Quick Take: False Claims About Covaxin’s Safety Debunked

GG News Bureau
New Delhi, 18th May. 
The Claim: A social media user on platform X has claimed that the Covaxin COVID-19 vaccine can cause death two years post-vaccination and has resulted in the deaths of crores of people across India.

Fact Check: Is it true that Covaxin can cause death even after two years of vaccination?

No, Covaxin cannot cause death two years after vaccination. There is no conclusive evidence linking Covaxin, developed by Bharat Biotech, to an increased risk of death or heart attacks occurring two years post-vaccination. Vaccines, including Covaxin, undergo rigorous testing for safety and efficacy before receiving approval and continue to be monitored after approval.

While some adverse events following vaccination can occur, they 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 World Health Organization (WHO) after a thorough risk-benefit analysis, highlighting its role in saving lives and controlling the spread of COVID-19.

It is important to consider that heart attacks and other cardiovascular events can occur due to various factors, including underlying health conditions, lifestyle, and genetic predispositions. These events happening two years post-vaccination are unlikely to be directly related to the vaccine itself.

Clinical Trials of Covaxin: Covaxin underwent extensive clinical trials:

  • Phase I and II trials in June 2020 involving approximately 1,000 participants demonstrated promising safety and immunogenicity results.
  • Phase III clinical trials began in mid-November 2020, involving 26,000 volunteers, marking the largest Phase III efficacy trial for any vaccine in India.

Regulatory Approvals: Covaxin has received several significant regulatory approvals:

  • India: Conditional market authorization by the Drugs Controller General of India (DCGI) in January 2022.
  • World Health Organization (WHO): Emergency use approval in November 2021. Supply through UN procurement agencies was temporarily suspended in April 2022 due to manufacturing practice concerns, not safety or efficacy issues.
  • United States: Bharat Biotech partnered with Ocugen for US market development. Phase II/III clinical trials were approved in February 2022, though emergency use authorization for pediatric patients was declined in March 2022.
  • Other Countries: Emergency use authorization in 20 countries and licensed for use in 23 countries, predominantly within India.

WHO Suspension of Covaxin Supply: The WHO suspended Covaxin’s supply for UN programs due to Bharat Biotech’s main manufacturing facility not fully adhering to good manufacturing practices. This was due to the urgent production demands during the pandemic, which affected the availability of certain equipment needed for strict quality control. However, the quality of Covaxin itself was not compromised, and the WHO confirmed its safety and efficacy.

How Covaxin Works: Covaxin is an inactivated vaccine, using a killed virus to stimulate the immune system to produce antibodies without causing COVID-19. It includes adjuvants to enhance the immune response and provide longer-lasting immunity.

Effectiveness and Side Effects: Covaxin has shown 77.8% effectiveness against symptomatic COVID-19. Mild side effects are common, such as pain at the injection site and flu-like symptoms, which typically resolve within 48 hours. Severe side effects are rare but can include allergic reactions.

Conclusion: The benefits of COVID-19 vaccines, including Covaxin, far outweigh the associated risks. It is crucial to rely on credible sources and consult healthcare professionals for any concerns regarding vaccination, rather than trusting unverified social media claims.

CDC and COVID-19 Vaccine Misinformation: The CDC actively monitors vaccine safety and combats misinformation through credible, evidence-based information and collaboration with health organizations.

Debunking Misinformation: False claims about COVID-19 vaccines and handling by governments have been debunked, emphasizing the importance of relying on verified information to make healthcare decisions.

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