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FDA vows ‘safety first’

THAILAND: The permanent secretary for public health, Kiatiphum Wongrajit, yesterday (Jan 10) defended the use of the Sinovac vaccine, saying the Chinese-made product is produced with reliable technology and no reports of serious side effects have emerged after its use.

CoronavirusCOVID-19drugshealthSafety
By Bangkok Post

Monday 11 January 2021, 09:31AM


Graphics: Bangkok Post.

Graphics: Bangkok Post.

Earlier, the deputy chairwoman of civil society group FTA Watch, Kannikar Kijtiwatchakul, voiced her concerns about the Sinovac vaccine, saying its efficacy and safety remain unclear, as it has yet to progress beyond Phase 3 trials.

To ensure its safety, the Food and Drug Administration (FDA) has pledged to prioritise patients’ well-being when it evaluates the vaccine, which is expected to arrive next month.

“The decision to approve that vaccine will depend on its safety and efficiency,” said Surachoke Tangwiwat, the FDA’s deputy secretary-general. “Our experts will look into the scientific evidence that will be sent to us.”

Dr Surachoke said the FDA is waiting for Sinovac to send documents for the FDA to review and insisted officials will not fast-track the approval process.

He admitted that the plan to administer the vaccine next month may still change, as the FDA will have to adhere to the strictest health and safety principles.

“And if we don’t have all required documents to verify its safety, it is possible we won’t approve it,” he told the Bangkok Post.

He noted that Sinovac’s vaccine is still awaiting approval from Chinese authorities.

Thailand’s FDA is currently reviewing the COVID-19 vaccine developed by US company AstraZeneca in partnership with the UK’s Oxford University and has received all relevant documents it requested. It has not, however, asked to be sent documents relating to the vaccines developed by US companies Pfizer-BioNtech and Moderna.

The director-general of the Department of Medical Sciences, Supakit Sirilak, said that before deciding to buy from a vaccine manufacturer, the government takes into account several factors, which include the vaccine’s properties, its price, as well as the manufacturer’s capacity to produce and deliver them.

However, Dr Supakit said, the government is expected to purchase the vaccine from no more than three manufacturers.

“There will be enough vaccine for everyone, free of charge,” he said.

Meanwhile, the Public Health Ministry has confirmed that people in four high-risk groups - including the elderly and frontline medical workers - will be the first to be inoculated against COVID-19 when Sinovac’s vaccine arrives in Thailand next month.

Director-general of the Disease Control Department, Opas Kankawinpong, said yesterday the vaccination programme will be managed in a prudent manner, taking into account the experiences of other countries in deciding which part of the population should be inoculated first.

Among those who will receive the first doses are frontline medical and/or public health workers; sufferers of congenital diseases who are obese; senior citizens aged 60 and above; and officials working to contain the virus in the hotspot provinces of Chanthaburi, Chon Buri, Rayong, Trat and Samut Sakhon, the ministry said.

The first, which will run from February to April, will see 2 million doses for 1.32 million people distributed across the hotspot provinces.

The second, from May to June, will see at least 26 million doses rolled out to cover vulnerable, high-risk groups across the country.

The ministry expects the final phase, which will see the vaccines being made available to the general public, to begin either late this year or early next year.

Dr Opas said each person will receive two jabs, a month apart.

To ensure the efficiency of the rollout, two vaccine distribution hubs will be set up - one at the Public Health Ministry and the other at the Government Pharmaceutical Organisation. From there, the vaccines will be distributed to community hospitals in the provinces by local public health agencies.

In Bangkok, the vaccinations will be carried out at public health centres, he added.

Some personnel training will be required, as the vaccine must be administered again within a certain period to ensure its efficacy. A follow-up session will be scheduled about four weeks after the first dose to see if the recipients develop any side effects.

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Foot | 11 January 2021 - 14:33:53

@Kurt.  When he says "...“There will be enough vaccine for everyone, free of charge,..” it usually means only Thai citizens. 
Bangkok Hospital Siriroj says B5,900 for everyone.  But, if you are Thai and test positive, they have to test + treat for free by Thai law. 

Kurt | 11 January 2021 - 11:13:42

Nice to read that vaccines will be free of charge! Quite different from that private hospital in BKK press release of that 'registration fee' of 6000 B + a few thousands on the bill for vaccination. 
So, that was scam?

Galong | 11 January 2021 - 10:33:14

China wouldn't allow WHO to investigate the source of the virus! That's a powerful statement. I see no reason to trust a Chinese company that is selling us the credentials that satisfied this same Chinese government. This is a level of "trust" that seems unprincipled at best.

 

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