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Another Dengvaxia-like controversy in the offing?

another dengvaxia like controversy in the offing - Another Dengvaxia-like controversy in the offing?

“I promise you, by the grace of God, I hope by December we will be back to normal. Let’s just wait for a vaccine. Let’s wait till December, if we can just be patient. We are not going back to a ‘new normal.’ It’s going to be normal again.” That is what President Rodrigo Duterte told the Filipino people during his regular briefing aired last Friday.

The President expects a vaccine against COVID-19 to emerge out of China by December. According to him, China promised to give priority to the Philippines once the vaccine is developed.

While the United States and the United Kingdom are striving to be the first in the race to create a vaccine that would put a stop to the COVID-19 pandemic, China is currently in the lead with Sinovac Biotech’s experimental vaccine about to become the country’s second vaccine (and third globally) to enter the final stages of testing at the beginning of August. Aside from Sinovac, China also has seven other vaccine candidates in human trials, CanSino among them.

China brought state, military, and private sectors together in the fight against COVID-19. A state-controlled entity completed two vaccine plants in two months while state-owned companies and the military have allowed experimental shots to be used on their personnel.

Duterte said the vaccine would first be administered to the police and military for free. Department of Finance Secretary Carlos Dominguez III said the government has the money to buy enough vaccines for the 20 million poorest Filipinos. Department of Health (DoH) officials estimate that the vaccine would cost $10 per dose. At two-doses per full vaccination for 20 million Filipinos, the government needs about $400 million or P20 billion.

Secretary Dominguez said government financial institutions like the Land Bank of the Philippines and Development Bank of the Philippines (DBP) will provide the funds with which to purchase the vaccine.

Not everyone, however, is thrilled about China’s fast development of a vaccine as it has had scandals over substandard vaccines in the past. Only a handful of countries have shown willingness to collaborate with China. None of the major European countries nor the United States has shown interest in China’s COVID-19 vaccines as they are focused on developing their own. Furthermore, vaccines take years to fully develop.

Vaccines contain a dead or weakened form of the disease-causing virus. These cause the body to make antibodies and other beneficial responses that protect the person from the disease. The risk for death or serious side effects is so small that epidemiologists find it hard to document.

In his eagerness to bring Filipino life back to normal, the President might find himself deep in trouble similar to what Sanofi Pasteur’s Dengvaxia got former president Benigno Aquino III in. In the spring of 2016, Sanofi Pasteur launched Dengvaxia in the Philippines, as the country, having been involved in every phase of clinical development, became the first in the world to access the live recombinant tetravalent vaccine meant to help protect people against the dengue virus.

Dengue fever is a mosquito-borne viral infection that resembles the flu and can develop fatal complications. It is prevalent in tropical and subtropical regions of the world, particularly in more than 100 countries and regions such as Southeast Asia, the Pacific Islands, and the Caribbean.

The figures released by the World Health Organization in 2017 showed that there are 390 million dengue fever cases worldwide each year, of which 96 million have clinical manifestations, and another 20,000 people die each year. Early diagnosis and effective care can keep mortality rates below 1%.

In the Philippines, dengue fever is a major cause of severe illness and death in children. The DoH spent $67 million on Dengvaxia and got a mass immunization program underway with the aim of vaccinating a million students by the end of 2016.

Sanofi also 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.

Sanofi expected a windfall from being the first to offer the dengue vaccine to global markets. By October 2016, Dengvaxia had received regulatory approval from 10 other countries, including Mexico, Brazil, and Indonesia, and in 2019 in the United States.

More than six months later, after more than 830,000 children had received at least one dose of the vaccine (Dengvaxia is administered as three injections, with six-month intervals), Sanofi learned from the results of its trials that people who had never been infected with dengue before but received the vaccine could be vulnerable to a more severe case of dengue fever. (Dengue has four serotypes and catching one does not impart immunity against the other three, so a person could conceivably get dengue four times. — Ed.)

It announced that it was changing its label to restrict its use to only those who had already been exposed to dengue virus. Whereupon the DoH immediately suspended the immunization program.

Soon after, the potential implications of the vaccination program had become a national scandal. In February 2018, lawyer Persida Acosta of the Philippines Public Attorney’s Office filed a suit against government officials and executives of Sanofi and distributor Zuellig Pharma. She sought damages on behalf of the parents of a 10-year-old girl who allegedly died after receiving the vaccine despite the fact that she had a pre-existing condition.

Several medical societies in the Philippines have said there was no credible evidence that links Dengvaxia to the deaths of the recipients. They questioned the validity of the reports of Dr. Erwin Erfe, which are the basis of Ms. Acosta’s lawsuits. The doctor’s field of expertise is forensic science, also known as criminalistics, which is the application of scientific methods and techniques to the investigation of crime.

If dengue-infected people who had been inoculated with Dengvaxia died, experts of infectious disease maintain it is the virus that had actually caused the death of recipients of Dengvaxia, not Dengvaxia. The vaccine merely failed to protect the patient from the virus, not caused the person’s death.

By February 2019, the Dengvaxia scandal had become the subject of two congressional inquiries and a criminal investigation. In the Senate, Senator Richard Gordon released his draft report that stated that former president “Benigno Aquino III is guilty of “malfeasance, misfeasance, and nonfeasance” in connection with his administration’s mass immunization program using Dengvaxia. 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.

In March, the Department of Justice (DoJ) filed charges against Sanofi and DoH officials, claiming the officials had ignored “the identified risks and adverse effects of the vaccine” and were therefore responsible for the subsequent deaths of several children.

Two advocacy groups — the Volunteers Against Crime and Corruption (VACC) and Vanguard of the Philippine Constitution, Inc. (VPCI) — filed criminal complaints with the DoJ against former president Benigno Aquino III, former Health secretary Janette Garin, former Budget secretary Florencio Abad, and several others over their alleged liability in the government purchase of the controversial vaccine. They accused the respondents of committing multiple homicide and physical injuries through criminal negligence, graft, technical malversation, and violation of the procurement law for the purchase of Dengvaxia, which they claimed caused the deaths of several recipients.

Going back to President Duterte’s promise of the availability of a vaccine from China by December, there would be hundreds, if not thousands of deaths caused by the coronavirus among those who would be inoculated with the vaccines. If we go by the action taken by the DoJ, PAO, VACC, and VPCI against Mr. Aquino, Dr. Garin, and Mr. Abad, then President Duterte, Health Secretary Duque, Finance Secretary Dominguez, and the other members of the Inter-Agency Task Force against COVID-19 would eventually be facing charges of malfeasance, misfeasance, and nonfeasance.

 

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.

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