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5 vaccines up for PH tests

DOH: Any anti-COVID drug has to be cleared first by experts’ panel, FDA

Five potential vaccines against COVID-19 have already been submitted for possible clinical trials in the Philippines.

Science and Technology Secretary Jaime Montoya on Friday said these vaccines are Sinovac from China; Sputnik V from Russia; and vaccines from Janssen, Clover Biopharmaceuticals, and AstraZeneca.

Before clinical trials can be run, a drug must get clearance from a panel of vaccine experts under the Department of Science and Technology (DOST). Once it is cleared by the DOST panel, it would also need approval from the Ethics Board and the Food and Drug Administration.

The government has earmarked P2.5 billion for COVID-19 vaccine procurement under the proposed 2021 national budget.

Meanwhile, the Department of Health said COVID-19 vaccines that have been given emergency use authorization (EUA) in other countries would still need to secure approval from Philippine regulatory agencies before the government can buy them.

Health Undersecretary Rosario Vergeire said this a day after presidential spokesman Harry Roque, Jr. said President Rodrigo Duterte will issue an executive order authorizing Food and Drug Administration to grant EUA to COVID-19 vaccines.

“If a vaccine has been given an EUA in another country, it will still have to go through our process. There’s the vaccine experts panel, the ethics board, the FDA and the health technology assessment team,” Vergeire said in Filipino. “Once it is approved, then that is the time we can proceed with procurement.”

Other countries with mechanisms for an EUA include the United States, China, the 27-member European Union, Australia, and Japan.

The government will decide this weekend which sectors will be given priority in receiving the free COVID-19 vaccine, the DOH said.

The DOH is hoping to vaccinate some 50 percent to 60 percent of the population from the original plan of 20 percent.

Vergeire said the government plans to give priority to certain sectors before reaching the whole expanded coverage.

“We are still working on that. The President has given the priorities as discussed with the Secretary of Health and our vaccine czar. We are going to finalize our prioritization over the weekend,” Vergeire said in an interview on ANC’s Headstart.

She said the government hopes to give the vaccine to 50 percent to 60 percent of the population.

Initially, the department aimed to get 20 percent of the population vaccinated, but after discussions with the country’s vaccine czar, Secretary Carlito Galvez Jr., expanded the target coverage to 50 percent to 60 percent.

Until this target is achieved, the public should continue observing minimum health standards—wear masks and maintain social distancing—to stem the spread of the virus, Vergeire said.

The DOH, she added, would ensure transparency in its COVID-19 vaccination program.

The Philippines, plans to purchase an initial 50 million doses of COVID-19 vaccines. Priority will be given to the poor, security forces, government front line workers and health care workers.

Vergeire acknowledged that the logistical cost of delivering the vaccine across the country could be more expensive than the vaccine itself, especially if the vaccine requires ultra-low freezer storage.

“We need to be able to cost the end-to-end process before we eventually expand the coverage to include at least 50 percent of the population for this vaccine,” Vergeire said.

“We are looking for many vaccines, but for those which require ultra-low freezer storage, that will require a lot of money because the cost will also include distributing these vaccines to different localities,” Vergeire said.

Only COVID-19 vaccines developed by American firms Pfizer-BioNTech and Moderna have been proven to be 95 percent effective in preventing COVID-19 infection so far.

But the vaccine developed by Pfizer will require ultra-low freezer storage of -70 to -80 degrees Celsius, which poses a great challenge for countries with a tropical climate and limited resources such as the Philippines.

Galvez earlier said that the Philippines is finalizing COVID-19 vaccine supply deals from at least three manufacturers from the US, UK, and China, and such agreements should be sealed by the end of the month.

The FDA said on Friday that the country’s vaccine expert panel recently received and is now studying the application of United Kingdom-based drugmaker AstraZeneca to hold COVID-19 vaccine clinical trials in the Philippines.

FDA Director-General Eric Domingo said they recently accepted an application from the British pharmaceutical company that has partnered with Oxford University to develop and COVID-19 vaccine.

Domingo said of all the applicants so far, only the Chinese company Sinovac has finished the pre-evaluation process of the vaccine expert panel.

He said there were only a few more requirements left before Sinovac becomes the first company to hold clinical trials for a COVID-19 vaccine in the Philippines.

There is still no definite date for the World Health Organization’s multi-country clinical trials, which will test several vaccines against COVID-19.

But the FDA said the Philippines is expediting its procurement of vaccines and may have a supply by the second quarter of 2021.

This week, the DOH asked President Rodrigo Duterte for an executive order allowing the FDA to issue an emergency use authorization (EUA) for COVID-19 vaccines.

The President is expected to issue the EO soon.

The EUA would allow the Philippines to shorten its evaluation process for vaccines and to recognize the approval of other regulatory bodies abroad such as the United States’ FDA.

The Palace on Friday welcomed the result of a survey showing that the majority of Filipinos are willing to get a COVID-19 vaccine, saying it reflects the public’s “trust” in the government’s vaccination program.

According to the Social Weather Station (SWS) survey, around 66 percent of surveyed adult Filipinos are willing to get the COVID-19 vaccine if it is available now while the other 31 percent are unwilling to get the vaccine.

Topics: potential vaccines , COVID-19 , clinical trials , Jaime Montoya , Sinovac , Sputnik V

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