KSL Investigates: Does rushed vaccine make it less safe?

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SALT LAKE CITY — With two pharmaceutical companies ready to obtain approval for their COVID-19 vaccines from the U.S. Food and Drug Administration, many Utahns are asking: "Is it safe?"

The FDA will review the first COVID-19 vaccine, produced by Pfizer, on Dec. 10. This vaccine was approved in the United Kingdom and has begun distribution.

As the U.S. rollout of a vaccine waits for FDA approval, Dr. Sankar Swaminathan, chief of the Division of Infectious Diseases at the University of Utah, said the public should feel comfortable with the vaccine, if approved.

"There's no evidence that any of the components of any vaccine that's approved for use is fundamentally dangerous," he said. "If it were, it wouldn't be approved."

Money, Resources & Prior Research Helped Speed Up Vaccine

There are multiple reasons scientists were able to so quickly develop and test the COVID-19 vaccine.

"There was a lot of economic investment, unparalleled amount of economic investment – both by the companies involved in developing these, as well as the government," said Swaminathan.

Since March, Operation Warp Speed has devoted more than $10 billion into research and development at seven pharmaceutical companies. This includes two companies seeking FDA approval: Moderna and Pfizer.

Rapid research was also a necessity to curb a global pandemic.

"We've really never had in our lifetimes a threat like this that has led to such widespread sickness, shutting down of economies and death," Swaminathan said.

It is also worth noting that researchers didn't start from scratch in vaccine development.

"MRNA vaccines had been in the process of development for some time, and so this was a perfect opportunity then to sort of slot in the COVID-19 protein that's being made by the vaccine," he added.

Also helpful was the access to trial participants.

Dr. Swaminathan pointed out that a widespread pandemic of the COVID-19 virus meant access to a statistically significant sample of those who had contracted the virus or could have a better chance of contracting the virus in order to test the vaccine.

"The trials got done sooner than you would expect because the disease has spread so alarmingly throughout the United States that they were able to enroll and have enough cases develop that they were able to demonstrate efficacy for the vaccines," he said.

After tens of thousands of people participated in each study for three drugmakers, researchers found the vaccines offer at least 90% efficacy.

Pfizer announced 95% vaccine efficacy (VE), Moderna listed 94.1% VE, and AstraZeneca claimed 90% VE. AstraZeneca is still conducting phase III of their trials after restarting it in October.Rapid research was also a necessity to curb a global pandemic.

"The measles vaccine is one of the most effective vaccines," Swaminathan compared. "It's over 90-95% and [the COVID-19 vaccine] is reported to be achieving that level of efficacy."

Past Pandemic, Epidemic Vaccines

To get an idea of how the COVID-19 vaccine might work, we looked at past epidemic and pandemic data.

As explained by Intermountain Healthcare, "An epidemic is a disease that affects a large number of people within a community, population, or region."

The Ebola outbreak in West Africa from 2014-2016 is considered an epidemic.

A pandemic is an "epidemic that's spread over multiple countries or continents."

COVID-19 is a pandemic, as was the H1N1 influenza virus in 2009.

The Health Resources and Services Administration operates the Countermeasures Injury Compensation Program to review claims of injury from pandemic countermeasures like emergency-authorized vaccines.

It covers diseases like Ebola, Zika, H1N1 and Anthrax exposure.

According to data gathered since 2009, only 494 claims of injury from countermeasures have been reported and requested compensation. Of those, 39 were eligible for payment for those injuries and 29 claims received a cumulative $6 million in compensation

CDC data showed that during the 2009-2010 H1N1 pandemic, an estimated 80.8 million vaccines were administered. A review of multiple studies of the vaccine's efficacy showed the H1N1 vaccine was about 80% effective in preventing the Swine Flu. It was most effective for children.

Are Side Effects Severe?

Another rumor circulating on social media is that side effects of the COVID-19 vaccine are severe.

In analyzing safety data from Phase 1 of the Moderna trial, most participants saw mild to moderate side effects. The most frequently reported symptoms included those associated with the shot itself that were usually resolved within two days.

The more severe symptoms were more frequent after the second dose of the vaccine and in the 71+ age group.

Pfizer reported fewer than 4% of a random subset of 8,000 of their study's participants experienced severe side effects. The greatest were fatigue (3.8%) and headache (2%). "Severe" was defined as "interrupting daily activities."

KSL previously reported Rep. Steve Eliason, R-Sandy, was a participant in the Moderna COVID-19 vaccine study.

"I thought I might as well give it a try," Eliason said.

He said he experienced minor side effects similar to those one might experience with a seasonal flu vaccine: a low-grade fever and some body aches.

"They were easily managed with a dose of Tylenol or Advil and lasted less than a day," he said.

A Utah teen who participated in the Pfizer study also reported mild side effects.

Clinical trials monitor participants following the injections to make sure there are no widespread adverse reactions. These would then be further studied to determine if it is a safety concern and if changes should be made.

What's In The Vaccine?

Until the FDA approves the vaccines, ingredient lists have not been made public.

What we do know is that they are being developed with mRNA.

"The mRNA vaccine is unique in that it's neither a protein nor an organism, dead or alive," said Dr. Swaminathan. "What it is, is the mRNA, which is a molecule which instructs the cell how to make a protein. So, what you're doing is you're injecting an RNA molecule that's synthesized in a laboratory that has the code for the protein. So, the cells in your arm will take up this mRNA particle and that particle tells the cells to make the viral protein."

He continued, "Once that viral protein is made by your own body, the body generates an immune response to it that basically teaches it how to fight off the virus if it actually encounters it in real life."

Swaminathan told the KSL Investigators that the vaccine will likely also contain lipids – tiny fat molecules that assist in the delivery of the mRNA.

"They sort of coat and encapsulate the messenger RNA, so that they get taken up by your cells," he said.

Ultimately, he said people should feel confident in receiving the vaccine if it is approved by the FDA.

"There's no evidence that any of the components of any vaccine that's approved for use is fundamentally dangerous. If it were, it wouldn't be approved," he said.

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