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

[martyp]

It can’t prevent infection unless it induces an immune response in mucosal membranes. Only the HPV vaccine does that. This is just like the mRNA vaccines minus the mRNA. It is a spike protein that stimulates an immune response in your body. Whether it stimulates a higher longer immune response in more people is what we want to know. I hadn’t heard about the 8 month dose interval but there is research that suggests that longer intervals are better. That a 3-4 week interval is not as beneficial as an 8-10 week interval. The dose amount per injection and the dose interval are variables that can vary the immune response.

 

[MuirWannabe]

It can’t prevent infection unless it induces an immune response in mucosal membranes. Only the HPV vaccine does that. This is just like the mRNA vaccines minus the mRNA. It is a spike protein that stimulates an immune response in your body. Whether it stimulates a higher longer immune response in more people is what we want to know. I hadn’t heard about the 8 month dose interval but there is research that suggests that longer intervals are better. That a 3-4 week interval is not as beneficial as an 8-10 week interval. The dose amount per injection and the dose interval are variables that can vary the immune response.

So, to be perfectly clear, you’re saying this novavax vaccine will not prevent folks from still getting omicron and it’s variants. But it may further protect from serious cases as is the benefit of the current mRNA vaccines? So, basically the same result, or maybe even better at limiting at seriousness of disease. But not avoiding the disease. If accurate, that’s disappointing from what I was hoping this was.

 

[cyber888]

It seems to provide mucosal immunity and sterilizing immunity, based on the FDA VRBAC presentation of Dr. Glenn from Novavax, which prevents asymptomatic transmission. Their vax with the 8 month boost has more durability than the mRNA vax with respect to the newer variants.

An MD PhD Professor from Stanford has a couple of thread on Twitter in reaction to the FDA presentation.

https://twitter.com/x/status/1541823681092935680

It can’t prevent infection unless it induces an immune response in mucosal membranes. Only the HPV vaccine does that. This is just like the mRNA vaccines minus the mRNA. It is a spike protein that stimulates an immune response in your body. Whether it stimulates a higher longer immune response in more people is what we want to know. I hadn’t heard about the 8 month dose interval but there is research that suggests that longer intervals are better. That a 3-4 week interval is not as beneficial as an 8-10 week interval. The dose amount per injection and the dose interval are variables that can vary the immune response.

 

[martyp]

Yes that is what I am saying. For whatever reasons many people won’t accept mRNA vaccines. This particular technology approach is more acceptable to many people and has been used in some previous vaccines. Biologically I see little difference but if it matters to some people then so be it. Some more people will become vaccinated as a result of Novavax becoming available. I think it will take a long time to figure out what the costs and benefits are because the uptake will be much slower and we are in a hopelessly complicated data environment for observational studies.

 

[cyber888]

So, to be perfectly clear, you’re saying this novavax vaccine will not prevent folks from still getting omicron and it’s variants. But it may further protect from serious cases as is the benefit of the current mRNA vaccines? So, basically the same result, or maybe even better at limiting at seriousness of disease. But not avoiding the disease. If accurate, that’s disappointing from what I was hoping this was.

It neutralizes the Omicron variants, and also future variants. This is the most laymanish video explaining it.

 

[martyp]

If that is true then great. It going to be a while before we see how it works in the real world. At this point in time we are in a very complex data environment for observational studies.

 

[MuirWannabe]

I appreciate all the replies trying to explain this. My plan is just to wait and see for now. Give it more time for information to be more definitive. But you guys are all great in sharing what you know. As with everything Covid, it’s complicated and time will tell.

 

[martyp]

It neutralizes the Omicron variants, and also future variants. This is the most laymanish video explaining it.

This is a nice video. Here are a couple of thoughts. It is nice that they are using conserved epitopes but you would think that a killed virus vaccine, like SinoVac, would be beneficial in the same way. Maybe even better because the entire virus is there for antibody matching. SinoVac has not proved to be particularly effective. This may also point to the dose concentration, the dose interval, and maybe the effect of the adjuvant as being important differences. One technical detail, though Novavax is not an mRNA vaccine the spike protein they are using is mRNA derived. They inject moth cells with mRNA to produce the spike protein and then extract that spike protein to use in the injectable vaccine. I'm happy Novavax is coming but we will have to wait and see the real world benefits, who it benefits, and how much benefit. We probably won't know until next year which makes anyone thinking they may want a booster now to have to navigate the current situation. I have had 2 AstraZeneca in 2021 and one Moderna in February this year. I was planning to wait for an updated vaccine in the fall but I got a mild Covid infection 2 weeks ago. I am thinking that I now have a sufficient immune response from 2 types of vaccines and now a recent current infection to not worry about it for the rest of the year.

 

[martyp]

It seems to provide mucosal immunity and sterilizing immunity, based on the FDA VRBAC presentation of Dr. Glenn from Novavax, which prevents asymptomatic transmission. Their vax with the 8 month boost has more durability than the mRNA vax with respect to the newer variants.

An MD PhD Professor from Stanford has a couple of thread on Twitter in reaction to the FDA presentation.

Also, there is no discussion of mucosal immunity here. Mucosal immunity would mean that the immune cells in the mucosal membranes of the respiratory system would kill the virus before infection and replication. You would never test PCR positive. What they discuss in the video is antibody effectiveness. Antibodies are produced in response to an infection.

 

[Irishgirlyc58]

I believe the Novavax does not use polyethylene glycol (PEGs) so people who are allergic to PEGs and couldn’t get the other vaccines will benefit from this one.
I know one poster on this forum said that they had family members affected by PEG allergies.

 

[Teacher Terry]

Between the 3 vaccines and getting Covid recently I figure I am good for this year unless I see research results that show otherwise.

 

[cyber888]

Also, there is no discussion of mucosal immunity here. Mucosal immunity would mean that the immune cells in the mucosal membranes of the respiratory system would kill the virus before infection and replication. You would never test PCR positive. What they discuss in the video is antibody effectiveness. Antibodies are produced in response to an infection.

Yes, not in this video, it’s in the FDA VRBAC June 28 meeting where mucosal immunity was discussed. This video was for effectiveness vs Omicron

 

[cyber888]

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

Also, there is no discussion of mucosal immunity here. Mucosal immunity would mean that the immune cells in the mucosal membranes of the respiratory system would kill the virus before infection and replication. You would never test PCR positive. What they discuss in the video is antibody effectiveness. Antibodies are produced in response to an infection.

This article talks about protection in the nose and upper respiratory system. This led to the talk on mucosal immunity during the FDA presentation - link below

Full-length SARS-CoV-2 prefusion spike with Matrix-M1TM (NVX-CoV2373) vaccine. Induced hACE2 receptor blocking and neutralizing antibodies in macaques. Vaccine protected against SARS-CoV-2 replication in the nose and lungs.
Absence of pulmonary pathology in NVX-CoV2373 vaccinated macaques.

https://www.biorxiv.org/content/10.1101/2020.08.18.256578v1.full.pdf

 

[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.

This is another FDA video with Harvard Professor Marasco commenting on Novavax's effective vaccine on Omicron

The caption of this YouTube video says:

FDA's advisor Professor Wayne Marasco from Harvard gives the VRBPAQ committee clear verdict. After reviewing the new Omicron Bivalent vaccines of 'Moderna and Pfizer/Biontec compared to the protein vaccine of Novavax. According to Prof Marasco the mRNA vaccines (Moderna and Pfizer) were the first to market but they showed to the committee that they cant provide wide protection against multiple variants as the Novavax vaccine does.

 

[Alan]

My wife and I have had Novavax so it is good to hear that it is apparently very effective against Omicron variants. The UK has announced a booster program this Fall and are still evaluating which vaccine or cocktail of Covid vaccines to use. (Novavax was approved for use here in February so I assume it is under consideration for the Fall booster program)

 

[N02L84ER]

My wife and I have had Novavax so it is good to hear that it is apparently very effective against Omicron variants. The UK has announced a booster program this Fall and are still evaluating which vaccine or cocktail of Covid vaccines to use. (Novavax was approved for use here in February so I assume it is under consideration for the Fall booster program)

Just curious, do you have any idea what percentage of administered Covid vaccines in your country were Novavax?

 

[Alan]

Just curious, do you have any idea what percentage of administered Covid vaccines in your country were Novavax?

Around 40k or more had it as part of trials but the vaccine committee (JCVI) has, for some reason, still not recommended it for general use here.

https://www.bbc.co.uk/news/health-61045810

But while more than 150,000 doses have now been administered in other parts of Europe, Novavax has still not been recommended by the Joint Committee on Vaccination and Immunisation (JCVI), who advise ministers in the UK.

 

[explanade]

Yeah if it was noticeably more effective vs. BA.5 than the other vaccines, people would be flocking to it in Europe, which is going through a BA.5 wave, a couple of weeks ahead of the US.

 

[cyber888]

I believe the Novavax does not use polyethylene glycol (PEGs) so people who are allergic to PEGs and couldn’t get the other vaccines will benefit from this one.
I know one poster on this forum said that they had family members affected by PEG allergies.

Hi Irishgirlyc58, The Massachusetts General Hospital, the largest teaching Hospital for the Harvard Medical School, had a big study (link to study below). And their data says:

"Among 52,805 health care employees who received mRNA COVID-19 vaccines, 2% experienced allergic reactions, and anaphylaxis occurred at a rate of 2.47 per 10,000 individuals."

So, for mRNA vaccines (Moderna and Pfizer), allergic reaction is 2.47 per 10,000 individuals.

Novavax just reported there's 2 potential allergic reactions out of 250,000 who took the jab in the EU, so much less than mRNA. It could not be linked to the vaccine, but it could potentially be. Well, if you give peanut butter to 100,000 people, maybe 2-3 will gets some allergies.

https://www.massgeneral.org/news/pr...ctions-after-receiving-covid-19-mrna-vaccines

 

[cyber888]

My wife and I have had Novavax so it is good to hear that it is apparently very effective against Omicron variants. The UK has announced a booster program this Fall and are still evaluating which vaccine or cocktail of Covid vaccines to use. (Novavax was approved for use here in February so I assume it is under consideration for the Fall booster program)

Apparently with the UK Health Secretary resigning and the political chaos in the UK, the UK JVCI has forgotten that they have another arsenal in their sleeves to fight the Omicron variant ? or did the UK have an excess supply of of the Oxford Astra-Zeneca vaccine that they are trying to dispose of?

 

[Alan]

Apparently with the UK Health Secretary resigning and the political chaos in the UK, the UK JVCI has forgotten that they have another arsenal in their sleeves to fight the Omicron variant ? or did the UK have an excess supply of of the Oxford Astra-Zeneca vaccine?

I don’t know but think that the government moved early, in December, to secure doses for 2022 before Novavax was approved, which is a shame because it is manufactured just up the road from where we live.

https://www.gov.uk/government/news/...proof-vaccine-rollout-in-light-of-new-variant

Government agrees new deals to future proof vaccine rollout in light of new variant

Government signs contracts to buy a total of 114 million additional Pfizer/BioNTech and Moderna doses for 2022 and 2023

The new contracts with Pfizer/BioNTech and Moderna were accelerated in light of the new variant, as part of the ongoing efforts to ensure the government is doing everything it can while scientists across the world learn more about Omicron. These future supply deals include access to modified vaccines if they are needed to combat Omicron and future Variants of Concern, to prepare for all eventualities.

 

[cyber888]

I don’t know but think that the government moved early, in December, to secure doses for 2022 before Novavax was approved, which is a shame because it is manufactured just up the road from where we live.

https://www.gov.uk/government/news/...proof-vaccine-rollout-in-light-of-new-variant

Right, the only problem is this particular UK deal was to fight Omicron BA 1, which is not in circulation anymore, and the FDA presentation of Pfizer and Moderna was to roll out a vax for BA 1 not for BA 5. Novavax FDA presentation showed they have the same protection for BA 1 to BA 5.

 

[Alan]

Right, the only problem is this particular UK deal was to fight Omicron BA 1, which is not in circulation anymore, and the FDA presentation of Pfizer and Moderna was to roll out a vax for BA 1 not for BA 5. Novavax FDA presentation showed they have the same protection for BA 1 to BA 5.

I agree.

 

[Out of Steam]

It seems to provide mucosal immunity and sterilizing immunity, based on the FDA VRBAC presentation of Dr. Glenn from Novavax, which prevents asymptomatic transmission. Their vax with the 8 month boost has more durability than the mRNA vax with respect to the newer variants. ]

The lack of durable immunity seems to be a real limitation of the mRNA vaccines so far.

It will be interesting to see whether the Novavax does better. Marching the whole population in for vaccination every six months with a booster is simply unrealistic.

 

[Chuckanut]

The lack of durable immunity seems to be a real limitation of the mRNA vaccines so far.

It will be interesting to see whether the Novavax does better. Marching the whole population in for vaccination every six months with a booster is simply unrealistic.

Many more traditional vaccines do not have durable immunity. It's not uncommon. The yearly flue shot is good for 3-4 months before the immunity degrades. That's why I no longer get it in early September. By the time flu season is in full swing, the protection is already going downhill. November seems to make more timing sense.