FDA ready for key role - Bangkok Post

FDA ready for key role

Food and Drugs Administration secretary-general Paisarn Dankum

It is hoped the fight against against Covid-19 is entering its penultimate chapter as vaccines become available and countries begin inoculating their population.

However, Thailand -- which recently was ranked as the fourth most proficient country in the world in its handling of the pandemic -- has recently run into some hurdles.

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While neighboring countries like Singapore, the Philippines and Indonesia have vaccination programmes underway, Thailand is still waiting anxiously for an imported shipment of the Oxford/AstraZeneca formula from a plant in Italy, with its exact arrival date still far from certain. The European Union is reported to be about to implement a ban on the export of Covid-19 vaccines to external territories, which would scupper the original plan to role it out in the kingdom on Valentine's Day.

Meanwhile, Sinovac, another potential supplier, has yet to finish its third trial phase.

At the moment, there is no vaccine supply in Thailand. The US-based Moderna is likely to move to register a vaccine here this month, while Pfizer, despite offices in Bangkok, has given no indication of its own plans for the region.

And for as long as supplies remain unavailable, the Food and Drugs Administration (FDA), the domestic body responsible for approving vaccines for the public and the Ministry of Public Health, under which it operates, remains firmly in the nation's crosshairs.

The FDA has been criticised for dragging its feet in securing access to one of the new candidates, an accusation the FDA secretary-general, Dr Paisarn Dankum, denies.

"The FDA has no policy to limit the registration of Covid-19 vaccines. The simple fact is that no companies have applied for import licences.

"Please understand the vaccine market during an outbreak belongs to the vaccine producers, not the clients," Dr Paisarn told the Bangkok Post in a special interview.

"It means that the pharmaceutical companies hold all the cards when it comes to negotiating with each country."

Dr Paisarn also pointed out that during the peak of the outbreak, Thailand was relatively free of the virus, and under no pressure to cave in and agree a high price.

Fast-track approval

In reality, experts at FDA have been busy since Dec 22 last year when they received almost 10,000 pages worth documents from AstraZeneca, which did decide to target the Thai market.

It was a lot of information to process, particularly when public safety is paramount, so it deployed around 100 experts, both from its own staff and external institutions, to comb through the submission with particular regard to safety, quality and efficiency.

Finally, on Jan 20, the drugs watchdog approved the Oxford/AstraZeneca vaccine candidate, which is proving to be one of the sought-after formulations, for use in Thailand, with AstraZeneca (Thailand) registered as its importer.

Currently it is waiting for China-based Sinovac to supply its own set of documents to register "CoronaVac" in Thailand. Thai authority had planned to use two million doses to kick start a mass inoculation campaign in February.

As of now, Sinovac's vaccine is in an expedited third trial phase which has allowed active Indonesia, Brazil and Turkey. However, this has left Thai health officials with a dilemma. "The FDA will approve CoronaVac only after China's health authority issues its own approval of the vaccine," said Dr Paisarn. He stressed the FDA currently permits private hospitals to import and administer vaccines but concedes that doing so would be a risk.

"The FDA's regulations clearly say the importer must take a full responsibility for any critical side-effects that may occur to the vaccine user. If any private hospitals can agree to that, the FDA will almost certainly grant their request to import the vaccine," he said.

Emergency vaccine

The Covid-19 vaccine is unique in that people are already receiving jabs only a year after work on it began, when vaccines usually take years, sometimes even a decade, to develop and get approval.

Clearly, this pandemic has turned the world upside down in many respects and Thailand's acquiescence to rolling out vaccines less thoroughly tested than for other contagious viral infections is no different to decisions made by leaders in almost every other country.

This has been classed as an "emergency vaccine," said Dr Paisarn. FDA also requires the Covid-19 vaccination management plan to include checks on any side effects.

"The vaccine must be administered under the supervision of a doctor. It cannot be sold in other drug stores," he said.

Siam Bioscience

Late last year, the FDA approved Siam Bioscience producing an early batch of the vaccine at its Pathum Thani plant so the FDA could assess its readiness to reproduce the formula provided by Oxford/AstraZeneca.

"Vaccine quality is the most important thing. The FDA must ensure that each batch is no different from the original," he said.

That review will be complete by May when it has been agreed that Siam Bioscience will begin producing 26 million doses for a mass vaccination drive following earlier inoculations of health workers and at-risk groups. Nevertheless, despite the urgency, Dr Paisarn said the FDA would remain "professional" as it does its job.