India’s Bharat Biotech applies for emergency use authorization in PH for its COVID-19 vaccine

Kristine Sabillo, ABS-CBN News

Posted at Jan 21 2021 11:54 AM | Updated as of Jan 21 2021 03:14 PM

India’s Bharat Biotech applies for emergency use authorization in PH for its COVID-19 vaccine 1

MANILA (UPDATE) — The Food and Drug Administration on Thursday confirmed that India-based Bharat Biotech has applied for emergency use authorization in the Philippines for its COVID-19 vaccine.

“They submitted an application this morning and pre-evaluation is going on,” FDA Director General Eric Domingo told ABS-CBN News.

Vaccine czar Secretary Carlito Galvez Jr. said during Thursday’s Laging Handa briefing that Bharat Biotech vaccine is one of those being considered for procurement by the Philippine government. But he said they have yet to see the results of its clinical trials.

The EUA application was also confirmed by IP Biotech and Ambica International, which have an exclusive agreement with Bharat Biotech to distribute the so-called COVAXIN vaccine in the Philippines.

According to the group, COVAXIN was developed by Bharat in collaboration with the Indian Council of Medical Research - National Institute of Virology. 

“The indigenous, inactivated, whole virus vaccine has a standard cold chain temperature of 2-8 degrees Celsius, making it ideal for tropical countries,” IP Biotech said in its statement, adding that traditional inactivated vaccines are seen as a “safe and proven” based on long-term studies.

According to the group, the Philippines is on its list of priority countries for the COVAXIN supply and that the Indian government itself earlier issued a letter mentioning this.

IP Biotech said Bharat has over 140 current, fully registered and licensed globally-patented vaccines and biotherapeutics, a number of which are approved and available in the Philippines. Among the most prominent, according to the group, is the IndiRab rabies vaccine. Bharat biotech also has vaccines on rotavirus, typhoid and polio.

Based on the World Health Organization’s draft vaccine landscape document, COVAXIN comes in 2 doses.

An Associated Press report recently cited Bharat Biotech advising those with weak immunity, allergies and bleeding disorder to not take the vaccine. The report said Bharat Biotech was involved in controversy after the Indian government allowed its use without an efficacy rate. 

The company said it will release its efficacy data by March.

Previous reports said the company plans to produce 700 million doses of its COVID-19 vaccine this year.

The Philippines' FDA has so far granted EUA only to Pfizer's vaccine candidate against the coronavirus.

It continues to assess the EUA application of AstraZeneca, Gamaleya Institute, and Sinovac for their respective vaccine products.

The government hopes to inoculate up to 70 million of the country's population to achieve herd immunity against COVID-19. Vaccine supplies are expected to start arriving next month.

On Wednesday, the COVID-19 death toll in the Philippines breached the 10,000-mark, as the cumulative total of infections soared to 505,939. Active cases stood at 28,904.

The Philippines confirmed its first COVID-19 case on Jan. 30 last year in a Chinese woman who arrived from Wuhan City, China where the disease is believed to have first emerged in late 2019.

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