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After nearly a year of interruptions in every aspect of our lives — work, school, social events and the like — parents finally have some good news: a COVID-19 vaccine.
The first vaccine approved by the Federal Drug Administration (FDA) is by drug giant Pfizer, who is working with the German company BioNTech and Chinese drugmaker Fosun Pharma. It shows a 95% effective rate for preventing a COVID-19 infection.
“Researchers are confident the COVID-19 vaccines will behave or act similarly to all other available vaccines we have today and protect us from a COVID-19 infection,” said Dr. Sarah Adams, a pediatrician at Akron Children’s Hospital Pediatrics, Hudson. “Though none of them are 100% effective, these vaccines have been shown to protect against severe disease and offer a reduced risk of long-term complications.”
To date, millions of COVID-19 vaccinations have been distributed and administered across the country to initial critical populations, with estimates of 1.3 billion doses to be distributed this year.
As cases surge across the country and here at home, this is good news for parents who are wondering what this could mean for their families and when their lives can finally get back to “normal.”
We sat down with Dr. Adams to get answers to your top questions regarding development, safety, efficacy and everything else parents need to know about these highly anticipated lifelines.
What are the key aspects we need to know?
First and foremost, these vaccines do not contain the live virus and do not carry disease, just like many of the other available vaccines today. For this reason, patients who receive the vaccine cannot get COVID-19.
In addition, it’s important to note the research and technology used to develop these vaccines are not new and have been around for more than a decade.
“Fundamentally, the COVID-19 vaccine works similarly to other available vaccines we have today, stimulating a natural immune response,” said Dr. Adams. “In the large clinical trials and continual observation, the vaccines have been deemed extremely safe and there is little reason to believe they will have unique safety concerns.”
Just like any other vaccine available today, the COVID-19 vaccine has been rigorously tested for safety and effectiveness. No corners were cut in developing this vaccine.
Should we be concerned with the FDA’s “Operation Warp Speed” program?
Despite an unprecedented accelerated pace, these COVID-19 vaccines have been rigorously tested for safety and efficacy before being authorized for use in the United States.
Moderna’s adult clinical trials included at least 30,000 people and Pfizer’s more diverse group included just under 45,000 people. That’s an excellent number for clinical trials.
“The FDA requirements and vaccine trials were performed exactly the same way as any other vaccine that is available today,” said Dr. Adams. “The difference is these vaccines were given more money, more people and researchers, and more attention to push it to the forefront to get the job done. Absolutely no corners were cut.”
In other circumstances, vaccine development can take years because companies have to first raise funds and staff the project to meet the FDA requirements. Because of the worldwide crisis, these major components were put in place, with help from the federal government and researchers around the globe, at the start of this project.
Have these vaccines been tested on children?
Children have largely been excluded from testing up until recently. Companies must first complete adult trials and then will move on to children. This is a common approach in vaccine trials.
Pfizer has already begun trials with children aged 12 to 17. Moderna has plans to begin testing this age group soon. The companies stated they will incorporate a step-down approach to test the vaccine on younger populations.
Dr. Adams offered an example. Once trials for the 12-17 age group ends, Pfizer will step down to kids ages 8 to 12, for instance, and so on, based on safety and efficacy.
How many doses will be needed?
Both of these vaccines require 2 shots to be effective. A second shot about 4 weeks after the first is necessary to receive the most protection against the virus.
Are there any known side effects?
After the second dose, researchers are seeing mild symptoms.
“Typically, patients are experiencing headaches, body aches and fever, but 70% to 80% of the cases are mild,” said Dr. Adams. “These symptoms are not caused by a COVID-19 infection, but instead are a result of the body’s immune response to the vaccine.”
Should kids get vaccinated?
Once it’s approved for children, it’s highly recommended that kids receive the vaccine.
According to the American Academy of Pediatrics, at the time of publishing more than 1.6 million children had tested positive for COVID-19 since the onset of the pandemic. That number continues to rapidly increase.
“I used to be able to say that children rarely get it,” said Dr. Adams. “They definitely get it and that number is increasing. I’m seeing the bump in my own practice here. More kids are coming in with COVID-19. Yes, severe cases are rare in children, but more research is needed, especially for any long-term effects.”
Until we get the vaccine, continuing to follow safety precautions (wearing masks, social distancing and washing our hands) is critical because it’s the best defense we have against COVID-19.
When will a vaccine be available for children?
No timeline for children has been established. However, company representatives have asked pediatricians to prepare to vaccinate patients. The hope is vaccines safe for children will be available before the fall of 2021.
If my child has tested positive for COVID-19 and recovered, does she still need the vaccine?
Yes. Even if you or your child have been infected with COVID-19, medical experts still recommend receiving the vaccine. Not enough information is known as to how long natural immunity lasts for those that have recovered from the virus.
“We know that some people with a prior COVID-19 infection can later become reinfected,” said Dr. Adams. “We also know that the vaccines are safe in those that previously were sick with COVID-19. So, regardless if you’ve had COVID-19 or not, we recommend everyone approved by the CDC strongly considers being vaccinated.”
However, it’s important to note if you are currently sick with COVID-19, wait to receive the vaccine until you have fully recovered and met the criteria to discontinue isolation.
How will we know who should get the vaccine?
Once a vaccine is available and we know more about natural immunity to COVID-19, the CDC Advisory Committee on Immunization Practices will make recommendations on who should receive the vaccine.
“Our job as providers is to build confidence around the vaccine to bend the curve of infections,” said Dr. Adams. “I have a lot of confidence in the FDA and the science behind these vaccines, if they approve them. So much so that I plan to get the vaccine for myself and my family, once it’s available for them.”
In the meantime, we still need to continue to wear our masks, physical distance and wash our hands frequently.
“Until we have a vaccine and the country’s full participation, these safety measures are critical and the best defense we have against the virus,” said Dr. Adams. “We need to continue to do all the preventative measures that we as an institution recommend to protect ourselves and our community from COVID-19.”
For additional questions or concerns, contact your child’s pediatrician to discuss if a vaccine is right for your child. Telehealth visits are now available.
Lyndsey Frey is a freelance writer based in Cleveland, Ohio. She specializes in blogging and content publishing, search engine optimization and social media marketing. Her work has been published online and in regional and national publications, such as Inside Business, Cleveland, Akron Life and Internet Retailer magazines.
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