By ROSARIO GUZMAN and MARICAR PIEDAD
(Second of Two Parts)
New wave of chaos
We are not exactly expecting the Philippines to be ahead of the vaccine race being a poor, non-industrial and import-dependent country. But despite our underdevelopment, we still deserve better and more efficient government handling of our predicament. Indeed, if the government handled things better then we would not be so far ahead in the number of COVID cases.
However, we are still seeing the same bungled response that we have had for over a year now. Seventy million adult Filipinos will supposedly be inoculated by the end of 2021 which means attaining the prescribed number for herd immunity. Yet at the rate we have been going since the first official vaccine shot on March 1, it will take over 13 years for the vaccination program to be completed. By 2034, herd immunity will have set in naturally from the spread of the virus among the population but at the price of thousands of unnecessary deaths.
The “vaccine cluster” to oversee the Philippine national vaccination roadmap is under the command of former Philippine Army general, Carlito Galvez, dubbed by Pres. Duterte as the “vaccine czar”. He is also the head of the National Incident Command of the National Task Force against COVID-19 (NTF COVID-19), which in turn is headed by the defense secretary Delfin Lorenzana. The NTF is the operational command of the Inter-Agency Task Force on Emerging Infectious Diseases (IATF-EID).
The vaccine cluster is composed of task groups on vaccine selection and evaluation, diplomatic negotiation and engagement, procurement and financing, shipment and storage, immunization program (distribution and deployment), and demand generation and communications.
The vaccine approval and acquisition process is straightforward. A vaccine expert panel (VEP) recommends the short-listed vaccines to the selection and evaluation task force, which then advises the negotiations by the vaccine czar. An official purchase agreement shall be reached through bilateral or multilateral negotiations. Procurement is a three-phase process: meetings with the manufacturers and signing of non-disclosure agreements; formal negotiations and exchange of the term sheet; and the national government submitting the term sheet to the financing banks for clearance and the parties finalizing the supply agreement. The supply agreement may be in the form of advanced market commitment, a supply agreement, or research and development investment.
The national vaccination roadmap is also clear on ensuring safety and efficacy. Only vaccines that are granted Emergency Use Authorization (EUA) or Certificate of Product Registration (CPR) by the Food and Drug Administration (FDA) will be purchased by the government. This should be ensured before delivery and payment of balance.
With the emergency of the pandemic, however, Pres. Duterte gave the FDA director-general the authority to issue EUA for COVID-19 drugs and vaccines and prescribe conditions under which the EUA may be used.
Still, this has not hastened the arrival of the vaccines. The authority even potentially throws official COVID response into a deeper mess. True enough, despite the supposed simplicity of the vaccine approval process, the Philippine vaccine roll-out has started with characteristic chaos.
Pfizer-BioNTech (US) and Oxford-AstraZeneca (UK) were granted EUA in the first and last week of January, respectively. But Sinovac (China), which previously applied for clinical trials in the Philippines to expand its data and pull up its low efficacy rate, opted to abandon the clinical trials and instead applied for EUA in the middle of January. This was after a supply agreement had apparently already been signed by the Duterte government and Beijing. Conveniently, the FDA granted the application right before the arrival of the first doses of Sinovac vaccines in the country in February.
On the other hand, Sinopharm (China) submitted its EUA application on March 2, a month after the FDA granted it a “compassionate use license” for 10,000 doses. This was given after the controversy that Philippine Security Group (PSG) personnel and other personalities were injected with the Sinopharm’s vaccine outside the procurement and legal processes.
Meanwhile, the Duterte government has already signed supply agreements from companies that have not yet applied for EUA, such as Moderna, Novavax (both US) and Janssen (Belgium). There is still no word when these companies will submit their EUA applications.
Muddled, late roll-out
When it comes to negotiations and procurement, the Duterte government is now caught up in the web of global supply constraints and its own inefficiency. Secretary Galvez has reported 125 million doses of confirmed orders out of the target 148 million doses. The orders are with Novavax (30 million), Sinovac (25 million), AstraZeneca (30 million), and COVAX (40 million). Only three (3) million doses have arrived as of April 12, of which 2.5 million are from Sinovac.
Novavax should theoretically not be able to make its deliveries without the EUA. On the other hand, the WHO-initiated COVAX facility, which supplies both AstraZeneca and Pfizer-BioNTech has also been much delayed. Only Sinovac is delivering on schedule. However, ambivalence regarding its low efficacy rate is pervasive and even Beijing’s top health official has recently mulled over combining it with other vaccines just to increase efficacy. This is not helping to increase public confidence in the entire vaccination program.
COVAX is a public-private funded global facility created to ensure the equitable distribution of vaccines. There are self-financing countries and there are funded countries in COVAX, including 92 low-income countries (the Philippines included) that can’t afford their own vaccines. COVAX aims to deliver enough vaccines for 20% of the participating countries’ populations for a total of about two (2) billion doses by the end of 2021. But COVAX is super-challenged at the moment because of the lack of investment, exports constraints, and governments making side deals with the giant pharmaceutical corporations to stake claims on large portions of vaccine supplies.
Notwithstanding COVAX’s risks of failing, half of the failure to deliver now is the Duterte government’s responsibility. The Philippines was one of the earliest countries to signify participation in the COVAX facility. But the Duterte government was slow in attending to prerequisites, in particular an indemnity agreement between the vaccine manufacturers and the national government where the former is freed of liability for any adverse impacts. The failure to clinch this caused huge delays in the arrival of the donated COVAX vaccines, until COVAX’s own problems caught up with such inefficiency.
This has been the main reason for the first health workers getting injected with the Sinovac vaccines instead of the expected Pfizer COVAX delivery. The absence of the indemnity clause has dragged the entire vaccine roll-out.
The Indemnification Bill was signed into law only on February 26. It frees vaccine manufacturers from any liabilities if Adverse Event Following Immunization (AEFI) happens. It also assigns the controversial PhilHealth to finance and manage a Php500-million budget dedicated to Filipinos who will experience AEFI. Yet, in March, the president continued to question having an indemnity clause in vaccine contracts, throwing us back to square one on the point of decision-making on mass vaccination.
The national government has also allowed private enterprises and local government units (LGUs) to procure vaccines for their constituents and employees provided that they sign a tripartite agreement with the national government and vaccine manufacturers. The tripartite agreement is meant to ensure vaccine manufacturers that the national government would cover indemnification and the cost of adverse effects.
This has practically relegated the national government to being a broker and at the same time a buffer for vaccine manufacturers. This undermines the basic principle of centralizing procurement for the sake of public health. It also opens up further the opportunity for profiteering and, of course, politicking. More importantly, it reinforces inequality in vaccine distribution. The poorer LGUs and small enterprises are left behind even if these are where the more socioeconomically at-risk population reside and work.
Lastly, its fund allocation gives away the Duterte government’s level of seriousness in having an efficient and equitable mass vaccination program. The national vaccine plan costs Php82.5 billion. Php10 billion will come from the standby fund for vaccines under Bayanihan 2, but only Php2.5 billion was allocated in the 2021 budget. The remaining Php70 billion will be sourced from “unprogrammed funds” depending on excess revenues or, as is the case now, with new debt from bilateral and multilateral lenders.
While it deserves another discussion, it should be said that the ones constantly benefiting from the deals no matter how blundered and inequitable for the public are the global pharmaceutical monopolies or Big Pharma. They are able to call the shots while the world seeks to resolve the pandemic crisis. The Duterte government meanwhile plays along as it maintains a neoliberal approach to vaccination – relying on the global market, debt, foreign capital, and even China, while decentralizing vaccine acquisition and bungling implementation. (Click here for Part I) Reposted by