Carefully authenticate COVID-19 vaccine before use: Health Ministry

Guidelines issued to ensure fake COVID-19 vaccines are not administered in India

September 05, 2021 08:00 pm | Updated September 06, 2021 07:52 am IST - NEW DELHI

The WHO noted that falsified Covishield has been identified in the WHO’s African Region and South-East Asia Region.

The WHO noted that falsified Covishield has been identified in the WHO’s African Region and South-East Asia Region.

 

Following the World Health Organization’s (WHO) warning that it has identified counterfeit versions of the Covishield vaccine in Southeast Asia and Africa, the Union Health Ministry has written to all States and Union Territories to identify counterfeit/falsified Covishield vaccines in India. Monitoring teams for COVID-19 vaccination in States are being provided with details for due diligence.

The Ministry said in its letter: “The states have been told to carefully authenticate vaccines before use. The Centre has provided details for identification of original labels of three vaccines being administered in India (Covishield, Covaxin, Sputnik V).” The Ministry has issued guidelines to ensure fake COVID-19 vaccines are not administered in India.

The WHO noted that falsified Covishield (ChAdOx1 nCoV-19 Corona Virus Vaccines-Recombinant) has been identified in the WHO’s African Region and South-East Asia Region. “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 are falsified. These falsified products have been reported at the patient level in Uganda, India and Myanmar,” the global health body said.

The genuine Covishield vaccine is indicated for active immunisation of individuals who are 18 years or older for the prevention of the disease caused by the SARS-CoV-2 coronavirus, the WHO added.

It also advised: “The use of genuine COVID-19 vaccines should be in accordance with official guidance from national regulatory authorities. 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 Union Health Ministry in its recent letter has indicated various features to ascertain genuine products. The anti-counterfeit features in the Covaxin label include an invisible helix (DNA-like structure) on the label that’s only seen under UV light; micro text hidden in the label claim Dots, which is written as Covaxin; the green foil effect in the ‘x’ of Covaxin; and the holographic effect on Covaxin.

On the Sputnik vaccine, the Ministry said that it’s an imported product from two different bulk manufacturing sites from Russia with two different labels for both these sites. “While all the information and design is the same, only the manufacturer’s name is different. For all the imported products till now, the English label is only available on the front and back of the carton of 5 ampoule packs while all other sides including the primary label on the ampoule is in Russian,” the Ministry said in its letter.

It has also listed indicators to identify the Serum Institute of India’s product labels for Covishield. The Ministry said that the label’s colour shade is dark green (‘Shade: Pantone 355C’) as per approved artwork, and the brand name appears with trade mark mentioned, that is, ‘COVISHIELDTM’. The text font of the generic name appears un-bold, it said, while listing other features to be considered.

Meanwhile, Additional Secretary, Education Ministry, Santosh Kumar Sarangi said earlier this week that over 80% of teaching and non-teaching staff in government and private schools across the country have been vaccinated so far.

The Health Ministry on Sunday said that, so far, more than 66.89 crore (66,89,80,635) vaccine doses have been provided to States; 1.56 Cr doses (1,56,96,450) are in the pipeline; and more than 4.37 Cr (4,37,83,160) balance and unutilised COVID-19 vaccine doses are still available with the States to be administered.

( Inputs from Priscilla Jebaraj in New Delhi )

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