Churning populist sentiments

COMMONSENSE - Marichu A. Villanueva (The Philippine Star) - January 13, 2021 - 12:00am

At the televised Senate Committee of the Whole hearing last Monday, we have seen the discussions chiefly revolved around universal access to the vaccines against the 2019 coronavirus disease (COVID-19) pandemic. During the almost daylong public hearing, Senators focused their guns on Dr. Rolando Domingo, the director general of the Food and Drug Administration (FDA). Using the words of Senate president Vicento “Tito” Sotto III during the hearing, most of the “sniper” questions targeted the FDA chief.

Curiously, the Senators spared Secretary Carlito Galvez Jr. whom President Rodrigo Duterte authorized as the only government official to decide on all negotiations related to the procurement of the anti-COVID vaccines.

Aside from vaccines, the FDA is the chief regulatory body that passes upon medicines, food and other products whether they are safe and fit for human consumption in the country. Actually, the FDA is a government agency that every country has and mandated to protect the public health by ensuring the safety, efficacy, and security of consumers.

Our own FDA has functions similar with that of its counterparts in other countries, most of which were patterned after the FDA of the United States (US). Our FDA in the Philippines, as one of the attached agencies of the Department of Health (DOH), practically performs the same functions and role. Dr. Domingo is previously one of the undersecretaries of DOH Secretary Francisco Duque III but was moved over and appointed to become the permanent FDA head almost a year ago now.

During the Senate hearing, the FDA chief obviously kept cool as a cucumber even while under intense grilling from the Senators. The Senators mostly pressed Domingo to allow the private sector and the local government units (LGUs) to procure directly from vaccine-makers their own anti-COVID inoculation program for their respective constituents. The Senators kept citing news reports that many LGUs, especially those in Metro Manila, have already signed agreements for their vaccine supply with AstraZeneca Pharmaceutical of the United Kingdom (UK).

This is not surprising because LGUs have, in fact, been already covered by the multilateral agreement signed by the Philippine government under the COVID-19 Global Alliance for Vaccines and Immunization (GAVI-COVAX) Facility of the World Health Organization (WHO). Since all the anti-COVID-19 vaccines are under clinical trials, this WHO Facility only allows government-to-government transactions with all the vaccine-makers.

On the other hand, the private business sector-led “Dose of Hope” vaccine procurement organized by presidential adviser for entrepreneurship Jose Concepcion also went through the same process. Under this tripartite agreement signed in November last year, half of the supply of 2.6 million vaccine doses will be donated to the government and the other half to the employees and workers of the private sector donors.

In fact, the ceremonial signing of the “Dose of Hope” private sector donation of the vaccine to the government and the LGU procurement of the AstraZeneca vaccine is slated tomorrow noon via zoom. But Concepcion admitted the actual arrival here of their AstraZeneca vaccines is towards end of May this year.

President Duterte last year approved advance payments for the vaccine – which is required by some drug makers and the GAVI-COVAX. This WHO Facility guarantees 20% of the Philippine population can be supplied with the vaccine, being among those classified as low and middle income countries.

At the same time last year, President Duterte signed Executive Order 121 that paved the way for our own FDA to invoke the emergency use authority (EUA). This shortened the review process to 21 days only from the existing minimum of six-month period within which our FDA to approve or reject products such as vaccine for use here in our country.

This is in consonance with the WHO requirement for emergency use only while vaccines are still on clinical trials yet.

AstraZeneca was the first one granted with EUA from the FDA of the UK last year. In fact, the initial batch of British people have been inoculated last Jan. 4. The US and several other countries followed one after other when vaccine-makers similarly received their EUAs from their respective countries’ FDA like Pfizer of US jointly with BioNTech of Germany, Sinovac and Sinopharma of China, Gamaleya’s Sputnik-V of Russia, et.al.

As of this time, there is no anti-COVID vaccine approved by the WHO as safe and efficacious enough for commercial deployment.

So no amount of braggadocio could change the science of vaccines.

The Senators supposedly echo the frustration and public disappointment that our country is seemingly being left out in the race to acquire vaccines for the Filipinos. Our neighbors like Singapore, Thailand, and Indonesia are reportedly on the initial vaccination phase already.

But our neighbor Japan – one of the richest countries-- seems to be in no hurry to administer yet any anti-COVID vaccine. The Japanese government tentatively set next month the rollout of their vaccine program while apparently awaiting results of the initial vaccinations done by other countries. This, despite Japan is back to its strict lockdown due to resurgence of their COVID-19 cases.

Domingo consistently insisted he was simply implementing and enforcing the FDA mandates under our country’s laws. In so many words, Domingo was simply telling the Senators he cannot – nor would not – do anything beyond what the existing regulations authorize him to do as the head of the FDA. But the Senators just ignored the repeated responses of the FDA chief and simply reworded the same questions.

Some of these Senators who played deaf were too obvious trying to sound populist and ignore science and facts.

Expect more of populist statements will be churned out, especially from the halls of Congress for the rest of the year. With the 2022 presidential elections just around the corner, our vaccine program will be turned into a political arena.

COVID-19 FDA
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