How the COVID-19 vaccine is produced so quickly and why it will be safe if approved

By the end of the year, Moderna expects 20 million doses of the vaccine in the U.S., and Pfhizer with 50 million doses globally.

LITTLE ROCK, Ark. — Concerns about the safety of the COVID-19 vaccine are arising as more companies are posting promising results during phase three trials.

On Monday, Moderna announced its vaccine is showing 94 percent effectiveness. Last week, Phizer posted similar results, with at least 90 percent effectiveness.

“The challenge that we have is, we only have press releases to base our information on,” Dr. Robert Hopkins, Professor of Internal Medicine and Pediatrics at UAMS said.

Dr. Hopkins with UAMS said he is cautiously optimistic about Moderna and Pfizer’s vaccine trials. Doctors won’t be able to get the full story about the effectiveness or potential side effects until they’re done with phase three trials and it is approved by the FDA.

“Once we know some of that information, then we can start making a conclusion on whether we are going to take a vaccine or not,” he said.

The COVID-19 vaccine will be the first vaccine of its kind if approved. Dr. Hopkins said companies are using a new technology developed within the last 20 years that makes it easy to find a good candidate by identifying the genetic sequence of the genetic material of the virus, which basically makes it easy to identify an effective vaccine quickly. 

He said with previous technology, it took years to find a good vaccine candidate.

Scientists started using this new technology to try and develop other coronavirus vaccines more than a decade ago.

“We started ahead of where we would’ve been for another new disease because we had some candidate ways of making vaccines from previous coronaviruses [SARS and MERS] that we were able to start from,” Dr. Hopkins said.

The production of these coronavirus vaccines stopped because of funding. 

That’s what sets the COVID-19 vaccine apart; there’s plenty of funding from the government. Dr. Hopkins said this also allows companies to speed up the vaccine process by taking a number of steps and doing them parallel with each other. 

“We’ve seen the small trials done at the same time as they were starting some of the larger trials,” he said.

Companies are already producing millions of doses of the COVID-19 vaccine before it is even approved. Therefore once it is approved, it will be available almost immediately. This is a step no company has ever taken before with a new vaccine because it is a big risk. If it does not get approved, all those vaccines will have to be thrown away.

“I can say with great confidence that we are not skipping steps looking at safety,” Dr. Hopkins said.

Dr. Jennifer Dillaha with the Arkansas Department of Health said there is some preliminary data showing all the common side effects of the vaccine are identified within the first two months. 

These side effects include a sore arm and mild fever. 

Extremely rare side effects are much more difficult to identify with any vaccine because vaccines only go through three phases; with the final phase testing the most people, between 30 to 60 thousand.

“If there is a rare side effect that only occurs in 1 out of one million people, you’re not likely to see that in the phase two or three clinical trial,” she said.

This is where the monitoring of the vaccine comes into play. Dr. Hopkins said there will be at least four major safety pathways that are going to be watching these vaccines as people are vaccinated, looking for any signals doctors should be concerned about. This is typical for every vaccine.

“I think we have a very robust safety pipeline that a lot of people don’t know about, they haven’t heard that information or seen that information,” Dr. Hopkins said.

Dr. Dillaha hopes people will do their research when the vaccine comes out and make an educated decision for themselves.

“I encourage people to learn about the process so that they’re really informed. If people just go with their gut reaction, that could be wrong, and we want people to make their decision based on good information and not have regrets later on,” she said.

By the end of the year, Moderna expects 20 million doses of the vaccine in the U.S., and Pfhizer with 50 million doses globally.