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AstraZeneca [and other] vaccine trial experience

AstraZeneca [and other] vaccine trial experience

 
Old May 14, 2021, 7:51 am
  #226  
 
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Originally Posted by ajGoes
Or that it's equally effective?
96% vs the Wuhan strain, 86% vs the UK strain, 50% vs the South African strain. Boosters on the way for the latter.

Novavax measures efficacy against symptomatic covid. So this is vs mild, moderate, or severe.

https://time.com/5946225/novavax-cov...ase-3-results/
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Old May 14, 2021, 8:02 am
  #227  
 
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Originally Posted by Kgmm77
Is there confirmed evidence that it has demonstrably less side effects?
Yep...slides 8, 9, and 10. Moderate fatigue after Dose 2 was the most common side effect , but it only occurred in 20% of participants.

For the Pfizer/Moderna side effect profile, I'm going off of widely reported anecdotal experiences. Novavax has many faults, but one of their virtues is that they've been extremely open with their data. Compare that with JNJ, which has masked their vaccine's poor performance by defining "efficacy" as against severe disease only.

https://www.novavax.com/sites/defaul...lenn-FINAL.pdf
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Old May 14, 2021, 9:13 am
  #228  
 
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Originally Posted by lobo411
Yep...slides 8, 9, and 10. Moderate fatigue after Dose 2 was the most common side effect , but it only occurred in 20% of participants.

For the Pfizer/Moderna side effect profile, I'm going off of widely reported anecdotal experiences. Novavax has many faults, but one of their virtues is that they've been extremely open with their data. Compare that with JNJ, which has masked their vaccine's poor performance by defining "efficacy" as against severe disease only.

https://www.novavax.com/sites/defaul...lenn-FINAL.pdf
I may be missing something, but the comparison of side effects in the slide pack appears to be with the placebo, not with other vaccines?
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Old May 14, 2021, 12:46 pm
  #229  
 
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Originally Posted by Kgmm77
I may be missing something, but the comparison of side effects in the slide pack appears to be with the placebo, not with other vaccines?
Ya that's just a slide showing the rate of side effects in the Novavax trial. I'll have to do some research to find out what the rate of side effects is for the Pfizer or Moderna vaccines. I assume they have a similar publication to the Novavax one, but it's going to take a bit of digging. Right now I have a headache, and I don't know if it's from Novavax dose 2 or just because I'm hungry!
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Old May 14, 2021, 3:40 pm
  #230  
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Originally Posted by lobo411
Yep...slides 8, 9, and 10. Moderate fatigue after Dose 2 was the most common side effect , but it only occurred in 20% of participants.

For the Pfizer/Moderna side effect profile, I'm going off of widely reported anecdotal experiences. Novavax has many faults, but one of their virtues is that they've been extremely open with their data. Compare that with JNJ, which has masked their vaccine's poor performance by defining "efficacy" as against severe disease only.

https://www.novavax.com/sites/defaul...lenn-FINAL.pdf
I'm all for transparency, but the J&J vaccine is pretty effective at symptomatic covid too - 66%. It's a much more useful vaccine now that Novavax is because it's getting into people's arms.

https://www.cdc.gov/coronavirus/2019...g%20vaccinated.
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Old May 14, 2021, 5:59 pm
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Originally Posted by TTT
I'm all for transparency, but the J&J vaccine is pretty effective at symptomatic covid too - 66%. It's a much more useful vaccine now that Novavax is because it's getting into people's arms.
Novavax is paying the price for JNJ's sins. JNJ skated through approval despite lacking a viable manufacturing and QC plan, as the present situation demonstrates. You have the Emergent fiasco, and the blood clot fiasco, and now we find that JNJ has delivered far fewer shots than promised. The paltry number of shots being delivered now are actually manufactured overseas because JNJ can't get its factories in order.

So because the FDA got burned by JNJ, they're forcing Novavax to go through a much more rigorous approval process. JNJ got a free pass, and Novavax is paying the price.

https://www.politico.com/news/2021/0...vaccine-487070
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Old May 25, 2021, 12:25 pm
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Let the great experiment begin! I was a placebo in the Novavax trial, and they've announced that they won't seek a US EUA until July at the soonest. This means no trip to Europe without a CDC card for an EMA approved vaccine, so I decided to go for the JNJ vaccine today. I'm far from the only participant in the Novavax trial who got live vaccine and then decided to get an EMA vaccine, and Novavax recently changed the trial protocol to say that this is permitted.

I decided I wanted JNJ *because* it has the lowest reported efficacy of any vaccine available in the US, and I thought this might make it least likely to cause heavy side effects in an already vaccinated person. Also, it's a viral vector vaccine, and there are currently "mix and match" studies underway that use a viral vector vaccine + either Pfizer or Novavax.

What is different about what I've done is that I finished the full, active Novavax 2 shot regimen less than two weeks ago. Most folks who have gotten double-vaccinated have waited a few weeks between vaccinations, but I read an article saying that the JNJ shots being administered right now in the US were actually made in the Netherlands. Once the Emergent facility (the one with many, many, many contamination issues) is certified, millions of Emergent-made doses will be administered in the US. So I felt it wasn't prudent to wait.
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Old Jul 20, 2021, 2:29 pm
  #233  
 
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Confused about Novavax Trial Protocol

Originally Posted by lobo411
Let the great experiment begin! I was a placebo in the Novavax trial, and they've announced that they won't seek a US EUA until July at the soonest. This means no trip to Europe without a CDC card for an EMA approved vaccine, so I decided to go for the JNJ vaccine today. I'm far from the only participant in the Novavax trial who got live vaccine and then decided to get an EMA vaccine, and Novavax recently changed the trial protocol to say that this is permitted.
I tried to be in the Novavax COVID-19 vaccine clinical trial, but I was too late because recruiting was completed by the time I contacted a local clinical trial center. Nevertheless, it is the vaccine of my choice. Re: trial participants getting an EMA vaccine. I understand the reason for doing so, but I don't understand "Novavax recently changed the trial protocol to say that this is permitted." How can their trial data mean anything if participants can take other vaccines? Is it because they've finished collecting data? I would be grateful for an explanation if you can explain it. Thank you.
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Old Jul 20, 2021, 2:43 pm
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Originally Posted by forumfriend
I tried to be in the Novavax COVID-19 vaccine clinical trial, but I was too late because recruiting was completed by the time I contacted a local clinical trial center. Nevertheless, it is the vaccine of my choice. Re: trial participants getting an EMA vaccine. I understand the reason for doing so, but I don't understand "Novavax recently changed the trial protocol to say that this is permitted." How can their trial data mean anything if participants can take other vaccines? Is it because they've finished collecting data? I would be grateful for an explanation if you can explain it. Thank you.
A couple of reasons.

1. They know we're going to get EUA vaccines no matter what they say because we have to have proof of vaccination to live. So this is a way to keep subjects from ghosting entirely.

2. Yes, the EUA application will be based entirely on pre crossover data. So there's no harm in participants getting an EUA vaccine.

3. Even those who have been unblinded or gotten an EUA vaccine are still needed for safety data. Let's say a person got two different kinds of vaccines, and then they had a serious, adverse event. If that adverse event was a known issue with Vaccine 1 and not with Vaccine 2, then you would still know with a high level of probability which vaccine caused the event.

4. The vaccines are all designed to produce antibodies of slightly different shapes. If you know that Patient X got Vaccine 1 and Vaccine 2, then you can figure out which vaccine is still active 6 or 12 months later by examining their blood.

So there's still useful data to be had, and arguably it's better to get some useful data than none.
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Old Jul 20, 2021, 2:47 pm
  #235  
 
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Thank you, lobo411. Good explanation.
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Last edited by forumfriend; Jul 20, 2021 at 2:49 pm Reason: to explain who I am replying to
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Old Jul 27, 2021, 2:25 pm
  #236  
 
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I’ve posted in the wider experience thread an update that from Monday I am now shown as fully vaccinated in the NHS app showing my vaccine as “ covovax” manufacturer novavax cz as. Giving my batch numbers etc.. for domestic and international travel - as to when other countries will accept it is anyone’s guess. Anyhow progress.
T
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Old Jul 27, 2021, 4:12 pm
  #237  
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Originally Posted by Telecasterman
I’ve posted in the wider experience thread an update that from Monday I am now shown as fully vaccinated in the NHS app showing my vaccine as “ covovax” manufacturer novavax cz as. Giving my batch numbers etc.. for domestic and international travel - as to when other countries will accept it is anyone’s guess. Anyhow progress.
T
Thank you for supporting the testing programme.

The legislation (Statutory Instrument) written for Amber country arrivals gives you a straightforward right to avoid vaccination anyway. I know a lot has been made about the NHS App in this area, but in terms of filling in the PLF you tick the relevant box, it then appears on the top of the PLF that you are exempt from self isolation. The airlines don't care about this area (since some passengers will be self isolatng anyway), and if either NHST&T or the police enquire - both unlikely I would say - then you have documentary evidence of your participation in the trials.
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Old Sep 24, 2021, 9:24 am
  #238  
 
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Booster vaccine

Today (24/9) I received a Pfizer booster and flu jab. I received a txt (23/9) from my GP to get a booster, I contacted NHS Novavax UK Trial lead asking their advice- they replied that I should take the offered booster. My last Novavax dose was 8th December. All went smoothly and I should expect the booster jab to show up in my NHS app soon.
Hope that helps anyone in a similar position
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Old Oct 25, 2021, 3:47 pm
  #239  
 
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Seems a shame that this thread is stagnant as to me it’s still very relevant.
last week I received a mail and follow up call from the Northern Care Alliance (NHS). The rub was about prof Van Tam and his efforts to get G7 to agree that novavax trial candidates be recognised as being fully vaccinated. Seems it fell on deaf ears hence a follow up mail and call and I received a Pfizer (booster) on 24/9 and will now get a second on in the second week of November.
I think it’s timely to state that I volunteered for NHS research in August last year and had no idea if/when they might call me. The whole novavax thing was unsolicited. as we come out of / live with this I have a business to run and it affects me and my family
I read comments now on various media in disbelief, people are wrapped up in mostly self serving nonsense.
If it wasn’t for the many volunteers they would not, repeat not, be going on these trips etc….
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Old Oct 28, 2021, 3:36 pm
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Just by way of an update, Novavax finally applied for approval from the mhra yesterday. An application to the EMA should come in the next couple of days. WHO app is already in the works. FDA app sometime in mid December.
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