by Kathryn Cleary
Not sure what the difference is between side-effects of a COVID-19 vaccine and adverse events that could be related to the vaccine or the vaccination process? It may not be rocket science, but understanding and reporting on vaccines, their potential side-effects and safety protocols is not easy.
To provide some insights into adverse events that follow immunization with COVID-19 vaccines, the Internews Health Journalism Network hosted Dr. Gagandeep Kang, Prof, Department of Gastrointestinal Sciences, Christian Medical College from Vellore, India for a webinar on the 27th of April. In case you missed this webinar, we’ve done a round-up of the key points and questions from the session. You can also listen to the webinar here.
Side effects versus adverse effects
A side-effect, according to Kang, is a well-documented reaction, such as pain, fever or swelling near the injection site, following vaccination. Most side-effects occur within six weeks to two months of vaccination, she says. While some people may be skeptical of COVID-19 vaccines since they have not been around for a long period of time, Kang says that the available safety data for these vaccines can address these concerns.
Whenever we have seen side-effects there is a window. We certainly for [COVID-19] vaccines, have more than two months of data. The only place that I know of where there is an existing vaccine where it happens much later, is with the Dengue Fever vaccines, and it’s not a vaccine related side-effect, it’s just a performance characteristic of the vaccine.
With side-effects, Kang says that if certain things are expected you can be prepared in advance to handle them. For example, many immunizations for children have side-effects that can be mitigated with baby aspirin. While reactions that children may have to vaccines are well-known, Kang says that side-effects in adults are less straightforward.
How do we know if this is related to the vaccine, or something else?
Adverse effects following vaccination could be related to the vaccine itself or to the vaccination process, says Kang. How do we decipher this? “This requires that you have an ability to assess cause and effect, and there are specific steps that the WHO have outlined which allow us to do a causality assessment,” says Kang.
For a causality assessment, Kang says that a vaccinated population can be compared to an unvaccinated population to establish a baseline for how frequently this kind of condition is seen, and if the number of cases for the condition is actually more in the vaccinated population versus the unvaccinated population. “In every country, safety monitoring of vaccines requires that there is a structure that is able to monitor adverse events that follow immunisation, as well as do causality assessments,” she adds.
“When we look at causality assessment, we look at, was this event caused by the vaccine or was it coincidental. Was it just that this was going to happen in any case and it happened to a person who was vaccinated. What is important to be able to see if something is coincidental or not, is you need a baseline of how frequent those events are,” she says.
The advantage of knowing how common or uncommon a side-effect is, is to be able to do what Kang calls, benefit risk assessments. “For vaccines which are given to healthy people, it’s very important to do a benefit risk assessment, and understand that when you give something to healthy people, benefits have to significantly outweigh the risks.” This is the situation we are in now with COVID-19 vaccines, she says.
“We are continuing to accumulate data on safety but the benefit risk assessment has been conducted and the benefits far outweigh the risks, so we really need to make sure that this is a message that is conveyed to everyone we deal with. Vaccines have value and they need to be used, even as their use is moderated,” says Kang.
How do we advise the media on COVID-19 vaccinations for immunocompromised persons?
Unfortunately, people who are immunocompromised need more protection, says Kang.
“If they do develop COVID-19 disease it is more severe in the immunocompromised than in immunocompetent individuals. Unfortunately, even though we advise them to take vaccines, we do have to tell them that their immune response may not be as good as somebody who is immunocompetent, which means that even after being vaccinated they will continue to need to be careful and protect themselves from potential infection.”
What way can the media modify the way in which it presents stories about adverse events from vaccines?
Kang notes that one thing the media can emphasize is that each time an adverse event is reported, it means that the country’s safety monitoring is doing its job. “Every safety event, whether true or not, should be assessed and should figure out if it is related [to the vaccine] or not. It does not make the vaccine dangerous, it makes a system more successful in being able to monitor the performance of a vaccine,” she says.
Itching for more information? Check out the Let’s Talk Vaccines e-learning course here, set to launch on the 19th of May. This self-study course is packed with everything you need to know to better report on the biggest story of 2021…vaccines!