Posted on 02/04/2021 1:14:55 PM PST by SeekAndFind
Novavax (NASDAQ: NVAX) shares climbed 2,700% last year as investors bet on the biotech company's investigational coronavirus vaccine. But the share price's story doesn't end there. Last week, the stock soared nearly 65% in just one trading session. What prompted such a jump? Novavax said its vaccine candidate was effective against the U.K. and South African strains of the virus in clinical trials. This was welcome news given one of the biggest worries these days -- that currently available vaccines won't hold up against these new strains. The company also reported phase 3 efficacy data concerning the older version of SARS-CoV-2.
You're probably asking yourself whether all of this offers Novavax an advantage over its more advanced rivals, Moderna (NASDAQ: MRNA) and Pfizer (NYSE: PFE). The U.S. Food and Drug Administration (FDA) offered their vaccines Emergency Use Authorization (EUA) late in 2020. Let's take a closer look at three key points to see how Novavax measures up.
1. Efficacy
A first glance, general efficacy shows Novavax's candidate lagging behind those of its commercialized rivals. Moderna and Pfizer reported efficacy of 94.1% and 95%, respectively, for their vaccines. Like Novavax's candidate, these vaccines both involve two doses, and full efficacy kicks in after the second dose.
Novavax reported 89.3% efficacy. But here's one important factor to keep in mind: Novavax's phase 3 trial took place in the United Kingdom -- home of the U.K. strain. And the U.K. strain has become more and more prevalent both there and elsewhere. Moderna and Pfizer generated their trial data before the newer variants of concern had gained ground. Their vaccines were primarily fighting the virus they were designed to fight: the original strain of SARS-CoV-2.
Novavax's vaccine -- like those of Moderna and Pfizer -- also was designed to combat the first version of the novel coronavirus; it's clear that efficacy will be higher when faced only with that version. In fact, Novavax calculated its candidate's efficacy against the earlier coronavirus at 95.6%.
2. New strains
Let's talk about new strains of the virus. Moderna and Pfizer have said their vaccines can handle the newer variants.
Moderna performed in vitro studies with blood serum from those vaccinated and found neutralizing antibody levels remained about the same when the U.K. strain was introduced. The South African strain resulted in a sixfold decline in antibody levels -- but they still remained high enough to maintain protection. Pfizer, in a similar in vitro test, introduced engineered viruses with key mutations from the U.K. and South African strains. The company's findings echoed those of Moderna.
As for Novavax, its investigational vaccine actually confronted these new strains during clinical studies rather than during in vitro testing. The company said its vaccine candidate was 85.6% efficacious against the U.K. strain in the U.K. phase 3 trial. In South Africa, a phase 2b trial demonstrated 60% efficacy against SARS-CoV-2 -- and about 90% of cases detected in the trial were of the South African strain. (This includes only HIV-negative trial participants.) This strain contains a mutation that helps it escape antibodies produced post-vaccination. Novavax's vaccine candidate demonstrated some protection against this variant -- and even some protection is welcome.
3. Severe disease
It's difficult to make a firm statement on severe disease due to the difference in trial size among the three companies, though Moderna and Novavax have an edge so far. Both companies reported no cases of severe coronavirus among those who received their vaccines in phase 3. Pfizer, however, reported one case of severe COVID-19 in a vaccinated trial participant.
Why is prevention of severe disease so important? Severe disease is what leads to hospitalization, complications, and even death -- so one of the biggest goals of vaccination is to prevent extreme illness. A vaccine that could fully protect against this over time could clearly take market leadership.
So, how do things look for Novavax?
Looking at overall efficacy against the original SARS-CoV-2 virus, Novavax is on par with Moderna and Pfizer. As more and more data are collected from the trials, the numbers may shift slightly. But all three so far have reached more than 94% efficacy against the original strain. And that's positive news.
Novavax has tackled new strains in the real world and showed its candidate can hold up. However, it's possible that the Moderna and Pfizer vaccines, if also tested now in the U.K. and South Africa, would produce similar results. After all, their in vitro tests were encouraging.
As for preventing severe disease, Novavax and Moderna are leading in this area.
Overall, I would say Novavax may be on its way to becoming one of the strongest players. The biotech company clearly could enter the market on the same footing as its more advanced rivals. And that means billions of dollars in revenue it's hoping for are looking more and more likely.
NOTE: The author, Adria Cimino has no position in any of the stocks mentioned. The Motley Fool recommends Moderna Inc.
| Company | Trial Participants | COVID-19 Cases | Cases in Vaccine Group | Severe Cases in Vaccine Group |
|---|---|---|---|---|
| Moderna | 30,000 | 196 | 11 | 0 |
| Novavax | 15,000 | 62 | 6 | 0 |
| Pfizer | 43,000+ | 170 | 8 | 1 |
Thank you for the information! Good news for pro-lifers as well since the Novavax vaccine did NOT use fetal stem cells at any stage of research and development or production; just like Moderna and Pfizer.
Some of the after-the-fact (in other words, they already had produced the vaccine, bottled it, and readied it for shipping) confirmatory testing did use fetal stem cells, but that’s due to FDA requirements for independent testing, beyond Novavax’s control, and wasn’t used to make the product. It would be effectively the same as if someone tested Tylenol today with fetal stem cells. That wouldn’t make Tylenol unethical. It was produced and bottled without using fetal stem cells. Novavax used insect cells for their R*D and testing.
The Oxford/Astrazeneca and Johnson & Johnson vaccine candidates DID use fetal stem cells in their R&D and in-house testing. Fetal stem cells are NOT in the final product, but they are definitely tainted by the use of cells originally obtained from abortion.
What about the Brazilian strains?
I still want to know how Fauci and Gates had their vaccine (Moderna) out before anyone knew of Covid-19 in Oct. 2019.
And don’t bother demanding proof as it’s been scrubbed off the Gates Foundation site. Do a search for it on past FR posts around April.
Here’s how it works two weeks after the second dose you drop dead. 😆
One is about as good as another. The vaccines were not made against specific strains. They’re different from flu vaccines. They coronavirus vaccines were made to cause the body to make antibodies against the virus’ tool for invading good cells.
Isn’t that racist to call them the Brazilian and UK strains ?!?
Novavax says:
“About NVX-CoV2373
NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is adjuvanted with Novavax’ patented saponin-based Matrix-Mâ„¢ 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. Over 37,000 participants have participated to date across four different clinical studies in five countries. NVX-CoV2373 is currently being evaluated in two pivotal Phase 3 trials: a trial in the U.K that completed enrollment in November and the PREVENT-19 trial in the U.S. and Mexico that began in December.”
To me (as an interested layman) this seems to be a different technology than the Pfizer and Moderna. My gleanings indicate that the Johnson & Johnson and the Oxford are both based on non-human cold viruses?
Novavax mentions Operation Warp Speed. Seems as though Trump had his fingers in a lot of pots, hedging his bets. Not only did he support a bunch of different vaccine approaches, he paid for the manufacture of candidates long before any tests were conducted. Now, rather than recognizing his amazing foresight, he is blamed for not having enough vaccine. No one else ever thought of his approach and were prepared to sit around 5 - 10 years to see if anything would happen.
I can’t speak to the specifics of NovaVax’s testing as I’m passing on second-hand reported information, but what I can say is that the FDA does require fully independent testing be performed to confirm the in-house testing of the manufacturers.
In other words, you have to test your own product to make sure it works as expected, but you then have to pay someone else and hand them your product so they can also test it. How they test it is up to them. You have zero control. At the end, you submit both your results and the independent test results to the FDA, who reviews everything ensuring that everyone is in agreement that your product does what it’s supposed to do.
Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.