Mexico grants Bharat Biotech’s Covaxin EUA; PH pending

Published April 15, 2021, 6:00 AM

by Edgard Hilario

Mexico’s health regulator Cofepris recently authorized the emergency use of India’s COVID-19 vaccine COVAXIN. Mexico has registered over 2.2 million Covid-19 cases and 209,000 deaths, ranking 14th in the worldwide report.

Mexico is  a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), a non-binding, informal cooperative arrangement between various regulatory authorities in the field of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use; it aims at harmonising inspection procedures worldwide by developing common standards in the field of GMP. Accordingly, Mexico is the first Latin American country to roll out its vaccine program, and the second PIC/S country to grant approval for Covaxin.

IP Biotech, Inc. (IPB) is the exclusive importer and distributor of Covaxin to the Philippines. It has appointed Ambitech Biopharmaceuticals Inc. (Ambitech) as its consolidator.

The vaccine is developed using Whole-Virion Inactivated Vero Cell derived platform technology. Many vaccines for diseases such as Seasonal Influenza, Polio, Pertussis, Rabies, and Japanese Encephalitis use the same technology to develop inactivated vaccines and is claimed to be the well-established, and time-tested platform in the world of vaccine technology.

“Mexico’s EUA approval of Covaxin is a stamp of approval by a PIC/S member country, further building global confidence behind Covaxin,” said Deppu Bhatia, Vice President of Ambitech.

According to its phase 3 clinical trial interim results, Covaxin demonstrated 81% efficacy rate. The study included 28,500 participants in India aged 18-98. Trials are currently underway to determine if children as young as two years old can take the vaccine.

Bharat Biotech recently announced that they will scale up production of Covaxin to 12 million doses a month starting July 2021, from the current 5 million. The Philippines has currently secured at least 8 million doses from Covaxin through IPB and Ambica, which is subject to increase pending further negotiations.

“The entry of Covaxin into the Philippines can be a real game changer for the country’s efforts to combat COVID-19. The inactivated whole virion approach is effective against multiple strains, and the validation of use of Covaxin for a younger age group can expand the government’s vaccination scope.” said IP-Biotech Chairman Enrique Gonzalez. “Normalcy is protecting both young and old, and providing security for the entire family.”

To date, eight countries have granted EUAs to Covaxin. These are India, Mexico, Myanmar, Nepal, Iran, Mauritius, Guyana, and Zimbabwe.