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Novavax, Inc. (NVAX)

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172.77 +10.80 (+6.67%)
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  • a
    anne
    Dec. 3/21 Italian article: "Novavax "vaccine against Omicron in January 2022" / "93% efficacy on other variants"
    Niccolò Magnani
    Novavax announces the production of the ad hoc vaccine against Omicron from January 2022: in the meantime, evaluations are underway on the effectiveness of the current serum against the South African variant.

    Novavax has announced that from January 2022 the production of a specific vaccine against the latest variant of Covid-19 arriving from Africa, the so-called Omicron , will begin . While the US biotech awaits the green light from the European Medicines Agency (EMA ) for the anti-Covid vaccine against Alpha and Delta, here is the announcement of the imminent production against VoC ("variant of concerns", the most dangerous ones ) sequenced in South Africa.
    With a press release directly released by Novavax , two announcements in particular made by the US multinational: first of all, Novavax is currently evaluating the effectiveness of its vaccine against the variant discovered in South Africa , as it has already done for previous variants including Alpha, Beta and Delta. Secondly, Novavax has started the development of a specific vaccine against Omicron thinking of a commercial scale production to start already in the first month of the new year. " Novavax has started the development of a specific construct for Omicronof its SARS-CoV-2 Spike protein (rS) antigen, currently in use in NVX-CoV2373. The initial stages necessary to produce a specific peak for Omicron are underway and GMP production in a commercial facility is scheduled for January 2022. The laboratory evaluation of a new nanoparticle vaccine combined with the strain will begin within a few weeks, "they say. from biotech.
    NOVAVAX, THE EFFECTIVENESS OF THE CURRENT VACCINE

    The company that is preparing to receive the green light from the EMA - thus becoming the fifth anti-Covid vaccine on the market in Europe - following the appearance of other VoC variants ( Alpha, Beta, Delta ), has analyzed the antibody responses in the Phase 1/2 study in the United States and Australia. Well, patients who received a third dose (6 month booster) ) of NVX-CoV2373 were evaluated for the production of antibodies against known VoCs in August 2021: the responses are currently very encouraging and practically approaching the similarly to other vaccines with the mRna method (Pfizer and Moderna). "Enhanced anti-Spike IgG responses were greater than those seen in our Phase 3 clinical trials. 96% against the prototype strain and 86% against Alpha. Efficacy in the US / Mexico was 100% against non-VoI / VoC, 93% against VoI / VoC and 94% against Alpha», Novavax notes again. A third booster of Novavax vaccine resulted in ' low rates of adverse and serious events " and was also well tolerated: most recently, " for the time being. After potentiation, all study participants developed consistently high levels of functional hACE2 responses against all VoCs tested. There was a 10.8x increase against Alpha, a 6.6x increase against Beta, and an 8.1x increase against Delta. The responses against Delta and Beta suggest the maturation of the immune response and an efficacy comparable to that observed in our Phase 3 studies."
  • a
    alberto
    Six different Covid vaccines are safe and effective when used as boosters, UK study finds.- CNBC
    Key Points :
    The phase 2 trial, published Thursday in The Lancet medical journal, looked at the safety and efficacy of seven vaccines given after two initial doses of either the Oxford-AstraZeneca or Pfizer-BioNTech vaccine.
    All seven vaccines boosted immunity when given 10 to 12 weeks after two doses of the Oxford-AstraZeneca vaccine, the study found.
    All of the vaccines except Valneva’s boosted immunity in participants whose initial two doses were the Pfizer-BioNTech vaccine, researchers said.

    ″[This study] gives confidence and flexibility in developing booster programs here in the U.K. and globally, with other factors like supply chain and logistics also in play,” he said in a press release on Thursday.

    “Further work will generate data at three months and one year after people have received their boosters, which will provide insights into their impact on long-term protection and immunological memory.”

    Other limitations included the age range of participants, the fact that most of those taking part in the research were white and the shortened timeframe between doses, which the report’s authors said could dent immune responses.

    The research team is now studying the effects of boosters seven to eight months after their initial doses, with results expected in 2022.
  • F
    Fire Truck
    Australian government website....Novavax, finally! Let's go beeches! Hold on for long. Only approvals for the next few weeks.

    "I'm very hopeful that there may be the first international approval over the course of the next week, and that Australia is in a very similar timeframe. I'm hopeful that we might see some positive news before Christmas." - Australian health minister

    https://www.health.gov.au/ministers/the-hon-greg-hunt-mp/media/interview-with-neil-mitchell-from-3aw-mornings-on-3-december-2021-on-covid-19-cases-update-on-the-novavax-rollout-and-retirement-from-federal-politics
    Read the transcript of Minister Hunt's interview with Neil Mitchell from 3AW Mornings on 3 December 2021, on COVID-19 cases, update on the Novavax rollout and retirement from federal politics.
    Read the transcript of Minister Hunt's interview with Neil Mitchell from 3AW Mornings on 3 December 2021, on COVID-19 cases, update on the Novavax rollout and retirement from federal politics.
    www.health.gov.au
  • W
    Who.m.I
    If you look at the following EMA statement on 17 November again, EMA said it would take “weeks”, now it’s 12 working days, e.g 2 weeks, its so close to the approval now, same to the MHRA approval considering today’s UK news related to the vaccine.

    “News 17/11/2021
    EMA has started evaluating an application for conditional marketing authorisation for Novavax’s COVID-19 vaccine, Nuvaxovid (also known as NVX-CoV2373). The assessment will proceed under an accelerated timeline, and an opinion on the marketing authorisation could be issued within weeks if the data submitted are sufficiently robust and complete to show the efficacy, safety and quality of the vaccine.
    Such a short timeframe is only possible because EMA has already reviewed a substantial portion of the data on the vaccine during a rolling review. During this phase, EMA’s human medicines committee (CHMP) assessed data from laboratory studies (non-clinical data), some information on the quality of the vaccine and the way it will be produced, and data on its safety, immunogenicity (how well it triggers a response against the virus) and efficacy against COVID-19 from clinical studies in adults. “

    Agree it or not, it makes sense that some hidden forces have inside information for the imminent EMA or MHRA approval, they want to accumulate cheap shares as much as possible before any major approvals, plus those shorting activities, which could explain today’s sudden drop, do you have better explanations?
  • B
    BHVR
    WSJ

    The Food and Drug Administration is laying the groundwork for the rapid review of Omicron-targeted vaccines and drugs if they turn out to be needed, according to people familiar with the matter.

    The agency, building on rules established earlier this year to assess shots and treatments, has been meeting with drugmakers and setting guidelines for the studies and data needed to swiftly evaluate products targeting the new Omicron Covid-19 variant, the people said…….. For vaccines, the companies wouldn’t have to conduct large, lengthy trials enrolling thousands of subjects that wait for a certain number to catch symptomatic Covid-19. Instead, they could, for example, study the immune responses in a few hundred subjects.
  • M
    MartinS
    Before omicron news broke Novavax was almost a sure thing with imminent approvals about to send the stock price flying. Since Omicron surfaced there are increased risks and doubts, and that is probably why the stock price has been so volatile.

    There is a false narrative going around that omicron is more mild than delta and other covid variants, meaning there would be less need for vaccinations against it and if it is far more contagious it could displace worse variants and hasten the end of the pandemic. If this had proven to be true it would have been great for the world but bad for vaccine stocks. But it is not looking like it is more mild. Hospitalizations (a lagging indicator) are now rising rapidly in Sth Africa and will likely be followed by steep rises in severe illness and deaths. I’d say things are very likely to get much worse for the world but it might take a little while to make that clear, and in the meantime there is a lot of downplaying of omicron.

    There was a possibility that Moderna and Pfizer vaccines would prove effective enough against the new variant that no modification would be needed, but that Novavax might not be as effective against it due to omicron having some similarities to beta. I think it is likely that if Novavax needs to modify its vaccine for omicron that the other vaccines will need to too. All of the vaccines will likely still show fairly good protection against severe illness and death including Novavax, but it is too early to tell if a new vaccine will be needed. I'm thinking it is more likely than not.

    If all vaccines end up needing to be modified Novavax is seen as slow and coming from behind having not been approved for its original vaccine. This is only a perception and Novavax can prove it false and actually take the lead on this as they are now saying they will start manufacturing an omicron vaccine in January for use in clinical trials - earlier than I would have expected.

    If the vaccines show low efficacy against omicron it would be bad at first for all vaccine stocks, but it should be worse for the previously established vaccines as it upsets the status quo and threatens them the most, while it actually opens a door for Novavax to compete in a new race for a vaccine and opens up the market again that was previously saturated. It could mean that current boosters are not seen as very effective against omicron which would bring their use to a halt and that opens the possibility for large new orders for any large producer of an omicron vaccine. Novavax is in a much better position to compete in that race than they were last time as they have now managed to overcome assay and regulatory issues and scale up their manufacturing. This could actually be the best thing to happen to Novavax, but it will need to play out first. There are still a lot of unknowns.

    I expect with all of this uncertainty over omicron the stock price will be volatile for a while until investors are able to make clearer predictions. Approvals will help give Novavax credibility again that they are in the race and can produce a variant vaccine if it is needed. It could be that an approval from a major regulator will send Novavax stock up much higher than it otherwise would have because it will mean Novavax is now very competitive in a changing market.
  • C
    Coronaman
    The study is very limited in my opinion period the most important part of the study is that the NVAX vaccine is the safest period also all of the vaccines for the most part are immunogenic period what’s not clear is the significance of the antibodies period at the different levels clinically significant period there is no clinical endpoint period also, perhaps the levels increase very quickly with RNA vaccines and drop off, whereas perhaps the NVAX vaccine level stay higher longer period no one knows period follow-up studies are needed period finally, it has nothing to do with the quality of the antibodies. The NVAX antibodies may be better, perhaps more clinically relevant because of the approach to the spike protein period

    Again, the most significant part of the study in my opinion is that the NVAX vaccine is the safest and that’s really what people are interested in.
  • M
    Matt
    Mix and Match results are very favorable to Novavax not only because it showed excellent boosting capability with minimal side effect and no myocarditis but also because half dose 2.5 mgs with 25 mgs of Matrix M works quite well with even milder reactogenicity. This may turn out to be a big deal in the future when Novavax readies it’s Omicron specific antigen. They can not only make Polyvalent (mix 2.5 of wild type with 2.5 of Omicron) they may also get away with using only 25 mgs of Matrix M. This will double the available dosage and profits.
  • N
    Nick
    Perhaps today was the final dump before the pump. Big boys trying to get as many cheap shares as they could.

    This evening:

    -The Lancet finally published the results from 🇬🇧 UK mix and match booster trial. Nvax did well, even with only a 1/2 dose.

    -The Health Minister of Australia Greg Hunt said he expects nvax to get international approval within days and Australia to approve right after, likely before Christmas.

    -Already 5 confirmed cases of Omicron in NY alone.

    Short Sale Rule in effect tomorrow, so they won’t be able to hold us back. Expecting deep green tomorrow even for a Friday. Already up $7-8 AH. 🤞🤞
  • C
    Cedric
    The mix and match study shows Viral Vector (AZ) and Inactivated (OCGN, ShinoVac, …) don’t work as booster. This big market will be shared by MRNA and Protein Subunit. MRNA may have better peak performance which lasts only 1-2 days, our best-in-class safety profile and easy to store property will make us the boost of choice. And since Sanofi is giving up, we have no competition.
  • O
    Ole
    The Lancet paper describing the results of boost with 7 different vaccines is published.

    Key information:

    1. Titre of neutralizing antibodies drops 4-6 fold for Delta vs wild type (wuhan-1) due to escape mutations in the spike of Delta. This is well know and expected. It is also well know the correlate of protection is the specificity and concentration of neutralizing antibodies. Total spike-specific IgG does not correlate with preotection.
    2. The frequency of spike specific T cells remains roughly unchanged across all vaccines. Some variability but all vaccine induced a robust memory T cell response. The key is there was no drop in WT-specific T cells vs Delta or Beta T cells across all vaccines.

    Since the data lock for the trial occurred on Aug 19.21 lot has happened in the world. Omicron is now gaining ground and out-competing Delta.

    The mutation profile of the spike in Omicron is far more than for Delta and its unknown if this will result in up to 100% escape of protection from infection. However, it is expected that Omicron will be a high level escape mutant and evade antibodies elicited by immunization with WT sequence of the spike protein and data will eventually come out showing the level of escape.

    This could play out where many previously infected or vaccinated do get infected by Omicron but the data still supports high level protection from severe disease, hospitalization, or death.
  • K
    Kuruman
    NVAX demonstrated the highest efficacy of any vaccine against the original strain, and had much higher efficacy against Alpha and Delta than either of the mRNA vaccines. It also produced the highest antibody levels as I remember, although there may be assay differences that made this difficult to truly compare.

    This has to suggest that there is more to the issue in the real world than antibody numbers. NVAX has the entire protein spike in its vaccine. Perhaps it elicits a broader array of antibodies that then confer broader coverage against variants. There is absolutely no evidence that the higher numbers seen with mRNA boosters translates to better coverage against the virus variants currently circulating. None.

    Of course NVAX is way, way behind and the press will not care to add any nuance to these results. NVAX needs to do better than it’s BP competitors to get any respect, and these results are disappointing in that regard.

    It will probably take months and much more research to see which booster is actually best in the real world. Until then the press will crown mRNA vaccines champion, which is deeply irritating.
  • t
    trublurain
    TRANSCRIPT;
    "Novavax, Inc. (NVAX) Presents at Evercore ISI's 4th Annual HealthCONx Virtual Conference (Transcript)
    Dec. 02, 2021 11:47 AM ETNovavax, Inc. (NVAX)
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    Novavax, Inc. (NASDAQ:NVAX) Evercore ISI’s 4th Annual HealthCONx Virtual Conference December 2, 2021 9:15 AM ET

    Company Participants

    Filip Dubovsky - Chief Medical Officer

    John Trizzino - Chief Commercial Officer and Chief Business Officer

    Conference Call Participants

    Josh Schimmer - Evercore ISI

    Josh Schimmer

    Welcome everyone for our next session with Novavax. We have Filip Dubovsky, Chief Medical Officer and John Trizzino, Chief Commercial Officer and Chief Business Officer. Gentlemen, welcome and thank you for your efforts from COVID pandemic to develop one of the more advanced vaccines. So, why don’t we dig in and give us a quick snapshot of where we are with Novavax COVID vaccine?

    John Trizzino

    Yes. So, let me kick off, Josh. I think we are at a point where we’re feeling more confident than ever about where we are from getting to approval. We, over the last several weeks, have made regulatory submissions to the EU, UK, Canada, Australia and a variety of others that on a harmonized regulatory submission that allow us to be able to move very quickly. We’re in the process now of coordinating with the various regulatory authorities, responding to some of the questions that they have relative to the filing, but feeling good about the feedback. There was a nice communication from EMA about a week or so ago, regarding our submission to them and moving along very nicely, coordination with our partners Serum Institute on the CMC section of all of those filings, and a readiness on their part to be able to produce hundreds of millions of doses. So, we’re feeling good and confident about where we are.

    Question-and-Answer Session

    Q - Josh Schimmer

    Well, you had the data in the hand for a while. So, let’s maybe kind of take us through what the gating steps have been towards regulatory approvals, and some of the assay development work that you’ve needed to do?

    Filip Dubovsky

    Yes. So, maybe I’ll just kick off with the clinical data. So, you’re right. We’ve announced our results from our two Phase 3 studies, and these were Phase 3 studies that were done in different places, one in the UK and one in the U.S. and Mexico. And the results we’ve presented and are published were really quite good, and they were remarkably consistent. So, our efficacy overall was right around 90% in both studies. There is less than a single percentage point between difference. And although variants were emerging in both the UK and the U.S. at the time, our efficacy against variants is also good, including specifically against severe disease in the U.S. study, which was the launch of the studies, we actually saw a 100% protection against moderate and severe disease in that study. And that included, I guess all the variants that were circulating at the time. So, that’s been filed, and the regulators have had that for a while, and we’ve been interacting with them around the details of those responses.

    What has held us up until now was getting our CMC package together and filed. And that was really just all about the analytics, about our vaccine and what was in our vaccine. Our vaccine is a new technology, and it includes a particular recumbent protein and a particular adjuvant. So, to develop the assays to distinguish those two into a level that the regulars are happy with, it was a tricky part. That’s been done, and that’s part of the consolidated file we have in all the regulators. John?

    Josh Schimmer

    Sorry. John, were you going to add anything to that or…?

    John Trizzino

    No, no. I think that covered it. Yes. That was great. Thank you.

    Josh Schimmer

    So then, where are you in scaling up on manufacturing capacity and where do you expect to be in terms of doses produced into this year and into next?..."

    Continued in reply;
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  • A
    Andrea
    EUROPEAN UNION EMA Chief Emer crooke: Novavax vaccine approval could happen in a matter of weeks.

    The head of the EU's drug regulator struck a reassuring tone following reports that the newest coronavirus variant, named Omicron, had spread to many countries.

    "We know that viruses mutate, and we’re prepared," said Emer Cooke, the executive director of the European Medicines Agency, in testimony to the European Parliament's health committee Tuesday.
    Cooke said that regulations have already been in place since February allowing vaccine makers to fast-track the approval process if modified coronavirus vaccines are needed.
    In any case, a careful assessment was needed to say whether a modified vaccine was actually required for the new variant, specified Cooke. The large number of mutations found in the Omicron variant — particularly in the crucial spike protein — have raised concerns that it might be able to bypass immunity granted by existing vaccines.
    "We have contingency plans in place," said Cooke, who added that the agency was working with other regulators, as well as with the World Health Organization and the European Centre for Disease Prevention and Control, to prepare for any worst-case scenarios.
    The EMA head added that compared to last winter the bloc was in a much better situation, with "more tools" in place.
    She detailed how vaccines were working — pointing to her home country of Ireland where 93 percent of the adult population was immunized. COVID-19 deaths per million in Ireland stood at 15, versus the 250 per million registered in two unnamed EU countries with vaccination rates below 50 percent.
    Meanwhile, authorization of the Novavax vaccine could happen in a "matter of weeks," said Cooke, adding that the regulator was working on a strategy for mix-and-match boosters that will be published soon, possibly by the end of the week.
    Cooke also said that the EMA was working with member countries to provide them advice on emergency use of the new antiviral pills developed by MSD and by Pfizer ahead of EU-level marketing authorization.
  • J
    John
    I just read the mix and match trial data published in Lancet. Overall all vaccines included showed adequate immunity. But novavax didn't show any regional or severe side affects after receiving the shots. All mentioned severe side affects are mrna and astrazeneca.
  • F
    Flipp
    Mix and Match booster study proves for the first time that one half dose of #Novavax 2373 antigen (2.5 mgs) with 25 mgs of Matrix M (not 50 mgs as in Full dose) works quite well with even milder reactogenicity. This is a big deal in the near future when $NVAX readies it’s #Omicron specific antigen. They can not only make one of a kind Polyvalent (mix 2.5 of wild type with 2.5 of Omicron) formulation but they may also get away with using only 25 mgs of Matrix M (half dose) ! This will not only double the available dosage and profits Overnight but will also enable the company to be a leader in the global fight against the pandemic like no other as double the number of people can access it. Matrix M is the most valuable component in the vaccine.

    I like this part the most! Half the dose still good and safest vaccine.
  • D
    Denis
    Something is up. The media in Europe started to cover NVAX at an accelerated pace.
  • P
    Philip
    So I just read the mix and match study from the lancet. For a quick resume, BNT and MRA vaccine gives bigger numbers of spike IgG after boosting than NVAX does. NVAX has fewer side effects.

    There is an important quote in the article that basically says we don't know if big numbers are important: Regarding spike IgG third dose response, it is important to recognise that, as yet, there is no established or well defined correlate of long-term protection.

    So basically NVAX will be able to be used as a booster around the world based on this study but it seems that MRNA vaccine might have an advantage as far as boosting go for immediate immune response. Lower side effect and easier logistic will still make Nvax a good choice.

    The battle of the variant booster just begun, whoever can get it done the faster will win over a good portion of the booster market. NVAX seems to have a pretty good shot at being first based on their latest statement.

    Please comment if you think I am wrong or I missed something.
  • J
    Jerry
    Novavax will spike higher

    Taylor Carmichael (Novavax): Like the vaccines from Moderna and Pfizer-BioNTech, Novavax's focuses on the spike protein. And that is why the efficacy levels of these vaccines are so high. So, theoretically, if there are many mutations in the spike protein, the original COVID-19 vaccines won't be as effective.

    Nonetheless, Novavax is confident that it will find a vaccine candidate for this new threat. The biotech is now testing its original vaccine, CoV2373, against the omicron variant to see what kind of protections vaccinated people might expect. The company says it will have lab data on that question in a matter of weeks.

    Simultaneously, Novavax has initiated development of an omicron-specific construct of its spike protein antigen. First steps are underway, and the company says it will start manufacturing the antigen in January.

    Because it's not an mRNA drug but a protein-based vaccine, many experts believe the Novavax vaccine is an ideal booster shot. In a recent article in Nature, the authors concluded that the protein vaccines have a superior safety profile to the mRNA vaccines.

    Of course, most of Novavax's COVID-19 shots will be used to vaccinate people abroad. Nonetheless, the U.S. has already acquired 100 million doses of its vaccine candidate. So if there's a demand for boosters next year, Novavax investors should do really well.
  • H
    Holding
    Today's fireside chat, while holding potentially good news, e.g., NVAX's vaccine formulation for the newest variant Omicron, I believe the market/manipulators/bots/shorts are taking advantage of Trizzino saying they are still having conversations with regulators - which could have been interpreted as a negative and a reason to manipulate downwards. One of the near term anticipated approvals would end this manipulation.

    Been there, done that before - I am HOLDING.