One way (maybe the only way) we’re going to get out of this pandemic is to vaccinate a large portion of the global population. To the WHO, this means reaching 70% of the population by mid-2022, which is ~3 billion unvaccinated people with 6-9 billion doses before another variant of concern.
What are the chances of these two being offered within the US? I know there are some that do not like the idea of the RNA vaccines. Also, think these would eventually make great boosters as they work on a different part of the immune system.
I wouldn't be surprised if Novavax is approved in about two months? CORBEVAX probably won't be available because without funding getting a large enough clinical trial in the US would take a ton of time.
Add to that Peter Hotez's thought that he can vaccinate the world, and the US Government can take care of the citizens. He will have adequate numbers in well-designed trials, but since they're not done here, FDA won't accept them most likely!
This is what I was wondering. Will the people who are afraid of the mRNA vaccine be more open to these? Especially Corbevax since they shared the way to make it, that seems like it would eliminate the concerns about the greed behind pharmaceutical companies.
Hotez and Botazzi are rock stars. Makes me wish I was still at the Texas Medical Center.
I've been anxiously awaiting both of these vaccines because they're safe, effective and don't have to employ a huge distribution infrastructure. We really can vaccinate the world. And, I applaud Dr Hotez's novel employment of a good Texas-originated vodka for funding. What most people don't appreciate is how much work goes into funding research and development and how little of it comes from the Feds.
I also especially like getting a bit more diversity in the classes of vaccines available. Perhaps (I know I'm stretching) using the Novavax technology will reduce some hesitancy among the skeptics.
I don’t know ANYTHING about funding but I can and will go buy a bottle of Tito’s in thanks for their support! This information is very important to me and I thank you for taking the time in your busy schedule to keep us posted.
Relative to your opening comment, is there a concise explanation for why natural immunity is inadequate to achieve that goal? Consensus reports seem to be that Omicron is significantly less lethal then the 2020 virus, is now the dominant strain, has spread worldwide, and is profoundly communicable.
If true, doesn't the rapid spread of this highly communicable but mild virus, added to the now substantial pool of previously infected but recovered persons get us to international herd immunity sooner than vaccines? Also are we right in assuming that natural immunity is superior to vaccinated immunity in terms of protection against future variants?
First, in a rapidly changing virus like omicron, immunity conferred by infection, at least in terms of antibodies, tends to be somewhat more specific for the variant you were infected with, and not a broader spectrum of variants.
Omicron has been mischaracterized as mild. However, we are better able to treat it, and it has displayed different clinical characteristics than earlier variants, e.g., its propensity to not attack alveolar tissue. However... this is one variant, and we don't know what the next significant variant will bring us. Omicron (BA.1) is merely the original omicron, while BA.2 appears a bit more transmissible but unlikely to outcompete BA.1 at this time
We have learned a lot about how to treat COVID patients to achieve better outcomes. This often makes new Variants of Concern appear less severe: We're treating people better and achieving better outcomes. However, for omicron, deaths are still increasing. It'll be another few days to weeks before we see this lagging indicator finally peak.
And, I will add to your excellent reply, that the likelihood of developing any infection-derived immunity from pre-Omicron infections has been correlated to the severity of the infection. To the extent that an Omicron infection is less severe than a pre-Omicron infection, that may result in an even greater percentage of those who have fallen victim to an Omicron infection not having any effective infection-derived immunity.
For an n=1 study, in 2020, I had a mild instance of COVID-19 (perhaps Wu-1?). I was subsequently enrolled in a convalescent plasma study. My titers were consistently some of the highest at that institution according to the director of the blood bank.
I'm hoping that infection with omicron, on top of an up-to-date vaccination schedule, just might offer us a little more protection because of the conformational changes in the RBD and S1 proteins. But only time will tell...
Thanks, I’m just trying to understand the ongoing enthusiasm for new vaccines in the context of my immediate felt experience in the northeast where almost everyone I know has or had Omicron, and the experience is uniformly benign. The problem appears to be solving itself. Also, and we’ve all become amateur biologists since this started LOL, but my impression has been that the most recent wisdom around durable immune response lies with T-cell behavior not antibodies per se.
I've seen data showing that Omicron is less lethal than the Delta variant, but not necessarily the original variant (which would put Omicron somewhere in the middle). Do you have data I can refer to? I agree, that would be a big deal.
Why do you assume that natural immunity is superior to vaccine-induced immunity? I am not qualified to have an opinion on that, but I would love to see the data behind that assumption if you can share it.
So important to report on. Thank you! And I appreciated the addition of the global map that shows how woefully behind the US is in vaccination rates compared to most of the world.
As you say, the mRNA vaccines are solutions for wealthy countries who can support the logistics of ultra cold storage.
The world needs alternatives, and these are promising. The challenge is, as you point out, that the Novavax trials were conducted with vaccines that were apparently not manufactured to FDA standards for purity and reproducibility between batches (there have been public statements citing CMC issues). The risk is that it is difficult to know whether the safety and efficacy data from different batches are comparable. I suspect this conundrum explains why there has been such a long delay between the conduct of the trials and the EUA. Very frustrating from everyone's perspective. Hopefully the path for sorting this all out is now established.
It's unclear from the reporting I've seen whether the vaccines in the trial had these purity issues, or whether it's simply a matter of problems scaling up production to larger levels without introducing purity issues.
Maybe "simply" wasn't the best word. But doing something at a small scale and doing it at a larger scale are often different problems. So I would not assume that QC problems necessarily indicate a problem with the study.
Nice to see moths doing something other than putting holes in my knitting yearn. Nice reporting job....Bon chance to Tito's Vodka as well.
Sorry, just a retired Micrrobiologists humor. You are giving us wonderful information.
What are the chances of these two being offered within the US? I know there are some that do not like the idea of the RNA vaccines. Also, think these would eventually make great boosters as they work on a different part of the immune system.
I wouldn't be surprised if Novavax is approved in about two months? CORBEVAX probably won't be available because without funding getting a large enough clinical trial in the US would take a ton of time.
Add to that Peter Hotez's thought that he can vaccinate the world, and the US Government can take care of the citizens. He will have adequate numbers in well-designed trials, but since they're not done here, FDA won't accept them most likely!
Novavax applied for EUA on January 31, so it may be available sooner than that.
This is what I was wondering. Will the people who are afraid of the mRNA vaccine be more open to these? Especially Corbevax since they shared the way to make it, that seems like it would eliminate the concerns about the greed behind pharmaceutical companies.
Hotez and Botazzi are rock stars. Makes me wish I was still at the Texas Medical Center.
I've been anxiously awaiting both of these vaccines because they're safe, effective and don't have to employ a huge distribution infrastructure. We really can vaccinate the world. And, I applaud Dr Hotez's novel employment of a good Texas-originated vodka for funding. What most people don't appreciate is how much work goes into funding research and development and how little of it comes from the Feds.
I also especially like getting a bit more diversity in the classes of vaccines available. Perhaps (I know I'm stretching) using the Novavax technology will reduce some hesitancy among the skeptics.
I don’t know ANYTHING about funding but I can and will go buy a bottle of Tito’s in thanks for their support! This information is very important to me and I thank you for taking the time in your busy schedule to keep us posted.
I'm a regular for Tito's. It's a Texas product, as I am even if I'm now an expatriate in Colorado.
Thank you for reporting on this wonderful news. I appreciate your column very much.
Relative to your opening comment, is there a concise explanation for why natural immunity is inadequate to achieve that goal? Consensus reports seem to be that Omicron is significantly less lethal then the 2020 virus, is now the dominant strain, has spread worldwide, and is profoundly communicable.
If true, doesn't the rapid spread of this highly communicable but mild virus, added to the now substantial pool of previously infected but recovered persons get us to international herd immunity sooner than vaccines? Also are we right in assuming that natural immunity is superior to vaccinated immunity in terms of protection against future variants?
First, in a rapidly changing virus like omicron, immunity conferred by infection, at least in terms of antibodies, tends to be somewhat more specific for the variant you were infected with, and not a broader spectrum of variants.
Omicron has been mischaracterized as mild. However, we are better able to treat it, and it has displayed different clinical characteristics than earlier variants, e.g., its propensity to not attack alveolar tissue. However... this is one variant, and we don't know what the next significant variant will bring us. Omicron (BA.1) is merely the original omicron, while BA.2 appears a bit more transmissible but unlikely to outcompete BA.1 at this time
We have learned a lot about how to treat COVID patients to achieve better outcomes. This often makes new Variants of Concern appear less severe: We're treating people better and achieving better outcomes. However, for omicron, deaths are still increasing. It'll be another few days to weeks before we see this lagging indicator finally peak.
And, I will add to your excellent reply, that the likelihood of developing any infection-derived immunity from pre-Omicron infections has been correlated to the severity of the infection. To the extent that an Omicron infection is less severe than a pre-Omicron infection, that may result in an even greater percentage of those who have fallen victim to an Omicron infection not having any effective infection-derived immunity.
For an n=1 study, in 2020, I had a mild instance of COVID-19 (perhaps Wu-1?). I was subsequently enrolled in a convalescent plasma study. My titers were consistently some of the highest at that institution according to the director of the blood bank.
I'm hoping that infection with omicron, on top of an up-to-date vaccination schedule, just might offer us a little more protection because of the conformational changes in the RBD and S1 proteins. But only time will tell...
Thanks, I’m just trying to understand the ongoing enthusiasm for new vaccines in the context of my immediate felt experience in the northeast where almost everyone I know has or had Omicron, and the experience is uniformly benign. The problem appears to be solving itself. Also, and we’ve all become amateur biologists since this started LOL, but my impression has been that the most recent wisdom around durable immune response lies with T-cell behavior not antibodies per se.
I've seen data showing that Omicron is less lethal than the Delta variant, but not necessarily the original variant (which would put Omicron somewhere in the middle). Do you have data I can refer to? I agree, that would be a big deal.
Why do you assume that natural immunity is superior to vaccine-induced immunity? I am not qualified to have an opinion on that, but I would love to see the data behind that assumption if you can share it.
So important to report on. Thank you! And I appreciated the addition of the global map that shows how woefully behind the US is in vaccination rates compared to most of the world.
We're way behind Israel. Then again, Israel just hit a new high for death rate. Go figure.
Is there reason to hope that immunity from Novavax might last longer than from the mRNA vaccines? Thanks for all of your work!
As you say, the mRNA vaccines are solutions for wealthy countries who can support the logistics of ultra cold storage.
The world needs alternatives, and these are promising. The challenge is, as you point out, that the Novavax trials were conducted with vaccines that were apparently not manufactured to FDA standards for purity and reproducibility between batches (there have been public statements citing CMC issues). The risk is that it is difficult to know whether the safety and efficacy data from different batches are comparable. I suspect this conundrum explains why there has been such a long delay between the conduct of the trials and the EUA. Very frustrating from everyone's perspective. Hopefully the path for sorting this all out is now established.
It's unclear from the reporting I've seen whether the vaccines in the trial had these purity issues, or whether it's simply a matter of problems scaling up production to larger levels without introducing purity issues.
Novavax announced they completed their Phase 2 and Phase 3 clinical trials for their vaccine in March, 2021: https://wordpress.cels.anl.gov/covid-vaccine-efficacy/2021/03/12/novavax-nvx-cov2373-vaccine-trials-complete-partial-data-released/
Given the pressing need for this product, that "simply" might not be accurate.
Maybe "simply" wasn't the best word. But doing something at a small scale and doing it at a larger scale are often different problems. So I would not assume that QC problems necessarily indicate a problem with the study.
I would love to read your comments about Cuba's development of 5 different vaccines.
Any update on the US military's vaccine development efforts?
Next update will take some time. I'm waiting, too, but don't expect it "real soon".
Thanks so much for your reporting. Appreciate your perspectives (including as a mom) and your personal touch.
Thanks for your very helpful updates, and this one is hopeful, too!
We could sure use something new. Have you seen Israel's death rate?
Love this! So exciting!