A study by the American health regulator FDA, which shows an increased risk of heart disease after Covid-19 Vaccination by mRNA, caused a buzz on vaccination protocols. And although India uses replicative vector vaccines such as Covishield and inactivated pathogen vaccine Covaxinconcerns arise because it is also in the deployment process of its own mRNA vaccine.
The study, which was published in the peer-reviewed medical journal The Lancet, shows an increased risk of myocarditis or pericarditis, particularly in young men between the ages of 18 and 25, after mRNA vaccination. Myocarditis is inflammation of the heart muscle and pericarditis is inflammation of the outer lining of the heart. However, the study states that the incidence is “rare”.
Professor Gagandeep Kang, Gastrointestinal Sciences, Christian Medical College, Vellore, and one of India’s most trusted virologists, said: “This risk was first identified in Israel a year ago. The condition is rare, usually mild, and those affected recover. The important thing with every vaccine is that when there is a known side effect, people need to be educated so they can recognize and report the condition when it occurs and receive appropriate advice and management.
Globally, mRNA vaccines have driven inoculation programs in the United States and Europe as they have taken advantage of recent advances in molecular biotechnology to deploy them more rapidly. Explaining the study, Dr Chandrakant Lahariya, medical epidemiologist and vaccine expert, said: “The Lancet study validates what we have known for some time. The increased risk of myocarditis and pericarditis after mRNA vaccines in older children and young adults has been documented and reported since these vaccines began to be rolled out. What we know is that this risk is inversely proportional to the age of the vaccinee. The study was conducted in an adult population and found that this increased risk is almost similar for the two currently licensed mRNA vaccines. Not part of The Lancet study, but teenagers have been documented to have a higher risk than even young adults aged 18-25.
Asked about other vaccines, Dr Lahariya said: “Other vaccines, especially viral vector vaccines, such as Oxford-AstraZeneca (Covishield in India) have been shown to be associated with an increased risk of blood clotting in groups of younger ages. This is the reason why many countries, which have given emergency authorization to the Oxford-AstraZeneca vaccine, do not use it for their population under the age of 30. It is not approved for children under 18.
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Excluding panic, he explained: “We have to remember that regulators approve vaccines based on their safety profile. They are made as safe as possible. However, rare adverse events are possible as we learn more about various Covid-19 vaccines. Their use is also determined by the benefit/risk ratio. If the benefits of administering the vaccine in preventing disease are considered high and the risks lower, these are recommended. All regulators are following this approach and we know that the benefits of currently licensed Covid-19 vaccines are far greater and the risk is acceptable. However, these safety data are very useful for governments to design and select appropriate vaccines for different age groups and also to determine whether to vaccinate a certain age group or not. Second, these safety data allow vaccine makers and researchers to identify mechanisms and reduce the risk of adverse events.
According to him, the risk of pericarditis and myocarditis has also been found “in Novavax, which is approved as Covovax in India. Thus, the risk is not exclusively related to adverse events related to the mRNA vaccine.
“The occurrence of pericarditis and myocarditis in young men receiving mRNA vaccines was first reported in Israel and subsequently confirmed in the United States and Europe. American athletes, who were screened for muscle function heart disease after Covid-19 vaccination, exhibited these effects but recovered without lasting effects.There is concern about repeat mRNA vaccines as boosters in this age group of men, although the overall risk is judged It is safer to use mRNA-free vaccines, especially subunit protein vaccines, as boosters for this population group India has not used mRNA vaccines and has not been witnessed this adverse effect,” said Dr Srinath Reddy, Chairman of the Public Health Foundation of India and former Head of Cardiology Department at AIIMS.
Dr Sanjeev Jadhav, Chief Cardiothoracic Surgeon and Director of Heart and Lung Transplantation at Apollo Hospital in Mumbai, would much rather concern himself with the Indian context. “From an Indian perspective, most received Covishield and Covaxin and we observed other types of complications in a subset, mainly thromboembolic vessels producing clots in the heart or peripheral vessels and migrating to the lungs. Pulmonary thromboembolism is more common in our subset – but there is still a long way to go to understand what is happening and what molecular biology knowledge is needed on the clinical situation regarding the mRNA vaccine,” did he declare.
However, the US FDA study, along with the benefit-risk profile, continues to support inoculation with either of the two mRNA vaccines. India’s own mRNA vaccine, supported by the Department of Biotechnology (DBT), is under intense study by drug regulatory authorities. This mRNA vaccine, according to its makers, can also be modified to be effective against new variants.
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