Moderna COVID-19 vaccine gets emergency use authorization
MANILA, Philippine — The COVID-19 vaccine of American pharmaceutical firm Moderna has been granted an emergency use authorization (EUA), the Food and Drug Administration said Wednesday.
FDA Director General Eric Domingo said the agency only took about 10 days to approve the EUA application of the drug firm, which it submitted on April 26.
“After a rigorous and thorough review by regulatory and our medical experts using the currently available published and unpublished data, the FDA is granting an emergency use authorization for the COVID-19 vaccine Moderna,” Domingo said in a Kapihan sa Manila Bay forum.
“All conditions for an EUA are present and the benefit of using the vaccine outweighs the known and potential risks,” he added.
The EUA will only be valid within the duration of the declared public health emergency or upon the issuance of a certificate of product registration, he said.
Interim data from ongoing Phase 3 trials of the vaccine show that the vaccine has an overall efficacy rate of over 94% in preventing COVID-19, he added.
Its efficacy rate is also consistently above 80% among all age groups above 18 years old and special groups such as health workers, people with comorbidities and the elderly.
The vaccine is administered in two doses, Domingo said, with the second dose given four weeks after the first shot.
The EUA clears the vaccine for individuals aged 18 years and above, he added.
Domingo said adverse effects reported in clinical trials and actual use were “mostly mild and transient” which is similar to common reactions expected after vaccination.
This is the seventh vaccine to secure an EUA in the country, including Pfizer-BioNTech, AstraZeneca, Sinovac Biotech, Gamaleya Institute, Janssen, and Bharat Biotech.
Domingo said 46 other countries have given Moderna an EUA, including an emergency use listing by the World Health Organization.
The government and the private sector earlier signed a tripartite agreement with Moderna for 20 million vaccine doses.
Under the agreement, the government will secure 13 million doses while the private sector will have seven million doses for its workers.
Vaccine czar Carlito Galvez Jr. earlier said the government also ordered an additional five million doses of the said vaccine.
Philippine Ambassador to the US Jose Manuel “Babe” Romualdez earlier said that about 200,000 doses of the Moderna vaccine are expected to arrive in the Philippines in June.
EDV
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