Before I received the first shot of the AstraZeneca Covid-19 vaccine at Lira Regional Referral Hospital, I signed a consent form. However, one of the vaccine recipients asked why they were signing a consent form – yet they never signed one when their children were receiving vaccines per the immunisation schedule. Both the question and the consent form were intriguing. So, in today’s article, we look at what you need to know about the consent form and why you sign one.
We define a consent form as a signed document that outlines the informed consent of an individual for a study, clinical trial, or any activity. When you enter a hospital or clinic, we imply that you’ve come to get medical treatment. But you may sign a consent form for treatments or surgical procedures to show that you’ve understood the specifics of the treatment modalities at play.
A consent form protects the caregiver against any eventualities that may occur after you’ve received the treatment. If you are a volunteer in a research study or clinical trial, it gives you the right to make informed choices, even halting to participate.
We sign the consent form to receive the AstraZeneca Covid-19 vaccine because the vaccine is currently under emergency authorisation use, so it is more or less still a new investigational drug. Per protocols, you only voluntarily take up an investigational drug and, you must show that you understand the specifics of the said drug with evidence. The only evidence there’s for such is a consent form you’ve signed.
You must understand that all drugs undergo clinical trials in phases and, by the time it reaches you, the researchers and pharmaceutical companies have detailed their safety profiles. In drug or vaccine development, clinical trial phase 4 involves enrolling people at the population level to gather further information about the efficacy, effectiveness, and safety profile of the vaccine at play – which they did not observe in controlled environments.
In the consent form, you concur that the vaccine administrators have discussed the risks and benefits of the Covid-19 vaccine. And that, you’ve understood. You also got an opportunity to ask questions with answers to your satisfaction and consent to receive the vaccine. I caution you that if you still have doubts about the vaccine, here is the opportunity to ask and get things straight. No one will coerce you into getting the vaccine.
You also understand that the vaccine requires two doses to confer immunity. And if you do not receive both of them, you won’t have full benefit from the vaccine. You also agree that, like with any other vaccine, there’s no certainty that you will become immune or that you won’t experience any adverse events from the vaccine. You voluntarily assume full responsibility for any events that may result due to vaccination. The longest follow up among people who have received the vaccines, say Pfizer-BioNTech or Moderna is eight months. No other study has established immunity among people who have received the Covid-19 vaccine beyond eight months for obvious reasons – all the vaccines are still new. None has lasted a year.
The consent form further states that you understand that you should remain in the vaccine administration area for 30 minutes after vaccination: vaccine administrators monitor you for any potential adverse reactions. You should report any adverse events that you may experience beyond 30 minutes to the health worker or vaccine administrator. You can also visit the nearest health centre or WhatsApp 0791415555 or call National Drug Authority on 0800101999. It asserts that you further understand that even after immunisation is complete, you will continue following all Covid-19 safety guidelines as the Ministry of Health requires.
Lastly, you agree that you’ve answered all the screening questions to the best of your knowledge. They include a history of an allergic reaction to any vaccine, a positive Covid-19 test in the last six months, pregnancy or breastfeeding, and any chronic illnesses hypertension inclusive. All these may lead to a reconsideration about whether you receive the shots or not.
In a nutshell, the AstraZeneca Covid-19 vaccine consent form should not scare you. It is there to give you autonomy about all the decisions you make and that whatever choice you make about the vaccine, it is an informed one and not coercion. You must understand that taking the Covid-19 vaccine is voluntary. Do not spread fake news among those that want the vaccine. Do not discriminate against those that have either got or not got the shots. It is everyone’s responsibility to safeguard one another. Be responsible and protect those at risk.