Country’s vaccination program politicized

On April 15, 2018 Senator Richard Gordon, chairman of the Senate Blue Ribbon Committee, released his report recommending charges of graft and violation of the government ethics code against former President Benigno Aquino, former Health Secretary Janette Garin, former Budget Secretary Florencio Abad, and seven other former health officials for allegedly conspiring to approve the government purchase of the anti-dengue vaccine Dengvaxia.

“The confederacy to procure and inject en masse was not merely ill-advised, or unwise. It was criminal. The greatest sin and transgression of Aquino was to put the lives of Filipino children in grave peril. He simply did not care. He was insensitive and did not have compassion,” the report said.

Other signatories of the report were Senators Ralph Recto, Manny Pacquiao, Win Gatchalian, Tito Sotto, Gregorio Honasan, Juan Miguel Zubiri, JV Ejercito, Nancy Binay, and Grace Poe.

Mr. Aquino repeatedly explained during his appearance before the Blue Ribbon Committee that he approved the purchase of the vaccine in response to the dengue outbreaks that had resulted in numerous deaths. He rejected insinuations of corruption in the purchase of Dengvaxia.

The risk of dengue illness is present throughout the Philippines, with transmission occurring year-round. Transmission peaks during the rainy season — from May to November. Dengue infection is characterized by flu-like symptoms which include a sudden high fever. Complications can lead to circulatory system failure and shock, and can be fatal.  Severe dengue fever has been a major cause of severe illness and death in children. There is no antiviral treatment available.

The development of a safe and efficacious dengue vaccine capable of preventing clinically significant disease eluded vaccine developers for almost 70 years. The only licensed dengue vaccine is Sanofi Pasteur’s Dengvaxia, which has been registered in 20 dengue endemic countries, including the United States and European Union (EU) nations. Sanofi Pasteur had high hopes for Dengvaxia, the development of which had taken 20 years and cost around $1.8 billion. Officials predicted that the vaccine would bring down infection rates by 24% within five years.

In December 2015, President Benigno Aquino met with Sanofi Pasteur executives in Paris. Because dengue is epidemic in the Philippines, he approved the commercial sale of Dengvaxia in the country. The government spent $67 million on Dengvaxia and got underway a mass immunization program with the aim of vaccinating a million students by the end of 2016. About 700,000 individuals were inoculated at least one dose of the vaccine.

In November 2017, Sanofi Pasteur disclosed that Dengvaxia posed risk to individuals, mostly schoolchildren, who have not had a previous dengue infection. This prompted the Department of Health to suspend the vaccination program in schools, giving rise to a political controversy over whether the program was run with sufficient care and who should be held responsible for the alleged harm to the vaccinated children.

But in September 2019, the Philippine Medical Association urged the government to allow the use of Dengvaxia on willing patients and on those who have been exposed to dengue, as cases soared to more than 208,000. Since the World Health Organization recognized the use of the vaccine as a preventive measure, the organization of physicians recommended that Dengvaxia be given to “individuals who are interested, willing, and aware of the benefits and possible risks of the vaccine.

“Clinical trials and studies have shown that the dengue vaccine will help individuals who had previous dengue infection from getting severe disease,” the group said.

For 10 months now we have been faced with a more massive source of serious infectious disease. The coronavirus SARS-Cov-2 which causes COVID-19 has infected 418,818 individuals and caused 8,123 deaths as of this writing (last Sunday).

On Oct. 15, President Rodrigo Duterte announced that the government has secured the source of funds for the acquisition of vaccines for the COVID-19 mass vaccination. “I have the money already for the vaccine but I will look for more because you know there are now 113 million Filipinos. To me, ideally, all should have the vaccine without exception,” the President said in a televised address.

The President had previously indicated that the vaccine would likely be sourced from China and Russia, having expressed his trust on the vaccines being developed by those countries.

The announcement that several pharmaceutical companies, including the American giant Pfizer, have developed safe and efficacious vaccines against COVID-19 thrilled leaders of nations. Last Thursday, the President announced that the Philippines will enter into advance market commitments (AMCs) with private manufacturers of anti-COVID-19 vaccines after approving the conduct of negotiations and the signing of AMCs, including authorizing advanced payments for negotiated terms.

Presidential Spokesperson Harry Roque explained that the process for AMCs would include the signing of a Confidentiality Data Agreement, negotiation and signing of AMCs, registration with the Food and Drug Administration (FDA) through Emergency Use Authority (EUAs), advance payment based on negotiated terms, and mobilization and delivery.

National Task Force against COVID-19 Chief Implementer Carlito Galvez explained the various modes of vaccine financing that include direct procurement, multilateral loans, bilateral loans, and private sector financing through tripartite agreement with the government, the pharmaceutical company, and the private sector company.

On the issuance of EUAs, Task Force head Galvez said that EUAs can shorten the process of getting an approval with the FDA from six months to only 21 days. He assured that although the EUAs will skip some processes in vaccine approval, the Philippines’ vaccine expert panel and ethics review board, as well as the FDA, will be conscientious in their evaluation of the vaccines. He said that through collaborative regulatory evaluation with other countries, the Philippines can be assured that once the vaccine has been approved by FDAs with stringent commissions, its safety is most likely assured.

According to the procurement law’s implementation rules and regulations, advance payments should only be made after the President has approved them and cannot reach 15% of the contract value, unless otherwise ordered by the President. In addition to acquiring vaccines supplied by private companies, advance payments are still expected to procure vaccinations from the COVAX Global Alliance for Vaccination and Immunization, which is intended to guarantee adequate doses for 20% of the population of the participating countries.

However, not everyone is thrilled about China’s fast development of a vaccine as it has had scandals over substandard vaccines in the past. While the vaccines developed by Pfizer and Moderna looked very promising, experts say it may be too soon to discount the possibility of adverse long-term effects. There are many other questions about them like the length of the immunity they render and their efficacy among the young and elderly that remain unanswered.

The silence of Senators Sotto, Gordon, Recto, Pacquiao, Gatchalian, Zubiri, and Poe, who all found anomalous the purchase of Dengvaxia, on this planned advance payment for the massive purchase of anti-COVID vaccines is deafening. What matters to them is the political color of the powers that be, not the health of the people.

Oscar P. Lagman, Jr. is a retired corporate executive, business consultant, and management professor. He has been a politicized citizen since his college days in the late 1950s.