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The COVID-19 Vaccine is Safe and Effective

Still undecided about getting your COVID-19 vaccine? Here are the facts you need to make a science-based decision.

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Updated:

May 22, 2021

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All Pennsylvanians aged 12 and older are eligible for the COVID-19 vaccine

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According to the Pennsylvania Department of Health, as of May 5, there are 3,646,861 Pennsylvanians who have been fully vaccinated, and about 88,000 people per day are receiving the vaccine. However, many Pennsylvanians are still undecided about the COVID-19 vaccine.

At Penn State Extension, we are proud to deliver educational programs based on the best available science. We believe good information – based on facts – leads to good decisions. But the constant flow of contradictory, and often sensational, news surrounding the COVID-19 vaccines can make the decision to get vaccinated or not feel very difficult and even scary. Here, we want to provide you with the science and facts you need to make the best decision for you and your family.

People often argue that none of the COVID-19 vaccines are FDA (Food and Drug Administration) approved. Their concern is that the Emergency Use Authorization (EUA) granted to the COVID-19 vaccines does not follow the same safety standards. So, what is the difference between the FDA approval and the Emergency Use Authorization? EUA is a process which makes new drugs available quickly in response to a public health emergency when there are no existing FDA approved alternatives. If there had already been an FDA approved vaccine against COVID-19, then a newly developed vaccine would have required full FDA approval. For example, if a new measles vaccine was developed today, it would represent an additional option, but not the only option, so there would be no urgent need to make it available, even during an epidemic. Thus, it would follow the usual FDA approval process. By contrast, SARS-CoV-2 is a new virus for which we did not have a vaccine when the pandemic hit. Because of the emergency of the situation, with well over a million cases and nearly 26,000 deaths in Pennsylvania as well as its impact on the economy, it has been crucial to make the new vaccine available as soon as safety and effectiveness data emerge during the clinical trials. The only difference between the EUA and the FDA approval is the FDA uses the available evidence to date instead of waiting for long term results, which might take months, years, or even longer to collect. In other words, the new vaccine is made available quickly to respond to a public health emergency.

Data on safety and effectiveness is continuously being collected and reviewed as the vaccine is deployed. Hence, no short cuts are taken when it comes to safety. This explains why a vaccine might be put on hold as soon as suspicion of serious side effects arises, as was recently the case for the Johnson & Johnson (J&J/Janssen) vaccine. This does not mean the vaccine is not safe, but it is the FDA’s duty to err on the safe side and suspend its distribution until all the data is thoroughly analyzed. This is not to say that vaccines, including the COVID-19 vaccines, do not carry risks. Side effects can range from mild to severe adverse reactions. Mild adverse effects ranging from local pain, swelling and redness at the injection site, tiredness, nausea, headache, muscle pain, chills, and fever are common. Life-threatening reactions (e.g., blood clots) are extremely rare. The FDA ensures these risks do not outweigh the benefits of the vaccination. It has now been several weeks since I received my second dose of vaccine. I only experienced mild pain in my arm for a few hours and some fatigue the following day. These side effects are known and expected, and are signs that the immune response is working. Be reassured if, like me, you do not experience any side effects, the vaccine is still working.

Another common concern is the use of mRNA technology. While this technology is new to most of us, it has been around for a while and is well studied by scientists. Messenger RiboNucleic Acid (mRNA), used in the Pfizer and Moderna vaccines for COVID-19, is produced synthetically and contains precise instructions to produce the surface “spike" proteins of the SARS-CoV-2 virus, which are recognized by our immune system and trigger the production of specific antibodies. The mRNA vaccines do not contain SARS-CoV-2 virus and, therefore, cannot make you sick with COVID-19. It also does not have the ability to modify our DNA (DeoxyriboNucleic Acid). In addition, DNA is contained in the nucleus of our cells and the mRNA does not penetrate or enter the nucleus.

All available COVID-19 vaccines are highly effective at reducing risk of infection, severe illness, and death from COVID-19 (ranging from 95% to 72% overall effectiveness depending on the vaccine). However, just like any vaccine, none are 100% effective. The chance of becoming ill with COVID-19 after being fully vaccinated is very small. The more people who get vaccinated, the less people are susceptible to getting the virus. This is called herd immunity. When most of the population is fully vaccinated, it becomes very difficult for the virus to spread and reach those who are still vulnerable or those in whom the vaccine was less effective. If you develop COVID-19 symptoms shortly after the first or second dose, it does not mean the vaccine was ineffective or that the vaccine gave you COVID-19, but rather that you received your vaccine during the incubation period (the time between when you become infected and when you develop symptoms). In other words, you were previously infected, but asymptomatic (without symptoms) at the time you received your vaccine. It is important to understand that it takes several weeks for your body to develop full immunity. Therefore, an individual is considered fully vaccinated only 2 weeks after the second dose of a two-dose vaccine or 2 weeks after a single dose vaccine.

One issue we should all be concerned about is the emergence of new virus variants. These variants are the result of mutations that can happen any time the virus replicates itself. This is normal and expected for viruses such as the SARS-CoV-2. The faster we achieve immunity, the less time there is for the SARS-CoV-2 virus to evolve into new variants, which current available vaccines could be less effective against. There are already several variants identified throughout the world, some of which are more contagious and/or more deadly. The tendency of some viruses to mutate is also why we might need booster or yearly vaccination against COVID-19 in the future, as we do for the flu. Either way, the sooner everyone receives the vaccine, the less chances for new variants.

There is no doubt COVID-19 vaccines are safe and effective. But our motivations to get the COVID-19 vaccine can be diverse. For parents, it might be about creating conditions to allow their children a safe return to the classroom. Families want to start visiting and hugging loved ones. The adventurer wants to resume their travels. Reopening businesses and rebuilding the economy is important to business owners. For most of us, the decision to vaccinate will be based on our desire to return to normal. We want to return to the office, feel safe at the gym, dine at restaurants, and attend social events. Our communities want to provide healthcare workers some rest. So many people have lost loved ones to COVID-19 and breaking the physical isolation, which added to their grief, is vital for their healing. You might also feel getting vaccinated is simply the right thing to do to protect your family, friends, neighbors, and community members.