×

1089
1090

Vaccine NewsNovavax Covid vaccine highly effective in U.S. trials, including against variants, company says (nbcnews.com)

submitted by Jeffmister

top 200 commentsshow all 359
sorted by:
best (suggested)
topnewcontroversialoldq&a

[–]AutoModerator[M] [score hidden] stickied commentlocked comment (0 children)

This post appears to be about vaccines. We encourage you to read our helpful resources on the COVID-19 vaccines:

Vaccine FAQ Part I

Vaccine FAQ Part II

Vaccine appointment finder

I am a bot, and this action was performed automatically. Please contact the moderators of this subreddit if you have any questions or concerns.

[–]ozyozyoioi 231 points232 points  (253 children)

Something I'd like to point out pertaining to my ignorance on this subject. When they say it's "100% effective" that means that it is 100% effective at keeping you out of the hospital if you would have normally have had a severe to medium reaction to a covid infection. It doesn't mean it's 100% effective at preventing the spread of covid nor its symptoms. I had a breakthrough case after receiving both shots of the Moderna 2 months after my 2nd shot. Still can't taste or smell right. But without that vaccine, with my comorbidities, I should have been hospitalized or dead at this point. Vaccines work and this is good news overall.

[–]jeopardy987987 1 point2 points  (0 children)

It also doesn't have a big enough sample to claim that it is 100% effective at hospitalization/deaths.

We saw this with the other vaccine trials as well, where articles and claims about it were misleading due to the small sample sizes of severely sick people in BOTH the vaccinated AND the placebo groups. EDIT: for example, the Pfizer trial had zero deaths in both the vaccinated AND the placebo group, and yet people used that to claim that it was 100% effective at preventing deaths (does that mean the placebo was to?).

[–]onwrdsnupwrds 1 point2 points  (1 child)

Importantly, most vaccines were tested before variants like Delta became prevalent, so the 97% efficacy refers to the original variant. That's why we'll probably see more infections in vaccinated patients, but as far as we know, the vaccines still protect from severe causes and death. So good for you are vaccined, I wish you a quick recovery from your symptoms.

Disclaimer: I'm a doctor, treated hospitalised Covid patients until march

load more comments (4 replies)

    [–]joeco316 65 points66 points  (17 children)

    This says that Novavax intends to apply to FDA for an EUA in the third quarter. I recently read that FDA denied Bharat Biotech’s application, saying it will not be giving any more EUAs (at least for vaccines?). Does anybody know if Novavax would be an exception for some reason or is Novavax likely to be denied EUA and have to seek full approval to get into the US market?

    Edit: for anybody else wondering, someone on another sub said that fda said they wouldn’t be granting any euas to companies they hadn’t already had discussions with so it seems that’s the difference.

    [–]Stinkycheese8001 27 points28 points  (3 children)

    That’s an interesting question. Considering that EUAs are intended for scenarios where there are no fully approved options available, I wonder if Pfizer and Moderna’s choice to seek full approval impacts the EUA system.

    [–]Ncsu_Wolfpack86 2 points3 points  (2 children)

    Supply is a consideration in an EUA situation, not specifically if a therapy is approved or not.

    [–]Stinkycheese8001 2 points3 points  (1 child)

    Yes, the presence of fully FDA approved alternative therapies is absolutely a consideration for EUAs

    [–]SeattleIsOk 38 points39 points  (7 children)

    Novavax is intending to launch vaccines with multiple spike proteins for common variants, all within the same shot. I think there's some appetite for approving Novavax, but gosh, it seems like the FDA is playing favorites here. Novavax has been waiting months, and I'm not sure I understand the reasoning here.

    [–]eric987235Boosted! ✨💉✅ 13 points14 points  (0 children)

    I'm not sure I understand the reasoning here.

    It's considerably less urgent than it was in December.

    [–]nyokodo 4 points5 points  (0 children)

    Novavax has been waiting months, and I'm not sure I understand the reasoning here.

    The FDA can't play favorites until they have applications in front of them and Novavax hasn't submitted their application. The reason they haven't submitted their application is that to do so requires proof that the vaccine manufacturing process is up and running and Novavax has had major trouble scaling their manufacturing process. Novavax is a troubled company and manufacturing is hard at the best of times. Overall it doesn't seem like a legitimate criticism of the FDA in this case.

    [–]GimletOnTheRocks 6 points7 points  (0 children)

    I'm not sure I understand the reasoning here.

    Well, Pfizer/Moderna would certainly understand the reasoning here, assuming it's accurate.

    [–][deleted] 1 point2 points  (2 children)

    Politics.

    Modi won't approve Pfizer as he wants to give a monopoly to SII and the FDA is likely pissed about it.

    load more comments (1 reply)

      [–]whichwitch9 13 points14 points  (3 children)

      Novavax showing good effectiveness against variants could change the game, especially as the Delta variant starts to become dominant. If a more harmful mutation does occur, already approving Novavax has the potential to get us ahead of it.

      That the efficacy on variants is higher than the mRNA matters. It also may be more appealing to some of the vaccine holdouts in the US, who are wary of mRNA and J&J with its issues, potentially providing a boost in vaccination rates.

      In short, the FDA may find merit in this one from the data given.

      [–]lowlyworm314 2 points3 points  (2 children)

      I don't think we can say the efficacy is higher for the variants compared to mRNA. The UK variant made up the bulk of the variants occurring in this trial, and showed similar efficiency to the mRNA, near 90%. I don't think the data establishes a statistically significant difference. On the other hand we saw in the UK trial reduced efficiency against the SA variant, like down to 60%.

      [–]joeco316 3 points4 points  (0 children)

      I agree with this. I don’t mean to knock this vaccine at all, it seems quite good and will surely be of great use, but They also (perhaps conveniently, perhaps innocuously) didn’t break down what variants occurred in which arm. There were two cases of B.1.351 in the trial and we don’t know if they were in the vaccinated arm or placebo or one of each. Granted two data points is virtually useless anyway, but I’d still like to know.

      load more comments (1 reply)

        [–]redditgirlwz 2 points3 points  (0 children)

        I recently read that FDA denied Bharat Biotech’s application

        Why? The US may need another vaccine for male teens.

        [–]the_Senate840924Boosted! ✨💉✅ 45 points46 points  (7 children)

        Finally

        [–]shamblingman 16 points17 points  (3 children)

        i was in the trial. got a call from someone at UNC Chapel Hill.

        once the other vaccines became readily available, i asked if i was on the vaccine or placebo and found out that i was on the placebo.

        i was told that if i wanted to leave the trial and get vaccinated, it was my choice. of course i chose to get the pfizer vaccine.

        [–]Anomaly1134 11 points12 points  (2 children)

        Good news. It makes me wonder if it would be possible for a pharma to come right out the gates testing it for kids vs adults since so many adults are already vaccinated. Do we always have to start with testing on adults and move down?

        [–]_dekoorc 3 points4 points  (0 children)

        It makes me wonder if it would be possible for a pharma to come right out the gates testing it for kids vs adults since so many adults are already vaccinated

        I don't think they will have results by the time they plan to file for EUA, but Novavax did already expand this trial and has fully enrolled 2500 12 to 18 year olds.

        load more comments (1 reply)

          [–]Twrd4321 81 points82 points  (24 children)

          Phase 3 trials conducted in the UK should have been accepted for FDA approval. Loads of time have been wasted since then considering the number of lives that can be saved with more supply.

          [–]krazykris93Boosted! ✨💉✅ 36 points37 points  (1 child)

          Not just in the US, but other countries had the opportunity to approve it. To be fair though they did have manufacturing difficulties, so it would have been hard for them to make a bunch even with approval.

          [–]redditgirlwz 1 point2 points  (0 children)

          Not just in the US, but other countries had the opportunity to approve it.

          Especially in other countries. The US has had enough vaccine for months now. Most other countries still don't.

          [–][deleted] 26 points27 points  (7 children)

          Novavax

          Phase III trial started in last Dec in US and Mexico, US was not starving for vaccines, what's the reason to cut off the trial here before it reaches conclusion?

          [–]Twrd4321 16 points17 points  (6 children)

          The UK trial results were good and insisting on a US trial would have meant more time wasted conducting trials. The UK trials came to a similar conclusion as the US trials. It wasn’t necessary.

          [–]Stinkycheese8001 14 points15 points  (0 children)

          The UK trials tend to be demographically underpowered. The FDA has requirements for its Trials, and it’s not like there weren’t enough vaccines here in the US.

          [–]AmbiguouslyClear 6 points7 points  (2 children)

          Sure. But the EU Gave AZ the greenlight with laughably subpar trials and underwhelming (those early trials underestimated AZ's efficacy). So why didn't Novavax receive approval in the EU when they had better trials and better results? I also don't think earlier FDA approval would have saved lives stateside.

          [–]Twrd4321 5 points6 points  (1 child)

          Probably because Novavax did not apply for authorization? I’m not sure why Novavax waited till US trials are completed before applying for use.

          [–]klownyBoosted! ✨💉✅ 13 points14 points  (0 children)

          They were having difficulties with manufacturing, and manufacturing sign off is part of the approvals process. So even if the vaccine is solid, they have to demonstrate they can produce it consistently.

          [–][deleted] 2 points3 points  (0 children)

          US approval would mean other countries would also be more likely to approve it. It would be a major confidence boost of the vaccine.

          load more comments (1 reply)

            [–]Kaedylee 10 points11 points  (5 children)

            Phase 3 trials conducted in the UK should have been accepted for FDA approval.

            The FDA has very good reasons for not accepting trials conducted in other countries, specifically, demographics. UK demographics are not comparable to US demographics (there are far fewer people of Latino decent in the UK, almost no Native Americans, etc), and therefore, approving a vaccine for use in the US based only on UK trials means that we would be giving the vaccine to groups of people based on little to no testing for their group. And since efficacy, side effects, and adverse reactions can vary between different ethnic groups in some cases, that's potentially a big problem.

            So it's either that or the FDA says, "We approve this vaccine, but only for white people", which would be a big problem too.

            load more comments (8 replies)

              [–]rockriver74 12 points13 points  (7 children)

              Can someone ELI5 how this is different than Moderna or Pfizer?

              [–]Avarria587 36 points37 points  (2 children)

              This vaccine uses a synthetic spike protein mixed with a substance to stimulate your immune system to attack the proteins.

              The mRNA vaccines instruct your cells to make the spike protein. The immune system then attacks these proteins.

              Basically, this vaccine offloads the hard work of making the spike protein to giant bioreactors instead of instructing your body to make them.

              [–]rockriver74 4 points5 points  (1 child)

              Got it. Thank you!

              [–]fallenangel209x 6 points7 points  (0 children)

              Just to add a bit more: Novavax is using the same vaccine technology that is used for the HepB and pertussis vaccines.

              [–]thrillhouz77 15 points16 points  (2 children)

              This was tested against variants in a live trial and Pfizer/Moderna were not. In the UK trial NVAX showed to have 96.4% efficacy against the original Wuhan strain and in this larger trial it showed to have 100% efficacy against the original strain, so it is likely in the 98%+ zone when comparing apples to apples against the other two which were 95 and 94% respectively.

              This study also shows incredible protection for all age and comorbidity groups against the other strains and this cross strain protection means they shouldn't have to alter their formula for broad protection for some time (until newer breakthrough variants come start happening). They have been doing animal testing with their flu vax and this covid vaccine and it has shown to produce both high C19 and flu strain antibodies which will result in NVAX being the big booster winner on a global scale on a go forward (although the mixing of the two will likely have to go through some sort of safety trial so that may take some added time).

              ​

              The technology of this vaccine is more traditional as well and has shown an excellent safety profile with less side effects than their mRNA counterparts, it also has the added benefit of not killing young/middle aged women like Astra and the JnJ vaccines.

              [–]kalakuttaa 4 points5 points  (1 child)

              it also has the added benefit of not killing young/middle aged women like Astra and the JnJ vaccines

              Had this point be proven already or it's just an assumption that theoretically it won't be possible for this vaccine to have similar side effects as AZ/J&J.

              [–]thrillhouz77 13 points14 points  (0 children)

              It’s just a snarky and to this point unproven comment but JnJ and Astra seem to have a similar issue w blood clotting in younger women.

              [–]swni 2 points3 points  (0 children)

              I wrote a detailed covid vaccine explainer here https://ermsta.com/posts/20201221:

              Subunit vaccines (raw antigen)

              These vaccines involve directly injecting the antigenic molecule. These are called subunit vaccines because the antigen is one piece of the whole pathogen. For sars-cov-2, the only reasonable choice for antigenic molecule is the spike protein. By itself, the spike protein cannot cause any infection, as it is missing the rest of the virus, in particular the virus’s genome.

              Such vaccines are generally manufactured by creating recombinant cells (usually bacteria, but sometimes yeast, insect, or mammal) which contain the gene for the spike protein. These cells are grown and harvested, and then the spike protein is purified from the result.

              (In theory these vaccines could be manufactured by growing the pathogen directly; in this case, conceivably improper purification and sterilization could result in a vaccine accidentally causing the disease. However I’m not aware of any vaccines made this way, and sterilization can be done very reliably.)

              NVX-Cov2373, by Novavax, is a protein subunit vaccine in phase III trials. Various sources describe a protein subunit vaccine by Anhui Zhifei Longcom Biopharmaceutical as in phase II or III. There are an additional 9 such candidates in phase I or II and 65 vaccine candidates not yet in clinical trials.

              [–]MagnesusBoosted! ✨💉✅ 20 points21 points  (11 children)

              By the end of the trial, there were 77 cases of Covid-19: 63 in the placebo group and 14 in the vaccine group, for an overall efficacy of 90 percent, the company said.

              The numbers are pretty low for the placebo group. Seems currently vaccines have trouble ending the trials due to low infections.

              All cases in the vaccine group were mild, meaning the vaccine was 100 percent effective against moderate to severe illness. (The company's findings were presented in a news release and still must be submitted for peer review.)

              Saying that based on only 14 cases seems preliminary. I suppose the UK trial data was much better on this?

              [–]SeattleIsOk 2 points3 points  (0 children)

              There were different variants running around at the time of these trials. The efficacy is as good or better than others.

              [–]hwy61_revisited 1 point2 points  (0 children)

              Saying that based on only 14 cases seems preliminary. I suppose the UK trial data was much better on this?

              No, the UK trial saw only 6 cases in the vaccine group. But that's what happens with the most effective vaccines, there just aren't a lot of cases among the vaccinated.

              But as others have mentioned, none of these trials were big enough or long enough to determine efficacy against severe outcomes with any degree of certainty, so you always have to take the 100% figure with a massive grain of salt. Pfizer's interim readout in November, which was the basis for their EUA, only had 8 cases in the vaccine group and technically only showed 66.7% efficacy against severe disease (1 in the vaccine group vs 3 in the placebo). But the numbers for severe disease were so small that they were almost meaningless; 1 case was the difference between 66.7% and 100%.

              The vaccines are still exceptionally effective (likely in the high 90s) at preventing severe outcomes, but they were never going to be 100% and it was pretty unfortunate that the "100% effective against hospitalizations and death" got parroted around so much based on trial data that was never designed to make any real conclusions about that.

              [–]AmbiguouslyClear -2 points-1 points  (7 children)

              Few to none of the trials for any of the vaccines have had adequate data to make any claims about efficacy against severe illness and death.

              Edit: This comment was made just to point out that no stage 3 trial is ever going to be able to give good insight into protecting against severe disease and death, so there's nothing odd about this trials lack of data. For whatever reason, it seems to report efficacy against severe outcomes despite this apparent issue. Vaccines are still highly effective in preventing severe outcomes, and I do not dispute that.

              [–]dcolomer10 5 points6 points  (2 children)

              They are downvoting you but you are completely correct. Most trials have been for 30,000 people in around 100 days. Taking as an average 1500 deaths per million since the start of the pandemic (most developed countries have had from 1000-2000 deaths per million), then, taking an extremely crude average, you would expect 320 deaths per million over a 100-day span. So, for 15,000 in the placebo group, you would expect around 4 deaths. In some trials, the number in each was even lower, so the expected number dying would be lower.

              If, in your vaccinated group you get 0 deaths, and in the placebo, you get 3, you can conclude that you have 100% protection against death, which is just bad statistics.

              That being said, I am not saying they are not effective. Real world data with larger sample size has shown us that they are 95% effective against hospitalization.

              [–]AmbiguouslyClear 3 points4 points  (0 children)

              Yeah, I was just trying to point out that no stage 3 trial is calibrated to determine efficacy against severe illness and death, despite these things being reported as if they were primary endpoints. However, I can see how some might interpret that as a statement suggesting that I don't think the vaccines are effective in preventing these things. They're extremely effective.

              load more comments (1 reply)

                [–][deleted] 1 point2 points  (3 children)

                They have - the confidence intervals tell us the certainty.

                https://en.wikipedia.org/wiki/COVID-19_vaccine#Effectiveness

                load more comments (1 reply)

                  [–][deleted] 17 points18 points  (2 children)

                  This vaccine is great for the Asian or African countries once we start producing more of it

                  [–]the_Senate840924Boosted! ✨💉✅ 11 points12 points  (0 children)

                  Yeah apparently India and Korea will be producing it

                  load more comments (1 reply)

                    [–]ImaginaryRoadsBoosted! ✨💉✅ 6 points7 points  (0 children)

                    I haven't read the article, but this is good news and I hope the FDA gives it an EUA (assuming the data supports doing so). I'm sure some people will argue that our current vaccines are sufficient, but NovaVax uses a different technology (it's a protein subunit vaccine) which will offer an additional way of defense against variants. An EUA would enable us to swiftly deploy any stock we have should it be needed, and it eases the process to allow us to start including NovaVax in trials to determine the efficacy of mixing vaccines.

                    [–]NakDisNut 5 points6 points  (0 children)

                    I’m currently enrolled in this trial! It’s been quite interesting.

                    My entire family (3 kids + husband) got Covid diagnosed the same day I got my second NovaVax vaccine.

                    I had post vaccine symptoms that lasted about 24hrs. That was it. Three children snorting and snotting in my face + sleeping in the bed with my husband and never once did I catch it (noticeably).

                    Thankfully my family’s symptoms were incredibly mild. Kids had snot noses and headaches. Husband couldn’t taste anything, had headaches, and the most mild cough you could muster. (All had fatigue). Maybe their entire schtick lasted about 3-4 days.

                    Anywho … I didn’t get covid.

                    Now I need this joker to get approval as we want to go overseas in the later fall months (not the kids) and I need my vaccine to be approved. (Husband got Pfizer).

                    [–]katie4Boosted! ✨💉✅ 9 points10 points  (0 children)

                    I didn’t see it linked in the article, so here is their factsheet:

                    https://www.novavax.com/sites/default/files/2021-06/Novavax-PREVENT-19-Trial-Data-Factsheet-2021-06-14-FINAL-EN.pdf

                    From what I’ve been following, this vaccine is going to be first used globally and is applying for use in other countries before the US, which is fine, we’ve got enough supply of others. Only 15% of the world is vaccinated yet, and this one manufactures quick.

                    [–]longgamma 2 points3 points  (0 children)

                    SII is one of the manufacturers globally. Thankfully, we can get some more supply in India at some point in the future. I hope the Indian govt fast tracks this if WHO approves it.

                    [–]StrongAndStable 3 points4 points  (1 child)

                    Is this a one-shot or a two-shot vaccine? I can't seem to find this info anywhere?

                    [–]jtr489 3 points4 points  (0 children)

                    I participated in this trial and glad the data is looking good

                    [–]ayending1 2 points3 points  (1 child)

                    Hate to say this but they are way too late for the vaccine money.

                    [–]factualreality 4 points5 points  (0 children)

                    Not if this works best against variants. UK will likely do a booster shot of this in september all being well. Also the us and a few other countries maybe spoiled but the rest of the world is still desperately short of vaccines

                    [–]Throwawizzle23 1 point2 points  (0 children)

                    anyone have any idea when it will be available in the US roughly?

                    load more comments (23 replies)