The Dean of the Macau University of Science and Technology (MUST) Faculty of Medicine, Professor Manson Fok, stated today (Tuesday) that if local authorities finance efforts to develop a new vaccine candidate researched by the university, Macau residents would be the first to receive a Covid-19 vaccine.
It was recently revealed that MUST researchers in collaboration with Chinese academics and the Hong Kong Polytechnic University (PolyU) have managed to produce a novel coronavirus Covid-19 (SARS-CoV-2) vaccine that has induced a potent functional antibody response in several animals tested, including non-human primates.
The researchers involved indicated that primates tested with the vaccine in approved Mainland China facilities showed very reduced levels of the virus and a strong immune response, and have not shown any negative side effects in the three months after being treated.
Clinical trials in humans are expected to start in months or even weeks, and in an interview provided today, MUST Faculty of Medicine Professor Zhang Kang and Professor Fok stated that if funding is provided to the project, all stages of clinical testing and certification for the vaccine could maybe be completed by January, 2021.
The MUST Faculty of Health Dean noted that it was unlikely the vaccine could be the first to be available internationally when compared to other vaccines being developed worldwide, but it could be the first available to Macau and Hong Kong residents.
The research team previously indicated that they aim to reserve 8 million doses for residents of the two SARs once the vaccine is ready.
“We’re using the most traditional method for a protein-based vaccine, therefore large-scale manufacturing would be more cost-effective than other [candidates],” the academic noted.
According to Professor Fok, the many vaccine candidates being developed in the US, the UK, and mainland China have also been using newer and sometimes unproven methods to speed up testing and production, which could provide some limitations to their effectiveness.
Research on the vaccine was said to have cost “tens of millions of US dollars” through funding obtained by MUST partners and collaborators with no local government assistance, with professor Fok estimating that the full costs of completing a viable MUST vaccine could reach least HK$600 million (US$77.4 million).
“The virus has caused an economic impact of maybe hundreds and hundreds of billions. In that perspective, the cost of investing in a potential vaccine is a no-brainer. Even if we didn’t succeed, we tried our best,” the Faculty of Medicine Dean stated.
Professor Fok pointed out that back in February of this year the university made a MOP500,000 (US$62,639) subsidy request to the local Science and Technology Development Fund (FDCT) for a Covid-19 vaccine investigation, which was refused, with the researcher urging the Macau SAR to commit to the project.
Yesterday, Macau health authorities were non-committal over possible support to the MUST project, indicating only that they have been following several vaccine candidates worldwide and waiting for a successful Phase 3 completion of these candidates.
“If the Macau government feels this is something they can help push forward, they sould commit so that when a vaccine is on the table local citizens will be among the first to have it around a year or two before other countries,” he stated.
One of the main challenges for this vaccine candidate has been finding a manufacturing facility to produce the first batch to be used during clinical trials, and then facilities for large-scale production if the trials were successful.
According to Professor Fok, manufacturing facilities in Mainland China are currently in use by other companies and US regulations are reserving any successful candidate to be used only for residents in the country.
“I’ve been telling the [Macau] government for many years that we need to have our own vaccine manufacturing facilities. […] We don’t have manufacturing facilities, we don’t have a regulatory body. So even if we produce something who is going to certify it? There are many limitations for production in the region, so we have to try and find partners all over the world, ” Professor Fok stated.
Therefore, at this moment, MUST is in negotiations with “one of largest medicine manufacturers” in Taiwan to quickly produce the first batch of vaccines to be used for the first phase of clinical trials, with 10,000 to 30,000 individuals expected to be tested.
A novel vaccine candidate undergoes an elaborate development process after its discovery, which comprises of three stages.
These include a Phase I, when the first administration of a vaccine candidate to humans takes place to evaluate the safety and reactogenicity; a Phase II of clinical evaluation after achieving a satisfactory outcome in Phase I studies in terms of both safety and immunogenicity; and a Phase III defining the percentage of reduction of disease or infection among the vaccinated.
“Then the data needs to be looked into and the regulatory approval needs to be obtained after which we can go to large-scale manufacturing,” Fok added.
Meanwhile Professor Zhang Kang – which led the collaborative research team – once the manufacturing process for a trial vaccine batch is completed it would be possible to scale up production “pretty quickly”.
“This is a recombinant DNA vaccine and we should be able to produce millions and millions of doses very quickly within weeks,” Professor Zhang added.
The vaccine uses a protein receptor-binding domain named RBD – contained in the novel coronavirus itself – to reduce unwanted side effects while producing a stronger antibody than in human patients who had recovered from Covid-19.
Professor Zhang Kang also indicated, that after the first vaccines are produced and available, the priority would be to immunise healthy patients; however he noted that the strong antibodies generated could be used for blood plasma transplants that could assist seriously ill patients.
The vaccine study has already been peer-reviewed and published in the science journal Nature, as ‘A Vaccine Targeting the RBD of the S protein of SARS-CoV-2 Induces Protective Immunity’.