and 40 year-olds are still dying from it.”

Pharmacist and owner of Murdock Hometown Pharmacy, Dr. Jenni Villeneuve, PharmD, attempts to inform her clients about the significance of a vaccine.

“As a health-care provider, my job is not to judge, but to educate,” she said. “This vaccine is a novel vaccine in that we are not providing a live virus nor an attenuated virus to elicit an immune response. We are providing mRNA, which is a genetic code, that will help your body produce protein.”

As a biology teacher, Kimberly Hoyle understands the intricacies of vaccines and how they combat viruses like COVID-19.

“A vaccine is meant to train your immune system, so when your body encounters a pathogen it knows how to fight it,” she said. “The body can develop specialized cells to attack the virus, which doesn’t always work. The vaccine is essentially a shortcut to a specific response.”

Due to the rapid creation of a vaccine, some are skeptical of its effectiveness and how safe it is.

“I believe in the scientific process, so I don't believe that rapidity of the trial phases has in any way compromised the safety of the vaccine development and clinical trial process,” Dr. Villeneuve said.

Despite the alleged efficacy, Fannin feels that more progress can be made with the vaccine, especially since the process has been unusually fast and successful.

“I think that the one being made right now is okay to be released to the public just because, considering how fast it was made, it seems to be very effective,” she said. “But I do think that companies and the medical professionals should still keep researching it and find out as much as they can.”

Many nations around the world are hard at work testing different vaccines or undergoing clinical research to help the companies, which are close to making a COVID-19 vaccine fully public. Dr. Villeneuve has great confidence in the scrutiny that vaccines undergo before becoming available to the public.

“The government has put the Food & Drug Administration (FDA) in charge of the approval process of the vaccine after a vaccine manufacturer has completed their pre-marketing clinical trial,” she said. “The vaccine has to be deemed safe for administration in the general public based on tight FDA regulations.”

Currently, Pfizer and BioNTech are the closest companies to creating a successful and widely usable vaccine as both have proven to stop over 90% of people from developing COVID-19. 

“Our annual influenza vaccine has had efficacy ratings varying from 15-65% over the past five years,” Dr. Villeneuve said. “To see a vaccine have as high of an efficacy rating as the current COVID-19 vaccine candidates is really amazing.”

After FDA scrutiny, the manufacturers that have proven their safety may bring their vaccine to market for nationwide distribution.

“For a vaccine to be effective, we hope for disease prevention in at least 60% of trial participants,” Dr. Villeneuve said.

The trials are both double-blind and placebo controlled, meaning participants do not know whether an individual receives the vaccine or placebo (which contains no active vaccine).

“Comparing both the efficacy and the safety of the vaccine vs. the non-vaccine placebo sheds light on whether the vaccine will come to market or not,” Dr. Villeneuve said. “It is important to note that the trials have not included children under the age of 12, nor pregnant women.”

Efficacy seems to not be much of a worry amongst professionals and because of this, many are eager to hear a release date soon. 

“I expect that we'll likely see at least one of the vaccine candidates available by late December or early January,” Dr. Villeneuve said. “This will, of course, be rolled out in a stepwise fashion based on federal and state guidelines. It is my understanding that the National Guard will be employed to aid in vaccine distribution.”

Fannin is skeptical of a quick return to pre-COVID-19 normalcy.

“I would say we return to school earliest fall of 2021 but I would expect COVID-19 to not really go away until 2022, until things can actually start going back to normal,” she said. “I wouldn't expect complete normalcy for probably two years.”

Dr. Villeneuve is also unsure when society will be able to return to a pre-COVID-19 state, as additional information on the virus is continually being released.

“We don't yet know enough about the protection a COVID-19 vaccine will offer the general public to make an exact prediction of when the CDC will loosen masking recommendations, physical distancing, and other COVID-19 protective measures,” she said. “We see less transmission of COVID-19 in younger school aged children than we do in teenagers, however, there is still significant risk for those infected with COVID-19.“

The distribution of the vaccine has been in question for many, but to Dr. Villeneuve, it’s fairly straightforward.

“In Wisconsin, after front-line health care workers, front-line essential workers, and long-term care facility residents and staff, the next phases will include the elderly and those with underlying conditions; then on to the general public,” she said.

Even though general administration will occur eventually, the logistics could be a big challenge. 

“Distribution, storage, hospital and pharmacy staffing to provide the vaccine, physical environment to provide such a large number of vaccines on a mass scale, and cost will all be a challenge,” Dr. Villeneuve said. “It is my understanding that the vaccine will be provided at no charge to patients. I have heard that the actual production cost per dose of the vaccine may be as low as $3.50 per dose, but that does not include any other cost such as distribution and administration.”

Fannin worries potential side effects could create conflict in the future, especially with the rate of which vaccines will be released.

“I know that the companies making it are not 100% sure exactly what's going to happen, or if there are any side effects that could happen depending on who's taking it,” she said.

Dr. Villeneuve believes that despite possible unknown effects, the proper and necessary procedures are being researched and prioritized during this process.

“So far, the most commonly reported side effects have been injection site reactions such as redness and tenderness,” she said. “Health care providers are required to report any patient-reported side effects or adverse events to the CDC and FDA via the Vaccine Adverse Event Reporting System (VAERS). There has also been information given about a smartphone app that will be available called ‘V-SAFE’ where patients will be given information on how to enroll in this monitoring program when their vaccine is administered.”

Even with a vaccine, Fannin is doubtful that immunization will be able to completely erase the risk of COVID-19 infection in America.

“I think it will definitely help decrease the spread, but I don’t believe it will make it go away fully just because there are so many people out there that don’t want to take vaccines,” she said. “As of right now, I don’t believe we know if the virus can mutate and evolve like the flu because it hasn’t been around that long, but if it does, the vaccine would need a change too. It will definitely help but won’t end the whole pandemic.”

If COVID-19 adapts, Hoyle is concerned that several adjustments will need to be made.

“We don’t know how long the immunity will last,” she said. “If the virus evolves, the vaccine may be rendered ineffective.”

Even with that in mind, Dr. Villeneuve has an inclination to teach her clients about vaccines in hopes to allow for a smooth transition out of the pandemic.

“Because this is a relatively new vaccine concept, we are trying to educate the public about how the vaccine works and how it differs from other vaccines,” she said. “I respect different views from my patients about vaccines and their safety, but my hope is to see at least 50-60% of the American public receive the vaccine.”

Dr. Villeneuve is determined to see an end to the pandemic.

“If more Americans would be open to following what scientists have recommended, we could possibly be in a better situation right now,” she said. “Pandemic fatigue has set in, but we can't get lax now!”

By Sam Mollenhauer

Oshkosh West Index Volume 117 Issue 3

December 11th, 2020