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What are the chances that Novavax’s coronavirus vaccine is 90% effective?




Last week, Pfizer (NYSE: PFE) andBioNTech(NASDAQ: BNTX) announced positive results from the Phase 3 trial for their coronavirus vaccine. The drug, BNT162b2, met all of the study’s primary and secondary endpoints, with an incredible 95% effectiveness rate. Out of a subset of 8,000 volunteers, 162 people in the placebo group contracted COVID-19, and only eight people in the vaccinated group did so.

Not to be outdone,Modern (NASDAQ: ARNM) announced similar remarkable news. Ninety people in the placebo group tested positive for COVID-19, and only five in the vaccinated group. And finally, the vaccine named after the Russian satellite that was the first in space – Sputnik – recently reported 92% effectiveness.

Vials labeled Covid-19 Vaccine

Image source: Getty Images.

Of course, the world is in desperate need of a COVID-19 vaccine. Will each vaccine be 90% effective? Will some vaccines be insufficient? What will happen if theNovavax(NASDAQ: NVAX) is only 79% effective? Will it be high enough for FDA approval? Let’s go dig.

MRNA drugs are rocking, so don’t bother hitting

The mRNA vaccines could be the best in their class. This approach differs from traditional vaccination, in which an inactive, non-infectious version of the virus in question is administered to patients whose immune systems then respond to “antigens”, or “spike proteins”, outside the virus. . MRNA vaccines, on the other hand, provide the body with a specific messenger RNA molecule that has been designed to express the same spike proteins; the patient’s immune system reacts in the same way, but no real virus is required.

Using mRNA technology, scientists can find drug candidates very quickly and get drugs into clinical trials at astonishing speed. We’ve seen this early on, with mRNA drugs quickly taking a lead as other vaccines rush to catch up.

It is possible that mRNA vaccines are not only rapid, but qualitatively better than other candidate vaccines. The Russian vaccine goes against this theory – it is not an mRNA drug. On the other hand, some observers believe that Russian positive data is in fact politicized science. Even the vaccine’s name, Sputnik, has a political history (“first in space!”). So if we rule out the Russian vaccine, maybe mRNA vaccines have already won this vaccine race. Maybe these vaccines won the sprint (first to finish) but also the marathon (best-in-class).

Certainly, in the United States, the first spectacular results of mRNA vaccines have raised the bar on the level of effectiveness that we might expect from our coronavirus vaccines. The United States Food and Drug Administration (FDA) has indicated that it wants to see, at a minimum, efficacy levels of 50%. But now, with two drug companies reporting more than 90% effectiveness, it’s possible the agency will increase its review target to something higher, like 70%, and reject vaccines that don’t meet that. level.

Why not demand that every vaccine be 90% effective? Well, mRNA vaccines have delivery issues. Pfizer vaccine should be stored at minus 94 degrees Fahrenheit. But more importantly, the reported results come from subsets of data. 44,000 people were enrolled in the Pfizer study. We do not yet have the figures for all the volunteers. As more and more data comes in, it’s possible that the effectiveness rates will drop a bit. And different vaccines can have different results for different populations – for example, the elderly, who are a high-risk population.

Drawing of spike proteins on viral cells

Image source: Getty Images.

Maybe it’s the spike protein

At the start of the COVID-19 race, scientific researchers at the University of Texas and the National Institute of Health released the chemical structure of the spike protein from SARS-CoV-2, the coronavirus that has killed so many people. This coronavirus has many peaks that attach to proteins in order to infect people. The theory is that by targeting the spike protein, as Moderna and other mRNA vaccine makers do, a vaccine can create antibodies that prevent this fusion.

Jason McLellan and Barney Graham of the US National Institute of Allergy and Infectious Diseases (NIAID) solved this problem with the MERS vaccine. What McLellan discovered, according to Chemistry and Engineering News, is that adding two prolines to the spike protein of a vaccine could make it more stable and more effective. This focus on the cutting edge protein – and the 2P mutation technique – was widely adopted by several pharmaceutical companies early in the race, including Moderna, Pfizer, Novavax and Johnson & johnson.

Another major competitor of vaccines, AstraZeneca(NASDAQ: AZN), also focuses on the spike protein. However, unlike its rivals, the company does not use the 2P mutation in the formulation of its vaccine candidate. AstraZeneca trials were stopped twice due to two serious adverse events.

In Moderna’s press release announcing the success of Phase 3, CEO Stéphane Bancel credited this NIAID spike protein research: “I would like to thank the NIH, in particular the NIAID, for their scientific leadership … which led to the discovery of the best way to make advanced protein antigens that are used in our vaccine and others. “

Likewise, when Novavax CEO Stan Erck praised Pfizer on the company’s success, he also mentioned the spike protein:

It is a remarkable effort on their part. And it’s great for global health. It’s great for the vaccine industry. And this is really great for all the efforts of our colleagues who are developing a cutting edge protein to stop the coronavirus pandemic. This shows that the vaccine will work and kudos to Pfizer.

Novavax has signed distribution agreements with several countries to supply its COVID-19 vaccine, if the company’s drug is approved by medical authorities. In total, biotechnology has signed purchase agreements for 276 million doses of its vaccine. (This number does not include collaborative agreements with pharmaceutical companies in India, Japan, or South Korea.) At a price of $ 16 per dose (what the U.S. government paid to reserve 100 million doses) , Novavax is expected to make billions if its drug is approved. By focusing on the peak protein and using the 2P mutation technique, Novavax could benefit from similar levels of efficiency to Moderna and Pfizer. But what’s really important is FDA approval, not a 95% success rate.

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