As India plans to launch one of the world's largest COVID-19 vaccination drives on January 16, scientists have questioned the safety of both Covishield and Covaxin in light of several media reports on side effects of both the vaccines.
In Bhopal, people in the Covaxin trial claim to have suffered severe side effects after participating in the trials along with one person who died on December 21, 2020 days after participating in the Phase 3 trials of the vaccine. Bharat Biotech, producer of Covaxin, however, issued a press release stating that the preliminary investigations showed that the participant's death was not linked to the vaccine or the trial.
This is not the first instance of side effects of COVID-19 vaccines in India. Earlier, both Bharat Biotech and Serum Institute of India have been embroiled in controversies due to participants of their trials suffering mild, moderate as well as severe adverse events after being administered either the vaccine or the placebo.
A participant in the Serum Institute of India trial sued the vaccine manufacturer alleging he suffered neurological and psychological issues after participating in the Covishield trial in Chennai.
Along with these instances, several other side effects of all the various vaccines have been reported across the world. From the halting of the Oxford-AstraZeneca trials due to a participant suffering from a neurological issue, to participants in the Pfizer-BioNTech trials developing facial paralysis, adverse effects have also created a wave of vaccine hesitancy in the minds of several residents.
BOOM spoke to Vineeta Bal, biologist at the Indian Institute of Science Education and Research in Pune to understand the side effects that could arise due to the vaccine.
"If one sees what the vaccine does immediately after injection; are the so-called side effects of the vaccines which are immediate, immediate in the sense in within 48 hours. Normally, recipients tend to have local pain swelling at the site of injection, there is normally fever and headache and sort of, you know, loss of energy, what one be described as malaise, these are very, very common, and in a way, these are indications that the human immune system has kicked in into the into the recipient and the vaccine response has started. These are simply not outward signs of what is happening or what is wrong, but it is also an indication that the immune system has started working," Bal noted
The World Health Organization has delineated three separate levels of side effects caused by vaccines- minor, severe adverse effects, and serious adverse effects.
Minor effects
Minor reactions occur within a few hours of injection. They also resolve after a short period of time and pose little danger to the recipients. Some of the common effects include pain, swelling or redness at the site of injection, fever, malaise, muscle pain, headache or loss of appetite. All the COVID-19 vaccines have showed these side effects.
Severe Adverse
These effects usually do not result in long-term problems, can be disabling but according to the WHO are rarely life threatening. Some of the side effects include seizures, uncontrolled electrical activity in the brain, resulting in convulsion, physical signs, thought disturbances, or a combination of symptoms. and allergic reactions caused by the body's reaction to a particular component in a vaccine.
Several participants having pre-existing allergic reactions to different foodstuff also had an allergic reaction to the Pfizer vaccine in UK. The Medicine and Healthcare Products Regulatory Agency (MHRA), UK then issued an advisory recommending that the vaccine should not be administered to people who have medical history of allergic reactions.
Any person with a history of anaphylaxis to a vaccine, medicine or food should not receive the Pfizer BioNTech vaccine," MHRA Chief Executive June Raine said in a statement. "Most people will not get anaphylaxis and the benefits in protecting people against COVID-19 outweigh the risks. You can be completely confident that this vaccine has met the MHRA's robust standards of safety, quality and effectiveness. "
Serious Adverse
These reactions are any untoward medical occurrence that at any dose results in death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is life-threatening.
The role of the COVID-19 vaccines was ruled out in all the deaths that have occurred across the world among vaccine trial participants as well as those who received the vaccine .