2023-08-10 09:01:00
FDA Waiting for Phase 3 Results of HXP-GPOVac COVID-19 Vaccine, Registration Expected in September
The Food and Drug Administration (FDA) has announced that the HXP-GPOVac COVID-19 vaccine is currently awaiting the results of its Phase 3 trial. The official release, expected to be registered by the FDA in September, is being referred to as the Wuhan strain. Additionally, negotiations are underway with Mount Sinai to produce two additional vaccines, both in Thailand and outsourced. The agreement is pending on price. It has been indicated that if necessary, the species can be changed within six months, with actual production taking only two months.
During a meeting with senior executives of the Ministry of Public Health on August 9th, Mr. Anutin Charnvirakul, Deputy Prime Minister and Minister of Public Health, stated that there has been progress in the development of the COVID-19 vaccine by the Government Pharmaceutical Organization (GPO). The vaccine is close to obtaining registration with the FDA. The Ministry of Public Health, in collaboration with the Police Department and the Academic Institute of Vaccines from the United States, is working to provide Thailand with the vaccine produced by the Ministry’s vaccine factory. This collaboration is part of a larger effort by the National Vaccine Institute to coordinate with international partners, maximizing available resources for the benefit of the public.
“Efforts are being made to ensure that we have sufficient vaccines that are efficient and effective in taking care of people, not only in Thailand but also in other countries,” said Anutin. He emphasized the importance of having vaccines against COVID-19 for all strains, especially the latest variant, Omicron, to ensure stability in Thailand and strengthen the public health system. Anutin believes that investment, travel, and economic growth will flow into Thailand if its health system remains strong.
Dr. Mingkwan Suphanpong, Director of the Government Pharmaceutical Organization, provided details about the COVID-19 vaccine awaiting registration with the FDA, known as HXP-GPOVac. Unlike the killed vaccine Sinovac, HXP-GPOVac does not contain the virus itself. Instead, it contains the spike protein of the COVID virus and the Newcastle disease virus (NDV) that affects poultry. This unique production technology has shown promising results in Phase 1 and Phase 2 trials, with efficacy and safety established. Phase 3, focused on safety, has been completed successfully, with unofficial results deemed satisfactory. The official report is expected to be submitted on September 8th.
Dr. Mingkwan further explained that after the registration of the vaccine, a switch will be made from the Wuhan strain to the Omicron strain. This switch aims to ensure faster production in the case of a viral outbreak. Changing the production process for a different strain typically takes about four months. However, in an emergency situation, production can begin within two months. The Government Pharmaceutical Organization is currently negotiating with Mount Sinai for the production and testing of the Omicron strain. The cost of vaccine production is expensive, and negotiations are ongoing to determine the price.
In summary, the FDA is eagerly awaiting the results of the Phase 3 trial for the HXP-GPOVac COVID-19 vaccine. The registration process is expected to be completed in September. Furthermore, negotiations with Mount Sinai are underway to produce additional vaccines, and plans are in place to switch to the Omicron strain for faster production in case of an outbreak. These efforts aim to ensure that Thailand and other countries have access to efficient and effective vaccines to combat COVID-19.]
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