Dr. Kenneth Hartigan-Go, MD, MD (UK)
Long before COVID-19 and the global pandemic, vaccine hesitancy was already an issue in many countries. In fact, the World Health Organization listed in both 2019 that vaccine hesitancy, along with Pandemics, are part of the top ten Global Health Threats. The trust in vaccines in a country may be a function of the public’s trust in its government and public health authorities. The political misuse of a negative event to strengthen political profiles is one factor that contributes to erosion of trust in the vaccine and in vaccination.
In the Philippines, recent increases in vaccine hesitancy have been further exacerbated by public missteps in political governance, health marketing and messaging management which have served to erode the citizenry’s tenuous trust.
The complexity of vaccine hesitancy in the Philippines has unfolded in the media like an ongoing telenovela (serial TV drama/soap opera) with 5 episodes thus far:
“Justified” Smuggling
Industry-led vaccine purchase
Indemnity and immunity
The Sinovac Story
Uproar among the ranks
“Justified” Smuggling
In November 2020, the national government let slip that an undisclosed number of senior government officials and military personnel had already been inoculated as early as September with a COVID vaccine from Chinese company Sinopharm. Aware of the government’s own prioritization of health workers/frontliners and senior citizens as the first intended recipients of vaccines, netizens and citizens alike questioned why the government had secretly jumped its own queue by vaccinating some chosen members of its own ranks, including some from the Presidential Security Group (PSG).
In addition, the question was raised as to how the vaccine came to be allowed into the country without passing through any regulatory authority. The Food and Drug Authority (FDA) promised to investigate how a vaccine with neither Emergency Use Authority (EUA) nor authorization for compassionate use came to be administered without its knowledge. The Congress also called on persons of interest to submit themselves for questioning. But all attempts at investigation were shut down; the President himself barred the PSG from cooperating. There is neither clarity nor closure to this issue at this time as it was summarily dismissed.
The national government admitted that what happened was tantamount to smuggling but deemed it justified. Certain officials said the people who had been inoculated should not be prosecuted for breaking the law but instead be lauded for willingly taking on the risk of the donated (read, without using public funds) unregistered vaccine in the line of duty. Given that the national government appeared to hold itself to a different standard than that for other Filipinos, and was unrepentant about flouting its own rules, public trust in its authority has understandably dropped, as evidenced from chatter on social media.
Industry-led Vaccine Purchase
Perhaps what further contributed to public alarm in the previous issue was the seeming inability of the government to procure COVID vaccines for its populace. In the last quarter of 2020, the private sector, possibly sensing that the government’s vaccine procurement plan was stalled, offered to enter into a tripartite agreement with the Philippine Department of Health (DOH) and the pharmaceutical manufacturers, whereby businesses would order vaccines for their respective employees, and donate an equivalent amount of vaccines to the DOH for its public vaccination program. Following this announcement, devolved local government units (LGUs) in cities and municipalities likewise began making their own private arrangements with the pharmaceutical manufacturers to procure vaccines for their respective constituents.
At that time, the national government was the only entity authorized to procure vaccines; the new initiatives led to some confusion on whether the private sector and LGUs would be permitted to spearhead the purchase, as well as who would be responsible for the vaccines they procured. In the end, the national government explained that the private sector and LGUs could procure vaccines under the tripartite arrangement with the national government for the sake of expediency and it is assumed that the national government would take responsibility for all vaccines.
Still, additional questions were raised which have not yet been answered: Since the private sector is procuring vaccines for their employees, would businesses have to distribute the vaccines according to the national government’s priority listing? In the case of LGUs procuring vaccines for their residents, how does the national government deal with the issue of social inequity with respect to LGUs which cannot afford to do so?
Indemnity and Immunity
Alongside the issue of vaccine procurement, vaccine hesitancy has been an equally important concern. Health professionals attempted to address this issue through webinars and information sessions, declaring that “50% efficacy is better than zero” and “the best vaccine is the one that is available”.
Despite these efforts, the rate of COVID vaccine acceptance seems to be dropping, based on various surveys conducted. Social Weather Station (SWS) logged vaccine acceptance at 75% in September 2020. In January 2021, Pulse Asia reported an alarming 25% vaccine acceptance for COVID vaccine, and in February 2021, this dropped further to 19%, as reported by the University of the Philippines OCTA research team (OCTA is an independent group that is composed of University of the Philippines faculty and scientists. It is not an organic office under the University). The business community, in informal polling among employees of companies participating in the tripartite agreement, was shocked to discover that around 80% were unwilling to take the COVID vaccine; of the remaining 20%, some were only willing on the condition that the vaccines were of particular brands. In a food franchise outlet with 300 employees, only 5 were amenable to take the COVID vaccine when available. (KHG: Personal communications)
Vaccine hesitancy notwithstanding, in early February 2021, after much public discussion on vaccines, netizens began asking why there were still no vaccines but only unfulfilled promises of deliveries. The national government later admitted that vaccine deals had stalled because it had only been lately informed of the need for an indemnification law and an indemnity fund. Manufacturers insisted on ensuring immunity from legal action for themselves in case of adverse reactions to the vaccines.
There were competing opinions among government officials about whether the lingering Dengvaxia issue was what had led companies to seek to protect themselves. Some said the indemnity clause requirement was standard for all countries and had been in place since 2020 while others said it was a particular requirement for the Philippines. After all, the Philippines is the only country in the world to have banned the dengue vaccine, revoked the product license, placed a permanent ban on the product, and filed criminal charges against its manufacturer, Sanofi Pasteur, for deaths which could not be proven to have been caused by the vaccine. Contrary to the well-studied Dengvaxia, the COVID vaccines are very novel with only early trial results and are only being allowed under EUA to address a national emergency.
Whichever is the case, in February, an indemnity law was rapidly passed to comply with industry requirements. However, it is not clear how COVID vaccine-related adverse events following immunization (AEFI) are to be duly assessed.
In the meantime, discussions on indemnity and potential adverse reactions, incomplete verification (such as telegraphing extremely low risks) of adverse events playing out in the public arena contributed to doubts and heightened concern about vaccine safety among the populace.
The Sinovac story
In 2020, around the time of the discovery of the justified smuggling incident, the national government announced that the Philippines would be sourcing Sinovac from China, either through donation or procurement. At that stage, no FDA EUA had been issued for this or any other product. No clear reason was given for choosing this vaccine above all others.
During a Senate inquiry, the DOH Secretary added to the controversy by reporting that the price for one dose of Sinovac was USD75, compared to other COVID vaccines priced at USD 5-10. Upon further questioning, however, he finally admitted that the Sinovac price he mentioned was the result of a Google search.
At the end of February 2021, FDA Philippines announced that EUA had been granted to Sinovac, while stipulating that it would not be used for the following:
Health frontliners who work with COVID patients
The elderly, defined as 60 years old and above
Those with comorbidities
The FDA Director General cited Sinovac’s lower efficacy rates in clinical trials for his recommendation. When he overturned his recommendations a few days later, the damage of doubt had been done.
Uproar Among the Ranks
His updated recommendations sparked an uproar in the medical community. Health experts were not in agreement. 95% of the physicians in the state university hospital (and designated COVID treatment center) rejected Sinovac and preferred to wait for a “better” vaccine. Part of this argument among experts was held on social media with pro- and anti-Sinovac posts competing for dominance. Though the benefits and safety profile of the vaccine were discussed, doubts persisted. This uncertainty spilled over to the public; if health care providers refused Sinovac, then why should they settle for what they deemed a second class vaccine?
At the end of February, the medical community of the state university hospital met with DOH and experts for a town hall discussion. They reached a compromise to allow health workers to choose their preferred brands of vaccine. First, this assumes that the Philippines will have brands to choose from. Second, this complicates the vaccination process and may introduce additional risk.
In the meantime, a health advocacy group (HPAAC) calls for due process and access to more data. The group deemed that the government was skipping an important step unless Sinovac undergoes assessment and evaluation by the DOH Health Technology Assessment Council (HTAC). The council upheld what FDA initial recommendations..
In reality, the national government has numerous vaccine expert panels housed under different agencies. The DOH has several: Formulary Council, HTAC, National Immunization Technical Advisory Group (NITAG) and National Adverse Events Following Immunization Committee (NAEFIC). The Department of Science and Technology (DOST) has its own vaccine expert panel assisting FDA, whose members are undisclosed, assisting in deciding on issuing EUA and clinical trials approval. It is time that the chairs of these committees talked to each other to agree on a common stand instead of airing disparate opinions in individual interviews and adding to public confusion and hesitancy.
Conclusion
Where is the World Health Organization (WHO) and what should be their role in all these stories? Should the organization limit itself to being the arbiter of science or should it go beyond science to exercise relevant leadership which helps member nations act effectively and communicate critically during crises?
In a recent National Health Security forum, a former health secretary in the panel was asked how the country is faring in managing the pandemic. The government received an A+ for effort but a failing grade for delivery of outcome. To do better, it can start with 3 key lessons on communication from the abovementioned episodes:
Leaders at all levels must talk to each other through interagency collaboration and agree on priority actions to take
Decision makers, ever mindful of the impact and risk of unfiltered messages on the public, must be circumspect in giving public statements. Interviews are to be undertaken solely for the purpose of imparting useful information but must be mindful of the bigger context. For factual issues, transparency will minimize speculation. For issues requiring opinions, officials can avoid confusion by considering the issues together and agreeing on a uniform response before facing the media.
Health care professionals who express their personal opinions in public may be misconstrued as giving a professional and official opinion. Therefore, unless designated the national spokesperson expert in this pandemic, health care professionals can confine themselves to sharing their opinions in inter-agency meetings, particularly if there are differing opinions to work through.
As mentioned earlier, vaccine hesitancy (like many other issues) is a function of the public’s trust in the government. Trust is not freely given but must be earned by building a track record of putting the needs of the public first, consistently over time. Though a pandemic is not the ideal time to start earning the public’s trust, there is no time like the present.
Postscript: The first of March 2021 was a historic day for the Philippines, when the first legal vaccine (i.e., EUA given), Sinovac, was rolled out. Originally, FDA Philippines did not authorize its use for those over 60 years of age. Within a few days, the regulatory agency unilaterally authorized its use for those until age 65. No reason was specified but the update was announced on the heels of a sectoral clamor.
Citations:
Dr. Kenneth Hartigan-Go is an Adjunct Faculty at the Asian Institute of Management (January 2021-June 2021) and a Non-Resident Research Fellow of the Ateneo School of Government (Jan 2021 - )
He was Philippine Department of Health Undersecretary (2015-2016); Director General of Food and Drugs Administration (October 2012- October 2014); Deputy Director Bureau of Food and Drugs (1999-2001). He was the founding Executive Director of the Zuellig Foundation from 2001 to 2009. He was faculty of the UP College of Medicine (1990-2006), Ateneo School of Medicine and Public Health (until 2010) and AIM (2010-2015).
He holds Doctor of Medicine degrees from the University of the Philippines College of Medicine (1985), and from Newcastle University UK (1998, Clinical Pharmacology). He is a Fellow of the Royal College of Physicians (Edinburgh), a Fellow of the American College of Physicians, Honorary Fellow of the Academy of Medicine, Singapore and Honorary Fellow of the Singapore College of Physicians since 2017 and the President Philippine College of Physicians (2017-2018).
