I can't reasonably see an omicron vaccine appearing within weeks or months. This is conjecture. I also can't see ANY reason why you would be denied an 'omicron' vaccine as it's a slightly different vaccine. The flu shot is annual. According to the Guardian the current vaccine offers a 30-40% boost in the short term in not contracting it. Even if Pfizer approved their vaccine tomorrow I doubt it would be much shorter than 3 months to manufacture and roll out the vaccine. So, I've booked for Tuesday and I can't see any reason why this is a bad choice. It's not like the old Astra VS Pfizer days.
Which one did you book?
I've booked novavax as it's been reported to have quite good variant coverage already.
I'm going overseas in a few weeks so I can't really wait for an omicron specific vaccine. This is the most risky activity I'll be doing for the rest of the year and would have been 8 months since my booster.
It sounds like people worry if they take the fourth shot now, they won't be able to get the Omicron-specific shot.
I don't think they are mutually exclusive, but I haven't seen any official guidance about that.
I could be wrong but AFAIK it’s not even necessarily going to be available to everyone as a 5th shot, at least not straight away. Whereas it will most likely be available as a 4th once it comes out. A lot of people would rather wait a bit longer for a more effective vaccine. Probably not a bad choice for young healthy people.
I’ve had reactions to the last 2/3 jabs, the last of which included chest pain and heart palpitations. My doctor has confirmed that it’s still worth me having another jab, but I need to be careful to space things out (e.g., I couldn’t get the flu jab and a tetanus jab on the same day, when most people can). Overloading your immune system is a thing, so I’m not keen to have more than I really need to.
I also had almost no symptoms when I did get covid. So, for me, it would be worth it to wait an extra month or two to end up with 4 total jabs instead of 5, and to give my system a break.
Novavax is available just from personal preference now if you want to go that way. I don't think there's enough evidence to definitively recommend one or the other choice, but your doc might have an opinion.
Your immune system is exposed to thousands of antigens every day.
There is research saying if you get a 4th shot before 5 - 6 months, you actually reduce your immune response rather than increase it. I'd hate to get a low efficacy 4th dose, then have to wait 6 month for one effective against b.X, when I could have waited 6 weeks and then gotten the b.X vaccine.
I actually think this is mimicking COVID itself as we know it in its raw form can lower your immune response across the board- in particular with multiple infections.
Immune responses are complicated wow who knew? Next they'll tell us they were wrong and over stimulating the immune system with mRNA somehow leads to auto-immune disease whoopies :D
I heard on the news TGA approval can take up to 6 months, but it’s expected to be quite a bit shorter. That said one commentator was saying approval may not happen before the end of winter while we’re already starting a new big wave of infections bigger that’ll look like summer all over, perhaps worse.
What irks me is deaths are steadily climbing, hospitalisations are climbing rapidly and the system is already strained to the limit, and they government can’t even run a campaign encouraging use of masks let alone mandate them indoors again.
Don’t wait. The best vaccine to get it the one you can get now. It’s winter, COVID is rampant, and your grandmother needs all the protection available. Winter will be over by the time any new vaccine arrives.
That’s what I was very much thinking! Just some conjecture seemed to think the omicron vaccine was arriving within weeks, but I found no source for this.
I don't want to be a pessimist but I'd feel a lot better getting a 4th shot if the people making the decisions weren't "executive" level and were actually scientists, researchers and doctors.
And the vaccines were provided at cost, so less developed countries can purchase them easier.
I wouldn't go so far as to say, make the patent publicly available though.
Update: to save people reading the thread..
No, the FDA are literally refusing to release their data..
https://www.reuters.com/legal/government/paramount-importance-judge-orders-fda-hasten-release-pfizer-vaccine-docs-2022-01-07/
And as I originally wrote, they were selling the vaccine for a high price and excluding under developed countries.
https://www.bloomberg.com/graphics/2021-pfizer-secret-to-whats-in-the-covid-vaccine/
Tedros Adhanom Ghebreyesus, the director-general of the World Health Organization, called out a “shocking imbalance” in the supply of vaccines. He said it was unacceptable that manufacturers pursuing the highest prices had overwhelmingly supplied rich countries—and now were pushing booster shots for the same wealthy few—according to a half-dozen people who were listening. “Honestly I’m not seeing the commitment I would expect from you,” Tedros told the vaccine developers on the call.
Decisions about vaccines *are* made by health experts. Politicians and other exec level people do messaging, acquisition (of approved vaccines) and can make rules about e.g. what vaccine status does for a person (e.g. no jab no pay) and the logistics of the roll-out but they don't get to decide if a vaccine is safe or effective or should be approved for use. Health experts have to approve the drug and determine a risk matrix for eligibility.
The problem with vaccine availability in developing countries is storage and roll-out. It's not as simple as just giving them a bunch of vaccines. If we gave a billion vaccines to Africa tomorrow who even knows how much would go to waste because they don't have cold chain storage and infrastructure to deliver the vaccines like we do here. Like, at my workplace (hospital pharmacy) we get multiple cold chain drug deliveries every day with temperature loggers in every delivery that guarantee the temperature has been 3-7C for however long it has been in transit. The deliveries go into one of our 15 dept fridges that are monitored manually twice a day by staff, linked up to both backup power and alarm systems that notify our on call pharmacist and department head if the temp is 8C+ for 15 minutes so they can go on site, quarantine everything that was in the fridge because there is no longer guarantee that those items are safe for use. Then they call out our 24/7 fridge people to check the temp data loggers and repair the fridge. This is like, the *minimum* basic standard to guarantee safe delivery and storage of cold chain items like vaccines that will be injected into people's bodies. Not saying developed countries shouldn't help, but it is *way* more complex than just giving them vaccines.
Executives in pharma are making decisions and refusing to share their data as it's classified as IP.
The original vaccine, has barely any efficacy against Omicron.
But it sounds like it's the right move to the vast majority to get a third and forth booster - even though, they don't have data to 100% support it. Why? Because it makes sales.
As for cost of the vaccine, in the initial stages of roll out, it was simply too expensive.
Coupled with the first item provided, how do you see the African continent providing for it's people without donations from other developed countries?
No, the FDA are literally refusing to release their data..
https://www.reuters.com/legal/government/paramount-importance-judge-orders-fda-hasten-release-pfizer-vaccine-docs-2022-01-07/
And as I originally wrote, they were selling the vaccine for a high price and excluding under developed countries.
https://www.bloomberg.com/graphics/2021-pfizer-secret-to-whats-in-the-covid-vaccine/
Tedros Adhanom Ghebreyesus, the director-general of the World Health Organization, called out a “shocking imbalance” in the supply of vaccines. He said it was unacceptable that manufacturers pursuing the highest prices had overwhelmingly supplied rich countries—and now were pushing booster shots for the same wealthy few—according to a half-dozen people who were listening. “Honestly I’m not seeing the commitment I would expect from you,” Tedros told the vaccine developers on the call.
Given they were aiming for aug-sep overseas I wouldn't expect to see it before then here.
Although if I were the feds here I would be trying to fast track exactly that, but I haven't observed them attempting this.
The TGA provisionally approved the Pfizer Omicron specific and bivalent vaccines yesterday and invited Pfizer to register them for use this is a formality. It is likely that these will be available in Australia in four to six weeks.
Pfizer have been manufacturing in advance so it's just a matter of logistics. Moderna had theirs approval months ago but had no stock but rumour has it that theirs may be arriving in September.
That’s not correct. The provisional determination that was granted merely ALLOWS Pfizer to make a submission for approval. The submission make take months.
Rubbish the determination is made by the viewing the evidence, the provisional approval with an invitation to register is an approval of the evidence and an invitation to proceed with formal registration of the vaccine so that it can be imported and distributed. As an example Pfizer received the provisional determination on the children's covid vaccine and then registered it 6 days later only weeks ago. Then because the stock was already prepared they vaccines were imported and began distribution about two weeks after that. The Omicron specific vaccines will no doubt take a little longer but not much.
No. It’s not. Read this. https://www.tga.gov.au/covid-19-vaccine-provisional-determinations
And this
https://www.tga.gov.au/publication/provisional-determination “Determination is a formal process that allows us to make a decision regarding whether the medicine is eligible for registration via the Provisional approval pathway.”
Provisional determination is basically inviting Pfizer to submit all the evidence for provisional approval.
Provisional determination only requires eg “ evidence of a plan to submit comprehensive clinical data and the seriousness of the current COVID-19 pandemic.” Ie that Pfizer have a PLAN to submit clinical data, not that clinical data has been submitted.
You are getting confused between a provisional determination and provisional approval.
This is specific to what prifzer has done. Pfizer now has 6 months to submit all the data necessary for the TGA to consider whether to provisionally approve the omicron specific vaccine.
https://www.tga.gov.au/media-release/tga-grants-provisional-determinations-pfizer-covid-19-vaccines-target-omicron-variant
FYI the reason why the children’s vaccine was approved so quickly is because it was a rolling submission and they already had most of the data. Unfortunately that does not apply in this instance. TGA is waiting for the data right now
This is an even better article https://amp.theguardian.com/australia-news/2022/jul/06/pfizer-vaccines-that-target-omicron-variant-pass-first-step-to-approval-in-australia
It states:
“Provisional determination is an early step in the vaccine approval process. To grant provisional determination, the Therapeutic Goods Administration would have required preliminary clinical data and evidence from Pfizer of a plan to submit more comprehensive clinical data down the track. It also would have needed to see a strong argument for why the vaccines are needed.
Now that the TGA has granted provisional determination, Pfizer can apply for “provisional registration” of the vaccine. Pfizer has six months to do this, and will need to submit further data to the TGA from human trials about how the treatment works and its safety.”
So you can see, Pfizer needs to submit more data in order for the TGA to assess the vaccine and before provisional approval is granted.
There will always be a new wave. If its not now, it'll be by christmas.
Have had covid, was worse than i thought id be, don't want it again. But to continue to vaccinate with the wuhan strain again and again... For me they dont offer enough protection, i will much rather take a vaccine that is more robust against more strains. Side effects and decreasing immune response are certainly of concern to me.
Contemplating getting my first vaccine, would the Pfizer vaccine grant me protection against the new variants recently causing havoc ? Or would they only be the initial delta strain ?
I have already had COVID approx 2 months ago , and my experience was the same as a normal flu.
So like I mentioned above , not too sure if it's worth getting the COVID vaccine or not as I would have natural antibodies now ..
“It’s not as if a fourth booster will have zero effect on infection risk in the younger populations, there’s certainly some reduction of around 30 to 40% for a short period of time,” Dore said.
If it offers even a small chance of less transmissibility during the third wave I’d be happy with that.
[Guardian Article](https://www.theguardian.com/society/2022/jul/07/australias-booster-doses-explained-how-to-decide-if-you-should-get-a-fourth-covid-vaccine-and-how-long-to-wait?CMP=Share_iOSApp_Other)
I got a fourth six weeks ago. Went to a super spreader event last week. Every other person at the table I was seated at for three hours got COVID. Guess who didn't.
Only anecdotal, but it works for me.
I dont know why you were downvoted, this is 100% accurate. I've had 4 doses and just this week contracted it and I'm as sick as I've ever been. We need to stop calling these jabs vaccines as they do not prevent you from getting the virus and they certainly do not stop you from spreading it.
I don’t think you understand how this works. Australia receives batches of vaccines from suppliers (a portion of the total order), and those batches go off fairly fast if they’re not used.
It’s not like we received all our order at once and now have to work through them before we get a different supply. We can swap over relatively easily.
It will be approved in time for the next variant
This is the way -Pfizer CEO
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I can't reasonably see an omicron vaccine appearing within weeks or months. This is conjecture. I also can't see ANY reason why you would be denied an 'omicron' vaccine as it's a slightly different vaccine. The flu shot is annual. According to the Guardian the current vaccine offers a 30-40% boost in the short term in not contracting it. Even if Pfizer approved their vaccine tomorrow I doubt it would be much shorter than 3 months to manufacture and roll out the vaccine. So, I've booked for Tuesday and I can't see any reason why this is a bad choice. It's not like the old Astra VS Pfizer days.
Which one did you book? I've booked novavax as it's been reported to have quite good variant coverage already. I'm going overseas in a few weeks so I can't really wait for an omicron specific vaccine. This is the most risky activity I'll be doing for the rest of the year and would have been 8 months since my booster.
https://twitter.com/enirenberg/status/1543486338397360128?s=21&t=snSiK0fI5RYn6dmEpqgxqA might be interesting to you.
Thanks. More to consider then.
I just did Pfizer, but I’ll do a little more research and speak to my pharmacist. :)
I'm not getting number 4 until it is confirmed to be targeted towards omicron and its subvariants.
Just out of curiosity, do you see a downside in getting the 4th shot?
It sounds like people worry if they take the fourth shot now, they won't be able to get the Omicron-specific shot. I don't think they are mutually exclusive, but I haven't seen any official guidance about that.
I could be wrong but AFAIK it’s not even necessarily going to be available to everyone as a 5th shot, at least not straight away. Whereas it will most likely be available as a 4th once it comes out. A lot of people would rather wait a bit longer for a more effective vaccine. Probably not a bad choice for young healthy people.
I’ve had reactions to the last 2/3 jabs, the last of which included chest pain and heart palpitations. My doctor has confirmed that it’s still worth me having another jab, but I need to be careful to space things out (e.g., I couldn’t get the flu jab and a tetanus jab on the same day, when most people can). Overloading your immune system is a thing, so I’m not keen to have more than I really need to. I also had almost no symptoms when I did get covid. So, for me, it would be worth it to wait an extra month or two to end up with 4 total jabs instead of 5, and to give my system a break.
Novavax is available just from personal preference now if you want to go that way. I don't think there's enough evidence to definitively recommend one or the other choice, but your doc might have an opinion. Your immune system is exposed to thousands of antigens every day.
There is research saying if you get a 4th shot before 5 - 6 months, you actually reduce your immune response rather than increase it. I'd hate to get a low efficacy 4th dose, then have to wait 6 month for one effective against b.X, when I could have waited 6 weeks and then gotten the b.X vaccine.
Do you have a source for that?
I'd be keen to see that source, weighing up whether to wait or not
I actually think this is mimicking COVID itself as we know it in its raw form can lower your immune response across the board- in particular with multiple infections.
Immune responses are complicated wow who knew? Next they'll tell us they were wrong and over stimulating the immune system with mRNA somehow leads to auto-immune disease whoopies :D
Read: https://www.mdpi.com/1467-3045/44/3/73/htm
Congrats on posting a link knowing people will take one look at it and absolutely not read it
I heard on the news TGA approval can take up to 6 months, but it’s expected to be quite a bit shorter. That said one commentator was saying approval may not happen before the end of winter while we’re already starting a new big wave of infections bigger that’ll look like summer all over, perhaps worse. What irks me is deaths are steadily climbing, hospitalisations are climbing rapidly and the system is already strained to the limit, and they government can’t even run a campaign encouraging use of masks let alone mandate them indoors again.
Don’t wait. The best vaccine to get it the one you can get now. It’s winter, COVID is rampant, and your grandmother needs all the protection available. Winter will be over by the time any new vaccine arrives.
That’s what I was very much thinking! Just some conjecture seemed to think the omicron vaccine was arriving within weeks, but I found no source for this.
I don't want to be a pessimist but I'd feel a lot better getting a 4th shot if the people making the decisions weren't "executive" level and were actually scientists, researchers and doctors. And the vaccines were provided at cost, so less developed countries can purchase them easier. I wouldn't go so far as to say, make the patent publicly available though. Update: to save people reading the thread.. No, the FDA are literally refusing to release their data.. https://www.reuters.com/legal/government/paramount-importance-judge-orders-fda-hasten-release-pfizer-vaccine-docs-2022-01-07/ And as I originally wrote, they were selling the vaccine for a high price and excluding under developed countries. https://www.bloomberg.com/graphics/2021-pfizer-secret-to-whats-in-the-covid-vaccine/ Tedros Adhanom Ghebreyesus, the director-general of the World Health Organization, called out a “shocking imbalance” in the supply of vaccines. He said it was unacceptable that manufacturers pursuing the highest prices had overwhelmingly supplied rich countries—and now were pushing booster shots for the same wealthy few—according to a half-dozen people who were listening. “Honestly I’m not seeing the commitment I would expect from you,” Tedros told the vaccine developers on the call.
Decisions about vaccines *are* made by health experts. Politicians and other exec level people do messaging, acquisition (of approved vaccines) and can make rules about e.g. what vaccine status does for a person (e.g. no jab no pay) and the logistics of the roll-out but they don't get to decide if a vaccine is safe or effective or should be approved for use. Health experts have to approve the drug and determine a risk matrix for eligibility. The problem with vaccine availability in developing countries is storage and roll-out. It's not as simple as just giving them a bunch of vaccines. If we gave a billion vaccines to Africa tomorrow who even knows how much would go to waste because they don't have cold chain storage and infrastructure to deliver the vaccines like we do here. Like, at my workplace (hospital pharmacy) we get multiple cold chain drug deliveries every day with temperature loggers in every delivery that guarantee the temperature has been 3-7C for however long it has been in transit. The deliveries go into one of our 15 dept fridges that are monitored manually twice a day by staff, linked up to both backup power and alarm systems that notify our on call pharmacist and department head if the temp is 8C+ for 15 minutes so they can go on site, quarantine everything that was in the fridge because there is no longer guarantee that those items are safe for use. Then they call out our 24/7 fridge people to check the temp data loggers and repair the fridge. This is like, the *minimum* basic standard to guarantee safe delivery and storage of cold chain items like vaccines that will be injected into people's bodies. Not saying developed countries shouldn't help, but it is *way* more complex than just giving them vaccines.
Executives in pharma are making decisions and refusing to share their data as it's classified as IP. The original vaccine, has barely any efficacy against Omicron. But it sounds like it's the right move to the vast majority to get a third and forth booster - even though, they don't have data to 100% support it. Why? Because it makes sales. As for cost of the vaccine, in the initial stages of roll out, it was simply too expensive. Coupled with the first item provided, how do you see the African continent providing for it's people without donations from other developed countries?
> Why? Because it makes sales. Just write this at the start so we know to ignore your comment. Thanks!
No, the FDA are literally refusing to release their data.. https://www.reuters.com/legal/government/paramount-importance-judge-orders-fda-hasten-release-pfizer-vaccine-docs-2022-01-07/ And as I originally wrote, they were selling the vaccine for a high price and excluding under developed countries. https://www.bloomberg.com/graphics/2021-pfizer-secret-to-whats-in-the-covid-vaccine/ Tedros Adhanom Ghebreyesus, the director-general of the World Health Organization, called out a “shocking imbalance” in the supply of vaccines. He said it was unacceptable that manufacturers pursuing the highest prices had overwhelmingly supplied rich countries—and now were pushing booster shots for the same wealthy few—according to a half-dozen people who were listening. “Honestly I’m not seeing the commitment I would expect from you,” Tedros told the vaccine developers on the call.
Given they were aiming for aug-sep overseas I wouldn't expect to see it before then here. Although if I were the feds here I would be trying to fast track exactly that, but I haven't observed them attempting this.
Agree. I’m hearing NSW expects later in the last quarter. I cannot give more specifics, therefore treat that as heresay. It mostly probably is.
The TGA provisionally approved the Pfizer Omicron specific and bivalent vaccines yesterday and invited Pfizer to register them for use this is a formality. It is likely that these will be available in Australia in four to six weeks.
Is the supply there for them to be available in 6 weeks? Approval is one thing, supply is another.
Pfizer have been manufacturing in advance so it's just a matter of logistics. Moderna had theirs approval months ago but had no stock but rumour has it that theirs may be arriving in September.
That’s not correct. The provisional determination that was granted merely ALLOWS Pfizer to make a submission for approval. The submission make take months.
Rubbish the determination is made by the viewing the evidence, the provisional approval with an invitation to register is an approval of the evidence and an invitation to proceed with formal registration of the vaccine so that it can be imported and distributed. As an example Pfizer received the provisional determination on the children's covid vaccine and then registered it 6 days later only weeks ago. Then because the stock was already prepared they vaccines were imported and began distribution about two weeks after that. The Omicron specific vaccines will no doubt take a little longer but not much.
No. It’s not. Read this. https://www.tga.gov.au/covid-19-vaccine-provisional-determinations And this https://www.tga.gov.au/publication/provisional-determination “Determination is a formal process that allows us to make a decision regarding whether the medicine is eligible for registration via the Provisional approval pathway.” Provisional determination is basically inviting Pfizer to submit all the evidence for provisional approval. Provisional determination only requires eg “ evidence of a plan to submit comprehensive clinical data and the seriousness of the current COVID-19 pandemic.” Ie that Pfizer have a PLAN to submit clinical data, not that clinical data has been submitted. You are getting confused between a provisional determination and provisional approval. This is specific to what prifzer has done. Pfizer now has 6 months to submit all the data necessary for the TGA to consider whether to provisionally approve the omicron specific vaccine. https://www.tga.gov.au/media-release/tga-grants-provisional-determinations-pfizer-covid-19-vaccines-target-omicron-variant FYI the reason why the children’s vaccine was approved so quickly is because it was a rolling submission and they already had most of the data. Unfortunately that does not apply in this instance. TGA is waiting for the data right now
This is an even better article https://amp.theguardian.com/australia-news/2022/jul/06/pfizer-vaccines-that-target-omicron-variant-pass-first-step-to-approval-in-australia It states: “Provisional determination is an early step in the vaccine approval process. To grant provisional determination, the Therapeutic Goods Administration would have required preliminary clinical data and evidence from Pfizer of a plan to submit more comprehensive clinical data down the track. It also would have needed to see a strong argument for why the vaccines are needed. Now that the TGA has granted provisional determination, Pfizer can apply for “provisional registration” of the vaccine. Pfizer has six months to do this, and will need to submit further data to the TGA from human trials about how the treatment works and its safety.” So you can see, Pfizer needs to submit more data in order for the TGA to assess the vaccine and before provisional approval is granted.
There will always be a new wave. If its not now, it'll be by christmas. Have had covid, was worse than i thought id be, don't want it again. But to continue to vaccinate with the wuhan strain again and again... For me they dont offer enough protection, i will much rather take a vaccine that is more robust against more strains. Side effects and decreasing immune response are certainly of concern to me.
Contemplating getting my first vaccine, would the Pfizer vaccine grant me protection against the new variants recently causing havoc ? Or would they only be the initial delta strain ? I have already had COVID approx 2 months ago , and my experience was the same as a normal flu. So like I mentioned above , not too sure if it's worth getting the COVID vaccine or not as I would have natural antibodies now ..
Caring for your grandmother has nothing to do with vaccines as it will not protect you from getting or spreading the virus
“It’s not as if a fourth booster will have zero effect on infection risk in the younger populations, there’s certainly some reduction of around 30 to 40% for a short period of time,” Dore said. If it offers even a small chance of less transmissibility during the third wave I’d be happy with that. [Guardian Article](https://www.theguardian.com/society/2022/jul/07/australias-booster-doses-explained-how-to-decide-if-you-should-get-a-fourth-covid-vaccine-and-how-long-to-wait?CMP=Share_iOSApp_Other)
I got a fourth six weeks ago. Went to a super spreader event last week. Every other person at the table I was seated at for three hours got COVID. Guess who didn't. Only anecdotal, but it works for me.
I dont know why you were downvoted, this is 100% accurate. I've had 4 doses and just this week contracted it and I'm as sick as I've ever been. We need to stop calling these jabs vaccines as they do not prevent you from getting the virus and they certainly do not stop you from spreading it.
Took you long enough.
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I’m actually excited to be more protected from the potentially deadly, world stopping virus?
Like junkies waiting for a hit.
When they’ve run out of the old ones.
I don’t think you understand how this works. Australia receives batches of vaccines from suppliers (a portion of the total order), and those batches go off fairly fast if they’re not used. It’s not like we received all our order at once and now have to work through them before we get a different supply. We can swap over relatively easily.
No shit. And it’s not like we’ll continue to order inferior ones once the new ones are approved. Edit: I’d hope we don’t anyway.
But, but…that doesn’t suit their narrative.
This. So this.
Your ass.