Covid jab shortages prompt ASEAN countries to develop own vaccines
AMID a global shortage of vaccines and new wave of Covid19 infections, some countries in Southeast Asia are rushing to develop their own coronavirus shots.
After promising results from the Phase I clinical trial of the experimental ChulaCov19 vaccine, researchers from Thailand’s Chulalongkorn University began the Phase IIa trial on 150 volunteers on Aug 26.
“[Our vaccine] can induce a very strong antibody response, [which is] as good as Pfizer,” said Kiat Ruxrungtham, director of the ChulaCov19 mRNA vaccine development programme and founder of the Chula Vaccine Research Centre, the research team behind ChulaCov-19.
Unlike the inactivated vaccines that contain a protein or other small pieces taken from a virus, mRNA vaccines prompt the human body to make a protein that triggers an immune response.
According to the results released on August 16, based on the Phase I trial on 36 volunteers, ChulaCov19 is 94 per cent effective in preventing SARSCoV-2, the virus that causes Covid-19. It is capable of building immunity against virus variants including Alpha, Beta, Gamma and Delta.
“The vaccine is also able to induce a strong T-cell response,” Kiat told China Daily. T-cell response plays a vital role in getting rid of infected cells and reducing number of virus in the tissues.
After the Phase IIa trial, Kiat said there will be another, Phase IIb, trial on 5,000 volunteers in October and then possibly a Phase III trial on 15,000 to 30,000 volunteers.
He said he hopes the Thai Food and Drug Administration (FDA) can consider easing the regulations on Thai-made vaccines
and approve the team’s vaccine for emergency use without Phase III trial results as long as the vaccine’s safety and efficacy can be proved.
“There are a lot of people … asking a question whether we are too late to develop our own vaccine,” said Kiat, who hopes the team’s vaccine can be approved for emergency use before the Thai new year in April.
“I would say not at all.We have to make sure that our capability, capacity and value chain are complete. So we will be ready for any new variants and also for the next pandemics.”
Thailand is currently experiencing its worst Covid-19 outbreak, fuelled by the Delta variant of the virus.
The country plans to vaccinate 50 million people by early October but rollout has been delayed due to multiple reasons including supply shortage.
Noting that there are two among five vaccines using different
technologies entering the clinical trials in Thailand, Kiat said it is important for any country, including a small country like Thailand, to have its own capacity to make vaccines in preparation of other pandemics in the future.
For example, the NDV-HXP-S Covid-19 vaccine developed by the Government Pharmaceutical Organisation (GPO) entered Phase II clinical study on 250 volunteers at the Faculty of Tropical Medicine, Mahidol University, on August 16. The vaccine uses egg-based technology, similar to that used to produce influenza vaccines.
If the vaccine candidate is approved by the Thai FDA, the potential production capacity can reach 20-30 million doses a year to provide jabs for 10-15 million Thai people, according to GPO managing director Withoon Danwiboon.
Indonesia
Thailand is not the only country in Southeast Asia that is ramping up efforts to develop its own Covid-19 vaccines.
In Indonesia, the country’s Food and Drug Monitoring Agency (BPOM) has allowed Airlangga University, or Unair, and PT Biotis to further develop the home-grown Covid-19 vaccine Merah Putih.
Translated as “red and white” in the Indonesian language, Merah Putih was named after the colours of the nation’s flag.
BPOM chairperson Penny Lukito on August 18 said Unair and Biotis’ joint research is the most promising among the six domestic institutions and universities that are participating in the Merah Putih vaccine development.
Unair and Biotis are developing an inactivated vaccine – where researchers culture virus particles in the laboratory and later kill them to destroy their disease producing capacity. They have already concluded animal trials and may soon start human clinical trials.
Lukito said BPOM might issue emergency use authorisation by the first half of next year.
Health experts welcomed this development as it can help shore up Indonesia’s vaccine supply over the long term. But this will not solve the nation’s immediate problem — how to accelerate the pace of vaccination as the highly-transmissible Delta SARS-CoV-2 variant continues to infect and kill more people.
Indonesia is battling one of Asia’s worst Covid-19 outbreaks, with 4.07 million cases detected as of August 30, according to the Worldometer. The virus has killed over 131,000 people in the archipelago and has strained the country’s public health system.
“The journey [of developing homegrown vaccine] is still quite long. Merah Putih can’t help the vaccination programme in a very near future as we immediately need the supply now,” said Irma Hidayana, co-founder of LaporCOVID-19, a Jakarta-based independent data monitoring group.
Indonesia’s vaccination programme was launched in January with the aim of inoculating 181.5 million people this year. That target has been raised to 208 million to include the 12to 17-year-old group. But as of August 22, only 31.6 million Indonesians have been fully vaccinated.
A’an Suryana, visiting fellow at the Iseas-Yusof Ishak Institute, a leading socio-political and economic research centre in the region, said the Merah Putih vaccine development programme aims to make Indonesia more self-reliant in terms of vaccine supply. But he said it will still take time for Merah Putih to be rolled out since it is still at the animal trial stage.
“The key is supply. Previously, the government had problems in inoculating people due to inconsistent arrivals of vaccines. This inconsistent arrival of the vaccine was reflected in the inconsistent way the government set vaccination targets,” he said.
“Between August 1 and 6, the government was supposed to have injected 12 million doses of vaccines [in line with the two million dose-a-day target]. But, in those six days, only 4.5 million doses were injected,” he noted.
Vietnam
And in Vietnam, Nanogen Biopharmaceuticals and the research team behind locallydeveloped Covid-19 vaccine Nano Covax have been asked to provide more data before an emergency use licence can be granted.
The request was made by the Advisory Council for the Registration of Circulation of Drugs and Medicinal Ingredients after a meeting held late in the evening of August 29.
The council said in a press release that they and relevant units had carefully considered the application, adding that the dossier had been appraised by the Legal Subcommittee under the National Institute for Control of Vaccines and Biologicals twice; by the Quality Subcommittee four times, and by the Pharmacology and Clinical Subcommittee three times.
The Advisory Council acknowledged the results obtained for the application for a certificate of circulation of the Nano Covax vaccine which had been appraised by the expert subcommittees, and accepted by the Ethics Council. At the same time, the Advisory Council requested the company continue to supplement and clarify some content regarding application quality and pharmacological and clinical records.
Regarding pharmacological and clinical records, the council asked for more information regarding safety, immunogenicity and protection effect.
Specifically, the enterprise needs to add and update data on safety for all subjects who have been vaccinated with at least one dose of the vaccine up to the present time and clearly explain the cases of serious adverse events (SAE).
The council also asked for more data according to the latest amendment protocol approved by the Ethics Committee, including – assessment of immunogenicity on new strains (for example Alpha, Delta and others) and sample size for immunogenicity assessment should be carried out in accordance with the approved research protocol.
Regarding the protection effect, it is required that the enterprise coordinate with the research team to analyse and discuss the relationship between the immunogenicity of the vaccine and the protection effectiveness of at least 50 per cent, according to the guidance of the World Health Organisation.
Last week, the results from Nano Covax’s Phase IIIa clinical trials involving about 1,000 volunteers were given the green light from the National Committee for Ethics in Biomedicine Research.
Some volunteers reported typical side effects like pain at the injection site, itchiness, nausea, light fever after receiving the vaccine. Two suffered from shock reactions but have completely recovered.
The geometric mean concentration (GMC) of the antibody among the injected volunteers evaluated by PRNT50 tests on the original strain is at 63.5, while GMC for those given placebo is at five.
On day 42, the seroconversion rate reached 99.2 per cent.
Nano Covax, a recombinant spike protein vaccine, is the forerunner in the race for domestically produced Covid-19 vaccine, followed by Covivac from the Institute of Vaccines and Biologic Medical and mRNA vaccine ARCT-154 (by Arcturus and VinBioCare) just starting Phase II trials.