FDA recalls faulty rabies vaccines partly blamed for epidemic

[webfact]

FDA recalls faulty rabies vaccines partly blamed for epidemic

By The Nation

 

 

The Food and Drug Administration (FDA) has recalled and destroyed substandard rabies vaccines, which have been partly blamed for the current spread of rabies, in late 2016.
 

FDA deputy secretary-general Dr Surachoke Tangwiwat admitted on Sunday that three batches of vaccines were found to be substandard. 

 

“These rabies vaccines were imported from Spain. As soon as we found that their potency was below standard, we recalled and destroyed them in late 2016,” he said. “We have already taken legal actions against importers.”

 

The problem was detected after the Institute of Biological Products at the Public Health Ministry’s Department of Medical Sciences checked the batches, and then the FDA confirmed the quality of the vaccines was below standard. 

 

However, Surachoke said all vaccines on the market currently were in line with proper standards. 

 

“We have constantly monitored product quality. If we find anything dangerous, we will immediately alert the public,” he said.

 

Surachoke also urged people to alert the FDA if they detected hazardous products by calling the 1556 hotline or via the Oryor Smart Application.

 

This year, more than 400 people were infected with rabies, resulting in several deaths.

 

Source: http://www.nationmultimedia.com/detail/national/30341183

 

-- © Copyright The Nation 2018-03-19

[Cadbury]

59 minutes ago, webfact said:

“These rabies vaccines were imported from Spain. As soon as we found that their potency was below standard, we recalled and destroyed them in late 2016,” he said. “We have already taken legal actions against importers.”

It would be cynical of me to believe that higher commissions were paid to importers for low potency vaccines.

[Dexlowe]

If the batch was found faulty in 2016, was any effort made to warn the public? Was any effort made to trace the people who might have been injected? Who said the vaccine was partly responsible for the current rabies outbreak - health authorities or just The Nation writer? Will charges of homicide against those responsible - health officials, importer and vaccine producer - be laid?

 

If no satisfactory answer to the above is forthcoming, then someone has been dangerously incompetent and negligent. Jesus wept. 

[ukrules]

I like how they got the 'blame the foreigner' line in there pretty quickly. It's the first thing he said in the quote.

 

I wonder how many human medicines also come through the this supply chain and how many different companies in Spain export this vaccine...

[Dexlowe]

26 minutes ago, ukrules said:

I like how they got the 'blame the foreigner' line in there pretty quickly. It's the first thing he said in the quote.

Yep, and it took just 3 paragraphs for the writer to indulge in farang bashing. THREE paragraphs!!!!! Shame on the writer.

 

(sarcasm alert)

[nausea]

49 minutes ago, Cadbury said:

It would be cynical of me to believe that higher commissions were paid to importers for low potency vaccines.

My thoughts exactly. It would be interesting to know who else the Spanish exported to, and if they supply their home market; be a bit of an international/national scandal, I would've thought, if substandard vaccines were being supplied generally. Or was this a case of dumping an unmarketable product, maybe stuff that failed quality control, on Thailand. And if that's the case, yes, one has to suspect some financial incentive might've been involved.

[chrisinth]

2 hours ago, webfact said:

This year, more than 400 people were infected with rabies, resulting in several deaths.

First time I have seen these figures. Almost 100 a month so far?

 

Really?

[habanero]

Why would it even matter? It is my understanding that the rabies vaccine is good for 3 years but normally need a booster annually. So a shot is given in 2016 whether or not potent, would not be of much value in 2018.

Also, other than livestock or family pets it still does not address the animals living on the streets.

[Familyonthemove]

I would think that the % of people and animals vaccination in Thailand was low (as in most countries), so as mentioned, this is not relevant for the current outbreak.

[cmsally]

Does anyone remember this being news in 2016 ??

[cmsally]

Therapeutic failures with Rabies vaccine ....

 

Going back a bit but quotes as over 30% of vaccines being ineffective in Thailand.

Could also be problems of storage as well as quality.

Those darn Spanish must have disconnected the refrigeration system.

[dinsdale]

25 minutes ago, habanero said:

Why would it even matter? It is my understanding that the rabies vaccine is good for 3 years but normally need a booster annually. So a shot is given in 2016 whether or not potent, would not be of much value in 2018.

Also, other than livestock or family pets it still does not address the animals living on the streets.

Seems your understanding differs somewhat from the facts.

From WHO.

Routine booster vaccine doses after primary rabies vaccination are not required for the general public living in areas of risk.

From the net.

In a immuno-competent person, immunized by good quality modern anti-rabies vaccine, immunity lasts for more than 10 years. Still, if dog bites again, even after 3 months, it is advised to take booster doses (2 only) on day 0 and 3.

My worry is what quality vaccine did I get in 2014

[habanero]

8 minutes ago, dinsdale said:

Seems your understanding differs somewhat from the facts.

From WHO.

Routine booster vaccine doses after primary rabies vaccination are not required for the general public living in areas of risk.

From the net.

In a immuno-competent person, immunized by good quality modern anti-rabies vaccine, immunity lasts for more than 10 years. Still, if dog bites again, even after 3 months, it is advised to take booster doses (2 only) on day 0 and 3.

My worry is what quality vaccine did I get in 2014

I believe you are quoting facts about human rabies vaccination. Normally given to humans in the animal welfare divisions such as Vets, animal shelters, etc. 

 I am only talking about the vaccine for animals. Also, I am only getting my facts from the veterinarian for my two dogs.  Not saying all my facts are 100% correct. Only passing on what has been explained to me by the family Vet.

[Juan B Tong]

Wow!

And I thought it was feral dogs!

[dinsdale]

12 minutes ago, habanero said:

I believe you are quoting facts about human rabies vaccination. Normally given to humans in the animal welfare divisions such as Vets, animal shelters, etc. 

 I am only talking about the vaccine for animals. Also, I am only getting my facts from the veterinarian for my two dogs.  Not saying all my facts are 100% correct. Only passing on what has been explained to me by the family Vet.

Sorry. Haven't had my 2nd As for people like vets they get pre-exposure vaccines. My post is about post- exposure vaccines for humans whereas the article I guess is about the animal vaccine. Time for that 2nd

Edited March 19, 2018 by dinsdale

[mikebell]

4 hours ago, webfact said:

As soon as we found that their potency was below standard,

Was there no check before the purchase was made or was the commission sufficient to negate any such checks?

[RichardColeman]

4 hours ago, webfact said:

The Food and Drug Administration (FDA) has recalled and destroyed substandard rabies vaccines, which have been partly blamed for the current spread of rabies, in late 2016.

Ah here we go,someone used the money and then bought in something substandard or replaced them with water ! I think the Spain part is a bluff - maybe at best China mfg rerouted via Spain

 

[Lupatria]

What an irony, the usual copy cats suffer from rabies.

[anon467848]

As usual at the first sign of any public criticism, the Thais deflect the blame and say it's the Farangs' fault. Face saving b?llshit. They are the masters at deflection, deception, manipulation, narcissism.... they should grow a pair, and learn to accept responsibility.... Rant over, lol....

[JOC]

Poor poor Thailand...!!

The pesky foreigners did it again....This time they infected our holy land with rabies...!!

Time for all good Thai people to join the resistance 'Thailand First' and wear traditional Thai costumes at all occasions.....

 

 

[anon467848]

I'm surprised that the FDA hasn't issued a statement saying that the rabies has been brought into Thailand by Farang dogs used for breeding, ie. pedigree dogs....

[Orton Rd]

so decades of letting the soi dog numbers rise to millions has nothing to do with it then?

[ostyan]

Say it is Thailand only 55555

[BuaBS]

Vague article . Faulty rabies vaccines .... for who , humans or animals ? Did the vaccines cause animals or humans to developpe rabies or did the vaccine not work after they were bitten .

[Lemonltr]

I was earnestly assured that my 350 baht Rolex was manufactured in Switzerland.

[atyclb]

5 hours ago, Dexlowe said:

someone has been dangerously incompetent and negligent. Jesus wept. 

 

 

in thailand jesus simply "gave up"

[anon789561]

3 hours ago, mikebell said:

Was there no check before the purchase was made or was the commission sufficient to negate any such checks?

Exactly what I was thinking. It's the job of the Thai FDA to approve the use of the drugs before they can be sold in Thailand. Some think that those privileged people working at the Thai FDA often take back handers in order to get drugs and other products to market faster. Some also say the reason that the Thai FDA is dragging it's feet on agreeing to an ASEAN regulatory requirement is because they would then be missing out on the extra money they have been used to making on having their regulatory affairs requirements held in house. 

And bearing in mind a Regulatory Affairs Associate (usually Chula then Masters in the West) can expect to start on 100,000 baht a month then upwards plus benefits, i'd say they are pretty greedy taking back handers on top of that.

**If what some people say is true, i didn't say it! 555

Edited March 19, 2018 by Happy enough
**

[Emster23]

From Spain? I thought might be from that lab that came up with HIV cure a few years back here in Thailand

[TallGuyJohninBKK]

8 hours ago, webfact said:

However, Surachoke said all vaccines on the market currently were in line with proper standards. 

 

“We have constantly monitored product quality. If we find anything dangerous, we will immediately alert the public,” he said.

 

#1. How can anyone believe you this time, when obviously the prior vaccines imported and used here were NOT in line with proper standards?

 

#2. If you'll immediately alert the public, why are we only hearing NOW in spring 2018 about bad batches of the vaccine that were detected and destroyed in 2016?   That's immediately???

 

[TallGuyJohninBKK]

2 hours ago, BuaBS said:

Vague article . Faulty rabies vaccines .... for who , humans or animals ? Did the vaccines cause animals or humans to developpe rabies or did the vaccine not work after they were bitten .

How does The Nation write an article like that without ever specifying whether they're talking about the human vaccine or the animal vaccine, and whether they're the same or different????

 

Shoddy work in the extreme.