Thailand approves Johnson & Johnson's COVID-19 vaccine

[snoop1130]

FILE PHOTO: A woman leaves with her bike at Johnson and Johnson's subsidiary Janssen Vaccines in Leiden, Netherlands March 9, 2021. REUTERS/Piroschka van de Wouw

 

BANGKOK (Reuters) - Thailand has granted emergency authorisation to Janssen, the single-dose coronavirus vaccine of Johnson & Johnson, the country's health minister said on Thursday, the third vaccine to be cleared for local use.

 

Anutin Charnvirankul told reporters the Food and Drug Administration (FDA) had approved the vaccine, in addition to those of AstraZeneca and Sinovac Biotech, which have already been administered in the country.

 

J&J's vaccine is called COVID Vaccine Janssen after the J&J unit that developed it.

 

China's Sinopharm and the makers of Russia's Sputnik V and are preparing to submit requests for approval, Paisal Dunkhum head of Thailand's FDA said.

 

Moderna has said it would submit an application for approval while India's Bharat Biotech is in the process submitting documents for vaccine registration, Paisal said.

 

Thailand, which has recorded just over 28,000 coronavirus cases overall, has administered about 100,000 doses of vaccines among medical workers and high-risk groups so far.

 

It's main vaccine drive is expected to start in June, using locally-produced AstraZeneca shots and it plans to inoculate half of its adult population by the end of the year.

 

-- © Copyright Reuters 2021-03-25

 

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[ThailandRyan]

Put me in line coach.  Que number 1.

[starky]

Awesome bring on the roll-out then. Because obviously they would have plenty of units ordered or the go ahead to produce them locally under license right? Oh wait...

[edwardandtubs]

The thing about the J&J vaccine is it's marketed as single shot but it seems to be less effective than one shot of the Astrazeneca vaccine. I'm all for as many vaccines as possible but this one doesn't magically achieve in one shot what the others do in two.

[Jingthing]

16 minutes ago, edwardandtubs said:

The thing about the J&J vaccine is it's marketed as single shot but it seems to be less effective than one shot of the Astrazeneca vaccine. I'm all for as many vaccines as possible but this one doesn't magically achieve in one shot what the others do in two.

That may not be true. My understanding is that J and J is very protective against hospitalizations and death. What's the big deal if you get infected and it doesn't hurt you much? Also my understanding is that J and J was tested in the South African variant environment so it's not a level playing field looking at results.

[internationalism]

it would rather be only for private hospitals and probably in small quantities, so expensive.

 

he didn't mention anything about orders, which hospital networks. So it's in very early stages of planning 

[RichardColeman]

3 hours ago, snoop1130 said:

BANGKOK (Reuters) - Thailand has granted emergency authorisation to Janssen, the single-dose coronavirus vaccine of Johnson & Johnson, the country's health minister said on Thursday, the third vaccine to be cleared for local use.

Great, but in all likelihood they have probably not ordered enough of any consequence yet or ordered so late that my 4 year old daughter will have left university before it arrives

[Albert Zweistein]

1 hour ago, internationalism said:

it would rather be only for private hospitals and probably in small quantities, so expensive.

 

he didn't mention anything about orders, which hospital networks. So it's in very early stages of planning 

Probably not in any stage of planning, just sticking it out untill Thailand's own plant starts producing if ever and keeping the crowd happy with stories like this.

[edwardandtubs]

2 hours ago, Jingthing said:

That may not be true. My understanding is that J and J is very protective against hospitalizations and death. What's the big deal if you get infected and it doesn't hurt you much? Also my understanding is that J and J was tested in the South African variant environment so it's not a level playing field looking at results.

The first dose of the Astrazeneca shot has been 80% effective against hospitalisations in the real world of the UK mass immunisation campaign.

 

https://www.reuters.com/article/us-health-coronavirus-vaccines-singledos-idUSKBN2AV14I

 

The scientists who made it still think it will be effective against hospitalisations for the South African variant although they are still testing that (it wasn't very effective against mild illness). And one dose of the Pfizer vaccine is almost as effective as Astrazeneca in the real world of the UK vaccination campaign and appears to be very effective against the South African variant. So I think the one shot claim of this J&J vaccine is misleading marketing.

[edwardandtubs]

2 hours ago, hioctane said:

 

It is important to note that all these vaccines are 100% effective against hospitalization/death.  The efficacy is more about contracting with  little to mild symptoms.

 

Also, the early vaccines were tested before all the variants. So the efficiency is less when those are considered.

 

Essentially, don’t be picky. Take any vaccine you can get your hands on!

 

 

Absolutely. I'll take any vaccine if it's needed to travel or for public health reasons but if I had the choice it wouldn't be this one. Anyway, they're currently testing to see if two shots are more effective which they almost certainly will be.

[LomSak27]

3 hours ago, Albert Zweistein said:

Probably not in any stage of planning, just sticking it out untill Thailand's own plant starts producing if ever and keeping the crowd happy with stories like this.

 

I do not think we will be able to buy at a private hospital, until June, until the Thai plant starts producing vaccine. Still it keeps the peanut gallery, those fractious farangs, happy. On the other hand this the first step and the first in the door. Hopefully others will follow. 

[Jeffr2]

https://www.vox.com/22311625/covid-19-vaccine-efficacy-johnson-moderna-pfizer

 

Why comparing Covid-19 vaccine efficacy numbers can be misleading

The best Covid-19 vaccine for you is most likely still the first one you can get.

Timing is critical too. The Moderna and Pfizer/BioNTech studies finished enrolling participants in their phase 3 trials in October and reported their results in late November. The Johnson & Johnson phase 3 trial only finished enrolling participants in December 2020 and reported their results in January.

 

That means the Johnson & Johnson vaccine was tested during one of the most severe stages of the pandemic, when transmission, cases, and hospitalizations were at their worst in many places around the world, including the US. The trial also captured efficacy against the new variants of SARS-CoV-2 (the virus that causes Covid-19) which began circulating at this point in some parts of the world. Several of these variants have shown themselves to be more contagious, deadlier, and more likely to evade protection from vaccines and prior immunity.

[Jeffr2]

From a friend who's talking a class at Johns Hopkins on the virus:

 

Oxford is claiming to be “proven tech” but in reality it’s using a technology that has worked twice before (Zika and Ebola, both modern low volume vaccines) and uses an unproven vector in the chimp adenovirus (previous adenovirus vectors were Ad5 or Ad26, both used in Sputnik, Ad26 in J&J)

 

Some people have natural immunity to the vector (Chimp Adno). And if you do then again efficacy can be reduced as your body fights the vector before it delivers its payload. This ‘vector resistance’ is worse in some populations for Ad5 and Ad26 and hence Oxford’s novel use of a chimp adenovirus (global Britain needs a global vaccine!)

 

Oxford used a post-fusion spike as opposed to the two approved mRNA vaccines which have pre-fusion spikes, and achieved much higher efficacy in trials). We think the fact that antibodies are made “pre-fusion” (ie to the spike before it has fused with a cell) explains the better efficacy in the trial

 

Sinovac is “traditional” vaccine (inactivated virus). Again, devil in the detail. The inactivation uses a chemical β-Propiolactone. This chemical turns some viral spikes into post-fusion state (ie same as Oxford and opposite of Pfizer/Moderna). The interesting bit is depending on the batch you may have more or less post/pre fiction spikes (ie a mix) and this is what is thought to explain the radically different trial efficacy from Sinovac in Brazil, Turkey, Chile etc (+/- 20%)

 

For me ... the vaccine order is;

1. J&J (one dose, simple, less reactogenicity)
2. Either of the two approved mRNA (Pfizer/Moderna). Reactogenicity sucks but efficacy was highest
3. Sinovac
4. Oxford

 

Note that for the two approved mRNA vaccines they inject a full pre-fusion spike. This is a big protein. No one really knows the long term issues (as they don’t know the full story of SARS-CoV-2 in the body).  Long term issues are possible ... but hopefully not ????????

[mtls2005]

Be nice if SiamBioscience, or some other local entity, could license manufacturing from J&J Janssen.

 

I'm not certain J&J has issued, or will issue, any licenses. Or if the Merck agreement has any impacts for Thailand?

 

 

[vandeventer]

Just how many doses of the J&J have they ordered? And where is the end of the line? This is some very good news at any price!

[Bkk Brian]

6 minutes ago, vandeventer said:

Just how many doses of the J&J have they ordered? And where is the end of the line? This is some very good news at any price!

The J&J vaccine is supplied on a no profit basis same as Astrazeneca but how much that is I have not seen?

[mtls2005]

19 minutes ago, vandeventer said:

Just how many doses of the J&J have they ordered?

 

My sense is that the "government" will not be making the J&J vaccine part of their "plan". It has not been in any presentations to date.

 

And that this approval was pushed by private hopsitals.

 

Have not heard of any orders being placed by anyone here in Thailand.

 

I would imagine that private hopsitals here have consolidated their forecasted needs for a first tranche of vaccines, and tasked one entity to source the vaccine(s). 

 

 

 

 

 

 

[pizzachang]

Inquiring minds would like to know, how will we know the vaccine is a "success", when the published J&J "effectiveness rate", is lower than the natural survival rate?

[scorecard]

58 minutes ago, Jeffr2 said:

From a friend who's talking a class at Johns Hopkins on the virus:

 

Oxford is claiming to be “proven tech” but in reality it’s using a technology that has worked twice before (Zika and Ebola, both modern low volume vaccines) and uses an unproven vector in the chimp adenovirus (previous adenovirus vectors were Ad5 or Ad26, both used in Sputnik, Ad26 in J&J)

 

Some people have natural immunity to the vector (Chimp Adno). And if you do then again efficacy can be reduced as your body fights the vector before it delivers its payload. This ‘vector resistance’ is worse in some populations for Ad5 and Ad26 and hence Oxford’s novel use of a chimp adenovirus (global Britain needs a global vaccine!)

 

Oxford used a post-fusion spike as opposed to the two approved mRNA vaccines which have pre-fusion spikes, and achieved much higher efficacy in trials). We think the fact that antibodies are made “pre-fusion” (ie to the spike before it has fused with a cell) explains the better efficacy in the trial

 

Sinovac is “traditional” vaccine (inactivated virus). Again, devil in the detail. The inactivation uses a chemical β-Propiolactone. This chemical turns some viral spikes into post-fusion state (ie same as Oxford and opposite of Pfizer/Moderna). The interesting bit is depending on the batch you may have more or less post/pre fiction spikes (ie a mix) and this is what is thought to explain the radically different trial efficacy from Sinovac in Brazil, Turkey, Chile etc (+/- 20%)

 

For me ... the vaccine order is;

1. J&J (one dose, simple, less reactogenicity)
2. Either of the two approved mRNA (Pfizer/Moderna). Reactogenicity sucks but efficacy was highest
3. Sinovac
4. Oxford

 

Note that for the two approved mRNA vaccines they inject a full pre-fusion spike. This is a big protein. No one really knows the long term issues (as they don’t know the full story of SARS-CoV-2 in the body).  Long term issues are possible ... but hopefully not ????????

From above:

"Long term issues are possible ... but hopefully not "

Does this mean:

 

- Boosters will be needed very quickly, also meaning that governments (incl. Thai gov't.) will only recognize the person as having been vaccinated for 90 days after the final jab?

 

- There's an expectation of other longer-term health complications? 

 

- Or?

[mtls2005]

17 minutes ago, pizzachang said:

Inquiring minds would like to know

 

Do you really want to "know"?

 

19 minutes ago, pizzachang said:

how will we know the vaccine is a "success", when the published J&J "effectiveness rate", is lower than the natural survival rate?

 

I don't know what the natural survival rate is or means. Success would be measured by lower infection rates, fewer hospitalizations and fewer deaths.

 

 

 

 

[ThailandRyan]

9 hours ago, edwardandtubs said:

The thing about the J&J vaccine is it's marketed as single shot but it seems to be less effective than one shot of the Astrazeneca vaccine. I'm all for as many vaccines as possible but this one doesn't magically achieve in one shot what the others do in two.

However, the J&J vaccine is not an MRNA vaccine but a Adenovirus Vaccine.  That is the main difference and to me a lot healthier alternative for your system.

https://www.nytimes.com/interactive/2020/health/johnson-johnson-covid-19-vaccine.html

[Jeffr2]

1 hour ago, pizzachang said:

Inquiring minds would like to know, how will we know the vaccine is a "success", when the published J&J "effectiveness rate", is lower than the natural survival rate?

Please show a credible link that proves this.  Otherwise.....

 

In the end, the best stat is if you get any of the currently available jabs, you WILL NOT end up in the hospital with a tube jammed down your throat and die.  What's wrong with that?

 

2.8MM global deaths so far, and that's an under reporting.

 

https://gisanddata.maps.arcgis.com/apps/opsdashboard/index.html#/bda7594740fd40299423467b48e9ecf6

[Jeffr2]

46 minutes ago, scorecard said:

From above:

"Long term issues are possible ... but hopefully not "

Does this mean:

 

- Boosters will be needed very quickly, also meaning that governments (incl. Thai gov't.) will only recognize the person as having been vaccinated for 90 days after the final jab?

 

- There's an expectation of other longer-term health complications? 

 

- Or?

mRNA technology is brand new.  It was released under an emergency authorization.  Meaning...long term trials were not done.  So, who knows what the long term effects will be???

 

It's entirely possible boosters will be required.  Just like we do every year for the flu season.

[thailand49]

9 hours ago, Jingthing said:

That may not be true. My understanding is that J and J is very protective against hospitalizations and death. What's the big deal if you get infected and it doesn't hurt you much? Also my understanding is that J and J was tested in the South African variant environment so it's not a level playing field looking at results.

Correct!  People need to remember 50% is the standard?  My general reading the result was something like 85% effective tested against the SA variant the result was lower thus bringing down the total to something like 65% also noted effective in protecting against hospitalizations and death.

 

Many expert express it is a good vaccine even flip flop Faci?

[CharlieH]

Reported Troll/misinformation post and a response to it removed.

[hioctane]

1 hour ago, pizzachang said:

Inquiring minds would like to know, how will we know the vaccine is a "success", when the published J&J "effectiveness rate", is lower than the natural survival rate?

Simple, compare how many vaccinated got infected, hospitaized and/or died with those without the vaccine. Undoubtedly, it will be much less with those that are vaccinated.

 

50 minutes ago, scorecard said:

From above:

"Long term issues are possible ... but hopefully not "

Does this mean:

 

- Boosters will be needed very quickly, also meaning that governments (incl. Thai gov't.) will only recognize the person as having been vaccinated for 90 days after the final jab?

 

- There's an expectation of other longer-term health complications? 

 

- Or?

It remains to be seen how are the antibody levels are after 90 days. The data should be coming out any day now since most large quantity  vaccinations started around January.

[hioctane]

10 minutes ago, Jeffr2 said:

mRNA technology is brand new.  It was released under an emergency authorization.  Meaning...long term trials were not done.  So, who knows what the long term effects will be???

 

It's entirely possible boosters will be required.  Just like we do every year for the flu season.

 

mRNA is not exactly brand new. It has been around for over 10 years and have not been used because they were still studying long term effects like most traditional vaccines/medications. The only way to test long term is with time. It has been fast tracked due to dire circumstances.

[Jeffr2]

1 minute ago, thailand49 said:

 

Once again you can decide for yourself as in most things!  Why in the beginning he said there wasn't a problem with the Virus, then said you don't need to wear a mask, now it is two mask, then he said 60-70% need to have the vaccine to obtain herd immunity then said it is more like 80% the list goes on.

 

Faci, is a doctor researcher not a politician which the virus has pushed him to be he should stick to what he does best.  Yes, he is nothing now but a flip flop you like him then I guess you can't wait for him to be on  Dancing with the Stars hope he does better since he can't even throw a baseball 10 feet!????????

Do some research on credible sites.  You'll find the answers.  In the end, if you're bashing someone like Fauci for this, you're got bad information.  Get a better source for your news.

[Bkk Brian]

3 minutes ago, thailand49 said:

 

Once again you can decide for yourself as in most things!  Why in the beginning he said there wasn't a problem with the Virus, then said you don't need to wear a mask, now it is two mask, then he said 60-70% need to have the vaccine to obtain herd immunity then said it is more like 80% the list goes on.

 

Faci, is a doctor researcher not a politician which the virus has pushed him to be he should stick to what he does best.  Yes, he is nothing now but a flip flop you like him then I guess you can't wait for him to be on  Dancing with the Stars hope he does better since he can't even throw a baseball 10 feet!????????

Regards the masks I'm sure as with most countries at the time there was a shortage and it was priority to supply health workers with them first which makes sense. For other change in advice, its an evolving situation with new variants that are more contagious/deadly and new science with the vaccines, as such of course decisions need to change inline with evidence presented that was not there before.

 

Just my take on Fauci.

[Pancho]

Continuing delays.........

interesting.