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MABION [MAB] księga XIV w trakcie rejestracji CD20
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Mr.chabovsky
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Re: MABION [MAB] księga XIV w trakcie rejestracji CD20
REKLAMA
Re: MABION [MAB] księga XIV w trakcie rejestracji CD20
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Re: MABION [MAB] księga XIV w trakcie rejestracji CD20
I zwycięzcą dawki przypominającej jest... Novavax ! Gratulacje!
https://seekingalpha.com/article/443342 ... is-novavax
tutaj macie pełen artykuł:
Summary:
Stronger side effects and heart inflammation could potentially hamstring mRNA vaccines.
Novavax has the winning proposition on a direct comparison with BioNTech and Moderna.
Novavax could potentially generate a long-term Covid vaccine income stream on a Gross Profit basis in excess of $10bn per annum.
Novavax's share price is materially undervalued and could literally reprice to multiples of the current share price.
2+2=4?
Two unrelated scientific studies may very well indicate that the only Covid vaccine booster shot on offer over the longer term will be the one produced by Novavax.
The First 2
In a study published in Nature magazine, Danny Altmann, British immunologist, and Professor of Immunology at Imperial College London, observes the following: "Repeated doses of virus-based vaccines such as the Oxford–AstraZeneca one tend to be increasingly less effective because the immune system mounts a response against the adenovirus. RNA vaccines, by contrast, tend to trigger stronger side effects with added doses.” (My emphasis)
We do know that the safety data published by BioNTech on the side effects of their mRNA vaccine supports the observation of Prof. Altmann.
“Systemic events were reported more often by younger vaccine recipients (16 to 55 years of age) than by older vaccine recipients (more than 55 years of age) in the reactogenicity subset and more often after dose 2 than dose 1.”
The same result was reported by Moderna (MRNA).
“The severity of the solicited systemic events increased after the second dose in the mRNA-1273 group, with an increase in proportions of grade 2 events (from 16.5% after the first dose to 38.1% after the second dose) and grade 3 events (from 2.9% to 15.8%).”
The CDC reports on Pfizer-BioNTech (PFE) (BNTX): “Among persons who received Pfizer-BioNTech vaccine, reactions reported to the v-safe system were more frequent after receipt of the second dose than after the first.”
The CDC reports on Moderna: "Side effects (such as fever, chills, tiredness, and headache) throughout the body were more common after the second dose..."
Thus, there is direct mRNA Covid vaccine safety evidence supporting the observation of Prof Altmann, but it is limited to the two doses used so far. Will this trend actually materialize in the 3rd and 4th doses going forward? This uneasy question is not fully answered, yet, but it does indicate a very real commercial risk for the mRNA vaccines and the mRNA vaccine platform.
The Second 2
The second 2 is the emergence of a relatively recent safety issue now with a “probable link” to mRNA vaccines. Israel first reported the safety issue of heart inflammation in late April 2021.
It is also under investigation by the USA CDC and on 2 June 2021 Bloomberg reports that the Israel health officials have found a “probable link” between the Pfizer/BioNTech Covid vaccine and heart inflammation in younger men. Adding to the severity of side effects escalation observation, this link to heart inflammation is observed also after the 2nd dose.
Adding 2+2 to get 4, says that not only will side effects increase with increased doses but also that a severe event such as a heart inflammation which is rare after the second dose may become less rare and more prevalent. Do we have proof for such a hypothesis at this stage? No. Is it possible or even likely that the hypothesis may hold when by the time that 3rd and 4th doses are administered? Yes.
Can or should one ignore this potential existential risk to mRNA vaccine makers when making a commercial decision on buying or holding shares of mRNA vaccine makers? Your call.
The next Covid vaccine battle is Boosters
BioNTech/Pfizer and Moderna in close second place won the race for Covid vaccination. Safety events after vaccine rollout undermined the competitive positions of the adenovirus vaccines of AstraZeneca and J&J, as well as the Russian and Chinese manufacturers. Safety was already questioned at the time of their initial rollouts but the blood clotting issue, even though rare and ruled an acceptable risk, relegated them to use only when there was no other choice.
Would we need a similar ruling in the future on the mRNA Covid vaccines with regards to heart inflammation and the escalation of severity in side effects after every dosage? Perhaps, time will tell.
The two mRNA vaccines are presently dominating expectations of servicing the Covid vaccine booster market. That is not as certain as expected given the risk of escalating severity of side effects and heart inflammation. Relegate the mRNA’s (that includes CureVac) to the same space as the adenovirus vaccines and the only remaining Covid vaccine contender for the winning booster shot is Novavax. Does Novavax really need safety issues with mRNA vaccines to compete in the Covid vaccine booster space? Let’s have a look.
The Novavax Covid Vaccine vs mRNA Covid Vaccines of BioNTech and Moderna
Type of vaccine.
Novavax describes the vaccine as follows:
“NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of SARS-CoV-2... using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (NYSE:S) protein and is adjuvanted with Novavax' patented saponin-based Matrix-M™ to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19."
I found an excellent article from ScienceMag.org published in November 2020 that provides the best description of the Novavax Covid vaccine, as well as telling the story of Novavax’s rise and fall and rise again. It is a bioengineering process. Scientists piggyback a mimic Covid spike protein production using an insect-infecting baculovirus. The process starts by inserting the gene for the SARS-CoV-2 spike protein into the baculovirus, then infecting fall armyworm moth cells. Mimic Covid spike proteins subsequently form on the moth cell membranes for harvesting and processing into a protein-based Covid vaccine candidate.
The most important points are:
It’s a well-known technology. Manufacturing can be scaled, and boosting is not a problem. “Companies also already know how to manufacture recombinant proteins at scale. ‘This is established technology that has been around for decades,’ says Peter Hotez, vaccine scientist at Baylor College of Medicine in Houston, US.”
Can be combined with an annual Flu vaccine and Novavax has already created such a combination vaccine, NanoFlu™/NVX-CoV2373 combination vaccine candidate, for which they have already published very promising pre-clinical data.
Can rapidly respond to variants and mutations. “While many experts see the nimble mRNA technology that underlies the Pfizer and Moderna vaccines as the way of the future, Novavax executives maintain that it’s relatively simple to modify their vaccine to target different or multiple strains of the coronavirus.”
Can be formulated as a multivalent (multivariant Covid vaccine). “Researchers at Moderna Inc., Novavax Inc. and the University of Oxford are designing the shots, known as multivalent vaccines”
Safety Results – Winner: Novavax, with less severe adverse events
It is tricky to compare the safety results of the three vaccine manufacturers as there is no standardized reporting method. It would therefore be appropriate to also quote the reported safety results and links to the reports to allow everyone to independently review the results.
The Novavax vaccine safety results were generally better than the results reported by both BioNTech and Moderna. There were no reports of increased severity of side effects between the first and second doses of the Novavax Covid vaccine, though they do report increased incidence. Compare, for instance, the following extracts on adverse events between Novavax, Moderna, and BioNTech.
Novavax
“Unsolicited adverse events were predominantly mild in severity... There were no reports of severe adverse events.”
Overall, NVX-CoV2373 recipients reported higher frequencies of solicited systemic adverse events than placebo recipients... Grade 4 systemic adverse events were reported in two NVX-CoV2373 participants after the first dose and in one NVX-CoV2373 participant after the second dose."
"One related serious adverse event was reported in an NVX-CoV2373 recipient (myocarditis), which occurred 3 days after the second dose and was considered a potentially immune-mediated condition; an independent SMC considered the event most likely a viral myocarditis."
Moderna
“The frequency of unsolicited adverse events, unsolicited severe adverse events, and serious adverse events reported during the 28 days after injection was generally similar among participants in the two groups... Bell’s palsy occurred in the vaccine group (3 participants [<0.1%])... In the overall population, the incidence of treatment-related severe adverse events was higher in the mRNA-1273 group (71 participants [0.5%])...”
BioNTech
“Adverse event analyses are provided for all enrolled 43,252 participants... Sixty-four vaccine recipients (0.3%) and 6 placebo recipients (<0.1%) reported lymphadenopathy... Four related serious adverse events were reported among BNT162b2 recipients (shoulder injury related to vaccine administration, right axillary lymphadenopathy, paroxysmal ventricular arrhythmia, and right leg paresthesia).”
I believe it is self-evident from the safety reports of Novavax, Moderna, and BioNTech that Novavax generally achieved better safety results and particularly with regards to severe adverse events.
Novavax, however, does not escape the 2nd dose increased occurrence of side effects nor does it escape the heart inflammation effect even though “an independent SMC considered the event most likely a viral myocarditis” (see safety report quoted). Novavax has not yet seen its vaccine rolled out on a large scale as has been the case with BioNTech and Moderna, which means it has not yet been tested at that reality level. As mentioned, the 2+2=4 hypothesis discussed above is not proven, yet, but being alert to this development is important to the decision-making on buying, holding, or selling shares in each of the Covid vaccine manufacturers. So, on balance, and with a short head, Novavax wins the safety section.
Efficacy Results – Winner: Novavax
Novavax 96.4%
“Demonstrated 100% protection against severe disease.
Confirmed 96.4% efficacy against original strain of COVID-19 and 86.3% efficacy against B.1.1.7 variant strain...
Demonstrated efficacy of 88.9% in adults over the age of 65 and efficacy of 90.9% in adults with high-risk medical comorbidities...
Demonstrated efficacy of 55.4% among HIV-negative participants in South Africa Phase 2b trial, with the vast majority of cases due to the B.1.351 escape variant.”
BioNTech 95%
“... demonstrated 95% efficacy in preventing COVID-19 in those without prior infection 7 days or more after the second dose.”
Moderna 94.1%
“Vaccine efficacy against COVID-19 was 94.1%; vaccine efficacy against severe COVID-19 was 100%”
Comment: The Novavax later trials and their participation in the mix-and-match studies have given them access to more diverse data which could be very valuable in designing appropriate booster vaccine candidates, combo candidates, bivalent and multivalent candidates. Participating in the mix-and-match studies also positions them well for the booster shot market.
Stability (Storage & Logistics) – Winner: Novavax
Novavax
“NVX-CoV2373 is stored and stable at 2°- 8°C, allowing the use of existing vaccine supply chain channels for its distribution. It is packaged in a ready-to-use liquid formulation in 10-dose vials.”
BioNTech
"Before mixing, the vaccine may be stored in an ultra-cold freezer between -80°C and -60°C (-112°F and -76°F) (extended periods storage)
Before mixing, the vaccine may be stored in the freezer between -25°C and -15°C (-13°F to 5°F) for up to 2 weeks.
Before mixing, the vaccine may be stored in the refrigerator between 2°C and 8°C (36°F and 46°F) for up to 1 month (31 days).
Once mixed, vaccine can be left at room temperature (2°C to 25°C [35°F to 77°F]) for up to 6 hours."
Moderna (Slide 11)
“Shipping is in standard freezers (-20°C) and 100 doses in carton to pallet(s) (237,600 doses/pallet)
Storage is up to 6 months in a standard freezer [-25°C and -15°C (-13°F to 5°F)] and 4 weeks at refrigerated temperatures (2-8°C)
Only authorized mRNA vaccine that does not require on-site dilution”
Comment: The stability of the Novavax Covid vaccine is a major competitive advantage.
Manufacturing targets and track record – Winner: Pfizer/BioNTech
Novavax
Manufacturing Report from Novavax 10 May First Quarter Results state as objectives achieved:
“Secured additional manufacturing capacity for NVX-CoV2373 globally, with continued progress toward achieving full manufacturing capacity
Anticipated capacity revised to 100 million doses per month by the end of the third quarter of 2021, with remainder of capacity expected to come online in the fourth quarter to support 150 million doses per month.
Reached agreement in principle with GSK to support 'fill and finish' manufacturing of up to 60 million doses of NVX-CoV2373 for use in the UK.
Established manufacturing presence in Canada through Memorandum of Understanding with Canadian government to produce NVX-CoV2373 at National Research Council's Biologics Manufacturing Centre.”
The report on 22 May 2021 from Novavax upon signing a manufacturing Memorandum of Understanding with SK Bioscience, advises:
“Novavax and SK Bioscience agreed to potentially explore the development of new vaccine products, including COVID-19 variant vaccines, and/or an influenza-COVID-19 combination vaccine. ...collaborate in manufacturing of the vaccines utilizing SK bioscience's facility, with support from the Korean government.”
Manufacturing of the Novavax Covid vaccine, Covovax, in India has commenced "at risk" at the Serum Institute of India ("SII") based upon Memorandums of Understanding between Novavax, GAVI, and SII:
“today announced a Memorandum of Understanding with Gavi, the Vaccine Alliance (Gavi), to provide 1.1 billion cumulative doses of NVX-CoV2373...”
Novavax has been challenged to date to show that it is capable of managing the scaled manufacturing of its Covid vaccine. More than half of expected manufacturing has all been outsourced with Novavax providing the know-how and IP as Novavax had to sell some of their manufacturing capacity in a downsizing survival strategy implemented in 2019. Novavax owned facilities in the Czech Republic and Sweden adds to the manufacturing capacity.
Manufacturing is Novavax’s Achilles’ heel right now but should not be overemphasized. The strategic at-risk manufacturing by SII is an important development to show that the manufacturing is being attended to by an experienced, competent, and capable manufacturing partner in addition to their own and other manufacturing partners. Management insists that they are on track with manufacturing targets as recently as June 1st 2021 in their webcast of the Jefferies Virtual Healthcare Conference (follow around 11:14 for observations on filing EUA “in the next few weeks” which would include information on manufacturing, follow around 12:00 for issues around manufacturing including media, filters and bags all of which is being managed and on target with management being “confident” about manufacturing). It would be inappropriate to dismiss management’s confidence on manufacturing out of hand due to the difficulties experienced over the past few months. Management’s confidence combined with pilot manufacturing on an at-risk basis at SII should perhaps be taken more seriously.
Management’s observations on manufacturing strategy in the webcast are also informative. The choices between bivalent, multivalent, variant-specific, region-specific, and combo vaccines are discussed. The observation that sticks is that the choice must be informed by science and the variation in the Novavax Clinical Trials currently underway will produce highly informative data. Manufacturing going into the booster shots phase of Covid vaccines may well follow the lead of Flu vaccine manufacturing. Novavax has hands-on experience with their NanoFlu candidate already completing phase 3 clinical trials successfully in March 2020.
Manufacturing targets: 100mil doses per month by the 3rd quarter 2021, 150mil dose per month by the 4th quarter 2021 and around 2.1bn doses for 2022 onwards.
BioNTech
BioNTech and Pfizer’s latest manufacturing targets are 3bn doses for 2021 and 4bn from 2022 onwards. They have a proven track record of manufacturing and delivery but had none before the Covid vaccine.
Moderna
Moderna is targeting between 800mil and 1bn doses for 2021 and 3bn doses from 2022 onwards. They have a proven track record of manufacturing and delivery but had none before the Covid vaccine.
Novavax Advance Purchase Agreements (APAs) and Commercial/Financial Positioning
Novavax reports the following finalized APAs and potential other contracts:
1.1bn doses of NVX-CoV2373 sold to COVAX under a GAVI agreement. Novavax to manufacture 350mil doses and SII to manufacture the balance of 750mil doses. “Under the agreement, we expect to receive an upfront payment from Gavi and an additional payment after securing emergency use listing for NVX-CoV2373 by the World Health Organization ("WHO").”
52mil doses to the Government of Canada with an option to buy another 24mil doses.
SK Bioscience to supply 40 million doses to the Republic of Korea.
Japan – Agreement with Takeda to manufacture 250mil dose pa with funding and Government of Japan support. In May 2021, the Government of Japan announced that contract discussions were ongoing with Takeda to potentially order 150 million doses of NVX-CoV2373.
Sales pricing for the APAs and potential contracts are not officially available, but SII had announced a price cap of $3 per dose in August 2020.
A $3 price cap from SII for the sale of Novavax’s vaccine may not seem nearly as exciting as the around $23 rumored to be the purchase price of doses by the EU from Pfizer/BioNTech but it actually supplies vital information regarding the cost of manufacture of the Novavax vaccine. It is ridiculously cheap to manufacture, probably in the range of $1 to $1.5 as a Cost of Sales per dose. I have estimated the Cost of Sales of the Pfizer/BioNTech Covid vaccine to be around $5 per dose. Here we are faced with the reality of two competing vaccines where one is safer, more efficacious, stable, easier to store and handle, and also heaper to manufacture than the other, and it applies equally to the other mRNA vaccines of Moderna and CureVac (CVAC). Novavax will have direct absolute competitive advantages over the mRNA vaccines once it achieves manufacturing competence. Manufacturing competence may be closer than what the market believes at this juncture but how do these competitors compare on expected revenue, market capitalization, and share price.
Calculating or estimating a revenue number for Novavax on Covid vaccine sales presently will require significant estimation. That could change very fast once they start to deliver vaccine doses. Profitability would be exceptional should they get close to $20 per dose while having a cost of manufacture at around $1.5 per dose. Ramping up production once they and SII have proved capable should be very achievable.
The Duke Global Health Innovation Center estimates the total confirmed doses sold by Novavax at 1.319bn doses as of 4 June 2021. We know that the SII has indicated a cap of $3 in August 2020 but do not know to what extent that still holds. We also know from the comments at the Jefferies Virtual Healthcare Conference that Novavax expects to manufacture (and sell) 1.5bn doses this year and that they expect to manufacture half while they expect SII to manufacture the other half. A reasoned estimate of an average price achieved would be around $10 arrived at by averaging 750mil doses at $3 and 750mil doses at $17. Revenue, Cost of Sales and Gross profits from Covid vaccine sales can be projected for 2021 by using these numbers:
Revenue as 1.5bn doses at $10 = 15bn
Cost of Sales as 1.5bn doses at $1.5 = $2.25bn
Gross Profit at $12.75bn
These numbers are generally in line with the expected incomes of BioNTech and Moderna for 2021. It would not be a challenge for Novavax to maintain the same outcomes beyond 2021 and they have the competitive advantages to challenge for a larger market share in a booster shot environment. Boosters, and specifically annual boosters, are not yet a certainty though it is generally expected. Novavax can then, on the expectation of annual boosters, be expected to maintain a Gross Profit north of $10bn annually which would support a much higher, in multiples, share price. Selling 1.5bn to 2bn doses at an average of $10 per dose would be attainable even in a market oversupplied with Covid vaccine doses as I expect from 2022 onwards. Some of the Novavax profits may be diluted by transfer payments to manufacturing partners but Novavax has not announced any details of profit sharing or even mention of profit sharing which indicates a preference for contract-based manufacturing. The overarching result going forward is that Novavax is better positioned to maintain a larger Covid vaccine income stream than both BioNTech and Moderna once it has achieved manufacturing capacity.
Novavax, BioNTech and Moderna are going head-to-head in the Covid vaccine market, and their share prices will for the foreseeable future depend almost entirely on their Covid vaccine income streams. Novavax is the total underdog, yet it has the best competitive profile of all the Covid vaccines currently in the race including all the adenovirus vaccines, where it can even compete directly on a cost to manufacture basis.
The comparison shows how far Novavax is currently rated below the share prices and market capitalizations of Moderna and BioNTech. Novavax is rated to be worth about 25% of the value of BioNTech and at about 16% of the value of Moderna. Is that rationally justified?
Recently reported institutional support is telling with The Vanguard Group at 7.6%, BlackRock, Inc. at 6.9%, and RA Capital Management, L.P. at 5.1% holdings of total shares in issue for an almost 20% holding of total shares in issue held between only these three. Perhaps they’ve also done the numbers and realized that if the Novavax share price reprices to anything close to Moderna's market capitalization, then the indicative share price for Novavax would be more than $1000 per share.
Conclusion
The market’s over-disappointment with Novavax and unrealistic expectations on manufacturing and filing for US FDA Emergency Use Authorization (EUA) have caused the share price to crash from a high of $331 on 9 February 2021 to a low of $118 on 13 May 2021. It has since recovered some ground but is still badly lagging the share prices of competitors BioNTech and Moderna. A closer look at the competitive position of Novavax and clear progress reported by management on manufacturing suggest that this ugly duckling may well become the beautiful swan of the fairytale. Novavax's competitive positioning is poised to surpass both BioNTech and Moderna once manufacturing competence is achieved. The Novavax Covid vaccine is already on current evaluation as a stronger commercial product than both those of BioNTech and Moderna. Following the market on short-sighted punishment for strategic objectives which may be delayed for a few weeks seems almost foolish when looking at the bigger picture. The share price of Novavax could easily double or even triple on positive news relative to US EUA and manufacturing and it would still be significantly lagging BioNTech and Moderna despite a superior commercial competitive standing on a longer-term view.
This article was written by
Sarel Oberholster profile picture.
Sarel Oberholster
https://seekingalpha.com/article/443342 ... is-novavax
tutaj macie pełen artykuł:
Summary:
Stronger side effects and heart inflammation could potentially hamstring mRNA vaccines.
Novavax has the winning proposition on a direct comparison with BioNTech and Moderna.
Novavax could potentially generate a long-term Covid vaccine income stream on a Gross Profit basis in excess of $10bn per annum.
Novavax's share price is materially undervalued and could literally reprice to multiples of the current share price.
2+2=4?
Two unrelated scientific studies may very well indicate that the only Covid vaccine booster shot on offer over the longer term will be the one produced by Novavax.
The First 2
In a study published in Nature magazine, Danny Altmann, British immunologist, and Professor of Immunology at Imperial College London, observes the following: "Repeated doses of virus-based vaccines such as the Oxford–AstraZeneca one tend to be increasingly less effective because the immune system mounts a response against the adenovirus. RNA vaccines, by contrast, tend to trigger stronger side effects with added doses.” (My emphasis)
We do know that the safety data published by BioNTech on the side effects of their mRNA vaccine supports the observation of Prof. Altmann.
“Systemic events were reported more often by younger vaccine recipients (16 to 55 years of age) than by older vaccine recipients (more than 55 years of age) in the reactogenicity subset and more often after dose 2 than dose 1.”
The same result was reported by Moderna (MRNA).
“The severity of the solicited systemic events increased after the second dose in the mRNA-1273 group, with an increase in proportions of grade 2 events (from 16.5% after the first dose to 38.1% after the second dose) and grade 3 events (from 2.9% to 15.8%).”
The CDC reports on Pfizer-BioNTech (PFE) (BNTX): “Among persons who received Pfizer-BioNTech vaccine, reactions reported to the v-safe system were more frequent after receipt of the second dose than after the first.”
The CDC reports on Moderna: "Side effects (such as fever, chills, tiredness, and headache) throughout the body were more common after the second dose..."
Thus, there is direct mRNA Covid vaccine safety evidence supporting the observation of Prof Altmann, but it is limited to the two doses used so far. Will this trend actually materialize in the 3rd and 4th doses going forward? This uneasy question is not fully answered, yet, but it does indicate a very real commercial risk for the mRNA vaccines and the mRNA vaccine platform.
The Second 2
The second 2 is the emergence of a relatively recent safety issue now with a “probable link” to mRNA vaccines. Israel first reported the safety issue of heart inflammation in late April 2021.
It is also under investigation by the USA CDC and on 2 June 2021 Bloomberg reports that the Israel health officials have found a “probable link” between the Pfizer/BioNTech Covid vaccine and heart inflammation in younger men. Adding to the severity of side effects escalation observation, this link to heart inflammation is observed also after the 2nd dose.
Adding 2+2 to get 4, says that not only will side effects increase with increased doses but also that a severe event such as a heart inflammation which is rare after the second dose may become less rare and more prevalent. Do we have proof for such a hypothesis at this stage? No. Is it possible or even likely that the hypothesis may hold when by the time that 3rd and 4th doses are administered? Yes.
Can or should one ignore this potential existential risk to mRNA vaccine makers when making a commercial decision on buying or holding shares of mRNA vaccine makers? Your call.
The next Covid vaccine battle is Boosters
BioNTech/Pfizer and Moderna in close second place won the race for Covid vaccination. Safety events after vaccine rollout undermined the competitive positions of the adenovirus vaccines of AstraZeneca and J&J, as well as the Russian and Chinese manufacturers. Safety was already questioned at the time of their initial rollouts but the blood clotting issue, even though rare and ruled an acceptable risk, relegated them to use only when there was no other choice.
Would we need a similar ruling in the future on the mRNA Covid vaccines with regards to heart inflammation and the escalation of severity in side effects after every dosage? Perhaps, time will tell.
The two mRNA vaccines are presently dominating expectations of servicing the Covid vaccine booster market. That is not as certain as expected given the risk of escalating severity of side effects and heart inflammation. Relegate the mRNA’s (that includes CureVac) to the same space as the adenovirus vaccines and the only remaining Covid vaccine contender for the winning booster shot is Novavax. Does Novavax really need safety issues with mRNA vaccines to compete in the Covid vaccine booster space? Let’s have a look.
The Novavax Covid Vaccine vs mRNA Covid Vaccines of BioNTech and Moderna
Type of vaccine.
Novavax describes the vaccine as follows:
“NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of SARS-CoV-2... using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (NYSE:S) protein and is adjuvanted with Novavax' patented saponin-based Matrix-M™ to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19."
I found an excellent article from ScienceMag.org published in November 2020 that provides the best description of the Novavax Covid vaccine, as well as telling the story of Novavax’s rise and fall and rise again. It is a bioengineering process. Scientists piggyback a mimic Covid spike protein production using an insect-infecting baculovirus. The process starts by inserting the gene for the SARS-CoV-2 spike protein into the baculovirus, then infecting fall armyworm moth cells. Mimic Covid spike proteins subsequently form on the moth cell membranes for harvesting and processing into a protein-based Covid vaccine candidate.
The most important points are:
It’s a well-known technology. Manufacturing can be scaled, and boosting is not a problem. “Companies also already know how to manufacture recombinant proteins at scale. ‘This is established technology that has been around for decades,’ says Peter Hotez, vaccine scientist at Baylor College of Medicine in Houston, US.”
Can be combined with an annual Flu vaccine and Novavax has already created such a combination vaccine, NanoFlu™/NVX-CoV2373 combination vaccine candidate, for which they have already published very promising pre-clinical data.
Can rapidly respond to variants and mutations. “While many experts see the nimble mRNA technology that underlies the Pfizer and Moderna vaccines as the way of the future, Novavax executives maintain that it’s relatively simple to modify their vaccine to target different or multiple strains of the coronavirus.”
Can be formulated as a multivalent (multivariant Covid vaccine). “Researchers at Moderna Inc., Novavax Inc. and the University of Oxford are designing the shots, known as multivalent vaccines”
Safety Results – Winner: Novavax, with less severe adverse events
It is tricky to compare the safety results of the three vaccine manufacturers as there is no standardized reporting method. It would therefore be appropriate to also quote the reported safety results and links to the reports to allow everyone to independently review the results.
The Novavax vaccine safety results were generally better than the results reported by both BioNTech and Moderna. There were no reports of increased severity of side effects between the first and second doses of the Novavax Covid vaccine, though they do report increased incidence. Compare, for instance, the following extracts on adverse events between Novavax, Moderna, and BioNTech.
Novavax
“Unsolicited adverse events were predominantly mild in severity... There were no reports of severe adverse events.”
Overall, NVX-CoV2373 recipients reported higher frequencies of solicited systemic adverse events than placebo recipients... Grade 4 systemic adverse events were reported in two NVX-CoV2373 participants after the first dose and in one NVX-CoV2373 participant after the second dose."
"One related serious adverse event was reported in an NVX-CoV2373 recipient (myocarditis), which occurred 3 days after the second dose and was considered a potentially immune-mediated condition; an independent SMC considered the event most likely a viral myocarditis."
Moderna
“The frequency of unsolicited adverse events, unsolicited severe adverse events, and serious adverse events reported during the 28 days after injection was generally similar among participants in the two groups... Bell’s palsy occurred in the vaccine group (3 participants [<0.1%])... In the overall population, the incidence of treatment-related severe adverse events was higher in the mRNA-1273 group (71 participants [0.5%])...”
BioNTech
“Adverse event analyses are provided for all enrolled 43,252 participants... Sixty-four vaccine recipients (0.3%) and 6 placebo recipients (<0.1%) reported lymphadenopathy... Four related serious adverse events were reported among BNT162b2 recipients (shoulder injury related to vaccine administration, right axillary lymphadenopathy, paroxysmal ventricular arrhythmia, and right leg paresthesia).”
I believe it is self-evident from the safety reports of Novavax, Moderna, and BioNTech that Novavax generally achieved better safety results and particularly with regards to severe adverse events.
Novavax, however, does not escape the 2nd dose increased occurrence of side effects nor does it escape the heart inflammation effect even though “an independent SMC considered the event most likely a viral myocarditis” (see safety report quoted). Novavax has not yet seen its vaccine rolled out on a large scale as has been the case with BioNTech and Moderna, which means it has not yet been tested at that reality level. As mentioned, the 2+2=4 hypothesis discussed above is not proven, yet, but being alert to this development is important to the decision-making on buying, holding, or selling shares in each of the Covid vaccine manufacturers. So, on balance, and with a short head, Novavax wins the safety section.
Efficacy Results – Winner: Novavax
Novavax 96.4%
“Demonstrated 100% protection against severe disease.
Confirmed 96.4% efficacy against original strain of COVID-19 and 86.3% efficacy against B.1.1.7 variant strain...
Demonstrated efficacy of 88.9% in adults over the age of 65 and efficacy of 90.9% in adults with high-risk medical comorbidities...
Demonstrated efficacy of 55.4% among HIV-negative participants in South Africa Phase 2b trial, with the vast majority of cases due to the B.1.351 escape variant.”
BioNTech 95%
“... demonstrated 95% efficacy in preventing COVID-19 in those without prior infection 7 days or more after the second dose.”
Moderna 94.1%
“Vaccine efficacy against COVID-19 was 94.1%; vaccine efficacy against severe COVID-19 was 100%”
Comment: The Novavax later trials and their participation in the mix-and-match studies have given them access to more diverse data which could be very valuable in designing appropriate booster vaccine candidates, combo candidates, bivalent and multivalent candidates. Participating in the mix-and-match studies also positions them well for the booster shot market.
Stability (Storage & Logistics) – Winner: Novavax
Novavax
“NVX-CoV2373 is stored and stable at 2°- 8°C, allowing the use of existing vaccine supply chain channels for its distribution. It is packaged in a ready-to-use liquid formulation in 10-dose vials.”
BioNTech
"Before mixing, the vaccine may be stored in an ultra-cold freezer between -80°C and -60°C (-112°F and -76°F) (extended periods storage)
Before mixing, the vaccine may be stored in the freezer between -25°C and -15°C (-13°F to 5°F) for up to 2 weeks.
Before mixing, the vaccine may be stored in the refrigerator between 2°C and 8°C (36°F and 46°F) for up to 1 month (31 days).
Once mixed, vaccine can be left at room temperature (2°C to 25°C [35°F to 77°F]) for up to 6 hours."
Moderna (Slide 11)
“Shipping is in standard freezers (-20°C) and 100 doses in carton to pallet(s) (237,600 doses/pallet)
Storage is up to 6 months in a standard freezer [-25°C and -15°C (-13°F to 5°F)] and 4 weeks at refrigerated temperatures (2-8°C)
Only authorized mRNA vaccine that does not require on-site dilution”
Comment: The stability of the Novavax Covid vaccine is a major competitive advantage.
Manufacturing targets and track record – Winner: Pfizer/BioNTech
Novavax
Manufacturing Report from Novavax 10 May First Quarter Results state as objectives achieved:
“Secured additional manufacturing capacity for NVX-CoV2373 globally, with continued progress toward achieving full manufacturing capacity
Anticipated capacity revised to 100 million doses per month by the end of the third quarter of 2021, with remainder of capacity expected to come online in the fourth quarter to support 150 million doses per month.
Reached agreement in principle with GSK to support 'fill and finish' manufacturing of up to 60 million doses of NVX-CoV2373 for use in the UK.
Established manufacturing presence in Canada through Memorandum of Understanding with Canadian government to produce NVX-CoV2373 at National Research Council's Biologics Manufacturing Centre.”
The report on 22 May 2021 from Novavax upon signing a manufacturing Memorandum of Understanding with SK Bioscience, advises:
“Novavax and SK Bioscience agreed to potentially explore the development of new vaccine products, including COVID-19 variant vaccines, and/or an influenza-COVID-19 combination vaccine. ...collaborate in manufacturing of the vaccines utilizing SK bioscience's facility, with support from the Korean government.”
Manufacturing of the Novavax Covid vaccine, Covovax, in India has commenced "at risk" at the Serum Institute of India ("SII") based upon Memorandums of Understanding between Novavax, GAVI, and SII:
“today announced a Memorandum of Understanding with Gavi, the Vaccine Alliance (Gavi), to provide 1.1 billion cumulative doses of NVX-CoV2373...”
Novavax has been challenged to date to show that it is capable of managing the scaled manufacturing of its Covid vaccine. More than half of expected manufacturing has all been outsourced with Novavax providing the know-how and IP as Novavax had to sell some of their manufacturing capacity in a downsizing survival strategy implemented in 2019. Novavax owned facilities in the Czech Republic and Sweden adds to the manufacturing capacity.
Manufacturing is Novavax’s Achilles’ heel right now but should not be overemphasized. The strategic at-risk manufacturing by SII is an important development to show that the manufacturing is being attended to by an experienced, competent, and capable manufacturing partner in addition to their own and other manufacturing partners. Management insists that they are on track with manufacturing targets as recently as June 1st 2021 in their webcast of the Jefferies Virtual Healthcare Conference (follow around 11:14 for observations on filing EUA “in the next few weeks” which would include information on manufacturing, follow around 12:00 for issues around manufacturing including media, filters and bags all of which is being managed and on target with management being “confident” about manufacturing). It would be inappropriate to dismiss management’s confidence on manufacturing out of hand due to the difficulties experienced over the past few months. Management’s confidence combined with pilot manufacturing on an at-risk basis at SII should perhaps be taken more seriously.
Management’s observations on manufacturing strategy in the webcast are also informative. The choices between bivalent, multivalent, variant-specific, region-specific, and combo vaccines are discussed. The observation that sticks is that the choice must be informed by science and the variation in the Novavax Clinical Trials currently underway will produce highly informative data. Manufacturing going into the booster shots phase of Covid vaccines may well follow the lead of Flu vaccine manufacturing. Novavax has hands-on experience with their NanoFlu candidate already completing phase 3 clinical trials successfully in March 2020.
Manufacturing targets: 100mil doses per month by the 3rd quarter 2021, 150mil dose per month by the 4th quarter 2021 and around 2.1bn doses for 2022 onwards.
BioNTech
BioNTech and Pfizer’s latest manufacturing targets are 3bn doses for 2021 and 4bn from 2022 onwards. They have a proven track record of manufacturing and delivery but had none before the Covid vaccine.
Moderna
Moderna is targeting between 800mil and 1bn doses for 2021 and 3bn doses from 2022 onwards. They have a proven track record of manufacturing and delivery but had none before the Covid vaccine.
Novavax Advance Purchase Agreements (APAs) and Commercial/Financial Positioning
Novavax reports the following finalized APAs and potential other contracts:
1.1bn doses of NVX-CoV2373 sold to COVAX under a GAVI agreement. Novavax to manufacture 350mil doses and SII to manufacture the balance of 750mil doses. “Under the agreement, we expect to receive an upfront payment from Gavi and an additional payment after securing emergency use listing for NVX-CoV2373 by the World Health Organization ("WHO").”
52mil doses to the Government of Canada with an option to buy another 24mil doses.
SK Bioscience to supply 40 million doses to the Republic of Korea.
Japan – Agreement with Takeda to manufacture 250mil dose pa with funding and Government of Japan support. In May 2021, the Government of Japan announced that contract discussions were ongoing with Takeda to potentially order 150 million doses of NVX-CoV2373.
Sales pricing for the APAs and potential contracts are not officially available, but SII had announced a price cap of $3 per dose in August 2020.
A $3 price cap from SII for the sale of Novavax’s vaccine may not seem nearly as exciting as the around $23 rumored to be the purchase price of doses by the EU from Pfizer/BioNTech but it actually supplies vital information regarding the cost of manufacture of the Novavax vaccine. It is ridiculously cheap to manufacture, probably in the range of $1 to $1.5 as a Cost of Sales per dose. I have estimated the Cost of Sales of the Pfizer/BioNTech Covid vaccine to be around $5 per dose. Here we are faced with the reality of two competing vaccines where one is safer, more efficacious, stable, easier to store and handle, and also heaper to manufacture than the other, and it applies equally to the other mRNA vaccines of Moderna and CureVac (CVAC). Novavax will have direct absolute competitive advantages over the mRNA vaccines once it achieves manufacturing competence. Manufacturing competence may be closer than what the market believes at this juncture but how do these competitors compare on expected revenue, market capitalization, and share price.
Calculating or estimating a revenue number for Novavax on Covid vaccine sales presently will require significant estimation. That could change very fast once they start to deliver vaccine doses. Profitability would be exceptional should they get close to $20 per dose while having a cost of manufacture at around $1.5 per dose. Ramping up production once they and SII have proved capable should be very achievable.
The Duke Global Health Innovation Center estimates the total confirmed doses sold by Novavax at 1.319bn doses as of 4 June 2021. We know that the SII has indicated a cap of $3 in August 2020 but do not know to what extent that still holds. We also know from the comments at the Jefferies Virtual Healthcare Conference that Novavax expects to manufacture (and sell) 1.5bn doses this year and that they expect to manufacture half while they expect SII to manufacture the other half. A reasoned estimate of an average price achieved would be around $10 arrived at by averaging 750mil doses at $3 and 750mil doses at $17. Revenue, Cost of Sales and Gross profits from Covid vaccine sales can be projected for 2021 by using these numbers:
Revenue as 1.5bn doses at $10 = 15bn
Cost of Sales as 1.5bn doses at $1.5 = $2.25bn
Gross Profit at $12.75bn
These numbers are generally in line with the expected incomes of BioNTech and Moderna for 2021. It would not be a challenge for Novavax to maintain the same outcomes beyond 2021 and they have the competitive advantages to challenge for a larger market share in a booster shot environment. Boosters, and specifically annual boosters, are not yet a certainty though it is generally expected. Novavax can then, on the expectation of annual boosters, be expected to maintain a Gross Profit north of $10bn annually which would support a much higher, in multiples, share price. Selling 1.5bn to 2bn doses at an average of $10 per dose would be attainable even in a market oversupplied with Covid vaccine doses as I expect from 2022 onwards. Some of the Novavax profits may be diluted by transfer payments to manufacturing partners but Novavax has not announced any details of profit sharing or even mention of profit sharing which indicates a preference for contract-based manufacturing. The overarching result going forward is that Novavax is better positioned to maintain a larger Covid vaccine income stream than both BioNTech and Moderna once it has achieved manufacturing capacity.
Novavax, BioNTech and Moderna are going head-to-head in the Covid vaccine market, and their share prices will for the foreseeable future depend almost entirely on their Covid vaccine income streams. Novavax is the total underdog, yet it has the best competitive profile of all the Covid vaccines currently in the race including all the adenovirus vaccines, where it can even compete directly on a cost to manufacture basis.
The comparison shows how far Novavax is currently rated below the share prices and market capitalizations of Moderna and BioNTech. Novavax is rated to be worth about 25% of the value of BioNTech and at about 16% of the value of Moderna. Is that rationally justified?
Recently reported institutional support is telling with The Vanguard Group at 7.6%, BlackRock, Inc. at 6.9%, and RA Capital Management, L.P. at 5.1% holdings of total shares in issue for an almost 20% holding of total shares in issue held between only these three. Perhaps they’ve also done the numbers and realized that if the Novavax share price reprices to anything close to Moderna's market capitalization, then the indicative share price for Novavax would be more than $1000 per share.
Conclusion
The market’s over-disappointment with Novavax and unrealistic expectations on manufacturing and filing for US FDA Emergency Use Authorization (EUA) have caused the share price to crash from a high of $331 on 9 February 2021 to a low of $118 on 13 May 2021. It has since recovered some ground but is still badly lagging the share prices of competitors BioNTech and Moderna. A closer look at the competitive position of Novavax and clear progress reported by management on manufacturing suggest that this ugly duckling may well become the beautiful swan of the fairytale. Novavax's competitive positioning is poised to surpass both BioNTech and Moderna once manufacturing competence is achieved. The Novavax Covid vaccine is already on current evaluation as a stronger commercial product than both those of BioNTech and Moderna. Following the market on short-sighted punishment for strategic objectives which may be delayed for a few weeks seems almost foolish when looking at the bigger picture. The share price of Novavax could easily double or even triple on positive news relative to US EUA and manufacturing and it would still be significantly lagging BioNTech and Moderna despite a superior commercial competitive standing on a longer-term view.
This article was written by
Sarel Oberholster profile picture.
Sarel Oberholster
Ostatnio zmieniony 07 cze 2021 15:39 przez 90-125, łącznie zmieniany 1 raz.
08.01.21 napisałem, że Mabion podpiszę umowę Novavaxem - kurs 22 zł
NIKT NA FORUM MI NIE UWIERZYŁ
03.03.21 Mabion ogłosił umowę Novavaxem
NIKT NA FORUM MI NIE UWIERZYŁ
03.03.21 Mabion ogłosił umowę Novavaxem
Re: MABION [MAB] księga XIV w trakcie rejestracji CD20
Mi to wygląda na szczepionkowy innogene
Re: MABION [MAB] księga XIV w trakcie rejestracji CD20
WIECIE DLACZEGO BEDZIEMY W KOSMOSIE
oto jest klucz do sukcesu:
In a study published in Nature magazine, Danny Altmann, British immunologist, and Professor of Immunology at Imperial College London, observes the following:
1. "Repeated doses of virus-based vaccines such as the Oxford–AstraZeneca one tend to be increasingly less effective because the immune system mounts a response against the adenovirus.
2. RNA vaccines, by contrast, tend to trigger stronger side effects with added doses.”
WYDRUKUJCIE SOBIE I POWIEŚCIE NA ŚCIANIE !
oto jest klucz do sukcesu:
In a study published in Nature magazine, Danny Altmann, British immunologist, and Professor of Immunology at Imperial College London, observes the following:
1. "Repeated doses of virus-based vaccines such as the Oxford–AstraZeneca one tend to be increasingly less effective because the immune system mounts a response against the adenovirus.
2. RNA vaccines, by contrast, tend to trigger stronger side effects with added doses.”
WYDRUKUJCIE SOBIE I POWIEŚCIE NA ŚCIANIE !
Ostatnio zmieniony 07 cze 2021 15:48 przez 90-125, łącznie zmieniany 1 raz.
08.01.21 napisałem, że Mabion podpiszę umowę Novavaxem - kurs 22 zł
NIKT NA FORUM MI NIE UWIERZYŁ
03.03.21 Mabion ogłosił umowę Novavaxem
NIKT NA FORUM MI NIE UWIERZYŁ
03.03.21 Mabion ogłosił umowę Novavaxem
Re: MABION [MAB] księga XIV w trakcie rejestracji CD20
Kosmosa to będzie jak w końcu oficjalna umowa będzie w ESPI. Póki co to juiż 30% na akcjach Novavax mam
Re: MABION [MAB] księga XIV w trakcie rejestracji CD20
Ten 90 125 to nowe wcielenie czensa?
Re: MABION [MAB] księga XIV w trakcie rejestracji CD20
Raczej grubegojanuaregoTen 90 125 to nowe wcielenie czensa?
-
Mr.chabovsky
- Młodszy chorąży
- Posty: 686
- Rejestracja: 13 gru 2017 22:37
Re: MABION [MAB] księga XIV w trakcie rejestracji CD20
Czyzby Pietruszkiewicz nie stosowal sie do reko PKO BP...
Re: MABION [MAB] księga XIV w trakcie rejestracji CD20
Kiedyś jak będę mial za dużo czasu założę rachunek gdzie dla zabawy będę robił dokładnie inaczej niż twierdzą analeCzyzby Pietruszkiewicz nie stosowal sie do reko PKO BP...
Re: MABION [MAB] księga XIV w trakcie rejestracji CD20
Wy tu gadu, gadu, a Novavax 199 czyli + 9%
08.01.21 napisałem, że Mabion podpiszę umowę Novavaxem - kurs 22 zł
NIKT NA FORUM MI NIE UWIERZYŁ
03.03.21 Mabion ogłosił umowę Novavaxem
NIKT NA FORUM MI NIE UWIERZYŁ
03.03.21 Mabion ogłosił umowę Novavaxem
Re: MABION [MAB] księga XIV w trakcie rejestracji CD20
Wszystko zwiastuje, że w najbliższy czasie będzie się dużo działo
The Doors - Riders On The Storm
Re: MABION [MAB] księga XIV w trakcie rejestracji CD20
To że akcje Novavax rosną to ok ale dopóki nie ma podpisanej umowy pomiędzy Novavax a Mabion to wzrosty Mabion są tylko spekulacyjne.
Zakupy isajderów dziwne, nie kupowali akcji przy kursie 40+ a kupują po 70+.
Co do opinii naukowców to jedni twierdzą tak a drudzy inaczej:
https://wiadomosci.onet.pl/swiat/korona ... ku/b30ww9g
Jak na razie to w Europie i Stanach kto chciał to został zaszczepiony:
https://www.money.pl/gospodarka/szczepi ... 2400a.html
Zakupy isajderów dziwne, nie kupowali akcji przy kursie 40+ a kupują po 70+.
Co do opinii naukowców to jedni twierdzą tak a drudzy inaczej:
https://wiadomosci.onet.pl/swiat/korona ... ku/b30ww9g
Jak na razie to w Europie i Stanach kto chciał to został zaszczepiony:
https://www.money.pl/gospodarka/szczepi ... 2400a.html
REKLAMA
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