In the race for a COVID-19 vaccine, Novavax (NASDAQ: NVAX) seems to be in fourth place. (And that’s when we exclude the Russian and Chinese candidates for vaccines.)
On July 14, Modern (NASDAQ: MRNA) announced that Phase 3 trial for its vaccine candidate would begin on July 27. Less than a week later, AstraZeneca (NYSE: AZN) announced positive data from its phase 1/2 trial and found that it had already started a phase 2/3 trial its Candidate for vaccine for COVID-19. And on July 27, Pfizer (NYSE: PFE) announced that it had also begun its Phase 3 trial for a coronavirus vaccine.
One month later, on August 24, Novavax began vaccinating volunteers in their Phase 2 trial. The company plans to begin a phase 3 trial in September. At present, the fax specialist seems to be about two months behind its larger competitors. So how can it be possible first to mark?
Image Source: Getty Images.
The first COVID-19 vaccine on the market will be under an EUA
The U.S. Food and Drug Administration (FDA) has put in place a way to speed up drug use in emergencies; this is referred to as an authorization for emergency use, as EUA. The agency often uses this method to get important medicines to people as quickly as possible, and it has already been done 45 times in the fight against the coronavirus, allowing various healthcare companies to sell diagnostic tests, personal protective equipment, ventilators and medicines.
To be approved for a vaccine by the FDA, the company that creates it typically needs positive data from a Phase 3 trial, which is often a massive undertaking with thousands of people. For example, in the COVID-19 vaccine cases, drug companies register 30,000 volunteers or more. Johnson & Johnson, which has yet to begin its Phase 1 trial, recently announced that its final COVID-19 Phase 3 trial will recruit 60,000 volunteers worldwide.
Recruitment for fax studies is not a quick process. Since July, Pfizer has attracted 11,000 volunteers for its study. At that rate, Pfizer will not complete the registration until October. And of course, enrollment is just the beginning of a Phase 3 trial. You will have to wait a few months to see if the vaccine works. You will need to analyze the data and prepare a submission. Then the agency has to analyze the data. Even if everyone involved in things is in a hurry, it is difficult to see how a new medical application can be approved at the end of the year.
An EUA, on the other hand, can get a vaccine on the market in November or December. An EUA can be issued on the basis of strong Phase 2 data, or on interim data from a Phase 3 trial. And so Novavax can sneak into the market first.
What kind of vaccine data does a biotech need for an EUA?
Phase 1 trial data give companies a lot 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, these data were so positive that some analysts already thought the candidate was the best in class. However, the dramatic rise of antibodies produced by the candidate does not answer the real question of effectiveness: Would the vaccine make people sick?
To answer this question, every biotech company needs to do an important test. Novavax is preparing for a massive Phase 3 trial to begin in September with volunteers from around the world, but another major milestone is the relatively smaller 2,665-volunteer Phase 2 study currently taking place in South Africa. That country is experiencing a winter flood in COVID-19. In this trial, Novavax tested efficacy and safety, measured by placebo.
Who will win the race?
Of course, an EUA will only be issued if the FDA is convinced from the existing trial data that the vaccine candidate is safe and effective. Novavax has as good a shot as anyone to win that battle, with its candidate working in traditional ways and the company has experience with other virus outbreaks such as Ebola and SARS. (In fact, Novavax has vaccines for both diseases in the pipeline.)
AstraZeneca licensed its fax technology from Oxford University. Some critics have suggested that it did not really work in animal experiments, given that all vaccinated monkeys became infected when COVID-19 was introduced into their systems. Meanwhile, both Moderna and Pfizer rely on mRNA technology, a new method that holds great promise in vaccine development – but also some risks. The FDA has yet to approve mRNA vaccines, which are unstable and must be kept at a negative 80 degrees Celsius if they degrade. (Novavax vaccine can be stored in a refrigerator.)
The government program designed to accelerate fax development, Operation Warp Speed, wants a fax machine ready by January. None of these companies will likely have full phase 3 data by the end of the year. But all will have partial data on the safety and effectiveness of their candidates in people. With this data, the FDA should be able to decide whether to grant an EUA or not.
While Novavax is about two months behind its competitors, the biotech that the EUA receives will be the one with the best data on safety and effectiveness in a late-stage trial. That Novavax is still very much in the race.
