BY GERARD NAVAL
THE Food and Drug Administration (FDA) yesterday granted the American pharmaceutical firm Moderna Inc. emergency use authorization (EUA) for its coronavirus disease (COVID-19) vaccine, paving the way for the entry of the “COVID-19 Vaccine Moderna” to the Philippines.
The country expects the delivery of 194,000 doses of Moderna’s vaccine in May, and another one million shots in July.
Moderna, which filed its application for EUA on April 26, is the seventh to be given emergency use authority.
It has an overall efficacy rate of over 94 percent in preventing COVID-19, according to FDA Director General Eric Domingo.
“After rigorous and thorough review by our experts, using published and unpublished data, the FDA is granting EUA for the COVID-19 mRNA Vaccine or COVID-19 Vaccine Moderna,” he said in a media forum.
Domingo said the Moderna vaccine is given in two doses, like most, with the second dose given four weeks after the first.
It may be given to individuals 18 years and older, and to special groups like healthcare workers, persons with comorbidities, and the elderly.
Domingo also said the known adverse effects of the Moderna vaccine are mostly mild and transient, such as allergic reactions.
“All conditions for an EUA are present, and the benefits of taking the vaccine outweighs the known and potential risks,” he said.
Earlier given UAEs were US firm Pfizer-BioNTech, British-Swedish company AstraZeneca Plc, China’s Sinovac Biotech, Russia’s Gamaleya, Janssen/Johnson & Johnson, and India’s Bharat Biotech.
Domingo said the FDA is still waiting for an EUA application from Chinese state-owned firm Sinopharm after three entities sent letters of intent to apply for emergency use authority on behalf of the drugmaker.
President Duterte got his Sinopharm shot on Monday night, under a compassionate special permit issued by the FDA to the hospital of the Presidential Security Group.
Domingo on Tuesday said the FDA could not guarantee that the Sinopharm vaccine is safe and effective against COVID-19 because it has not undergone evaluation by the agency.
Vaccine czar Carlito Galvez, at the sidelines of the opening of the hemodialysis facility for COVID-positive patients at the National Kidney Transplant Institute (NKTI) compound in Quezon City, said the issuance of the EUA to Moderna would boost the country’s vaccination program.
He said last week that the government procured some 13 million doses from Moderna while the private sector ordered seven million doses.
Health Undersecretary Maria Rosario Vergeire, on Sputnik V, said the government has not received reports of minor and common adverse effects following immunization, which are pain in the inoculation site, flu-like feeling, muscle pain, and headache.
“As our experts say, Sputnik V is generally safe, based on their evaluation,” said Vergeire.
She said at least 2,600 individuals have been given Sputnik jabs from the initial delivery of 15,000 doses.
The country has so far received at least 4 million doses of different vaccines since last February.
DOH data shows at least 2 million Filipinos have been vaccinated as of May 4, including some 320,000 who have completed the two shots. — With Jocelyn Montemayor
