By The Corvallis Clinic
FDA authorized vaccines for COVID-19 are making their way to communities around the country. The purpose of the vaccines is to help protect people who come into contact with the virus (SARS-CoV-2) from contracting the disease (COVID-19). The more people who get the vaccine, the sooner our hospitals, families, businesses, schools, and communities will be able to safely return to normal.
Is It Safe?
As you would expect with a new vaccine, concerns have been voiced about its safety. In this case, the concerns are focused on the speed with which the vaccine was developed. There are a few factors that made it possible to produce an effective vaccine so fast, but first, it’s important to know that no safety steps or controls were skipped in the development of the approved COVID-19 vaccines.
Testing of new vaccines has two goals: to determine the safety and determine the effectiveness. The FDA enforces the testing standards for vaccine developers and will not provide authorization if they are not met. Participant pools for the COVID-19 clinical trials comprised 25% underrepresented minorities and 25% older age groups and people with conditions such as obesity, diabetes, heart conditions, and respiratory conditions. Trials for pregnant women and children under 12 will begin soon. Monitoring is ongoing to track any unexpected side effects. Both Pfizer and Moderna reported 95% effectiveness in preventing mild and severe symptoms of COVID-19, and effectiveness was not affected by age, race, or condition.
No trials have reported serious safety concerns. Trials for the first two vaccines, Pfizer and Moderna, have had independent safety monitoring boards, and the safety data are continuously reviewed by the FDA and an expert panel.
Speed of Development
To get a safe and effective vaccine to the public as quickly as possible, some testing phases were performed simultaneously. Developers had access to government funding that ensured adequate resources throughout the process. They also had access to genetic information about SARS-CoV-2 provided by China. Social media enabled the fast acquisition of diverse volunteers. Those volunteers were quickly exposed to the virus in real-world settings because of its infectivity, so trial results were available quickly. Once the vaccines were complete, manufacturing began preemptively to ensure the fastest possible delivery once the FDA gave authorization. These factors accelerated development, but the most important factor was the approach they used.
Pfizer and Moderna used messenger RNA instead of the traditional dead/weakened virus method for their vaccines. mRNA tells your body to make copies of a harmless piece of the virus, the spike proteins on the surface that you’ve probably seen in COVID-19 images. The spikes help the virus attach but cannot cause COVID-19 on its own. Instead, they teach your immune system to identify and destroy the protein, which is why you might feel slightly ill, and they cause the production of antibodies. If the real virus enters your body in the future, your immune system will recognize the protein and destroy it before it makes you sick. mRNA vaccines were already being developed before COVID-19 hit. It’s a much faster approach to vaccine development, which is why Pfizer and Moderna were able to enter the clinical trial stage so quickly. It’s believed to be more effective as well.
Possible Side Effects
The COVID-19 vaccine is designed to trigger your immune system. It can cause mildly uncomfortable symptoms like pain at the injection site, fever, sore throat, muscle aches, fatigue, and headaches. Symptoms are more likely to occur after the second injection and should not last more than 48 hours. If they do, you should contact your healthcare provider. During testing, it was noted that common side effects were much more tolerable than symptomatic cases of the virus.
“I support the use of COVID-19 vaccines because years ago, I chose to apply myself to the support of health and safety in my patients and my community. Decreasing the risk of transmitting this virus is vital. We have lost over 400,000 Americans, and many others have suffered/are suffering from this disease. Data from appropriate vaccine trials and current practice show the vaccines to be safe and effective, although my arm was sore for a couple of days. This layer of protection will help keep us healthy and assist in returning to more normal lives.”
– Tavis Cowan, MD, Occupational Medicine
If you choose to get the vaccine, that doesn’t mean you should stop wearing your mask and taking safety precautions when you’re in public. You might be one of the 5% for whom the vaccine does not work. Even if the vaccine works for you, there is not enough information to know if it prevents people from carrying and spreading the virus. The vaccine will help prevent infection and accelerate our return to regular social interaction. Still, until enough people have been vaccinated, it’s crucial to maintain all health safety protocols.
“Stopping this pandemic requires all the tools in our toolbox as a community. Vaccines work with your immune system, so your body will be ready to fight the virus if you are exposed. Other steps, like wearing masks and social distancing, reduce your chance of acquiring COVID or spreading it to others. Together, COVID-19 vaccination and following CDC’s recommendations to protect yourself and others will offer the best protection from COVID-19, for you and the people you love.”
– Robin McKelvey, MD, Internal Medicine
Should You Get the COVID-19 Vaccine?
The decision to get the vaccine should be made between you and your healthcare provider. While there are significant benefits to vaccinating most of the population, your health status and risk factors must be considered before a recommendation can be made.
Children and Pregnant Women
Clinical trials for children and pregnant women are not yet complete. Experts believe the vaccine will be safe for pregnant women and fetuses because the mRNA does not enter the nuclei of cells. Still, monitoring of clinical trial participants who became pregnant is ongoing. More information will be available after upcoming clinical trials. Pfizer’s vaccine was authorized for patients age 16 and up, and Moderna’s vaccine was authorized for patients age 18 and up. Please discuss the vaccine with your healthcare provider if you are pregnant or have children under the ages that the FDA has authorized.
People with common allergies should not have any unusual issues with the COVID-19 vaccine. However, if you have a severe allergy to injectables or any Pfizer/BioNTech vaccine ingredients, you should not get the vaccine until you speak with your healthcare provider. If you have severe allergies to another substance, you should talk with your doctor and be prepared to wait an extra 30 minutes after receiving the vaccine to be monitored for a reaction. A severe allergy is defined as anaphylaxis.
“I am very thankful to have gotten my vaccine. Although my personal risk of death from COVID is low, there have been people my age without pre-existing conditions who have died and even more who have suffered long-term effects. By getting vaccinated, I do my part to help protect my patients and their families, as well as my own aging parents, from getting COVID. I know the vaccine is new, but the illness is too. We have seen so much tragedy from the illness and almost none from the vaccine. For me, there was no question I would get it as soon as it became available, once it was approved by the FDA.”
– Christy Rivers, DO, Pediatrics
Please visit the Clinic’s COVID FAQ Page for vaccine information and updates in our community.