FDA grants EUA to six COVID-19 vaccines
By LESLIE ANN G. AQUINO & JHON ALDRIN CASINAS
The Philippines, which started its vaccination in March, has ranked third among Southeast Asian countries in terms of coronavirus disease (COVID-19) doses administered, as of April 14,2021.
According to the Department of Health (DOH), based on Bloomberg and reports from Foreign Service Posts, Indonesia ranks first with 15,811,449, followed by Singapore with 1,667,522, and the Philippines with 1,456,793.
Data presented by DOH undersecretary Myrna Cabotaje shows that as of April 17, a total of 1,264,811 Filipinos have received their first COVID-19 doses, while 191,982 have been administered their second doses.
Among healthcare workers, 960,191 have received their first doses, and 191,982 have been given their second doses.
The DOH says 128,018 senior citizens and 176,305 individuals with comorbidities got their first doses.
Cabotaje says about 76 percent of the jabs have been given to HCWS (Health care workers), 10 percent for seniors, and 14 percent to individuals with comorbidities.
The number of doses administered further increased to 1,562,563 on April 20, based on the latest vaccination rollout update of the DOH and the National Task Force Against COVID-19. This includes the 1,353,107 first doses given, and 209,456 second doses administered.
The seven-day average of daily vaccinated individuals is 43,835.
A total of 3,025,600 doses have already arrived in the country. Composed of donated and procured Sinovac and AstraZeneca vaccines, all have already been distributed to the 3,263 vaccination sites.
According to the DOH and NTF, all regions have started administering the second dose for the HCWs (Priority Group A1), adding that vaccination roll-out for Priority Group A2 (senior citizens) has started in 11 regions—Ilocos, Cagayan Valley, Central Luzon, Calabarzon, Mimaropa, Western Visayas, Central Visayas, Zamboanga Peninsula, Soccksargen, Cordillera Administrative Region (CAR), and NCR while for Priority Group A3 (persons with comorbidities) has begun in Central Luzon, Calabarzon, Western Visayas, Central Visayas, NCR, and CAR.
Due to limited supplies, the DOH is implementing the COVID-19 Prioritization Framework in order to protect first those most at risk and most vulnerable.
World Health Organization (WHO) representative to the Philippines Dr. Rabindra Abeyasinghe reminds the government to prioritize the 1.7 million HCWs in the vaccination program. “We need to still prioritize and ensure full coverage the frontline healthcare workers. We continue to emphasize that we must work on a priority basis to protect frontline HCWs,” he said. “About 63 percent of the HCWs have been protected. We are still short of protecting all HCWs.”
To the WHO official, the current surge in COVID-19 cases demonstrates the need to have HCWs fully protected so that they can care for the sick.
Health undersecretary Maria Rosario Vergeire says they are still far from their target of reaching 70 percent of the population. “Based on the targeted population that we need to vaccinate, which is 70 percent of the population, we are still far off,” she says. “But, at least, we have already started giving protection to the vulnerable sector in the country.”
Millions of vaccine doses to arrive
As the Philippines pushes through with its vaccination drive against COVID-19, authorities expect that the country will receive millions of vaccine doses in the coming months. Secretary Carlito Galvez, National Task Force Against COVID-19 chief implementer and vaccine czar, reports that around 2,195,000 doses from various vaccine manufacturers worldwide are expected to arrive in the country soon.
These include vaccines from China’s Sinovac Biotech, American drugmaker Pfizer-BioNtech, and Russia’s Gamaleya Research Institute.
Of Chinese-made CoronaVac vaccines, we are expecting 1.5 million doses to be delivered soon. Of the number, 500,000 doses have already arrived in the country. The first batch arrived on April 11, while the second batch arrived on April 22. Another 500,000 doses of Sinovac vaccines should have arrived.
On the other hand, Russia’s Gamaleya Research Institute will send 500,000 doses of Sputnik V vaccines. An initial 20,000 doses to be used for a “mini rollout” were scheduled arrive in the country on April 22, the remaining 480,000 doses on April 29.
A bulk of 195,000 doses of Pfizer vaccine have also been scheduled to arrive around the same time in the country from the COVAX facility.
In May, Galvez said that four million doses of vaccines are expected to be delivered to the Philippines. These include two million doses from Sinovac, one to two million doses from Gamaleya, and 194,000 doses from Moderna.
By June, a much larger shipment of vaccines will arrive in the country. Galvez reported that a supply of around eight million doses of vaccines will be delivered, with 4.5 million doses from Sinovac, two million doses from Gamaleya, and 1.3 million from AstraZeneca.
EUA granted to J&J, Covaxin shots
In a bid to widen the country's vaccine portfolio, the government has now allowed the emergency use of two COVID-19 vaccines in the Philippine immunization program.
The Food and Drug Administration (FDA) granted emergency use authorization (EUA) to the COVID-19 vaccines developed by Johnson & Johnson’s Janssen and Covaxin of India’s Bharat Biotech on April 19.
Covaxin
FDA director general Rolando Enrique Domingo said Bharat BioTech has filed its application for an EUA on Jan. 22, and has submitted their clinical trial data for their vaccine on March 9.
Domingo noted, however, that the EUA issued to the drugmaker was only “conditional” as the company has yet to submit a documentary requirement before it could import their vaccines.
“Our experts have studied their clinical trial data, and they decided that the benefit of using the vaccine outweighs the risk,” he said in a recent televised public briefing.
Based on data from the Department of Health (DOH), the Covaxin has an efficacy rate of 80.6 percent, and has a storage requirement of two to eight degrees Celsius.
The vaccine requires two doses and has to be administered 14 days apart.
Among the common adverse events reported during its Phase 3 clinical trials include headache, fatigue, fever, body ache, abdominal pain, nausea, and vomiting.
Janssen
Another COVID-19 vaccine that has been approved for emergency use in the Philippines is the single-dose shot developed by Belgium-based Janssen Pharmaceuticals, which is owned by American drugmaker Johnson & Johnson.
It applied for an EUA before the FDA on March 31.
The regulatory body has allowed the emergency use of the vaccine, despite an ongoing investigation overseas on possible adverse events of blood clotting among some vaccine recipients.
Some countries, including the US, has halted the use of the vaccine over blood clotting concerns.
“But, all in all, the benefit of using the vaccine definitely outweighs the risk of that possible clotting, which is one for every one million,” Domingo said.
Data from the DOH showed that the vaccine’s efficacy is between 66.1 and 66.9 percent against moderate to severe COVID-19 cases. It has a storage requirement of -20 degrees Celsius if stored for two years, or two to eight degrees Celsius if kept for three months. The common adverse events reported during the vaccine’s clinical trials include tiredness, headache, muscle pain, chills, fever, and nausea.
The FDA has previously granted an EUA to COVID-19 vaccines developed by Pfizer-BioNtech, AstraZeneca, Gamaleya Research Institute, and Sinovac Biotech.