FREQUENTLY ASKED QUESTIONS ON COVID-19 VACCINES #2
The current landscape of COVID-19 vaccine initiatives in the country is still dynamic - as discussions are still ongoing with potential partners. Here are some of the frequently asked questions (FAQs) on COVID-19 vaccine initiatives, as addressed by the office of DOST Assistant Secretary for International Cooperation. The contents of these FAQs will be updated regularly.
1. What is Coronavirus-2019 (COVID-19)?
It is an infectious disease caused by a newly discovered coronavirus –SARS-CoV-2. The disease is transmitted to humans through respiratory droplets or discharges from sneeze and cough, and saliva. Since its first recorded case in China, COVID- 19 had widely spread in the different parts of the world. With the continuous increase in the number of infected people, countries have taken numerous measures and/or strategies to control the spread of the disease – physical distancing, mandatory wearing of face masks and increased detection of cases with early isolation and quarantine among others. Also, the global scientific community has been working tirelessly searching for the vaccines to provide immunity against this virus.
2. How do vaccines work?
Vaccines work by introducing inactivated, weakened or killed copies of the whole or part of the disease-causing pathogen, for instance SARS-CoV-2, to our bodies just enough to stimulate our immune system to naturally produce cells or specific antibodies that will fight the virus. Once our immune system has successfully eliminated these foreign elements inside our bodies, it will remember the disease it caused and the antibodies it previously produced to fight it. If we are then exposed to the real SARS- CoV-2 in the future, our immune system already knows how to destroy the virus before it can even make us seriously sick.
3. What if there is no vaccine?
If there is no vaccine, transmission of the virus may slow down if enough people get infected and the country approaches herd immunity and gain at least a temporary respite from major outbreaks Some experts have estimated reaching that point would require as much as 60 percent to 70 percent of the population getting infected. However, death rate at 60 70 infections in the population will also increase.
4. Will there be a vaccine for COVID 19?
The SARS CoV 2 is a novel coronavirus, and vaccines against it have yet to be developed But experts think there will be a COVID 19 vaccine. In fact, there are more than 160 ongoing SARS CoV 2 vaccine developments being conducted across the globe by many research institutions, private and state-owned pharmaceutical companies, and universities. To date, these vaccine candidates are in various trial stages to ensure their efficacy and safety for human use. As of 20 August 2020 the World Health Organization ( records 30 candidate vaccines that are in various clinical trial stages while 139 are in pre clinical trial stage.
Health experts are accelerating research to study the origins of the virus and how it is spreading. The virus has been differentiated from SARS and MERS, but its contagiousness and virulence is still being studied.
5. What are the stages of vaccine development?
Vaccines undergo various clinical trial stages to ensure their safety and efficacy These stages include:
• Pre-clinical - Vaccines are tested in animals such as mice and monkeys to see if it produces an immune response
• Phase 1 - Vaccines are given to a small number of people 10 100 people) to test its safety
• Phase 2 - Vaccine are given to hundreds of people 100 to 1 000 people) to test its efficacy, determine the right dosage, and ensure that the desired effects are achieved
• Phase 3 Vaccine are tested in a larger group of people to confirm its efficacy and safety when compared to other treatments
6. How are clinical trials done?
In a clinical trial, a volunteer is usually assigned a specific study group Volunteers in one study group may receive the COVID 19 vaccine while others may receive a placebo or a comparator vaccine in order to assess its efficacy. The trial is usually a double-blind test where participants, physicians, and research staff do not know which volunteer receives a placebo and the active treatment. This will eliminate bias so that physicians and research staff will provide the same level of medical attention and care to all participants. The vaccine recipients are monitored for side effects at various time points during the trial, and tested for their immune responses to the vaccine components.
7. Who can participate in the clinical trials?
All potential recipients of the vaccines under the clinical trial will first be screened for certain inclusion and exclusion criteria. These criteria include physical examination, general state of health, and ability to follow instructions among others. Laboratory tests will also performed such as baseline RT PCR for SARS CoV 2 viral RNA, IgM and IgG tests, clinical chemistry examinations to detect abnormalities or disease conditions that may not be detected on physical examination alone.
8. What will participants get for joining in the clinical trial?
Participants of clinical trials in the Philippines will be given excellent healthcare services and closely monitored by the attending physicians They will also receive a minimal allowance to reimburse meals and transportation associated with participation to the clinical trial.
9. Are there risks associated with participation in the clinical trials?
Vaccination of investigational drugs or vaccines may have side effects including pain, redness, itchiness or swelling at the injection site, which may last a few hours Other side effects may also include fever, feeling of weakness or fatigue, headache, dizziness, diarrhea, and nausea. However, during the trial, the attending physician will determine if the side effects are causally related to the vaccines. Participants are also given diary cards and are expected to report to the vaccine trial monitors any side effects or development of COVID 19 signs and symptoms during the clinical trial period. Generally, the benefits of taking the vaccine outweigh the risks associated with its side effects.
10. Are all vaccines the same? Will they work for everyone?
There are several platforms being used for development of COVID 19 vaccine, each one having their own advantages and disadvantages Some are tried and proven and have worked for other viral illnesses Some can be produced much faster, but it is unclear if they will all be as effective Hence, parallel development of multiple types of vaccines is a good thing.
Also, a COVID 19 vaccine should have at least 50 efficacy rating which refers to the percentage reduction of disease in a vaccinated group of people compared to an unvaccinated group. The efficacy depends on the types of the vaccine and the population inoculated This means that different types vaccines and different populations may produce different outcomes.
11. What are the initiatives of PH government to provide vaccines for Filipinos?
The Philippines does not currently have the capacity to produce and manufacture its own vaccines Hence, the government has been in close collaboration with several countries and international organizations that are engaged in the development and manufacturing of possible COVID 19 vaccine. So far, the Philippines has had talks with seven foreign vaccine R&D institutes and manufacturers who are ahead in the race for COVID 19 vaccine Also, the government has signified its intent to participate in both the WHO Solidarity Trial on Vaccines and the GAVI COVAX Facility.
12. What are the criteria in choosing possible PH bilateral partners for COVID 19 vaccine?
The Philippines is looking into possible partnerships with bilateral partners who ( have COVID 19 vaccine development in the advance stage (i e vaccine candidate has finished Phase II Clinical Trial or currently on Phase III Clinical Trials), and ( willing to locally manufacture their vaccines in the Philippines.
13. What is WHO Solidarity Trial for Vaccine?
The World Health Organization leads the Solidarity Trial for vaccines which aims to i harness a global cooperation to develop and evaluate vaccine candidates as quickly as possible (identify vaccine candidates and their progress; (define the desired characteristics of safe and effective vaccines to combat the pandemic and ( coordinate the clinical trials across the world giving the best chance of safe and effective vaccines for all.
14. Can other vaccine developers outside the WHO Solidarity Vaccine Trial still conduct clinical trial in the Philippines?
Yes. Other vaccine developers can conduct independent clinical trials in the Philippines given that they will be able to fund their own trials and register their application with the FDA Independent trials would require a larger sample size based on the size requirements of a Phase III clinical trial and will be mainly overseen by the vaccine developers/manufacturers and the local. Contract Research Organization and/or medical team they will engage.
15. What is COVAX Facility?
The COVAX Facility, co led by Gavi, the Coalition for Epidemic Preparedness Innovations (CEPI), and the World Health Organization (WHO), is a platform that aims to accelerate the development and manufacture of COVID 19 vaccines and to ensure that every country in the world is able to access the successful vaccines.
16. How will the COVAX Facility ensure equitable access to COVID 19 vaccines?
The COVAX Facility works by incentivizing manufacturers to accelerate the development and manufacture of possible vaccine candidates This allows the facility to create the largest and most diverse portfolio of COVID 19 vaccines As soon as it becomes available, COVAX will deliver doses for at least 20 of each country’s population, prioritizing the most vulnerable and at risk.
17. Will there be a financing support available for the Philippines?
Yes. The COVAX facility provides opportunities for low income and lower-middle-income countries to access subsidies through the Gavi COVAX Advanced Marketing Commitment (AMC). The Philippines, as a lower-middle-income country, was recently announced as one of the countries eligible to access the COVAX facility.
Overall, the facility will require at least US 2 Billion of seed funds to fund the volume guarantees and deliver the vaccines to Low-Income Countries (LICs)and Lower Middle-Income Countries (LMICs).
18. What are the criteria for choosing a successful vaccine?
The vaccine technical evaluators use the WHO internationally accepted standards for vaccines for pandemic or outbreak response use or for long term use The WHO Target Product Profiles are used as reference standards, as well as other WHO Technical standards and FDA requirements.
A matrix is prepared to give weights on compliance of the vaccine candidates with respect to the following vaccine characteristics indication for use, contraindication, target population, safety/ reactogenicity, measures of efficacy, dose regimen, the durability of protection, route of administration, product stability and storage, co-administration with other vaccines, presentation, WHO Emergency Use Listing registration and pre-qualification, and accessibility. All pre-clinical and clinical data are rigorously evaluated.
19. What are the government’s measures to ensure the vaccine’s safety?
Aside from the Solidarity Trials, overseas clinical trials and prequalification from the WHO, the Philippine government has established additional measures to ensure vaccines safety and efficacy The sub Technical Working Group on Vaccine Development has created the DOST Vaccine Expert Panel, a group of technical experts and scientists tasked to identify, evaluate, and recommend possible vaccine candidates for the Philippines. The DOH Health Technology Assessment Unit as well as different medical and specialty societies have also suggested to the IATF safety nets to ensure vaccine safety when already in use through pharmacovigilance and surveillance.
20. When will the vaccine be available?
We are anticipating that the first vaccine supply will come from the GAVI COVAX Facility in the second quarter of 2021 But a lot of factors may affect this timeline that may result to advances or delays in the release of the vaccine.
There are other sources of vaccines aside from the COVAX Facility that PH is also exploring Vaccines may also be obtained through bilateral engagements with governments and foreign vaccine developers. However, there is no definite timeline yet for the release of these vaccines as it will depend on the results of the vaccine clinical trials.
21. Who will have the first access to the vaccines?
Once the vaccines become available, the government may prioritize vulnerable or high risk groups such as healthcare workers to receive the first doses of the vaccine Also, the indigent sector of the population (senior citizens, most vulnerable citizens, poorest of the poor, etc and those communities and areas with high risk factors, may also be provided access to the initial doses.
Succeeding supplies of the vaccine will be provided to the general population after the priority population have been given with the vaccine.
22. Will the immunity last for a lifetime?
Immunity induced from administering a vaccine fades over time and the protection differs with each kind of disease and their causative agent Since SARS CoV 2 is a novel coronavirus, any long term immunity may only be determined once vaccines become available and data on their efficacy of become available after about 6 months from when the phase III trials.
23. Does the Philippines intend to produce its own COVID 19 vaccines?
The Philippines currently does not have the capacity to produce a COVID 19 vaccine for its population But the government is working with foreign vaccine developers who would be willing to invest and manufacture their vaccines in the country Currently, local pharmaceutical companies have expressed willingness to establish a fill and finish facility in the Philippines With this, the country will only import bulk antigens from foreign vaccine developers and fill them in ampoules and vials These facilities are intended to be modular so that it can be used and repurposed for other vaccines in the future.
24. What is the Philippines’ long-term goals to ensure the vaccine self-sufficiency?
The DOST has initiated two long term action plans to achieve vaccine self-sufficiency One is the establishment of a Virology Institute of the Philippines ( that is currently a pending bill in the legislature, together with the reinstitution of the DOST Pharma Center The sub-Technical Working Group on Vaccine Development suggested to expand the VIP to include not only viruses but other pathogens as well These institutions will serve as research arms of the government to build its capacity to produce its vaccines and drugs especially for future pandemic situations The second long term action plan is to establish a vaccine manufacturing facility through the Vaccine Self Reliance Project of the Research Institute for Tropical that is currently in the pipeline.
25. What is the manufacturing process for vaccine?
The tools that are needed for manufacturing a vaccine vary considerably depending on its type But in many cases, vaccine development requires a bioreactor a giant tank that allows the organisms to grow that will be the source of vaccines
In addition to the bioreactor, there are other things to take into consideration, such as medical grade glass, a sterile vial or syringe which are generally limited and may eventually become a bottleneck if the goal is to produce billions of doses of the vaccine.
26. Are there other ways to protect us against the novel coronavirus?
A vaccine will be our best protection against the novel coronavirus. However, while the vaccine development is still underway, we have to continue instituting measures to limit the spread of the virus such as physical distancing, early detection and isolation of cases, use of face masks and other PPEs We should sustain our efforts to:
• Improve testing availability and turnaround times to help detect outbreaks
• Hire and train more contact tracers, creating more tools to assist them
• Produce high-quality N95 masks for daily public use
• Find effective treatments that speed up recovery and increase survivability
Written by Christine Jane Gonzalez
Published: 02 September 2020