UK’s reluctance to recognize SII jab is likely over branding
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MUMBAI : The row over the UK government’s reluctance to recognize Covishield boils down to the brand name, considering that the components and efficacy of the vaccine may be the same as the versions of the drug developed by AstraZeneca and Oxford University that have other brand names, said legal experts.
The UK relaxed quarantine rules for fully-vaccinated individuals earlier this week, but excluded those who have been given doses of vaccines manufactured in certain geographies, including Covishield, which is produced by the Serum Institute of India (SII).
The announcement triggered a massive row as tourists from India and other low- and middle-income countries travelling to the UK would have to follow the 10-day quarantine rules meant for the unvaccinated, despite receiving both doses of the vaccine.
“The Oxford vaccine is produced in different manufacturing sites by AstraZeneca and Serum Institute of India (SII). The technology and data on the basis of which the Oxford vaccine was registered and quality assured by World Health Organization remain the same. However, different brand names were given for high-income and low-income markets to prevent the SII product from being supplied to high-income countries. As a result, SII is not registered with the UK and European Medicines Agency," said Leena Menghaney, a legal expert on trade and public health.
In a U-turn, the UK on Wednesday, said it will recognize Covishield brands from the regulators of Australia, Antigua, Bahrain, Brunei, Canada, Dominica, Barbados, Israel, Japan, Kuwait, Malaysia, New Zealand, Qatar, Saudi Arabia, Singapore, South Korea, and Taiwan. India, however, still does not figure in the list of approved regulators.
SII did not respond to an email query from Mint asking for a clarification on the agreement it had signed with AstraZeneca regarding the use of its brand name in regulated markets.
In July, Nadhim Zahawai, minister for education, had told the UK parliament that though SII manufactures both Covishield and Vaxzevria brands of the AstraZeneca vaccine, while Vaxzevria was approved by the Medicines and Healthcare Products Regulatory Agency, it had not approved the use of Covishield in UK.
SII and its Netherlands subsidiary Bilthoven Biologics continue to manufacture the Vaxzevria vaccine brand. Though India has temporarily stopped exporting Covishield since March, more than 20 countries had received the vaccines from SII. Furthermore, over 90 countries from the low- and middle-income countries are expected to receive Covishield under the Covax facility in the coming months.
According to publicly available documents, the distribution and commercialization rights for ChAdOx1 nCoV-19, the original name of the vaccine candidate, now known as AZD1222, developed by Oxford University belongs to AstraZeneca, which also has the right to certify companies for selling the vaccine.
SII received a sublicence to distribute the vaccine under the Covishield brand for low- and middle-income countries. It is obligated to supply more than a billion vaccine doses under the agreement. The right to distribute the vaccine in advanced markets rests with AstraZeneca.
Menghaney said the Indian government and other countries, which have received the Covishield vaccine, must raise this discriminatory issue with the World Trade Organization.
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