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, the 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, the 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 the 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 are 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 be 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 in 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 the 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 ratings which refer 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 of 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 harness 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 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 in.

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 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 in 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 has been given with the vaccine. 

22. Will the immunity lasts 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 becoming 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 a 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

 

Source: http://www.pchrd.dost.gov.ph/index.php/news/6594-frequently-asked-questions-on-covid-19-vaccines-2 (Written by: Christine Jane Gonzalez)

MANILA -- The Department of Science and Technology (DOST) is urging researchers and inventors to maximize the recently-launched Science and Technology for a Resilient Community against the Pandemic (STRAP) program and get a maximum of less than PHP5 million grant for quick response technologies or projects that would help address the pandemic or deal with the "new normal".

"This (program) is an invitation to researchers and innovators to provide solutions to the new normal," Philippine Council for Industry, Energy and Emerging Technology Research and Development (PCIEERD) executive director Enrico Paringit told the Philippine News Agency in an interview Friday.

He said the STRAP program was approved in June, and that PCIEERD started soliciting project proposals in July.

To date, eight project proposals have been received and are being evaluated. Paringit said he estimates that if all these eight would be approved, these would be worth PHP40 million.

A total of PHP60 million was allotted for STRAP. Of this budget, less than PHP10 million was already provided for three ventilator projects of two universities and a startup company. Another PHP5 million was allotted to support testing the prototypes of other unsupported ventilator projects, Paringit said.

"Under the STRAP (program), we expect that the prototypes would be released within a year. The projects under this program normally have a one-year timeline," he explained, adding that only less than PHP5 million would be allotted per approved project since these are just short projects. "That (amount) is within our approving authority as a Council," he remarked.

Paringit also clarified that the DOST, at the moment, does not intend to allocate a budget for STRAP program on a yearly basis, and would only commit the PHP60 million funding to the researchers and innovators.

"After (all the PHP60 million fund are used), we would just await the result of researches that we supported," he said.

Paringit added that the DOST would likely look for other programs or research calls after the STRAP program is maximized.

"It (new program or research call) would depend on what would be the needs in the coming years with regard to Covid-19 or (the) new normal," he said.

Meanwhile, earlier in May, the DOST has announced up to PHP5 million grant, also for researches and technologies, that would help the economy adapt to the new normal after the pandemic.

The call is under the Collaborative Research and Development to Leverage Philippine Economy (CRADLE) Challenge, wherein applicants would need to formulate scientific and technical solutions that would shape the new normal for businesses. (By Ma. Cristina Arayata,PNA)

 

Source: https://www.pna.gov.ph/articles/1112334

Rates of thyrotoxicosis are significantly higher among patients who are critically ill with COVID-19 than among patients who are critically ill but who do not not have COVID-19, suggesting an atypical form of thyroiditis related to the novel coronavirus infection, according to new research.

"We suggest routine assessment of thyroid function in patients with COVID-19 requiring high-intensity care because they frequently present with thyrotoxicosis due to a form of subacute thyroiditis related to SARS-CoV-2," say the authors in correspondence published online in The Lancet Diabetes and Endocrinology.

However, notably, the study ― which compared critically ill ICU patients who had COVID-19 with those who did not have COVID-19 or who had milder cases of COVID-19 ― indicates that thyroid disorders do not appear to increase the risk of developing COVID-19, first author Ilaria Muller, MD, PhD, of the Department of Endocrinology, IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy, told Medscape Medical News.

"It is important to highlight that we did not find an increased prevalence of preexisting thyroid disorders in COVID-19 patients (contrary to early media reports)," she said.

"So far, clinical observations do not support this fear, and we need to reassure people with thyroid disorders, since such disorders are very common among the general population," she said.

Yet the findings add to emerging evidence of a COVID-19/thyroid relationship, Angela M. Leung, MD, told Medscape Medical News.

"Given the healthcare impacts of the current COVID-19 pandemic worldwide, this study provides some insight on the potential systemic inflammation, as well as thyroid-specific inflammation, of the SARS-Cov-2 virus that is described in some emerging reports," she said.

"This study joins at least six others that have reported a clinical presentation resembling subacute thyroiditis in critically ill patients with COVID-19," noted Leung, of the Division of Endocrinology, Diabetes, and Metabolism, Department of Medicine, UCLA David Geffen School of Medicine, Los Angeles, California.

 

Thyroid Function Analysis in Those With Severe COVID-19

Muller explained that preliminary data from her institution showed thyroid abnormalities in patients who were severely ill with COVID-10. She and her team extended the evaluation to include thyroid data and other data on 93 patients with COVID-19 who were admitted to high-intensity-care units (HICUs) in Italy during the 2020 pandemic.

Those data were compared with data on 101 critically ill patients admitted to the same HICUs in 2019 who did not have COVID-19. A third group of 52 patients with COVID-19 who were admitted to low-intensity-care units (LICUs) in Italy in 2020 were also included in the analysis.

The mean age of the patients in the HICU 2020 group was 65.3 years; in the HICU 2019 group, it was 73 years; and in the LICU group, it was 70 years (P = .001). In addition, the HICU 2020 group included more men than the other two groups (69% vs 56% and 48%; P = .03).

Of note, only 9% of patients in the HICU 2020 group had preexisting thyroid disorders, compared with 21% in the LICU group and 23% in the HICU 2019 group (P = .017). 

These findings suggest that "such conditions are not a risk factor for SARS-CoV-2 infection or severity of COVID-19," the authors write.

The patients with the preexisting thyroid conditions were excluded from the thyroid function analysis.

A significantly higher proportion of patients in the HICU 2020 group (13; 15%) were thyrotoxic upon admission, compared with just one (1%) of 78 patients in the HICU 2019 group (P = .002) and one (2%) of 41 patients in the LICU group (P = .025).

Among the 14 patients in the two COVID-19 groups who had thyrotoxicosis, the majority were male (9; 64%)

Among those in the HICU 2020 group, serum thyroid stimulating hormone (TSH) concentrations were lower than in either of the other two groups (P = .018), and serum free thyroxine (free T4) concentrations were higher than in the LICU group (P = .016) but not the HICU 2019 group.

 

Differences Compared With Other Infection-Related Thyroiditis

Although thyrotoxicosis relating to subacute viral thyroiditis can result from a wide variety of viral infections, there are some key differences with COVID-19, Muller said.

"Thyroid dysfunction related to SARS-CoV-2 seems to be milder than that of classic subacute thyroiditis due to other viruses," she explained.

Furthermore, thyroid dysfunction that is associated with other viral infections is more common in women, whereas there were more male patients with the COVID-19-related atypical thyroiditis.

In addition, the thyroid effects developed early with COVID-19, whereas they usually emerge after the infections by other viruses.

Patients did not demonstrate the neck pain that is common with classic viral thyroiditis, and the thyroid abnormalities appear to correlate with the severity of COVID-19, whereas they are seen even in patients with mild symptoms when other viral infections are the cause.

In addition to the risk for subacute viral thyroiditis, critically ill patients in general are at risk of developing nonthyroidal illness syndrome, with alterations in thyroid function. However, thyroid hormone measures in the patients severely ill with COVID-19 were not consistent with that syndrome.

A subanalysis of eight HICU 2020 patients with thyroid dysfunction who were followed for 55 days after discharge showed that two experienced hyperthyroidism but likely not from COVID-19; in the remaining six, thyroid function normalized.

Muller speculated that, when ill with COVID-19, the patients likely had a combination of SARS-CoV-2-related atypical thyroiditis and nonthyroidal illness syndrome, known as T4 toxicosis.

 

Will There Be Any Long-term Effects?

Importantly, it remains unknown whether the novel coronavirus has longer-term effects on the thyroid, Muller said.

"We cannot predict what will be the long-lasting thyroid effects after COVID-19," she said.

With classic subacute viral thyroiditis, "After a few years...5% to 20% of patients develop permanent hypothyroidism, [and] the same might happen in COVID-19 patients," she hypothesized.

"We will follow our patients long term to answer this question ― this study is already ongoing."

In the meantime, diagnosis of thyroid dysfunction in patients with COVID-19 is important, inasmuch as it could worsen the already critical conditions of patients, Muller stressed.

"The gold-standard treatment for thyroiditis is steroids, so the presence of thyroid dysfunction might represent an additional indication to such treatment in COVID-19 patients, to be verified in properly designed clinical trials," she advised.

 

ACE2 Cell Receptors Highly Expressed in Thyroid

Muller and colleagues also note recent research showing that angiotensin-converting enzyme 2 (ACE2) ― demonstrated to be a key host-cell entry receptor for both SARS-CoV and SARS-CoV-2 ― is expressed in even higher levels in the thyroid than the lungs, where it causes COVID-19's notorious pulmonary effects.

Muller says the implications of ACE2 expression in the thyroid remain to be elucidated.

"If ACE2 is confirmed to be expressed at higher levels compared with the lungs in the thyroid gland and other tissues, ie, small intestine, testis, kidney, heart, etc, dedicated studies will be needed to correlate ACE2 expression with the organs' susceptibility to SARS-CoV-2 reflected by clinical presentation," she said.

Leung added that as a take-home message from these and the other thyroid/COVID-19 studies, "Data are starting to show us that COVID-19 infection may cause thyrotoxicosis that is possibly related to thyroid and systemic inflammation.

"However, the serum thyroid function test abnormalities seen in COVID-19 patients with subacute thyroiditis are also likely exacerbated to a substantial extent by nonthyroidal illness physiology." (written by Nancy A. Melville, August 18, 2020)

The authors have disclosed no relevant financial relationships. Leung is on the advisory board of Medscape Diabetes and Endocrinology.

Lancet Diabetes Endocrinol. Published July 30, 2020.

Sources: https://www.medscape.com/viewarticle/935872#vp_1 / https://www.medscape.com/viewarticle/935872#vp_2 / https://www.medscape.com/viewarticle/935872#vp_3

MANILA -- The fund for virology research and development (R&D), which would cover virology and diseases in humans, animals, and plants, has been approved, Department of Science and Technology (DOST) Undersecretary Rowena Cristina Guevara said Wednesday.

"The amount is PHP284 million. Only R&D has been approved. The bill for the establishment of the VIP (Virology Science and Technology Institute of the Philippines) is still pending in the Senate," she said in a text message.

In May, DOST Secretary Fortunato dela Peña submitted a proposal for possible legislation for the establishment of a virology institute in the country. The establishment of the VIP would also be for the development of vaccines, diagnostics, and therapeutics, he said.

Guevara has been saying the Philippines does not have the capability to develop its own vaccine for coronavirus disease 2019 (Covid-19), due to the lack of facility.

In a virtual presser, DOST-Philippine Council for Health Research and Development executive director Jaime Montoya said the country has many things to do before it could develop a local vaccine.

"It requires a large investment and resources. We still have a lot of things to do and enhance to have the ability to manufacture a vaccine," he said.

Scientific talent, capacity building, training of human resources, are just among those that need to be enhanced, Montoya added.

In the same presser, Lulu Bravo, executive director of the Philippine Foundation for Vaccination, said it takes many years to develop a vaccine.

"From the time that one would be able to identify the microbe, the scientist will then determine which part of that microbe will be good enough to do a vaccine," Bravo said.

"China was able to identify the genetic composition of Covid-19 early this year, and they shared it to the world," she added.

With regard to safety, Bravo said researchers use animals first if it could develop an antibody, before trying it to humans if found effective.

"Every person has a different reaction to a vaccine. The average reaction is also being studied," she said. (By Ma. Cristina Arayata,PNA)

 

Source: https://www.pna.gov.ph/articles/1112834

 

 

The DOST-PCHRD will be conducting a Webinar Series on Intellectual Property and Technology Transfer. This webinar series aims to provide discussions on topics relevant to technology commercialization and intellectual property, specifically for researchers and technology transfer officers from institutions who avail of or are planning to avail DOST funds for their projects. 

 

The first topic of the series will be Technology Transfer Act and its Implementing Rules and Regulations (IRR), as Revised. The IRR of RA 10055 has been updated in 2019.  Our speaker, Atty. Marion Ivy D. Decena, is the Co-Chair of the Technical Working Group which formulated the amendments to the said policy. 

 

Join us on 25 August 2020, from 9:00AM to 10:30 AM, by registering through this link: bit.ly/iptmtta2009

 

Please feel free to disseminate the registration link to the members of your institution and your network.

 

For inquiries, you may reach us at This email address is being protected from spambots. You need JavaScript enabled to view it..

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