Fact Check: Can Covaxin Lead To Death After 2 Years Of Vaccination? – NDTV

Quick Take

As per a social media user, Covaxin COVID vaccine can cause death after two years of vaccination. The user also claims that the Covaxin has caused the deaths of crores of people. We did the fact check and it came out to be false.

The claim

An X user has shared a post which claims Covaxin COVID vaccine has caused the death of crores of people across India.

No, Covaxin COVID vaccine cannot cause death two years after vaccination. As of the latest available information, there is no conclusive evidence linking Covaxin, developed by Bharat Biotech, to an increased risk of heart attacks or death occurring two years post-vaccination. Vaccines, including Covaxin, undergo rigorous testing for safety and efficacy before approval and continued monitoring even after approval.

Some adverse events following vaccination can occur. But, these are generally observed within a short period after vaccination, and long-term severe side effects are extremely rare. Covaxin was approved for emergency use by the WHO, after a complete risk-benefit analysis. Moreover, vaccines are the most important tool in the fight against any disease. We must also remember we were combating a pandemic at that time. As we have stated it earlier, vaccines have saved lives and have helped in controlling the spread of disease.

It's important to consider that heart attacks and other cardiovascular events can occur due to a variety of factors, such as underlying health conditions, lifestyle, and genetic predispositions. These events happening two years post-vaccination are unlikely to be directly related to the vaccine itself.

Yes, Covaxin COVID vaccine underwent extensive clinical trials. In June 2020, the Ministry of Health and Family Welfare in India gave permission to start Phase I and II human trials for Covaxin after preclinical studies showed it was safe and produced a strong immune response in animals. Bharat Biotech conducted Phase I and Phase II trials involving approximately 1,000 participants. These trials demonstrated promising safety and immunogenicity results and were published in internationalpeer-reviewed scientific journals. Following these initial phases, the Phase III clinical trials for Covaxin began in mid-November, targeting the recruitment of 26,000 volunteers across multiple sites in India. This was the largest Phase III efficacy trial ever conducted for any vaccine in India, marking India's first and only Phase III efficacy study for a COVID-19 vaccine. The trials ensure the vaccine's safety and efficacy before approval and widespread distribution.

Covaxin has received several significant regulatory approvals to ensure safety:

The World Health Organization (WHO) stopped Covaxin supply for UN programs. This was because Bharat Biotech's main manufacturing facility in Hyderabad didn't fully follow good manufacturing practices (GMP). This happened because the facility had to focus entirely on making Covaxin due to the COVID-19 emergency. During this time, certain equipment needed for strict quality control wasn't available due to the pandemic. Bharat Biotech emphasised that Covaxin's quality was never compromised.

Furthermore, WHO has also mentioned that this does not raise concern over the safety and efficacy of the Covaxin. It remains safe and effective.

Covaxin is an inactivated vaccine developed from the SARS-CoV-2 virus, meaning it uses a virus that has been killed and cannot cause COVID-19. When you receive the Covaxin shot, your immune system recognizes the inactivated virus and produces antibodies against it. These antibodies help your body fight off the virus if you are exposed to it in the future. The vaccine also includes substances called adjuvants, which enhance the immune response and help provide longer-lasting immunity. Covaxin is easy to store, as it only needs refrigeration between 2 to 8C.

Covaxin has been shown to be 77.8% effective against symptomatic COVID-19 according to the final analysis of its Phase III trials. A booster dose six months after the second dose resulted in over 75% of participants having detectable neutralising antibodies, with even higher antibody levels than after the initial two doses. The booster also showed strong responses against the Omicron and Delta variants. Side effects are generally mild, including pain at the injection site and flu-like symptoms. Covaxin has also demonstrated strong safety and efficacy in children compared to adults.

Covaxin may cause mild side effects such as pain, swelling, redness, or itching at the injection site, as well as body ache, weakness, stiffness, nausea, vomiting, fever, malaise, and headache. These effects are typically temporary and resolve on their own.

However, severe side effects or consequences of Covaxin are rare but can include allergic reactions such as anaphylaxis. It's crucial to seek immediate medical attention if you experience symptoms like difficulty in breathing, swelling of the face or throat, rapid heartbeat, or severe dizziness after vaccination. Additionally, while extremely rare, there have been reports of blood clotting disorders associated with Covaxin.

After vaccination, most people experience a sore arm, with more widespread effects like fever and chills usually appearing within 8 to 12 hours. These side effects usually resolve within 48 hours. Since the vaccine cannot cause a COVID-19 infection, experiencing symptoms indicates a healthy immune response. While rare, allergic reactions can occur within the first 15 to 30 minutes after the jab. More common side effects include arm soreness, redness, and swelling at the injection site, with body-wide effects lasting 12 hours or more. Experts advise that these side effects generally cease within 24 to 48 hours after vaccination, although slight fatigue or arm soreness may persist. Comparing 48 hours of side effects to the risk of hospitalisation and death from COVID-19, experts emphasise the benefits of vaccination outweigh potential side effects.

The emergency approval of Covaxin before completing Phase III trials faced criticism from the Indian scientific community. Despite nearly 14 million COVID-19 cases, approval came as cases were dropping. The CDSCO's vague term restricted use in an emergency situation left many puzzled.

Groups like the All India People's Science Network called the approval hasty, while the All India Drug Action Network demanded transparency. Concerns grew after a Phase III trial participant died, with allegations of improper screening at the trial site.

However, 45 doctors, including former AIIMS directors, defended Covaxin, calling it India's gift to humanity and labelling the criticism as irresponsible.

If you have specific concerns about health conditions post-vaccination, it's advisable to consult with a healthcare professional. They can provide personalised medical advice and conduct any necessary evaluations. They can also help differentiate between vaccine-related issues and other potential causes of health problems. We would like to make it clear, one should not trust random and unreliable social media posts for making their healthcare decisions.

Yes, the CDC and other notable organisations have been actively monitoring COVID-19 vaccine-induced myocarditis. They provide transparent, evidence-based information on vaccine safety and participate in the WHO-led Vaccine Safety Net project. The CDC has launched investigations into myocarditis and pericarditis cases. Especially following mRNA vaccinations (Covaxin is an inactivated virus vaccine), with active surveillance in adolescents and young adults.

The CDC actively combats COVID-19 misinformation. To address false information on social media, the CDC uses a multimodal approach. It provides credible, evidence-based information on vaccine safety and adverse effects through its website and collaborates with health organizations. The CDC also uses social media to communicate with the public and dispel myths about COVID-19 vaccines.

We would like to conclude with, The benefits of COVID vaccines far outweigh the associated side effects.

We have debunked several claims regarding the COVID vaccines. Was COVID handling by the Government of India a huge scam?Has Japan's government banned the COVID-19 vaccine?Has the German government admitted there was no Pandemic?Has Japan declared an emergency over the explosion of mRNA cancers'?Are Covishield-vaccinated Indians susceptible to developing TTS?

(This story was originally published byTHIP Media, and republished by NDTV as part of the Shakti Collective.)

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Fact Check: Can Covaxin Lead To Death After 2 Years Of Vaccination? - NDTV