MANILA (UPDATE2) — The Food and Drug Administration on Thursday granted British company AstraZeneca emergency use authorization (EUA) for its COVID-19 vaccine, 3 weeks after its application.
“After a thorough review of the currently available data by our medical and regulatory experts, the FDA is granting an emergency use authorization to the COVID-19 vaccine AstraZeneca,” FDA Director General Eric Domingo said during a Laging Handa briefing.
This makes AstraZeneca’s vaccine the 2nd, after Pfizer's, to be approved for emergency use in the Philippines where 518,407 coronavirus infections have so far been confirmed.
“The vaccine regimen consists of 2 equal standard doses of .5mL, each given 4 to 12 weeks apart,” Domingo said.
He said the vaccine has an efficacy rate of 70% after the first dose, and trials are ongoing to determine the efficacy rate after the 2nd dose.
AstraZeneca previously caused confusion after it announced that a lower dosing regimen, involving use of half only of the first dose, resulted in higher efficacy.
But Domingo explained that the company found out that “the longer interval between the 2 doses was deemed responsible for the higher immunogenicity in the group that was given the lower 1st dose.”
This is why the Philippines will be following the standard regimen of 2 full doses given 4 to 12 weeks apart, he said.
While it is only 70% effective in preventing COVID, Domingo said those who took part in the trial only had mild to moderate symptoms of the disease.
“Yung data naman ng AstraZeneca shows that it is very good in preventing severe COVID-19. Halos 100% din. Kaya lang, siyempre, medyo maliit pa ang datos nila at maa-update pa yan as we get more data on the people included in the clinical trial,” he said.
(The data of AstraZeneca shows that it is very good in preventing severe COVID-19 - almost 100%. However, their data is still not sizable and it will get updated as we get more data on the people included in the clinical trial.)
While the initial rate is lower than the efficacy rate of vaccine frontrunners Pfizer and Moderna, which have rates of around 95%, AstraZeneca seems to be more favored by local government units in the Philippines because of its storage requirements.
Unlike those requiring ultra cold freezers, AstraZeneca’s vaccine can be kept in regular refrigerator temperatures as with more common vaccines kept by the Department of Health.
“The advantage of this vaccine is that it is stored at 2 degrees to 8 degrees. Hindi sya masyadong maselan, at madali syang ma-transport at i-store sa lugar ng pagbabakunahan,” Domingo said.
(The advantage of this vaccine is that it is stored at 2 degrees to 8 degrees. It is not that sensitive, and it can easily be transported and stored at the vaccination site.)
Domingo said there are also no special precautions specific for AstraZeneca’s vaccine, although that may change as more countries use it.
“Ang nakitang adverse effects niya are all very mild, very similar to getting any flu injection na karamihan ay pananakit sa lugar ng injection, konting sinat, konting sakit ng ulo that are all transient and easily managed,” he said.
(The adverse effects seen for this vaccine are all very mild, very similar to getting any flu injection - soreness in the injection site, slight fever, headache that are all transient and easily managed.)
Up to 39 local government units have signed a tripartite agreement with the national government and the private sector to secure 17 million doses of AstraZeneca's vaccine.
“This is great news! We are very happy to hear this and we look forward to the arrival of our order from them,” Pasig City Mayor Vico Sotto said of the FDA's approval, in a text message to ABS-CBN News.
Pasig City is the first local government unit in the country to gain the national government’s approval on vaccination plan. The city is also among the Health Department’s chosen site for the vaccine simulation.
But there is no definite date yet as to when vaccines are expected to arrive in the city.
“I’m sure they will get it here as soon as possible, all factors considered,” Sotto said.
In a separate statement, San Juan City Mayor Francis Zamora said the "FDA’s approval is a validation that purchasing from AstraZeneca is the right decision".
“An EUA from the FDA assures us that the vaccine has been well studied and reviewed by experts, and is safe for public use,” he said.
Zamora assured the LGU continues to prepare and fine tune the vaccination process as the city looks forward to the delivery of the vaccines.
Vaccine czar Secretary Carlito Galvez Jr. said Wednesday he is expecting 200,000 to 500,000 doses of AstraZeneca’s vaccine among the estimated 1 million vaccine doses the country will get next month.
AstraZeneca is one of the few vaccine developers that have received EUAs from stringent regulatory authorities (SRA) recognized by the World Health Organization, allowing its application to be expedited by the FDA.
The FDA had said those with approval from SRAs, like Pfizer's, can be approved within 21 days from application.
The remaining 3 companies awaiting FDA's EUA approval for their vaccine candidates are Russia’s Gamaleya Institute, China’s Sinovac, and India's Bharat Biotech.
The Philippines aims to inoculate up to 70 million people to achieve herd immunity against the coronavirus.
- with a report from Angel Movido, ABS-CBN News