The 14th of July Modern (NASDAQ: ARNM) announced that the phase 3 trial of its vaccine candidate will begin on July 27. Less than a week later, AstraZeneca (NYSE: AZN) announced positive data from its Phase 1/2 trial and noted that it has already started a Phase 2/3 trial for his COVID-19 vaccine candidate. And on July 27, Pfizer (NYSE: PFE) announced that it has also started its Phase 3 trial for a coronavirus vaccine.
A month later, on August 24, Novavax began vaccinating volunteers in its Phase 2 trial. The company plans to launch a Phase 3 trial in September. At present, the vaccine specialist appears to be around two months behind its main competitors. So how can he be the first to market?
The first COVID-19 vaccine on the market will be under an EUA
The United States Food and Drug Administration (FDA) has established a pathway to clear drugs for use more quickly in an emergency; this is called an Emergency Use Authorization, or EUA. The agency often uses this method to get important drugs to people as quickly as possible, and it’s already done 45 times in the fight against the coronavirus, allowing various healthcare companies to sell diagnostic tests, personal protective equipment, ventilators and medication.
In order for a vaccine to be approved by the FDA, the company that creates it usually needs positive data from a Phase 3 trial, which is often a massive undertaking involving thousands of people. For example, in COVID-19 vaccine trials, pharmaceutical companies recruit 30,000 or more volunteers. Johnson & Johnson, which has yet to begin its phase 1 trial, recently announced that its potential phase 3 trial of COVID-19 will recruit 60,000 volunteers worldwide.
Recruitment for vaccine studies is not a quick process. Since July, Pfizer has recruited 11,000 volunteers for its study. At this rate, Pfizer will not complete registration until October. And of course, enrollment is just the start of a Phase 3 trial. You have to wait a few months to see if the vaccine works. You need to analyze the data and prepare a submission. Then the agency must analyze the data. Even if everyone involved rushes things, it’s hard to see how a new drug application could be approved by the end of the year.
An EUA, on the other hand, could get a vaccine on the market by November or December. A EUA can be issued on the basis of solid phase 2 data, or on interim data from a phase 3 trial. And this is how Novavax could first squeeze into the market.
What kind of vaccine data does biotechnology need for AUS?
Data from Phase 1 trials provide companies with a wealth of information about their vaccine candidates. Specifically, Novavax now knows that its vaccine candidate (NVX-CoV2373) is safe and that it increases antibodies in humans. In fact, the data was so positive that some analysts have already rated the candidate as best in class. However, the dramatic increase in antibodies created by the candidate does not answer the real question of effectiveness: would the vaccine prevent people from getting sick?
To answer this question, every biotech company needs to do a pivotal trial. Novavax is gearing up for a massive Phase 3 trial that will begin in September with volunteers from all over the world, but another big step is the relatively smaller Phase 2 study of 2,665 volunteers currently underway in South Africa. This country is experiencing a winter increase in COVID-19. In this trial, Novavax is testing efficacy and safety, measured against placebo.
Who will win the race?
Of course, an EUA will only be issued if the FDA is satisfied from existing test data that the vaccine candidate is safe and effective. Novavax has as good a chance as anyone of winning this battle, given that its candidate works in the traditional way and the company has experience of other viral epidemics like Ebola and SARS. (Indeed, Novavax has vaccines for both diseases in its pipeline.)
AstraZeneca has licensed its vaccine technology to the University of Oxford. Some critics have suggested that this doesn’t really work in animal trials, given that all of the vaccinated monkeys were infected when COVID-19 was introduced into their systems. Meanwhile, Moderna and Pfizer are relying on mRNA technology, a new method that has a lot of promise in vaccine development – but also some risks. The FDA has yet to approve mRNA vaccines, which are unstable and must be stored at a negative temperature of 80 degrees Celsius or they degrade. (Novavax vaccine can be stored in the refrigerator.)
The government program designed to accelerate vaccine development, Operation Warp Speed, wants a vaccine ready by January. None of these companies are likely to have a full set of Phase 3 data by the end of the year. But all will have partial data on the safety and effectiveness of their candidates in humans. With this data, the FDA should be able to decide whether or not to grant an EUA.
While Novavax is about two months behind its competitors, the biotechnology that receives the EUA will be the one with the best data for safety and efficacy in an advanced stage trial. Novavax is therefore still very much in the race.