Thai-developed COVID-19 vaccine starts human trials

[webfact]

 

A health worker administers the Sinovac coronavirus disease (COVID-19) vaccine at the Samut Sakhon hospital in Samut Sakhon province, Thailand, February 28, 2021. REUTERS/Athit Perawongmetha

 

BANGKOK (Reuters) - Thailand started human trials on Monday of a domestically developed coronavirus vaccine and expects to deploy it next year, which its health minister said could give the country more freedom with its vaccine policy.

 

Thailand's vaccination drive is targeting the inoculation of half of its adult population by the end of the year using 61 million doses of AstraZeneca's vaccine, which will be locally produced from June.

 

The home-grown vaccine candidate is being developed by state drug maker, the Government Pharmaceutical Organization (GPO), with Mahidol University's Tropical Medicine Department and an American non-profit and uses an inactivated virus to trigger immunity.

 

"The vaccine, produced by Thais for Thais, is expected to be used next year," Piyasakol Sakolsatayadorn, chairman of the Mahidol University Council, told a news conference.

 

Thailand's progress comes as countries including Japan and Taiwan speed up domestic vaccine development programmes amid tight global supply and concerns about new COVID-19 variants.

 

Vietnam last week said its locally developed vaccine would be available by the fourth quarter of this year.

 

Mahidol University's dean, Bangjong Mahaisavariya, said 460 volunteers would be accepted for the human trials, 210 of whom would be used in the first phase. Phase two is expected to begin in July, with results by year-end.

 

The Thai vaccine candidate modifies the avian Newcastle Disease virus with a COVID-19 spike protein and is replicated using egg-based technology, the GPO said.

 

Health Minister Anutin Charnvirakul said the vaccine would give Thailand more options with less constraints.

 

"Even though we can produce vaccines in the country, it is from technology transfer and under management of brands," he told the news conference.

 

"But today, if we are successful we can set our own direction."

 

Another homegrown vaccine is being developed by Chulalongkorn University and uses Messenger RNA (mRNA) technology. It is expected to start human trials soon.

 

Thailand has recorded 27,876 coronavirus cases in total, with 91 deaths.

 

(Reporting by Chayut Setboonsarng; Editing by Martin Petty)

 

-- © Copyright Reuters 2021-03-22

 

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[keith101]

11 minutes ago, webfact said:

The vaccine, produced by Thais for Thais

That's perfectly OK but every Thai should have already been vaccinated by then, that's at least 9 months away and if they haven't been then the people in charge should be removed from office .

[YetAnother]

45 minutes ago, webfact said:

"The vaccine, produced by Thais for Thais, is expected to be used next year," Piyasakol Sakolsatayadorn, chairman of the Mahidol University Council, told a news conference

hint of racism there ? he might not even know that there are a couple hundred thousand of us non-thais (migrant workers aside) that live here for decades;

if he was competent, he would have qualified his statement with something like; 'others will be dealt with  later' at least acknowledging that there ARE others

[Moonlover]

26 minutes ago, keith101 said:

That's perfectly OK but every Thai should have already been vaccinated by then, that's at least 9 months away and if they haven't been then the people in charge should be removed from office .

We do not yet know about the long term effectiveness of vaccination. It is wise to prepare for a loss of efficiency of vaccination over time and a possibility of a resurgence of the virus.

 

Having your own supply, on your doorstep is a shrewd move IMO.

[Moonlover]

2 minutes ago, YetAnother said:

hint of racism there ?

Go have a good look around this forum!

[WHansen]

10 minutes ago, Moonlover said:

Having your own supply, on your doorstep is a shrewd move IMO.

IMO it is over a year late and a laughable exercise.

Everyone is waiting for the "own supply on your doorstep" from the mythical factory which so far has not produced anything

[DLock]

How did it go on rats and Macaques?

 

...or did it go straight to human trials?

 

I used to donate blood and sperm and do medical trials for money when I was in University...not sure I'd volunteer for a Thai vaccine however...how much do they pay...asking for a friend.

[Guderian]

I'd regard a Thai vaccine with the same level of suspicion that I do the Chinese versions. That's not being racist or anti-Thai, far from it, but their attitudes to health and safety in all aspects of life are simply different from ours. 

[Fex Bluse]

5 hours ago, webfact said:

The vaccine, produced by Thais for Thais, is expected to be used next year,"

Should give them enough time to think of an idiotic, xenophobic name. 

 

Thai Rak Thai Vac 

 

Or some such nonsense 

 

@Natai Beach are you still waiting for the Thai vaccine? Given Thai reputation, I guess we can expect it to be on time and work properly. ????

Edited March 22, 2021 by Fex Bluse

[Meat Pie 47]

36 minutes ago, Fex Bluse said:

Should give them enough time to think of an idiotic, xenophobic name. 

 

Thai Rak Thai Vac 

 

Or some such nonsense 

 

@Natai Beach are you still waiting for the Thai vaccine? Given Thai reputation, I guess we can expect it to be on time and work properly. ????

on what planet do you live ?

[Jingthing]

5 hours ago, keith101 said:

That's perfectly OK but every Thai should have already been vaccinated by then, that's at least 9 months away and if they haven't been then the people in charge should be removed from office .

The government has not announced a plan to vaccinate anywhere near nearly all Thais in that timeframe, or ever. If you've been following this, their goals are quite modest as far as percentages and speed. I have no idea why. 

[Jingthing]

OK, so this is by Thais for Thais.

So I'm assuming it will only be tested on Thais.

It seems to me that westerners should avoid this one if they have any other option. 

Edited March 22, 2021 by Jingthing

[Bkk Brian]

6 hours ago, webfact said:

460 volunteers would be accepted for the human trials, 210 of whom would be used in the first phase.

I'm a little confused here

 

For a successful human vaccine trial the actual virus needs to be prevalent in the country where the trial takes place? Particularly the phase 3 trials which will need thousands of volunteers.

 

So where in Thailand will that be? 

Edited March 22, 2021 by Bkk Brian

[Jingthing]

5 minutes ago, Bkk Brian said:

I'm a little confused here

 

For a successful human vaccine trial the actual virus needs to be prevalent in the country where the trial takes place? Particularly the phase 3 trials which will needs thousands of volunteers.

 

So where in Thailand will that be? 

That's a very good question.

Either the plan is to do it in a "hotbed" area in Thailand, or they plan to intentionally infect people, or it will be of questionable value. 

[Patong2021]

2 hours ago, Guderian said:

I'd regard a Thai vaccine with the same level of suspicion that I do the Chinese versions. That's not being racist or anti-Thai, far from it, but their attitudes to health and safety in all aspects of life are simply different from ours. 

Thailand supplied the hundreds of thousands of subjects over the years for HIV, and Dengue vaccine for US NIH and Army research. They would use the  new conscripts every year. I think they have learned enough how to do mechanics of clinical trial over the past 30 years, yes?

Ethically is a different issue that I cannot comment on because I do not have the knowledge of how the conscripts participate, but I do not think it is questionable like the organ donor supplier program in China.

Edited March 22, 2021 by Patong2021

[Bkk Brian]

2 minutes ago, Jingthing said:

That's a very good question.

Either the plan is to do it in a "hotbed" area in Thailand, or they plan to intentionally infect people, or it will be of questionable value. 

Possibly but the article says phase two will be carried out at the end of the year so the important phase 3 will not be until early next year. From June the government has promised 10 million vaccines a month to be given to people and they would of course target hot bed areas.

[Patong2021]

7 minutes ago, Jingthing said:

That's a very good question.

Either the plan is to do it in a "hotbed" area in Thailand, or they plan to intentionally infect people, or it will be of questionable value. 

They will not intentionally infect people. This is not Japan occupation of China where Japanese infected tens of thousands with deadly disease.  Thailand will conduct the  trials same way they are done in USA or EU.  Thailand has long experience in running quality mass population vaccine clinical trials. 

[Jingthing]

5 minutes ago, Patong2021 said:

They will not intentionally infect people. This is not Japan occupation of China where Japanese infected tens of thousands with deadly disease.  Thailand will conduct the  trials same way they are done in USA or EU.  Thailand has long experience in running quality mass population vaccine clinical trials. 

There have been cases of intentional infection in at least one Covid 19 trial. 

 

 

https://gizmodo.com/uk-will-intentionally-infect-volunteers-with-the-corona-1845438583

 

Look if they are testing in a low or no infection environment then all they are testing is safety, not effectiveness. 

Edited March 22, 2021 by Jingthing

[Bkk Brian]

5 minutes ago, Patong2021 said:

They will not intentionally infect people. This is not Japan occupation of China where Japanese infected tens of thousands with deadly disease.  Thailand will conduct the  trials same way they are done in USA or EU.  Thailand has long experience in running quality mass population vaccine clinical trials. 

You've not heard of "Human Challenge" trials then? https://www.who.int/biologicals/expert_committee/Human_challenge_Trials_IK_final.pdf

 

Covid-19: World's first human challenge trials to start in UK https://www.bbc.com/news/health-56097088#

 

That said I doubt Thailand will be attempting this. 

 

You say that Thailand will be conducting trials the same way as US or UK but those countries had rampant covid infection and thats why they could be conducted there. Thailand does not. Unlike when it did its HIV vaccine trials years ago.

[dcnx]

7 hours ago, webfact said:

"The vaccine, produced by Thais for Thais,

And some of you wonder why others complain and feel like they are treated unfairly.

 

These are the kind of statements that create resentment and a divide. 
 

**** Thailand.

[sammieuk1]

In your own time its only a pandemic????

[webfact]

Thailand’s inactivated COVID-19 vaccine starts human trials

By Tanakorn Sangiam

 

   

BANGKOK (NNT) - In addition to imported vaccines, several COVID-19 vaccine development programs conducted by Thai scientists are now making progress, with a vaccine candidate using inactivated virus technology starting human trials today.

 

The first 18 volunteers have received the vaccine prototype developed by the Government Pharmaceutical Organization (GPO) and the Faculty of Tropical Medicine, Mahidol University in a clinical trial.

 

The human trials of this inactivated virus vaccine candidate will be conducted with 460 volunteers in Phases 1 and 2.

 

In Phase 1, the candidate vaccine will be injected into 210 volunteers in different quantities, starting from the lowest to highest, in order to find two dosage options, or recipe for the Phase 2 trial scheduled for July.

 

In Phase 2, the vaccine will be administered to 250 volunteers aged from 18 to 75 years old, with the results of these two phases expected to be available by the end of this year.

 

The volunteers must be considered healthy, have no history of COVID-19 infection or allergy to medications or vaccines. They will need to have their medical history taken, have a physical examination, and blood tests to see if they are eligible.

 

The vaccine program is a cooperative venture between the GPO and the global health non-profit unit PATH. The inactivated virus vaccine prototype has been developed from the actual virus delivered last year from the Icahn School of Medicine at Mount Sinai in New York City and the University of Texas; the virus was then disabled, losing its ability to cause the disease.

 

Prior to the human trials, this vaccine prototype was tested for toxicity in rats which took place in India, as well as tested for its effectiveness in triggering an immune response in hamsters in the United States.

 

The GPO will be producing the vaccine model using its current technological capacity as a manufacturer of influenza viruses. The organization has joined hands with the Ministry of Higher Education, Science, Research and Innovation and the Food and Drugs Administration to expand the scope of the trials, file for regulatory approval, and seek approval for mass production of the vaccine.

 

 

-- © Copyright NNT 2021-03-23

 

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[zzaa09]

12 hours ago, keith101 said:

That's perfectly OK but every Thai should have already been vaccinated by then, that's at least 9 months away and if they haven't been then the people in charge should be removed from office .

Don't hold your breath....

[Deli]

If they make vaccines like roads, it will be a bumpy ride.

[pacovl46]

15 hours ago, keith101 said:

That's perfectly OK but every Thai should have already been vaccinated by then, that's at least 9 months away and if they haven't been then the people in charge should be removed from office .

Apparently you fail to realize that there’s no way the entire world can be vaccinated until the end of this year because there’s not enough vaccine and to expect all Thais to be vaccinated until the end of the year is a pipe dream! If they can develop their own vaccine to sped it up then kudos to them! 

[Fex Bluse]

If I had to make a semi educated guess, I would say Thailand won't achieve solid vaccination until year 3. They will start now and the most anxious people will get vaccinated. Then, the virus will slow down... Thais will stop getting vaccinated thinking it's safe. The virus will come back, etc etc etc. There will be a couple rounds like this.

 

Some countries like Pakistan are already seeing people unwilling to get the vaccine -- of course, some of that could be that Pakistan opted to take a risk with the Chinese vaccines.

Edited March 23, 2021 by Fex Bluse

[AlQaholic]

Why do they need human trials? It's just a copy of the already developed and trialed Chinese vaccine.

[wombat]

12 hours ago, Guderian said:

I'd regard a Thai vaccine with the same level of suspicion that I do the Chinese versions. That's not being racist or anti-Thai, far from it, but their attitudes to health and safety in all aspects of life are simply different from ours. 

I'd be more worried by the EU version with the spanking they are giving non EU members with supply issues 

[Ketyo]

460 volunteers would be accepted for the human trials, 210 of whom would be used in the first phase.

 

460 isn't enough to test efficacy. There is a low level of COVID in Thailand. Out of 460 people none of them might catch COVID for ten years. If the 460 is just to test safety then its OK. But they will need a far bigger study to test efficacy. But even then the levels of COVID are so low in Thailand they should do the efficacy phase of testing in a country where there is a lot of COVID like Brazil. Thats the best way to see if it works quickly. But....

 

The vaccine, produced by Thais for Thais,

 

... So he should have said produced by Thais for Thais and tested by foreigners....

 

 

[Kelsall]

Hopefully this vaccine when approved won't be the one mandated for annual visa extensions.