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COVID-19 Vaccine – Development and Safety

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The first of the COVID-19 vaccines in Utah are being distributed to frontline healthcare workers along the Wasatch Front. Even with this major turning point in the pandemic, it’s vital that the public understand that this fight is far from over, said Dr. Tamara Sheffield, Intermountain Healthcare’s medical director for community health and prevention.

Healthcare workers are the first to receive the vaccine, but the general public will likely have to wait several months before they can receive their shots. Those who are vaccinated are still urged to wear masks, social distance, and wash their hands often. Continued adherence to COVID safety guidelines will be key to getting infections under control.

There are many vaccines of different technologies and types, but the two vaccines that will arrive shortly are both mRNA vaccines. This is a newer technology that mirrors what happens naturally in your body to defend against disease.

The SARS-CoV-2 virus that causes COVID-19 uses a spike protein to insert itself into a person’s cells so it can then it can replicate itself and continue to infect the person.

The vaccines in development use the same spike protein but without the virus itself. By replicating that delivery mechanism, the vaccine trains the body to mount an immune response to prevent the attachment of the spike proteins. The immune system produces the natural antibodies that prevents the virus from inserting itself into a person’s cells.

And because the virus is never present, you cannot get COVID-19 from the vaccine.

It is important to note that mRNA vaccines do not enter the cell nucleus, nor do they effect a person’s  DNA or modify someone’s genetic makeup. In fact, the mRNA that gives the instructions breaks down fairly quickly from normal enzymes in the body. The person’s system, however, has been primed to produce antibodies to fight off what it thinks is an infection.

While mRNA vaccines are a new type of vaccine, they have been studied for decades. There are currently no licensed mRNA vaccines in the US, but they have been used in other parts of the world.

These vaccines are being developed under an Emergency Use Approval (EUA) process to speed the development and production process, but that does not mean steps are being skipped or safety is compromised. The same phased trials have also been conducted as would be done with any vaccine. Over 75,000 people have been involved in these vaccine trials, including people right here in Utah.

The Vaccines and Related Biological Products Advisory Committee (or VRBPAC) is an independent group the evaluate’s the safety and efficacy (or how well a vaccine protects a person) data involved in any vaccine development, and they are going through the same process they would with any vaccine. Both vaccines have to be approved by the FDA as advised by VRBPAC before they can be used.

One of the advantages to mRNA vaccines is they can be manufactured quickly. To speed delivery, the manufacturers have started producing vaccine before that approval process was completed. The simultaneous testing and manufacturing of the vaccine doesn’t normally take place because of the chance the vaccine wouldn’t be approved and the financial risk involved. Due to the nature of the pandemic, the government has financially contributed to offset this risk. It doesn’t mean safety was compromised. It simply means the process was overlapped to cut down delivery time.

Pfizer-BioNTech received EUA for their COVID-19 vaccine on Saturday 12/12/20 and Moderna will present their data to VRBPAC on Thursday 12/16/20. That advisory group will make the final recommendation to the FDA on approval to use the vaccines.

The Pfizer vaccine arrived at Intermountain Healthcare and University of Utah hospitals this week and if EUA is granted, it is expected that the Moderna vaccine will begin to arrive at Utah hospitals next week. The vaccine will be given to individuals at the greatest risk of COVID exposure. As more vaccine becomes available, state and local partners will give vaccines until everyone has the opportunity to be vaccinated. We don’t have an exact timeline but are excited to see the process rolling forward.

Until everyone has the opportunity to be vaccinated, we should all continue to wear masks, wash hands, social distance, and stay home if we have symptoms. And while we can’t all get a COVID vaccine yet, we can all get an influenza vaccination.

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For more information about Intermountain Healthcare, visit their website.

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