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COVID-19 vaccine: Is it really safe?

Safety and efficacy are always top of mind. We outline why that’s true.

placeholder image Photo: Getty Images

By Jackie Kruszewski
C. Kenneth and Dianne Wright Center for Clinical and Translational Research

What do a clinical trials expert, an infectious disease specialist and a pharmacist have in common? All three VCU health care professionals will receive the COVID-19 vaccine as soon as they’re able.

As the nation gets closer to authorized vaccines, VCU Health is gearing up to be part of the unprecedented distribution in central Virginia. And, like many health care providers who’ve been on the frontlines of the pandemic, F. Gerard Moeller, M.D., Gonzalo Bearman, M.D., and Kelly Goode, Pharm.D., won’t hesitate to receive the preventive dose.

“I’ll be vaccinated as soon as I can,” said Goode, a professor in the VCU School of Pharmacy. “It’ll protect me and the people around me, and it’ll be an essential part of a solution that will eventually return our lives to normal.”

With decades of experience in medical research and health care between them, Goode, Moeller and Bearman know that the vaccines’ rapid path to reality has resulted from the extraordinary efforts of scientists and researchers. And they understand the rigorous evaluation experts have given the drugs.

“It’s happened so fast because it’s a public health emergency,” said Bearman, hospital epidemiologist for VCU Health and chair of the Division of Infectious Diseases. “The urgency of the pandemic is driving vaccine development.”

Reward far outweighs risk

As of December 7, more than 282,000 people in this country have died of COVID-19. This number shows that the possibility of death from the virus, especially in high-risk populations, is far higher than any risk from a vaccine.

Moeller, a clinical psychiatrist, understands the fears people often have of vaccines: One is that they won’t work. Another is that they’ll have a significant side effect. 

“The risks of a side effect are tiny compared to other things that we do every day that we don't even think about risk-wise, like driving on Interstate 95,” he said.

Moeller compared it to playing the lottery. “You buy tickets for the lottery, even though there's a one in a million chance that you'll win because the risk is small and the benefit is huge. Why not get a vaccine when the likelihood of a benefit is much, much greater than winning a lottery and the risks are just as small?”

Nothing is without risk, noted Moeller, Bearman and Goode. But a vaccine that's safe and even partially effective in preventing infection, they would get.

“I'm pro-flu vaccine, even when the efficacy on a given season is 40%, because a 40% reduction is something,” Bearman said. “Even if it doesn't fully prevent infection, it can decrease the severity of infection, which is really important, too.”

The Centers for Disease Control and Prevention reports that flu vaccinations reduce the severity of the flu for people who get the vaccine and still get the flu. There’s reason to believe the same would be true for the COVID-19 vaccine.

Speed didn’t sacrifice safety

The COVID-19 vaccine has broken records in its path to reality. Similar to COVID-19 treatment drugs that the FDA approved this summer, the vaccine benefited from prioritization and urgency, as well as knowledge gained from previous research.

Vaccines help your body recognize a virus and activate your immune system to attack it, if you encounter the real thing.

“The leading COVID-19 vaccines are using a new technology called messenger RNA, which delivers genetic code to your body, stimulating that immune response,” Goode said. “While it seems like the technology has developed quickly, these companies have been doing research on other diseases, using this technology, for many years.”

Another factor in the speed? The companies making the vaccines received funding from the government to start creating doses before the drugs were approved.

“They’ve gone ahead and manufactured doses,” Goode said. “As soon as there’s FDA approval, those doses are ready to go. You don't usually see companies making that kind of investment if they don't know whether the drug is going to work or not, but they've had extra infusion of cash that's enabled them to go ahead.”

Tens of thousands of volunteers from diverse backgrounds participated in clinical trials for the vaccine. Goode, Bearman and Moeller cite the vaccine trial in the United Kingdom that was put on hold briefly as a sign of a process that is working properly.

“One patient in the study had an adverse effect, not necessarily directly related to the clinical trial,” said Moeller. “So they paused the study to look into that further and then resumed it. If there is a risk to this vaccine, it’s going to be known, and it’s going to be out there.”

The vaccine manufacturers also took the extraordinary step of making their methodology public, increasing the transparency in a move to build public trust. Advanced data has been published in journals.

It’s not happening faster because any corners are being cut, Goode added. It's happening faster because it's a pandemic and everyone has shifted their priorities.

Approval process is rigorous

The FDA approves vaccines with advice from the Advisory Committee on Immunization Practices at the Centers for Disease Control and Prevention, whose members are experts from around the country in the fields of immunology, infectious disease, public health and more. Data safety monitoring boards at the National Institutes of Health monitor every trial and scour the data for irregularities and safety concerns. The Virginia Department of Health will oversee administration in the commonwealth.

Scientists and doctors, career professionals whose mission is safety and public health, staff all these institutions.

“The NIH and the FDA review things and make a conclusion that it's safe,” said Bearman. “We should feel confident that that is correct based on the available data.”

Bearman also notes that after the vaccine begins to be distributed, health care professionals and others dedicated to ensuring medication safety will keep collecting data to make sure it’s still effective and safe.

“I've been doing clinical trials and clinical research for over 20 years,” said Moeller, director of the C. Kenneth and Dianne Wright Center for Clinical and Translational Research. “My experience with the FDA is that they have safety and efficacy at the top of their minds. People have been working there a long time through different administrations, and while they might change slightly in their approach to things, I have never seen them change their approach to safety and efficacy.

The people at the FDA who approve medications are not political appointees or elected officials. If it's an FDA-approved medication, I will get it.”

Vaccine isn’t a cure, though

Goode, Bearman and Moeller caution that the vaccine isn’t a license to return fully to normal. There will be a period of time in which people will still need to practice social distancing and wear face masks, even once some have had a vaccine.

Nationwide and global distribution will take months, maybe years. Achieving herd immunity means getting 70 to 90% of people vaccinated. Herd immunity is the percentage of a population that needs to be vaccinated in order to protect a community from the disease.

“We don’t want people to say, ‘OK, now I'm going to party and do all that stuff I miss doing because I've had the vaccine,’” Goode said.

One big question is how long the vaccine will protect someone from the virus.

“It’s possible a vaccine will only give us partial immunity to the virus,” Bearman said. “That's why you have to take an influenza vaccine every year, because it only gives you partial immunity. As the virus changes, the vaccine has to change. It’s not like a vaccine for mumps, measles or smallpox, which will give you immunity for life. It's a very different virus.”

Learn more about how VCU Health is keeping you safe during the COVID-19 pandemic.