May 18, 2024: Covaxin, an inactivated virus vaccine developed by Bharat Biotech in India, has played a significant role in this fight. However, with the constant stream of information, some myths and misconceptions have swirled around Covaxin (development name, BBV152), particularly regarding its long-term safety. This article aims to be a comprehensive fact check, addressing these concerns and providing clear, evidence-based information about Covaxin.
Debunking the Myth: Covaxin and the Two-Year Death Claim
One of the most concerning rumors surrounding Covaxin is the claim that it can cause death two years after vaccination. This is absolutely not supported by scientific evidence. Vaccines undergo rigorous testing for safety and efficacy before approval, and Covaxin is no exception. Extensive clinical trials evaluated its safety profile, and no link has been established between Covaxin and an increased risk of heart attacks or death two years post-vaccination.
It’s important to understand that heart attacks and other cardiovascular events can occur due to various factors, including underlying health conditions, lifestyle choices, and genetic predispositions. Attributing such events two years after vaccination to the vaccine itself is highly unlikely.
Covaxin’s Journey: From Development to Regulatory Approval, Covaxin’s development followed a well-defined process
Clinical Trials:
In June 2020, India’s Ministry of Health and Family Welfare gave the green light for Phase I and II human trials for Covaxin, following promising preclinical studies.
Bharat Biotech conducted these trials involving around 1,000 participants, demonstrating promising safety and immune response. The results were published in peer-reviewed scientific journals.
Mid-November 2020 marked the commencement of Phase III clinical trials, targeting 26,000 volunteers across India. This was the largest Phase III efficacy trial ever conducted for a vaccine in India.
Regulatory Approvals:
Covaxin received emergency use authorization (EUA) from India’s Drugs Controller General of India (DCGI) in January 2022.
The World Health Organization (WHO) granted Covaxin EUA in November 2021. However, in April 2022, the WHO temporarily suspended its supply due to deficiencies in implementing good manufacturing practices (GMP) at Bharat Biotech’s facility. This was attributed to the facility’s full focus on Covaxin production during the peak of the pandemic, leading to a lack of specific equipment needed for stricter quality control. It’s important to note that the WHO emphasized this suspension did not raise concerns about Covaxin’s safety or efficacy.
Covaxin has received EUA for adults in Mexico and emergency or full approval for use in over 20 other countries.
Understanding Covaxin: How it Works and its Effectiveness
Covaxin is an inactivated vaccine, which means it uses a weakened form of the SARS-CoV-2 virus that cannot cause COVID-19. When you receive the Covaxin shot, your immune system recognizes the inactivated virus and produces antibodies specifically designed to fight it. These antibodies provide protection if you’re exposed to the actual virus in the future. The vaccine also contains adjuvants, which enhance the immune response and contribute to longer-lasting immunity.
Covaxin offers several advantages:
Efficacy: Studies show Covaxin to be 77.8% effective against symptomatic COVID-19, according to the final analysis of its Phase III trials.
Booster Dose: A booster dose administered six months after the second dose strengthens immunity further, with over 75% of participants demonstrating detectable neutralizing antibodies. This booster dose also showed promising results against the Omicron and Delta variants.
Storage: Covaxin is relatively easy to store, requiring only refrigeration between 2℃ to 8°C.
Side Effects of Covaxin: What to Expect
Like most vaccines, Covaxin can cause mild side effects, including:
Pain, swelling, redness, or itching at the injection site
Body ache
Weakness
Stiffness
Nausea
Vomiting
Fever
Malaise
Headache
These side effects are usually temporary and resolve on their own within a day or two. However, it’s crucial to seek immediate medical attention if you experience severe side effects like:
Difficulty breathing
Swelling of the face or throat
Rapid heartbeat
Severe dizziness
In extremely rare cases, blood clotting disorders have been associated with Covaxin.
It’s important to remember that the benefits of vaccination far outweigh the potential risks of side effects.
Addressing Concerns and Misinformation
With the abundance of information available online, it’s easy to fall prey to misinformation surrounding vaccines. Here’s how to navigate this landscape effectively:
Seek Credible Sources: Rely on information from reputable sources like the World Health Organization (WHO), Centers for Disease Control and Prevention (CDC), and official government health websites. These organizations provide evidence-based information on vaccine safety and efficacy.
Consult a Healthcare Professional: If you have specific concerns regarding your health post-vaccination, schedule an appointment with your doctor. They can provide personalized medical advice and conduct any necessary evaluations to address your concerns and differentiate between vaccine-related side effects and other potential causes of health issues.
Be Wary of Social Media: Social media can be a breeding ground for misinformation. Avoid making healthcare decisions based on unverified social media posts or anecdotal stories.
Active Monitoring and Addressing Vaccine Safety
Regulatory bodies like the CDC and WHO actively monitor COVID-19 vaccine safety. They continuously analyze data to identify any potential risks associated with vaccines. Additionally, they work collaboratively to combat misinformation and provide transparent, evidence-based information on vaccine safety and adverse effects. For example, the CDC actively investigates cases of myocarditis and pericarditis, particularly following mRNA vaccinations (Covaxin is an inactivated virus vaccine), with heightened surveillance in adolescents and young adults.
The Final Word: Vaccination is Our Best Defense
Vaccines are a powerful tool in our fight against COVID-19. They significantly reduce the risk of severe illness, hospitalization, and death. While Covaxin, like any medication, can cause mild side effects, the benefits of vaccination far outweigh the risks. By getting vaccinated and following public health guidelines, we can protect ourselves, our loved ones, and our communities from the devastating effects of COVID-19.
In conclusion, Covaxin is a safe and effective vaccine that has undergone rigorous testing and regulatory approval. Don’t be misled by misinformation. Vaccination remains our best defense against COVID-19.
(This is an extract from the original story published by THIP Media )
