From development to distribution: the vaccination process for COVID-19

By Lucy Wing, Reporter

In January of 2020, the first case of COVID-19 was confirmed in the U.S. Now, a little over a year later, vaccine distribution is fully underway. Kristen Cohen, Ph.D. works at Fred Hutchinson Cancer Research Center and has been actively involved in the vaccine development process.

“Our lab does immunogenicity, so we look for what immune responses are induced by vaccines,” Cohen explained. Usually, her lab would be looking at vaccine testing for other infectious diseases, primarily HIV. But for the past year, Cohen’s lab has been testing immune responses for COVID-19 vaccines.

The vaccine producing process is extremely long, involving several phases of testing, editing, and more testing. When it is finally approved to test on people, there are three phases the vaccine must go through before it can start being distributed.

In Phase One, the vaccine is tested on a small number of young, healthy adults. Next is Phase Two, which looks more closely at immune responses in a larger number of people. Finally, the vaccine goes to Phase Three, efficacy trials, where scientists prove the effectiveness of the vaccine. However, the testing process for the SARS-CoV-2 vaccine was sped up, and Phase Two was skipped entirely.

“Usually it’s very sequential, and while there’s still a sequential aspect of everything that’s happened for COVID, it’s been much more overlapping,” Cohen said.

“Even GMP manufacturing, which is the good manufacturing process, and is critical for making any products that are going to actually be injected into people, is usually not started until you have really good preclinical data.”

This is where the federal government stepped in.

“Companies could go ahead and do things in parallel that they would not normally do because there would be too much financial risk from moving on without completing the first step.”

As companies reached Phase Three for the COVID-19 vaccine, their goal was to prove efficiency as quickly as possible, and so massive trials were conducted. These trials involved upwards of 30,000 people. After Phase Three testing is complete, companies normally have additional testing before federal approval, but because of the rushed timeline and lack of data, COVID-19 vaccines have not gained FDA approval yet. However, the FDA and similar organizations around the world are aware that distributing vaccines as quickly and safely as possible is the top priority, so distribution started without FDA approval.

Once a distribution plan is created in state and local governments, vaccines can begin to be administered.

On Vashon, the Vashon Pharmacy has teamed up with Vashon Be Prepared to create a drive-thru operation that has been administering an average of 150 vaccines per day. Because Vashon’s average age is higher than in other areas, a higher percentage of the population is eligible for this first stage of vaccinations, meaning it is impossible to ensure everyone who wants a vaccine will get one.

“It’s been really hard for us to watch all these people not get an opportunity to get vaccinated quickly,” Tyler Young, who owns Vashon Pharmacy with his wife Amy, said. “The appointment availability has been the biggest negative. We filled up 850 slots a week ago in roughly an hour and a half of time… and this past Monday, we had about 150 spots left that we filled for Tuesday’s clinic. Those filled up in 13 minutes”

Vashon’s small population means a higher percentage of the population has been vaccinated than in other areas, and Young expects to be allocated fewer vaccines from the state in the next few weeks as those other, larger areas catch up.

“[Vashon Be Prepared] really deserves a lot of credit for making the efficiencies of this possible. As a stand-alone entity, Vashon Pharmacy could have vaccinated some, but we’ve been able to scale this probably five to six-fold because of their dedication and willingness to support this project,” Young said. “… they are the engine and all I did was supply the gas.”

Vashon owes a gratitude to those at Vashon Be Prepared, as well as the many volunteers who help run the vaccine distribution, and the world owes a deep gratitude to the scientists, doctors, and nurses who are working tirelessly to ensure the safety of their fellow citizens, both from this pandemic and world health crises in the future.

“I think that HIV vaccine research and vaccine development for other diseases is going to be greatly advanced by the massive amount of investment into vaccines that has happened in the past year,” Cohen said, “I think this will actually benefit the scientific community and public health community in the future for dealing with infectious diseases.”