PORTLAND, Ore. (KOIN) — The Oregon Health Authority is following each step of the COVID-19 vaccine approval process, and Oregon’s top public health officials are following the data safety monitoring board, which closely reviews the trials.
They’re pouring through data from a committee that’s tasked with advising the FDA on the vaccine. Then, OHA is going to look at the Advisory Committee on Immunization Practices, which meets to recommend items to the Centers for Disease Control, or CDC.
Finally, the Western States Scientific Safety Committee, which involves scientists from Washington, Oregon, California and Nevada, is reviewing the research together to ensure all the safety steps have been taken to make sure that this is not only an effective vaccine but also a safe vaccine.
NEW APPROACH TO VACCINES
The mRNA vaccines are a new type of vaccine to protect against infectious diseases. To trigger an immune response, many vaccines put a weakened or inactivated germ into our bodies; however, that’s not the case with mRNA vaccines. Instead, they teach our cells how to make a protein — or even just a piece of a protein — that triggers an immune response inside our bodies. That immune response, which produces antibodies, is what protects us from getting infected if the real virus enters our bodies, according to the CDC.
Messenger RNA, known as mRNA, is genetic material – it’s like an outline or a framework or code to build proteins. In order to get the mRNA into the cell, it has to be encapsulated into a fatty globule of a little nanoparticle. The fatty lipid acts as a protective barrier, otherwise when injected enzymes in our body would destroy the mRNA. The nanoparticle allows it to melt into the cell wall and put the mRNA into the cell.
“Then it’s like, it’s like instructions for Legos,” Dr. Joe Sullivan, senior health advisor for the Oregon Health Authority, explained. “The instructions for Legos tell you which piece to put where, and that’s how it builds the protein. Once the protein is built, then that’s what triggers the immune system’s response, the building of antibodies and the building of those cellular memory cells.”
If the Pfizer and Moderna vaccines are approved — it will be the first-ever mRNA vaccines on the market. It is new, but not unknown. Scientists have been studying it for more than a decade. This advancement has been happening behind the scenes, and the COVID-19 pandemic has accelerated it.
THE BENEFITS
It’s fast
In fact, scientists were able to develop the mRNA for COVID-19 within a month of figuring out the DNA sequence. Since this method of vaccine development doesn’t require growing specific cells, it’s easier to standardize and scale.
For example, take the most common way to make the flu vaccine: to produce it at scale, scientists grow the vaccine in the cells of fertilized chicken eggs, then incubate the eggs for days before being able to manufacture them for public use. That method is cumbersome, time-consuming and resource-intensive.
In contrast, mRNA can all be done in test tubes. No cells required.
“They were able to develop this fast, but in addition that’s why they could start their trials early,” Sullivan said.
A lot of the basic science had been done ahead of time for how to put the vaccine in lipid particles. Operation Warp Speed helped with manufacturing these things. The U.S. government funded these efforts so the pharmaceutical companies didn’t have to make financial risks while attempting to make a vaccine.
“Great financial risk oftentimes is what slows down the vaccine process,” Sullivan explained. “Companies don’t want to put in that much risk until they’re really sure.”
Doesn’t touch our DNA
Even though mRNA is genetic material, it doesn’t interact with our own DNA.
“It doesn’t get into our vault where we have all of our genetic information in the nucleus — it doesn’t enter that part of the cell at all,” Sullivan said.
No virus needed
Unlike other vaccines which rely on a dead or weakened form of the virus to build immunity, the best part of the mRNA vaccine is that it cannot make a coronavirus.
“It’s only the spike protein, meaning people cannot get COVID-19 from these vaccines,” Sullivan said. “No way.”
Power in numbers
Some vaccine trials may only have 5,000 people. But for COVID-19 trials, scientists have gotten 30,000 to 45,000 people.
“These trials are much bigger, which allows us to get information much quicker,” Sullivan said. “Through these trials we’ve been able to learn that these vaccines really protect against the most severe type of COVID-19 that puts people in the hospital, requiring oxygen or an ICU bed.”
REMAINING QUESTIONS
At this time scientists have determined the vaccine does build immunity in the participants, with both Pfizer and Moderna vaccines touting near 95% efficacy. However, they still aren’t sure how long the immunity lasts.
“We won’t know for several months — five, six, 12 months about how long this lasts as far as effectiveness,” Sullivan said.
OHA is on the lookout for any safety surprises. Dr. Sullivan said he’s curious to know more about the vaccine’s effect on subpopulations, like older folks, people with chronic disease, children, and those who’ve been historically disproportionately affected by this disease, such as people of color.
“Those are the things that I’d like to drill down and make sure that these vaccines, both of them, are effective for all races and ethnicities and all ages that they’ve been tested in,” he said, “That’s what we want confirmation of.”
The Pfizer vaccine had enrolled kids down to 16. Now they’re looking at kids as young as 12. This week, Moderna announced that it was starting a 3,000-person placebo-controlled trial in kids between 12 and 18.
The vaccine trials have given us information that shows these are very effective vaccines. Dr. Sullivan said we’re even luckier to have two of them available so we can start to end this pandemic.
“If all that data comes to pass, as scientists have understood, that’s a real boon for Oregon and the rest of the world,” Sullivan said.