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Are the COVID-19 vaccines safe?

Wondering about the COVID-19 vaccine’s safety? Jayne Morgan, M.D., a cardiologist and clinical director of Piedmont's COVID-19 task force, shares information about the safety and effectiveness of the vaccines as well as how they were developed so quickly.

How safe are the COVID-19 vaccines?

So far, two COVID-19 vaccines have been given emergency use authorizations by the Food and Drug Administration (FDA). The vaccines went through rigorous trials to make sure they are as safe as possible.

“The safety profiles of both the Pfizer-BioNTech and Moderna vaccines were very good based on the data that went to the FDA,” says Dr. Morgan.

The Centers for Disease Control and Prevention (CDC) has systems to continually monitor the safety of the vaccines as they are distributed to more people.

How effective are the COVID-19 vaccines?

“The efficacy – how well it protects you from contracting COVID-19 – was phenomenal. To give an example, the flu vaccine we take every year generally has an efficacy rate of 45 to 60%. The COVID-19 vaccines from Moderna and Pfizer-BioNTech have efficacy rates of 94.5% and 95%, respectively. They knocked it out of the park – those aren’t rates we commonly see with vaccines.”

She also notes that Black patients in both trials comprised the only subgroup to have no incidents of COVID-19-positivity after the second dose. This means they experienced 100% efficacy, compared to 94.5% and 95% for all groups.

COVID-19 vaccine side effects

While not everyone who gets the vaccine will experience side effects, some people will experience symptoms, more commonly after the second dose.

Dr. Morgan notes that patients over the age of 65 are less likely to have symptoms than those under 65.

Learn more about COVID-19 vaccine side effects.

How were the COVID-19 vaccines developed so quickly?

The vaccines’ development time was based on multiple factors, says Dr. Morgan.

Years of research

“One thing we should consider when we think about how quickly they developed these vaccines is that this is the third time we’ve seen an outbreak of the virus that causes the disease we call COVID-19,” explains Dr. Morgan. “The first time we saw it was in 2003 with the first SARS [severe acute respiratory syndrome] outbreak. Then we saw it again in 2012 with the MERS [Middle East respiratory syndrome] outbreak.”

For the past 17 years, researchers have completed all the preclinical work, benchmarked the data, identified the spike protein as being a key part of the virus that confers infection, and identified the genomic sequence of the virus.

“All of this was done before the United States ever had its first confirmed COVID-19 case,” she says. “So, 17 years of research had been completed and was ready when we ended up with this outbreak. That’s the platform on which we started the development of the vaccine – a lot of the work was already done behind the scenes.”

New vaccine technology

Secondly, researchers developed a different vaccine platform using messenger RNA (mRNA) technology, which is easier to produce and manufacture, notes Dr. Morgan.

Extensive resources

“Third, because we are in a pandemic, we had all types of resources directed toward developing this vaccine,” she says. “If you have the resources, you can do a lot of things. People can be pulled from other projects; you can open more study sites and enroll people more quickly.”

A different clinical trials process

Fourth, researchers began a new process of overlapping the phases in clinical trials.

“Instead of having phase 1 complete before starting phase 2 and so on, the researchers did interim analyses,” says Dr. Morgan. “The data looked good, so they started the next phase. Then, when phase 3 ended, they filed that data to the FDA. All the doses of the vaccine had been given, but after that, they generally follow all patients for up to a year to understand how long immunity is conferred. That’s why we have emergency use authorizations.”

All of these factors came together to have the appearance of rapid development of the vaccine.

Who should get the COVID-19 vaccine?

The Pfizer-BioNTech vaccine has an emergency use authorization for people ages 16 and up. The Moderna vaccine has an emergency use authorization for people ages 18 and up.

If you’ve ever had a severe allergic reaction to any component of the COVID-19 vaccine, you shouldn’t receive the vaccine. If you’ve had a severe allergic reaction to another vaccine, you should talk to your healthcare provider before getting vaccinated. However, people with allergies to food, oral medications, environmental triggers, latex, pets and insects can get vaccinated.

There is limited COVID-19 vaccine safety data for women who are pregnant or breastfeeding. However, the American College of Obstetricians and Gynecologists (ACOG) recommends that the vaccine not be withheld from those who are breastfeeding or pregnant. Talk to your healthcare provider to see if the vaccine is right for you.

The vaccines haven’t been studied or tested in children yet, so they are not approved for children at this time.

Regardless of whether or not you’ve been vaccinated, you should still wash your hands, wear a mask and watch your distance to reduce the spread of the virus.

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