FDA has approved the NOVAVAX vaccine today July 13, 2022 - Protein-based Vaccine

[cyber888]

The US FDA Approved the Novavax Vaccine today as the 4th Vaccine in the US. Unliked Pfizer and Moderna, it is a traditional protein-based vaccine and not an mRNA vaccine. It has 90% efficacy and highly effective vs. Omicron BA 5

https://www.fda.gov/news-events/pre...gency-use-novavax-covid-19-vaccine-adjuvanted

https://www.kitv.com/news/coronavir...ml?utm_medium=social&utm_source=twitter_KITV4

The Key Take Away from the Novavax news today - (1) Novavax is Omicron ready, (2) Biden Administrator has ordered, (3) After CDC signs off, it will be available quickly. Govt. is anxious to distribute it (4) Will be offered to teens and kids soo

Based on the US FDA June 28, 2022 presentation, it has very high antibodies for Omicron BA5, the latest Omicron strain.

 

[MuirWannabe]

Interesting. Are they claiming this vaccine will provide protection from infection of omicron and its variants? Is so, to what degree? Or is this just more of the usual ‘doesn’t stop you from getting it but helps with severity’ mantra.

I’ve not been interested in a 4th Moderna shot. Especially given my recent antibody testing results which reveal still very strong vaccine antibodies present. But if this vaccine is promising protection from omicron variant infections then that would definitely merit attention.

Speaking of which. We had operation warp speed under the prior administration that did yield the current vaccines quickly. When the mRNA tech with these vaccines were released one of the big promises was how fast they could be adapted for new variants. Well, that was 2 years ago. Lots of new variants. No new mRNA shots addressing them. Why? Cause the mRNA promise of adaptation was bogus? Cause there’s no warp speed anymore in this administration? Or are all of the above assumptions and the way I’m remembering them just plain incorrect? Just wondering.

 

[Chuckanut]

Speaking of which. We had operation warp speed under the prior administration that did yield the current vaccines quickly. When the mRNA tech with these vaccines were released one of the big promises was how fast they could be adapted for new variants. Well, that was 2 years ago. Lots of new variants. No new mRNA shots addressing them. Why? Cause the mRNA promise of adaptation was bogus? Cause there’s no warp speed anymore in this administration? Or are all of the above assumptions and the way I’m remembering them just plain incorrect? Just wondering.

We owe the fast vaccine development to many people. One of them is this guy: General Gus Perna. He was in charge of making sure those who developed and distributed the vaccine got what they needed without unnecessary delay.

https://www.cbsnews.com/news/covid-19-vaccine-distribution-60-minutes-2020-11-08/

David Martin: So if this distribution of vaccine is-- doesn't go according to plan, where does the buck stop?
General Gus Perna: Me. Conversation's over. It's pretty easy, me. I hold myself 100% personally accountable to that end.

Obviously, the general is not a politician.

 

[MuirWannabe]

We owe the fast vaccine development to many people. One of them is this guy: General Gus Perna. He was in charge of making sure those who developed and distributed the vaccine got what they needed without unnecessary delay.

https://www.cbsnews.com/news/covid-19-vaccine-distribution-60-minutes-2020-11-08/

Obviously, the general is not a politician.

Agreed that he isn’t a politician and that there were of course numerous people involved in delivering the vaccines quickly. Still, he was part of the administrations warp speed program.

 

[audreyh1]

Wow, that’s very promising!

I wonder what the recommendations will be for those of us already boosted.

 

[Freedom56]

Speaking of which. We had operation warp speed under the prior administration that did yield the current vaccines quickly. When the mRNA tech with these vaccines were released one of the big promises was how fast they could be adapted for new variants. Well, that was 2 years ago. Lots of new variants. No new mRNA shots addressing them. Why? Cause the mRNA promise of adaptation was bogus? Cause there’s no warp speed anymore in this administration? Or are all of the above assumptions and the way I’m remembering them just plain incorrect? Just wondering.

The development is running much faster. Here are the facts. mRNA Vaccines were only made possible by DARPA funding in 2014 without which there would be no mRNA vaccines from Moderna. Moderna was founded from government grants in 2011 after the administration during that period wanted newer technology to develop vaccines after the H1N1 outbreak in early 2009. BionTech was funded by the German government and was not part of Operation Warp Speed. mRNA research spanned decades of research and did not originate from Operation Warp Speed. The original strain of coronavirus was sequenced January 6th 2020. BionTech had 20 candidates ready for testing at the end of January 2020 before Operation Warp Speed existed and a month before a pandemic was even declared. Moderna then focused on the COVID-19 vaccine and had candidates ready for testing in February 2020 still before Operation Warp Speed existed. Pfizer/BionTech self funded the development and production and received EUA on December 11, 2020. Moderna received over $1Billion to develop and produce the vaccine from Operation Warp Speed. AstraZeneca and Novavax received billions in funding but AstraZeneca was never approved by the FDA and Novavax just received approval. So we are talking about 11 to 12 months from discovery to EUA for the mRNA vaccines. The efficacy of both vaccines were announced in mid to late November 2020. Johnson & Johnson announced efficacy was announced two months later but was supposed to be a one shot vaccine. In the end it proved to be ineffective.

The Omicron strain emerged in Mid December 2021 and break-though infections of vaccinated individuals were confirmed late December 2021. Both Pfizer and Moderna confirmed that the original vaccine would not prevent infections from the Omicron strain in late January 2022. Both Moderna and Pfizer worked on Omicron containing bivalent booster and on June 8th, 2022 Moderna announced their results and are working towards EUA. Pfizer/Biontech is about to report their results. So is January 2022 to June 2022 timeline really a slower pace?

https://investors.modernatx.com/new...ntibody-Response-Against-Omicron/default.aspx

https://www.fiercepharma.com/pharma...es-high-neutralizing-antibody-responses-trial

The FDA has asked both Pfizer and Moderna to modify their vaccine to target the BA4 and BA5 variants that recently emerged. Both companies plan to have vaccines ready for the fall.

 

[cyber888]

Interesting. Are they claiming this vaccine will provide protection from infection of omicron and its variants? Is so, to what degree? Or is this just more of the usual ‘doesn’t stop you from getting it but helps with severity’ mantra.

I’ve not been interested in a 4th Moderna shot. Especially given my recent antibody testing results which reveal still very strong vaccine antibodies present. But if this vaccine is promising protection from omicron variant infections then that would definitely merit attention.

Speaking of which. We had operation warp speed under the prior administration that did yield the current vaccines quickly. When the mRNA tech with these vaccines were released one of the big promises was how fast they could be adapted for new variants. Well, that was 2 years ago. Lots of new variants. No new mRNA shots addressing them. Why? Cause the mRNA promise of adaptation was bogus? Cause there’s no warp speed anymore in this administration? Or are all of the above assumptions and the way I’m remembering them just plain incorrect? Just wondering.

Yes, it is effective against all Omicron variants by training Conserve Epitopes. This is the most laymanish video I could find

https://youtu.be/2gzBNd4mxIg

 

[cyber888]

Wow, that’s very promising!

I wonder what the recommendations will be for those of us already boosted.

On July 1, Novavax said that its vaccine prompted "broad immune responses" against all COVID variants, including BA.5, in clinical data. Novavax has not publicly released the data, but some experts are optimistic that it might outperform mRNA vaccines against BA.5 due to its technology.

“I wonder if we’re not witnessing some of the limitation that there may be [with] the mRNA vaccines. Yes, they were first out of the gate. But they don’t appear to have that breadth of protection,” Wayne A. Marasco, an FDA adviser and virology professor at the Dana-Farber Cancer Institute, told the Washington Post about the potential benefits of Novavax's protein-based jab. Marasco said that Novavax's data on new variants was impressive, and says the Novavax data also intrigued other FDA advisors.

https://fortune.com/2022/07/14/novavax-covid-vaccine-approved-fda-omicron-ba-5-subvariant/

 

[MuirWannabe]

The development is running much faster. Here are the facts. mRNA Vaccines were only made possible by DARPA funding in 2014 without which there would be no mRNA vaccines from Moderna. Moderna was founded from government grants in 2011 after the administration during that period wanted newer technology to develop vaccines after the H1N1 outbreak in early 2009. BionTech was funded by the German government and was not part of Operation Warp Speed. mRNA research spanned decades of research and did not originate from Operation Warp Speed. The original strain of coronavirus was sequenced January 6th 2020. BionTech had 20 candidates ready for testing at the end of January 2020 before Operation Warp Speed existed and a month before a pandemic was even declared. Moderna then focused on the COVID-19 vaccine and had candidates ready for testing in February 2020 still before Operation Warp Speed existed. Pfizer/BionTech self funded the development and production and received EUA on December 11, 2020. Moderna received over $1Billion to develop and produce the vaccine from Operation Warp Speed. AstraZeneca and Novavax received billions in funding but AstraZeneca was never approved by the FDA and Novavax just received approval. So we are talking about 11 to 12 months from discovery to EUA for the mRNA vaccines. The efficacy of both vaccines were announced in mid to late November 2020. Johnson & Johnson announced efficacy was announced two months later but was supposed to be a one shot vaccine. In the end it proved to be ineffective.



The Omicron strain emerged in Mid December 2021 and break-though infections of vaccinated individuals were confirmed late December 2021. Both Pfizer and Moderna confirmed that the original vaccine would not prevent infections from the Omicron strain in late January 2022. Both Moderna and Pfizer worked on Omicron containing bivalent booster and on June 8th, 2022 Moderna announced their results and are working towards EUA. Pfizer/Biontech is about to report their results. So is January 2022 to June 2022 timeline really a slower pace?



https://investors.modernatx.com/new...ntibody-Response-Against-Omicron/default.aspx



https://www.fiercepharma.com/pharma...es-high-neutralizing-antibody-responses-trial



The FDA has asked both Pfizer and Moderna to modify their vaccine to target the BA4 and BA5 variants that recently emerged. Both companies plan to have vaccines ready for the fall.

Interesting stuff. I’ve not been paying close attention. Glad to hear the mRNA vaccine makers have omicron ready vaccines. Kind of wondering what the holdup is if they are effective against omicron and it’s variants infection.

 

[ShokWaveRider]

When can we get it?

 

[MuirWannabe]

On July 1, Novavax said that its vaccine prompted "broad immune responses" against all COVID variants, including BA.5, in clinical data. Novavax has not publicly released the data, but some experts are optimistic that it might outperform mRNA vaccines against BA.5 due to its technology.

“I wonder if we’re not witnessing some of the limitation that there may be [with] the mRNA vaccines. Yes, they were first out of the gate. But they don’t appear to have that breadth of protection,” Wayne A. Marasco, an FDA adviser and virology professor at the Dana-Farber Cancer Institute, told the Washington Post about the potential benefits of Novavax's protein-based jab. Marasco said that Novavax's data on new variants was impressive, and says the Novavax data also intrigued other FDA advisors.

https://fortune.com/2022/07/14/novavax-covid-vaccine-approved-fda-omicron-ba-5-subvariant/

This is hopeful. Worth keeping an eye on this one to see if it lives up to promise. Thanks.

 

[cyber888]

When can we get it?

I believe end of this month or next month some CVS should have it

 

[cyber888]

Interesting stuff. I’ve not been paying close attention. Glad to hear the mRNA vaccine makers have omicron ready vaccines. Kind of wondering what the holdup is if they are effective against omicron and it’s variants infection.

Based on the FDA meeting on June 28, the mRNA vaccine makers created a vaccine for Omicron BA1 strain - which is not in circulation in the US anymore. They did not provide any data for BA5, but Novavax did provide data that their vax is effective against BA5 after 8 months

 

[audreyh1]

Can it be used as a booster?

 

[explanade]

Yes, since most people have been vaccinated already, all they have left is mostly the booster market.

But I thought I read that they were also working on Omicron specific formulations as well.

It’s not mRNA which is limiting effectiveness vs. newer strains. Remember that Astra Zeneca and J&J fell off the map with Delta and then not sure they bothered much to test them vs. Omicron, even as boosters.

Instead, all vaccines targeted the whole spike protein which has seen many mutatIons.

Now the new approach, from Caltech and others, is to target parts of tHe spike protein, just parts which haven’t mutated much or at all. But those vaccines may take until 2024.

 

[Freedom56]

I would be skeptical of any claims of BA4/BA5 immunity made by Novavax until they release real data. My brother is a Physician (radiology and nuclear medicine) and now back on COVID ICU duty one day a week and he was skeptical of the J&J vaccine claims in late 2020 and recommended we use Pfizer or Moderna. He is planning to get either the new Moderna or Pfizer boosters unless he sees some concrete evidence that the two shot Novavax regimen is effective.

 

[cyber888]

I would be skeptical of any claims of BA4/BA5 immunity made by Novavax until they release real data. My brother is a Physician (radiology and nuclear medicine) and now back on COVID ICU duty one day a week and he was skeptical of the J&J vaccine claims in late 2020 and recommended we use Pfizer or Moderna. He is planning to get either the new Moderna or Pfizer boosters unless he sees some concrete evidence that the two shot Novavax regimen is effective.

They did release data in the FDA June 28 meeting showing very durable protection from BA5 after an 8 month boosts. The FDA said they would verify this data, and after verification, they would approved. There is a Youtube video of the meeting where you can hear the FDA advisor said they would verify the data and then approve if the data is verified.

 

[cyber888]

Can it be used as a booster?

Yes, it's been used as a Booster in other countries with no problems - Australia, S.Korea, etc.

 

[omni550]

I would be skeptical of any claims of BA4/BA5 immunity made by Novavax until they release real data. My brother is a Physician (radiology and nuclear medicine) and now back on COVID ICU duty one day a week and he was skeptical of the J&J vaccine claims in late 2020 and recommended we use Pfizer or Moderna. He is planning to get either the new Moderna or Pfizer boosters unless he sees some concrete evidence that the two shot Novavax regimen is effective.

Freedom56,

Please keep us posted as to what you hear from your brother.

omni

 

[pacergal]

Good news for another piece in our Covid arsenal.
Looks like protection for newest Omicron is after 2 shots, 8 months apart.

would be interesting to read other research on it, wondering if the Omnicrom protection would be as high if it is a 5th booster after either 4 mRNA vax?
Might be great Fall booster older folks, me included!

 

[audreyh1]

Good news for another piece in our Covid arsenal.
Looks like protection for newest Omicron is after 2 shots, 8 months apart.

would be interesting to read other research on it, wondering if the Omnicrom protection would be as high if it is a 5th booster after either 4 mRNA vax?
Might be great Fall booster older folks, me included!

Exactly what I’m hoping. It would be nice to get broader protection.

 

[Freedom56]

Freedom56,

Please keep us posted as to what you hear from your brother.

omni

All that he has told us is that the BA.5 variant is showing lesions in the lungs, , like the Alpha and Delta variants. This is from the CT scans he has read correlated to the patient viral samples their lab has sequenced. Some patients are once again reporting that they have lost their sense of taste and smell. Most of the patients in the ICU at his hospital are 45 years and older. So far he said that most are recovering.

 

[martyp]

A June 7 Science magazine report stated that most of the Novavax clinical data is from before Delta and Omicron. I’m pretty sure they are injecting the original spike protein. If it is effective against Omicron then it should be noted that the current vaccines are also effective. Statistically those who have received three doses of the current vaccines are much more likely to suffer less severe Covid symptoms. I would not expect Novavax to be dramatically better but we will see. Some first time vaxxers will accept Novavax because it is a different technology. That’s fine. Whatever.

 

[Scuba]

Exactly what I’m hoping. It would be nice to get broader protection.

If this new vaccine requires 2 shots, 8 months apart, to protect against the variant currently circulating, I don’t see that as particularly helpful. Who knows what the variant of concern will be in 8 months? Almost certainly something different.

What am I missing here?

 

[MuirWannabe]

If this new vaccine requires 2 shots, 8 months apart, to protect against the variant currently circulating, I don’t see that as particularly helpful. Who knows what the variant of concern will be in 8 months? Almost certainly something different.

What am I missing here?

Darn good question. And I’m still confused based on conflicting posts information above if this vaccine prevents omicron infection. That would be new amongst our vaccine choices. Although, as you say, 8 months from now is not quite as helpful as now.