FDA grants EUA to Moderna's COVID-19 vaccine

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Metro Manila (CNN Philippines, May 5) — The Food and Drug Administration authorized Moderna's COVID-19 vaccine for emergency use on Wednesday, FDA Director General Eric Domingo announced.

"Today, after rigorous and thorough review by regulatory and medical experts using the currently available published and unpublished data, FDA is granting an emergency use authorization to Zuellig Pharma Corp. for the...COVID-19 vaccine Moderna," Domingo said in a briefing.

Moderna's vaccine has shown an overall efficacy rate of well over 94% in preventing COVID-19, based on clinical trials involving thousands of participants, with side effects mostly limited to "mild and transient," Domingo noted. But he said they will keep an eye on allergic reactions linked to the shot.

He added that while the efficacy rate among some groups is less than 94%, it is "consistently above 80%" among all age groups above 18 years old, and special groups including healthcare workers, people with comorbidities, and the elderly.

The two-dose vaccine is given four weeks apart, the FDA chief said. Under its EUA, Moderna's vaccine can only be administered to those aged 18 and older.

DOH Undersecretary Maria Rosario Vergeire said in a separate briefing Moderna's vaccine can be stored at freezers with temperatures of 2 degrees Celsius to 8 degrees Celsius for up to 30 days. But its "normal storage requirement" is between -25 degrees Celsius and -15 degrees Celsius, she added.

An initial shipment of nearly 200,000 doses of Moderna's vaccine, which was co-developed by the National Institute of Allergy and Infectious Diseases’ Vaccine Research Center in the United States, is scheduled to arrive in the country on June 15.

The Philippines earlier signed a tripartite agreement with the American pharmaceutical and biotechnology company for 20 million doses.

Under the deal, 13 million will be allocated to the government, while seven million will go to the private sector.

The Philippines is also mulling to procure Moderna's coronavirus booster shot candidate, vaccine czar Carlito Galvez said last month.

Other COVID-19 vaccines approved for emergency use in the country are those made by Pfizer, AstraZeneca, Gamaleya, Sinovac, Bharat Biotech, and Janssen.