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Biggest vaccine maker ready to help PH

SERUM Institute of India Pvt. Ltd. (SII), the world’s largest vaccine manufacturer, and its local partner Faberco Life Sciences Inc. are in talks with the government to bring the COVID-19 vaccine of Novavax Inc. to the Philippines.

SII has a license agreement with US biotechnology company Novavax Inc. for the manufacture and commercialization in low- and middle-income countries of NVX‐CoV2373—a COVID-19 candidate vaccine engineered from the SARS-CoV-2 virus and created using Novavax’s patented technology. It is now on the third phase of clinical trial in the US and on its final stage in the UK.

Once approved, NVX‐CoV2373 is considered ideal for the Philippines because it can be distributed using the standard cold chain system for vaccines in tropical countries.

“For tropical countries like the Philippines, the storage requirement of the Novavax vaccine that doesn’t require extreme cold is an edge,” said Dr. Luningning Villa, Medical Director of Faberco Life Sciences Inc., a long-time partner of SII in the Philippines.

SII, which is known for developing, producing and supplying vaccines that are relatively inexpensive worldwide, plans to manufacture more than one billion doses of NVX‐CoV2373.

The government earlier disclosed a plan to procure 60 million COVID-19 vaccines to develop immunity among Filipinos, with the most vulnerable and poorest communities receiving priority.

Malacañang Palace said the government is open to purchasing COVID-19 vaccines from all countries, including India subject to the review of an expert panel. The Palace said there are no obstacles in sourcing them from India.

“We’re open to purchase vaccines sa lahat po ng magkakaroon ng vaccine pero meron tayong expert panel na magre-review kung epektibo at kung sensitive nga po ang mga bakunang ‘yan… ‘Yung vaccine galing sa India, wala pong hadlang para kumuha rin tayo sa India,” Presidential Spokesman Harry Roque said in a press briefing.

Villa said SII has become a supplier of choice for those looking for high-quality vaccines and India has a good track record and enjoys a high level of trust.

NVX‐CoV2373 is being thoroughly evaluated in different geographies, various age groups, including the elderly and other groups most affected by COVID-19, people living with HIV, and racial and ethnic minorities.

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The vaccine underwent the initial phases of the clinical trials in Australia, South Africa and India. Phase three trial is currently done in the UK with 15,000 subjects and also ongoing in the United States and Mexico with 30,000 subjects.

The clinical trials involve a sizeable population of around 50,000 subjects to ensure extremely robust clinical data prior to approval by relevant regulatory bodies including the World Health Organization (WHO).

Novavax’s NVX‐CoV2373 has a favorable product profile that will allow handling in an unfrozen, liquid formulation that can be stored at 2°C to 8°C allowing for distribution using the standard cold chain system for vaccines in the Philippines.

SII said it is capable of increasing production and assures supplies wherever commitments are crystalized. The company has been a dependable supplier to the Philippines of various vaccines used in the Expanded Program for Immunization.

The company is a part of the Cyrus Poonawalla Group of Companies that is headquartered in Pune, India. It has been developing, producing, and supplying reliable high-quality vaccines that are accessible to mid and low-income populations.

SII’s modern laboratories are equipped with highly sophisticated machinery and equipment designed to meet the highest standards set by WHO and various regulatory agencies.

Vaccines manufactured by SII are prequalified by WHO, benefitting national immunization programs of more than 170 countries across the globe. It is recognized and has worked closely with the WHO, UNICEF, PATH, Bill and Melinda Gates Foundation, and GAVI among others.

Faberco Life Sciences is also SII’s partner for its other key programs in the country such as the Inactivated Polio vaccine, Rotavirus vaccine, Pneumococcal Conjugate vaccine and the COVID-19 vaccine.

Indian companies have played a pivotal role in reducing the cost of medicines in the Philippines and legislators took inspiration from it when it passed the Cheaper Medicine Law.