Resulting from a tripartite synergy among the government, education and private sectors, innovation development by Thai people is driving the promotion of “Anti-Covid nasal spray” to ultimately pass the standard certification and successfully enter the market.
The “nasal spray containing antibodies to prevent physical effects of COVID-19″ under the brand VAILL COVIDTRAP Anti-Cov Nasal Spray (VAILL COVIDTRAP Anti-Cov Nasal Spray) has obtained product registration from the Food and Drug Administration (FDA)and was available for sale on October 1, 2022. It was a tri-lateral cooperation between government, education and private sectors, including the Faculty of Medicine, Chulalongkorn University, the Public Health Systems Research Institute (HSRI), Silpakorn University, and the pharmaceutical organization Hibiocy Co., Ltd. The project received funding from the Program Management Unit for Competitiveness (PMUC) to conduct experiments to assess the safety for product registration and develop medical innovations to prevent the spread of COVID-19. Even though the current pandemic is likely to improve, COVID-19 will not disappear from the world and will remain a contagious disease that stays with us forever. Consequently Thai research teams from the public and private sectors are working together to develop medical innovations to address this public health concern. Resulting efforts include developing vaccines, testing kits, ventilators, as well as developing innovative technologies for containing and inhibiting the physical effects of COVID-19 around the nasal area, materializing in the form of a prototype nasal spray product called “Vaill Covitrap” which can finally pass the necessary safety standards and enter the market.
Thumbs up for the Chulalongkorn University research team for successfully bringing the research
“off the shelf”.
The development of an innovative antibody that has the ability to contain and inhibit physical effects of COVID-19 around the nasal cavity was achieved by a team of researchers led by Dr. Trirak Phisitkul, M.D., Faculty of Medicine, Chulalongkorn University. He shared that, since the abrupt of the global COVID-19 pandemic, various antibodies have been continuously developed and introduced around the world. However, the research team at the Faculty of Medicine, Chulalongkorn University, in cooperation with the Faculty of Pharmacy, Silpakorn University, was the first group to successfully develop an innovative antibody against COVID-19 in the form of a nasal spray. Subsequently, the technology was transferred to the private sector, and has received cooperation from various parties, pushing the product to successfully pass human tests. As such, the technology has been registered under international standard, which is considered the first for Thailand.” PMUC, who provided funding for the human test in order to be approved by the FDA, the last step in the commercialization of a product. Incidentally, PMUC did not only provide funding for research, but also offered input in terms of technical and commercial perspectives, as well as bringing various cooperative networks, all helping to bring the research off the shelf successfully.”
PMUC supports ”human test”, the final hurdle before FDA approval.
PMUC, by the Science Promotion Fund research and innovation provided funding in “a double-blind, randomized, controlled trial to evaluate the safety and efficacy of hypomellose containing SARS-CoV-2 antibody cocktails in
volunteer subjects with no health conditions”, with Dr. Paporn Prasitdamrong, M.D. as the project leader. It is thought that the outbreak of SARS-CoV-2 was mainly due to airborne parasitism, and has become a global problem that requires additional measures, in addition to vaccination, in order to prevent the spread of the infection. The entry point for SARS-CoV-2 into the human body is through the nasal epithelium. Therefore, to protect the body against Covid-19, a local protection method is important, particularly, an antibody- based immunity stimulation in the nasal epithelium. Most of the vaccination methods being used against COVID-19 promotes antibodies within the nasal epithelium only for a short period of time. Therefore, an approach which promotes repeat immunity stimulation is needed to control the rate of SARS-CoV-2 outbreak, especially for new strains such as Omikron, which has developed immunity against the available vaccines.
Vaill CoviTRAP is a novel innovative in the midst of unprecedented crisis. It is a medical device applied to the nasal epithelium and acts as a physical barrier to prevent SARS-CoV-2 from entering the nasal septum. It can immediately support the self-defense immunity within the nasal septum to stop the spread of the virus. It is an important tool to complement other COVID-19 prevention strategies such as vaccination, social distancing and wearing masks.
Such research clearly indicates that the physical barrier function of this product is achieved via two mechanisms: 1) the formation of a steric barrier at the cell surface level by the cohesive cellulose derivative called HPMC, and 2) the trapping of SARS-CoV-2 virus particles via SARS-CoV-2 resistance with two types of monoclonal cocktails that have been proven in vitro to have the ability to block all major SARS-CoV-2 VOCs, including the Delta and Omicron strands, from entering into the cells. These constituents are macro-molecules that remain only in nasal mucus, so as not to enter the circulation system. This helps to prevent the virus from entering the host by way of a physical barrier mechanism. It is the starting point for the prevention of SARS-CoV-2 entering into the body. It can be used multiple times in both nostrils by persons at risk of being infected.
In the research, the security and effectiveness is clearly demonstrated, as well as the fact that the nasal antibody spray has the ability to inhibit COVID-19 by creating a physical barrier that inhibits the adhesion and entry of SARS-CoV-2 into the nasal septum cells by leveraging 2 important active ingredients: 1) Hypromellose (Hydroxypropyl Methylcellulose -HPMC), which makes the mucus layer on the nasal septum viscous, preventing the movement of SARS-CoV-2 bacteria from reaching and attaching to ACE2 protein on the cells within the nasal septum. 2) The antibody against RBD protein found in SARS-CoV-2 has the ability to inhibit SARS-CoV-2 binding to ACE2 protein on the cell surface within the nasal septum.
The results from the safety and efficacy tests of Vaill CoviTRAP nasal spray has been registered as a Category 4 medical device with the Food and Drug Administration (FDA) and has been approved for sale.
Join in celebrating the success of the latest innovation: “Antibody nasal spray to inhibit physical effects of COVID-19”
On September 26, 2022, Assoc. Prof. Siree Chaiseri, Ph.D., director of PMUC, and Prof. Dr. Sansanee
Chairoj, chairman of the Health and Medicine Subcommittee, PMUC, participated in the launch of the
product Vaill Covitrap Anti-Cov Nasal Spray” at The Mitr-Ting Room, Sam Yan Mitrtown Hall. Also in
attendance were partner agencies that have contributed to the collective success, including Dr. Nopporn Chuenklin, director of the Public Health Systems Research Institute (HSRI), Assoc. Prof. Chanchai Sitthiphan, Ph.D., dean of the Faculty of Medicine, Chulalongkorn University, Dr. Witoon Danwiboon, director of the Government Pharmaceutical Organization, Dr. Nimit Prasitdumrong and Mrs. Worawan Chaikamnerd, executives of Hibiocy Co., Ltd.
Dr. Nopporn Chuenklin, HSRI director, said that since the inception of the COVID-19 outbreak situation in Thailand and around the world since December 2019, many people have been infected in many countries around the world. And though there is a good chance that the situation will improve, COVID-19 will still remain a contagious disease that needs to be monitored. From this situation the research team has developed a prototype product in the form of a nasal spray, which is one of the important innovations in Thailand that has been demonstrated. This serves as a ground on which we can all work together to overcome this epidemic. “I would like to commend the success of the nasal spray against COVID-19 activity inside the nasal cavity, which resulted from cooperation of network
partners from the public and private sectors that contributed to developing and introducing this innovation invented by Thai people to show to the rest of the world the true potential of Thai people. It is an alternative to allow the people to have an added choice to help prevent the spread of COVID- 19. It is a model health innovation for taking care of Thai people’s health and preparing the nation in dealing with any outbreak situations that may occur in the future. It supports access to health services and increases the ability to be self-reliant for all Thai people, ”said Dr. Nopporn.
Prof. Dr. Chanchai, dean of the Faculty of Medicine, Chulalongkorn University, said that research done
by the institution in the area of prevention and treatment of patients with COVID-19, which together
with various faculties, still continue to develop important medical innovations at national level, such
as the development of the ChulaCov-19 vaccine, testing kits, ventilators, etc. Chulalongkorn is very
pleased and proud to transfer the knowledge from research work by a team of researchers from
Chulalongkorn University towards developing antibodies that have the ability to inhibit physical
activity of COVID-19 within the nasal cavity, which the research team has cultivated and developed
since the beginning of the outbreak. With support from both the public and private sectors, namely
HSRI, they were able to push towards the successful development of the prototype antibody. The
team has already filed a patent and is ready to transfer this knowledge to the private sector for
further development, conducting clinical research, and creating innovative products that help to
successfully prevent or treat COVID-19. Dr. Chanchai also discussed about the Human Monoclonal
Antibody technology that such technology is advanced biological technology, and was developed by
decoding antibodies obtained from volunteering subjects who had recovered from COVID-19 with
excellent immunity levels.
Dr. Witoon Danwiboon, director of the Government Pharmaceutical Organization, spoke about the
role of the agency as the main organization in the continuous production and supply of medicines and
medical supplies during the COVID-19 situation. The aim is to promote innovative health products
that can be domestically produced for use within the country. With expertise in the production of
medicine and medical supplies that meet internationally accepted standards, the Government
Pharmaceutical Organization has been responsible for the production and quality control of
innovative products including the “Nasal spray to prevent COVID-19 physical activity within the nasal
cavity”. This innovation was researched and produced domestically for use in the country. The
Government Pharmaceutical Organization has received a medical device manufacturing registration
certificate, with the approval from the FDA to produce medical devices in the Respiratory Care
services category specifically for producing the Nasal Spray Solution products. As well it has received
ISO – 13485: 2016 certification under quality management standards for medical devices from UIC
Certificaion service, which is an inspection agency specializing in international standard assessment
certification, which serves to demonstrate that this facility has met safety and quality management
standards and is suitable for the production of good medical devices, and the the Government
Pharmaceutical Organization has the production ability and capacity as well as the confidence in the
quality and safety of its products, which are ready for full-scale commercialization. This will ultimately
give all Thai people the access to health innovations to prevent and manage with the COVID-19
outbreak, as well as promotes a stronger national public health system.
Ms. Worawan Chaiyakamnerd, Chief Executive Officer of Hibiocy Co., Ltd. (Currently Chief Executive
Officer of Rojukiss International Public Co., Ltd., or KISS, an innovator and creator of beauty and
health products, said that the cooperation between the public and private sectors played in
instrumental role in the research and product development processes, ultimately resulting in the
launch of the VAIIL COVITRAP Anti-Cov Nasal Spray, which is truly an innovation by Thai people for
Thai people. “This is the pride of the Thai people: an innovative nasal spray product to physically
inhibit COVID-19. Vaill Covitrap is the first such innovation developed in Thailand that is ready to be
shown to the world, which has the ability to trap and inhibit COVID-19 by working immediately and
continuously for 6 hours based on 2 working principles: 1. Trap the COVID-19 virus with HPMC which
effectively coats the surface of the nasal cavity decreasing the ability of the virus to bind to the cell
surface within the nasal cavity. 2. Physically inhibit the COVID-19 virus from entering the body via the