Lancet study, mRNA vaccine, India

‘Lancet study on mRNA vaccines that increase heart risk is not alarming’

A study by the US health regulator FDA showing an increased risk of heart disease after COVID-19 mRNA vaccination, has sparked a buzz about vaccination protocols. And while India uses replicating vector vaccines such as Covishield and the inactivated pathogen-based Covaxinconcerns arise as it is also in the process of rolling out its own mRNA vaccine.
The study, published in the peer-reviewed medical journal The Lancet, shows an increased risk of myocarditis or pericarditis, especially in young men between the ages of 18 and 25, following mRNA vaccination. Myocarditis is inflammation of the heart muscle and pericarditis is inflammation of the outer layer of the heart. However, the study clarifies that the incidence is “rare.”

Prof Gagandeep Kang, Gastrointestinal Sciences, Christian Medical College, Vellore, and one of India’s most trusted virologists, said: “This risk was first identified a year ago in Israel. The condition is rare, usually mild, and affected people are recovering. The most important thing with any vaccine is that when there is a known side effect, people should be educated so they can recognize and report the condition when it occurs and receive appropriate advice and management.

Worldwide, mRNA vaccines have sparked vaccination programs in the United States and Europe, as they have taken advantage of recent advances in molecular biotechnology to accelerate their rollout. dr. Chandrakant Lahariya, physician-epidemiologist and vaccine expert, explained the study: “The Lancet study confirms what we have known for a while. The increased risk of myocarditis and pericarditis following mRNA vaccines in older children and young adults has been documented and reported since its introduction of these vaccines. What we know is that this risk is inversely related to the age of the vaccine recipient. The study was conducted on an adult population and found that this increased risk is nearly equal for both currently approved mRNA vaccines. part of The Lancet study, but it has been documented that adolescents are at higher risk than even young adults aged 18-25.”

When asked about other vaccines, Dr. Lahariya: “The other vaccines, especially the viral vector vaccines such as the Oxford-AstraZeneca (Covishield in India) were found to be associated with an increased risk of blood clotting in younger age groups. This is why many countries, which have given emergency authorization to the Oxford-AstraZeneca vaccine, are not using it for their populations under 30 years of age. It is not approved for children under the age of 18.”

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Panic exclusively, he explained: “We must remember that regulatory authorities approve the vaccines based on their safety profile. They are made as safe as possible. However, there are rare side effects possible as we learn about different Covid-19 vaccines. its use is also determined by the benefit versus risk trade-off. If the benefits of administering the vaccine in preventing disease are considered high and the risk lower, they are recommended. All regulatory authorities follow this approach and we know it is benefit of the currently approved Covid-19 vaccines is much greater and the risk is acceptable.However, such safety data is very useful for governments to design and select appropriate vaccines for different age groups and also to determine whether a particular age group is should not be vaccinated.Secondly, such safety data enables vaccine manufacturers and researchers to identify mechanisms and reduce the risk of side effects.”

According to him, the risk of pericarditis and myocarditis has also been found “in Novavax, which is approved in India as Covovax. So the risk is not just for mRNA vaccine-related side effects.”

“The occurrence of pericarditis and myocarditis in young men receiving mRNA vaccines was first reported from Israel and later confirmed in the US and Europe. American athletes, who were screened for heart muscle function after Covid-19 vaccination, showed these effects but recovered with no lasting effects. There is concern about repeating mRNA vaccines as boosters in this age group of men, although the overall risk is estimated to be low. It is safer to use non-mRNA vaccines, especially subunit protein vaccines, as boosters for this population. India has not used mRNA vaccines and has not witnessed this adverse effect,” said Dr. Srinath Reddy, president of the Public Health Foundation of India and former chief of cardiology at AIIMS.

dr. Sanjeev Jadhav, Chief Cardiothoracic Surgeon and Director of Heart and Lung Transplantation, Apollo Hospital, Mumbai, would much rather deal with the Indian context. “From an Indian perspective, most have been given Covishield and Covaxin and we’ve seen other types of complications in a subgroup, mainly thromboembolic vessels that produce clots in the heart or peripheral vessels and migrate to the lungs. Pulmonary thromboembolism is more common in our subgroup – but there is still a long way to go to understand what is happening and what is the molecular biology knowledge that needs to be acquired about the clinical situation regarding the mRNA vaccine,” he said.

However, the US FDA study, along with the benefit-risk profile, continues to support inoculation with either of the two mRNA vaccines. India’s proprietary mRNA vaccine, supported by the Department of Biotechnology (DBT), is under close scrutiny by drug regulatory authorities. This mRNA vaccine, the makers claim, can also reportedly be modified to be effective against newer variants.

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