Wednesday, April 14, 2021

Philippine COVID-19 Vaccine Roadmap

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Sec. Carlito Galvez
Secretary Carlito Guancing Galvez Jr. is the country’s COVID-19 Vaccine Czar. Since March 2020, he has been serving as the Chief Implementer of the Philippines’ Declared National Policy Against COVID-19. A member of the PMA Sandiwa class of 1985, he is a retired Philippine Army general serving as the Presidential Adviser on the Peace Process since 2018 in the Cabinet of President Rodrigo Duterte.
From a paper delivered during the Dec. 10 webinar, “Health and Economic Outlook for 2021—Sparking Hope: Will a Vaccine see an end to the Pandemic?” conducted by the Philippines Graphic-BusinessMirror, in partnership with the Pharmaceutical & Healthcare Association of the Philippines (PHAP).

This morning, I will discuss the Philippine COVID19 roadmap. We will also discuss some of the highlights of the government’s vaccine development program and present the Philippine COVID19 National vaccine roadmap. We will also discuss the ongoing public and private partnership that we have undergone lately.

We have more or less 200 vaccines being developed and more or less, we have 12 undergoing clinical trials. As we have seen, BioNTechPfizer takes the lead with the roll out in the UK and most likely, there will be a rollout in Canada. We are also looking at Astra Zeneca to follow in the UK, and Johnson and Johnson. There are other vaccines that have already been approved for limited use like the Sinovac, SinoPharma, the CanSino, the Gamaleya and the other vaccines in Russia.

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As you can see, there is an ongoing shortfall based on the capacity that had been produced by the different vaccine companies. And more than 80% of this capacity has been prebooked to the 15% of the population, meaning countries like us will be fighting for more or less the 18%. And considering that some of the clinical trials have been delayed, most likely the capacity will be further reduced.

More than 3.7 billion capacity have been preordered by rich countries. The US, UK, EU and Canada procured more than their population. We can also say that Canada has procured more than six times its population. The US procured three times its population.

The rest of Southeast Asia is now actively planning, including the Philippines. For us, we have already 2.6 million doses reserved from Astra Zeneca and now we have ongoing negotiations with five manufacturers and it will also include another four more. Then we have reserved more than US$1 billion from the Asian Development Bank (ADB) and the World Bank.

During our negotiation with ADB and World Bank, initially, they were reserving US$300 million but it was expanded to US$500 million each. The Secretary of Finance is also reserving P73 billion from ADB, Landbank, and from different GOCCs. About P72.5 billion had been allocated for vaccine procurement in the bicameral Congress.

EQUITABLE ACCESS 

The roadmap is based on the need for equitable access with regard to the vaccine, particularly with the poorest of the poor. This is in accordance with President Duterte’s guidance. And he wants to have all Filipinos vaccinated, rich or poor.

He (Duterte) is also always looking, during the UN Convention and also during the ASEAN Convention; he is appealing, he is making it his clarion call that no one is safe unless everyone is safe. So with that, he is calling for humanity— that poor countries like us should be given equal access to the vaccine.

As to the Vaccine Roadmap Strategic Framework, our main consideration is basically safety and efficacy. This is absolute. It cannot be compromised. We can also look at the sensitivity of handling different vaccines, considering that some of the vaccines are having sub zero, 17, 20 and 80 handling requirements. We also considered the world supply and demand, the timing and the timeline of the distribution will be dependent on the availability of the supply. And of course the cost and complexity of the supply chain requirements. We will have some concept of prioritization and distribution and this will also be dependent on the results of the clinical trials.

In our strategic roadmap, we have seven processes which include: 1) scientific evaluation and selection,  2) access and acquisition, 3) procurement and financing, 4) production, shipment and storage, 5) distribution and deployment; 6) implementation of nationwide vaccination and assessment, and 7) evaluation and monitoring.

This is a parallel process, it is not a series process. This means that we are doing the different stages at the same time so that we can conserve resources and time. Our desired endstate objective is to have a safe, equitable, and cost effective immunization for 60% to 70% of the Filipino population. And the main objectives for this include: containing pandemic, full recovery of our economy, saving more lives, and also going back to normalcy. We would like to sustain the immunization program from three to five years, considering that there are still many variables; there are many uncertainties on the production of the vaccine.

There are updates on the different stages we are having now. The vaccines expert has already produced the list of different possible vaccines that we have to procure and negotiate for. Now, we are on Stage 3 on the process of gaining access through diplomatic and other means and the procurement process and financing process being done by the Department of Finance.

The DOH is now gearing for the implementation of nationwide vaccination and using our ongoing vaccination of rubella and measles and the polio vaccines as some sort of assimilation exercise. And then we are undergoing continous evaluation and assessment and monitoring by the DOH, DOST and the vaccines expert panel.

NEGOTIATIONS

Brazil is closer to getting its first COVID-19 vaccine, as phase 3 trials for a shot made by Chinese biopharmaceutical firm Sinovac have surpassed the 50% efficacy threshold imposed by the country’s sanitary agency, said Covas Dimas Tadeu Covas, director of the Butantan Institute. (AP Photo/Carla Carniel)

This is the basis of the roadmap for the potential roll out of the vaccine: While we are doing assessment, planning and preparation, we are looking at the possibility that we will have a vaccine, more or less 3 to 5 million of either Sinovac or Gamaleya. The negotiation is still ongoing. I just came from a dinner meeting with the Chinese ambassador and the meeting was very fruitful. More or less, there is some sort of an assurance that we will be having a Chinese vaccine by March.

And also, we are continuing negotiations with Astra Zeneca. This Friday I will talk to Gamaleya. More or less, Astra Zeneca has given an allocation of more or less 15 to 20 million in a span of one year.

We are now negotiating with Pfizer and we have already signed with the COVAX facility. (Led by the World Health Organization (WHO), the Global Alliance for Vaccine Initiatives (GAVI), and the Coalition for Epidemic Preparedness Innovations (CEPI), COVAX is a coalition that will facilitate the equitable access and distribution of COVID-19 vaccines to protect people in all countries.—Ed.). And we have also signed a Confidential Disclosure Agreement (CDA) with J&J, Novavax and Moderna. We are looking at a majority of the vaccines, considering the limitation and the shortfall that we had earlier.

The bestcase scenario is that we will be having a vaccine rollout, the majority of it will be at the end of the second quarter or the middle of the third quarter.

The worse case scenario—if there is some inability to get the vaccine— would be the fourth quarter of 2021 or the first quarter of 2022. This is the way we project this to the media so that the people will not be expecting. But the government, the administration of Mayor Duterte, is looking forward to us having the vaccine, really, in the first quarter, despite the limitations that we have.

There are phases of the roadmap with critical activities, meaning the critical activities that might fail or succeed in our campaign for the vaccination. So this is just an illustration of how we plan for the nationwide unprecedented vaccination of more or less 75 to 80% of our population.

There are critical timelines. By end of December, we have to finish stage 1, 2 and 3, meaning the contracting and the financing should be completed because if we are not able to complete contracting and financing, most of the preordered vaccines will take three to six months before the balance vaccine will be delivered.

The COVAX facility has assured us that 20 million people will be vaccinated. But there is an attached clause to the COVAX: that we will have only 3 million in July and the 17 million will be at the end of December or early January. So with this, we need to add more, different strategies so that we can get more access by using the bilateral, tripartite and multilateral arrangements.

We have ongoing negotiations from G to G with different listed countries. We capitalize on the good relations that we have particularly with Australia, China, Russia, South Korea and even Singapore, Israel and also the US. On the tripartite, we were able to succeed on having a tripartite agreement with the government, Astra Zeneca, and the business sector and it gathered 30 major business tycoons who participated in the tripartite agreement. This tripartite agreement has a long term effect considering that in the future when the vaccine is made commercially available, this might be used in order to control the vaccination by the DOH. And also in the multilateral, we are now in the finishing touches on unlocking the fund from the ADB and the World Bank. All the necessary procedures have been undertaken and more or less coming this December 15, we can access the fund, more or less US$1 billion.

VACCINE DEPLOYMENT

Based on the President’s guidance, we will give equal access to the poor and indigents and we will prioritize the frontliners, the soldiers, healthcare workers and the essential services. Considering his guidance, all Filipinos should be vaccinated, except for those who are not volunteering.

We have a strategy that is geographical and sectoral which are also based on the recommendations of the private sector, particularly former Health Secretary Manuel Dayrit, that our strategy should aim to contain immediately, contamination and transmission, and at the same time reduce death.

We considered what we call geographical. We will concentrate on the focus areas. Those who emerge as one of the most contaminated or what we call the epicenter of the pandemic. Then also we prioritize by sectoral. As we have said we will prioritize the health workers, the vulnerable and the poor communities. And then we can have multiple strategies wherein there is a private, public partnership wherein the public will concentrate on the priority areas and sectors while the private will concentrate on their workers, their consumers and market and their donation to the Philippine government. The main purpose of this concept of the deployment of vaccines is basically to immediately contain the virus, thus providing consumer confidence and full economic recovery as soon as possible. We have seen that the country has been badly damaged by the pandemic with the contraction of our GDP to 16%.

A nurse from a hospital in Leuven, Belgium holds a vial of the COVID-19 vaccine developed by BioNTech and Pfizer. (AP Photo/Francisco Seco, Pool)

There will be priority by geographic region. CALABARZON and Region IV A are the priority. We will see that the NCR, Region 3 and Region 4A will be a Metro Manila region so that we will deploy Pfizer or we will deploy one vaccine in that geographical area. So there will be probable priority areas by geographical region based on the confirmed cases that we have tracked.

As directed by the President and delineated by the framework of the DOH, our priority will be the frontline health workers to be followed by indigent senior citizens and the remaining senior citizens and the remaining indigent poor population and the uniformed personnel which comprise more or less 25 million.

With the private public sector arrangement, we can expand this prioritization by allowing the private sector to buy—through a tripartite agreement—the vaccines and access to vaccines where we can vaccinate teachers, both the public and private, and other government workers. The LGUs can also do that and also the essential workers from the business sector like for example the agriculture, food industry, transportation, tourism and the other sectors that have been badly punished by the pandemic. And also we include overseas Filipino workers and also the seafarers and the other remaining workers. This is more or less 10 to 11 million so our target for next year is to cover all priority sectors so that we can minimize death and at the same time we can normalize our economy.

LOGISTICS

As a way forward, the President has already approved the Advance Market Commitment. Based on our law 9184 (Government Procurement Reform Act), we are the only country  not allowed to have Advance Market Commitment and because of this, we cannot make advances. That is one of the reasons why our procurement has been some sort of challenged.

We were able to have the Advance Market Commitment approved by the President so now we are having advanced market commitment negotiations with other companies.

The President also approved that we will have a portfolio of vaccines with different platforms with different countries. This is to hedge the possible risk because of uncertainties in efficacy and safety.

And also he approved the private public tripartite agreements with the government, private sector and the vaccine company at no cost to the government. And also, to the issuance of Executive Order 121 giving the Food and Drug Administration the authority to issue emergency use authority.

Normally the authorization from FDA will take six months but now it can only take 21 days to 30 days without any bypass on the process. The process of having the evaluation by the vaccine expert panel, by the ethics review board and the FDA is still intact. The only change in the process is that most of the timeline has been reduced to about one month.

So these are based on the ranking given by the vaccine expert panel. These are the possible vaccines that we are now negotiating with—the Chinese vaccine, with Novavax, Johnson and Johson, the Gamaleya, Astra Zeneca, Pfizer, Moderna and also with Cansino and other possible vaccines that are ready for the market. Most of these vaccines are now applying for FDA and five of these vaccines will undergo clinical trial including the Sinovac, Johnson and Johnson, Gamaleya, Astra Zeneca and also Clover. These are the five companies that will be undergoing clinical trials in the Philippines by early January or late December.

Los Angeles Fire Department Capt. Elliot Ibanez (left) receives the Moderna COVID-19 vaccine given by LAFD paramedic Anthony Kong at Station 4 in Los Angeles. (Gary Coronado/Los Angeles Times via AP, Pool)

And the modes of financing that we have set the direct procurement under Republic Act 9184, the different ancillary consumables like syringes and the mobilization of additional personnel and also other consumables and other products will be undertaken by the SDBM.

Multilateral loans ADB and World Bank will be undertaken by DOF. The good thing here is the ADB and the World Bank have very stringent qualifications for releasing funds so the President is very, very clear that the transaction will be clean considering that these very highly reputed organizations will make sure that the procurement will be clean. Meaning ADB and the World Bank will be our financial manager and at the same time, procurement agent. And also we have bilateral loans possibly with UK or China and also the private public sector tripartite agreement. So I have said earlier that ADB had already reserved more or less US$300 to US$500 million. World Bank has also reserved us US$300 to US$500 million because of our good credit rating and also the Department of Finance already allocated P73 billion for the vaccines.

So this is our preparation for the December 16 logistics. We all know that there is a great preparation for procurement, manufacturing, transport to country and in country distribution, shipment and delivery to endusers.

So on December 16, we will be having a nationwide logistics summit. It will be handled by the Boston Consulting Group and also by the Philippine Disaster Resilience Foundation (PDRF) under Bill Luz and also Paolo Borromeo. And we will be handling different models of this so that we will have some sort of lessons learned from countries like  UK, US and also Canada and other countries.

The preparation, especially the Oplan Warp Speed and also the roll out of UK will also be taken up in this with several different factors particularly important. This is the physical assets of Cold Chain, the security, the bio refrigeration, data and technology meaning tracking data and communication considering 66% of all Filipinos are willing to be vaccinated and also the mobilization of frontliners. So this is the magnitude of our preparation right now, preparing the logistics of the nationwide unprecedented immunization of more or less 25 to 35 million Filipinos next year.

We will be creating a vaccine war room. We will have continuous strategic planning and then we will have the operation management in the prioritization and allocation, the administration and POD of mobilization and distribution and supplies and also communications and public updates. We will also take up with the ITC requirements, the dashboard that we will be requiring and also the funding and the budgeting, legal and the regulatory factors.

And this is the configuration of our preparation with the war room, with the DOH and we will transcend this to the LGUs so that they can prepare the regional classification of prioritization and at the same time, we will get the LGUs involved. Today, I will be speaking with the different LGUs and so with the National Peace and Order Council in Malacanang and we will be discussing the possibility of how the national government and the LGUs will work together in this very unprecedented initiation program.

As the President has said, we are not safe until everyone is safe. This is the continuing clarion call of President Duterte for global equal access to the vaccines in the UN and ASEAN Conventions.

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Sec. Carlito Galvez

Secretary Carlito Guancing Galvez Jr. is the country’s COVID-19 Vaccine Czar. Since March 2020, he has been serving as the Chief Implementer of the Philippines’ Declared National Policy Against COVID-19. A member of the PMA Sandiwa class of 1985, he is a retired Philippine Army general serving as the Presidential Adviser on the Peace Process since 2018 in the Cabinet of President Rodrigo Duterte.

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