A SHOT IN THE ARM
After many stumbles and delays, Thailand’s st manufacturing centre for the influenza vaccine is finally expected to star t production in three years
Thailand found itself in the hot seat in 2009 when the country could not find vaccines to purchase during the H1N1 flu pandemic that wreaked havoc in many countries and killed over 12,000 worldwide in that year alone. While the country struggled to buy the shot, the United States and Japan had inoculated their citizens six months earlier.
“Under normal circumstances, the world has an oversupply of vaccines, which can be available at a low price. But in times of epidemic, it’s a different story. Show your money and still no one will sell it,” said Dr Nopporn Cheanklin, executive managing director of the state-owned Government Pharmaceutical Organisation (GPO).
When demand is greater than supply, there is no better solution than producing our own.
“It’s called vaccine security,” he added.
To meet the government’s strategy to control flu infection and guarantee a sufficient supply of the flu vaccine for all Thais, the idea of building a vaccine factory was initiated a decade ago. And now, after a long delay caused by redesigning, more budget requirements and flooding, the factory in Saraburi province is now near completion. It is expected to produce the first batch of flu vaccine in 2020. Operated by the GPO, this is Thailand’s first manufacturing centre for flu shots.
“We were questioned by the public why it took this long,” said Dr Nopporn. “One of the reasons was that at one point the factory needed to be redesigned so as to meet safety standards in handling live viruses. The redesign required another approval, which took two years, as well as more budget. Then the country faced a regime change, which caused a delay in budget approval. There was also a heavy deluge.”
After all this, everything was given the green light in February 2015. The construction part is finished. Right now machines and equipment are being installed and test-run — all under the standard of the World Health Organization (WHO) and Thailand’s Food and Drug Administration (FDA). The construction budget was around 1.4 billion baht. The training for technological know-how was also supported by the WHO and Japanese firm Kaketsuken, specialising in research, development, manufacturing and supply of vaccines and blood-plasma products.
The factory’s normal manufacturing line is designed mainly for the influenza vaccine, which is manufactured using a virus grown in eggs, explained Ruangchai Kaweepornpoj, director of the GPO’s Viral Vaccine Division. Right now the vaccine is in its third phase of clinical trials, which means it is now being given to people and tested for safety. The trial is expected to be completed next year, allowing the vaccine to be licensed and mass-produced for commercial purposes thereafter.
The most common way flu vaccines are made is with an egg-based manufacturing process that has been used for more than 70 years. The production of flu shots here in Thailand uses the eggs of white leghorn hens. In normal production, said Ruangchai, a batch of 25,000 eggs is delivered to the factory, where they will be cleaned and then screened for suitability for growing the virus. After full-scale expansion, the factory expects to be able to handle 60,000 eggs per batch.
“White leghorns lay white eggs, making the embryo inside more easily visible than in brown eggs. The eggs will be incubated in the hatch room for 11 days, after which they will be screened again if they are normal. Bad eggs will be discarded and abolished, while good eggs will be sent to the next part of the process, where the liquid is sucked out and the vaccine virus injected into the eggs,” explained Ruangchai, adding that what virus strain will be made into the vaccine each year will be specified by the WHO.
The virus-injected eggs will be incubated for a maximum of three days, to allow the virus to replicate. The virus-containing fluid is harvested from the eggs. Then it takes another two weeks for the vaccine to be sterilised and purified.
The next step is bottling, particle-screening and labelling. Bottled and labelled vaccines will be randomly examined by the Department of Medical Sciences to ensure their safety before using them on the public.
“From day one, when all the eggs arrive until the vaccine is approved by the Medical Sciences Department, it takes up to five months for the shot to be ready for use,” Ruangchai added.
The GPO’s executive managing director said that in the first phase, when the factory is fully operational, it is expected to be able to produce 2 million doses of the flu vaccine per year. After full expansion, nonetheless, the factory has the capacity to manufacturer up to 10 million doses annually.
“At present, Thailand purchases 3.4 million doses a year, which means it is likely that in the future, the country will see no need to buy the flu shot from other manufacturing countries,” he said.
The technology and equipment at the Saraburi factory is primarily designed for the production of the influenza vaccine, which means the plant cannot produce other types of vaccines, especially those that require starkly different technology and know-how.
“It doesn’t mean this factory can also produce the HPV vaccine [for cervical cancer],” explained Ruangchai. “It might be able to manufacture vaccines that use quite similar technology. Otherwise, we might have to consider building more vaccine factories for other types of shots.”
Dr Nopporn is of the opinion that right now Thai people have more awareness and better understanding with regard to the importance of vaccines, which is a positive sign for the country’s healthcare development.
“Thailand sees an increasing demand for vaccines because people realise it is paramount to get themselves protected by means of a jab,” he said. “Owing to this, the government should expand its services, providing the public with necessary shots.”
The GPO’s plan is to enable its vaccine production to achieve WHO
It is likely that in the future, there will be no need to buy the flu shot from other manufacturing countries
pre-qualification, allowing them to sell the shots across the world.
“Larger production means the vaccines can be sold at a cheaper price, which will benefit not just Thais but consumers in other countries,” Dr Nopporn concluded.