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WHO redflags counterfeit Covishield vaccines circulation in India, Uganda

WHO said fake COVID-19 vaccines should be identified and weeded out as they pose a serious risk to global public health and place an additional burden on vulnerable populations and health systems.

August 18, 2021 / 15:00 IST
Counterfeit drugs and vaccines are a major problem in South Asia and Africa. WHO has expressed concern about fake vaccines in circulation. (Representative image)

The World Health Organisation (WHO) has issued a Medical Product Alert about counterfeit Covishield vaccines circulating in India and Uganda.

The falsified products were reported to WHO in July and August 2021.

"The genuine manufacturer of Covishield (Serum Institute of India Pvt. Ltd.) has confirmed that the products listed in this alert are falsified. These falsified products have been reported at the patient level in Uganda and India," WHO said.

WHO said the products were confirmed as falsified on the basis that they deliberately/ fraudulently misrepresent their identity, composition or source.

The counterfeit Covishield vial detected in Uganda was a 5 ml dosage form containing 10 doses. It had a batch number 4121Z040 and the falsified expiry date of August 10.

COVID-19 Vaccine

Frequently Asked Questions

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How does a vaccine work?

A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.

How many types of vaccines are there?

There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.

What does it take to develop a vaccine of this kind?

Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.

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The fake one detected in India was 2 ml - 4 doses vial. SII doesn't produce such vials.

WHO's Global Surveillance and Monitoring System for Substandard and Falsified Medical Products has unearthed these counterfeit vaccines.

This isn't the first time that counterfeit COVID-19 vaccines have been detected. WHO has earlier identified as counterfeit Pfizer-BioNTech COVID-19 circulating in Americas. These counterfeit products were supplied and administered to patients outside of authorised vaccination programmes.

Counterfeit drugs and vaccines are a major problem in South Asia and Africa. WHO has expressed concern about fake vaccines in circulation.

"Falsified COVID-19 vaccines pose a serious risk to global public health and place an additional burden on vulnerable populations and health systems. It is important to detect and remove these falsified products from circulation to prevent harm to patients," the agency said.

Strengthen surveillance

WHO requested increased vigilance within the supply chains of countries and regions likely to be affected by the falsified products.

"Increased vigilance should include hospitals, clinics, health centers, wholesalers, distributors, pharmacies, and any other suppliers of medical products," the global agency said.

"All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked. Seek advice from a healthcare professional in case of doubt," WHO added.

For the public, WHO said if any one used these products, or suffered an adverse reaction having used these products, the person should seek immediate medical advice from a qualified healthcare professional and to report the incident to the National Regulatory Authorities and National Pharmacovigilance Centre.

It also asked National regulatory and health authorities to immediately notify WHO if these falsified products are discovered in their country.

Viswanath Pilla
Viswanath Pilla is a business journalist with 14 years of reporting experience. Based in Mumbai, Pilla covers pharma, healthcare and infrastructure sectors for Moneycontrol.
first published: Aug 18, 2021 12:39 pm

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