And in a few days, a meeting of the US Food and Drug Administration (FDA) could offer clues as to what will happen next. The Vaccines and Related Biologics Advisory Committee will meet on October 22 to discuss studies to be performed to further confirm the safety and efficacy of candidate vaccines (before or after approval).
In a backgrounder, the FDA stressed that any Emergency Use Authorization (EUA) must be supported by Phase 3 data. And the agency said that before granting an EUA, the committee would meet for an open session to review this data. With the finish line on the horizon, investors may wonder which players have the best chance of winning the much-desired EUA. Let us take a closer look at the position of some leaders.
Pfizer and BioNTech
Pfizer (NYSE: PFE) and German biotech partner BioNTech (NASDAQ: BNTX) have 37,000 volunteers currently enrolled in the phase 3 study of their investigational vaccine, of whom 28,000 received their second of two doses of vaccination. In an October 16 update, Pfizer CEO Albert Bourla reiterated that companies could find out if their vaccine candidate is working as early as the end of October. Pfizer previously said companies could potentially apply for a regulatory review by the end of October. But in the update, Bourla changed the timeline. He estimated that companies would have the two months of safety data required by the FDA by the third week of November and said Pfizer would request an EUA “shortly thereafter.”
Meanwhile, Pfizer and BioNTech have started continuous submissions in Canada, as well as in Europe through the European Medicines Agency (EMA). Progressive submissions allow a company to submit data as it becomes available so that regulators can start the review process, instead of waiting to file a full submission only when all results are ready. .
The data published so far is promising. In phase 1, volunteers aged 18 to 55 produced levels of neutralizing antibodies 3.8 times higher than those seen in patients with recovered coronavirus. And volunteers aged 65 to 85 produced levels 1.6 times those seen in recovered patients. Neutralizing antibodies are considered a key element because their role is to block infection.
Moderna Therapeutics (NASDAQ: ARNM) was the first company to begin human trials of a coronavirus vaccine candidate. Competitors such as Pfizer and BioNTech have since caught up, but this clinical-stage biotechnology remains one of the pioneers. CEO Stephane Bancel recently said Moderna would not be ready to apply for an EUA until November 25, when it should have generated enough test data. Indeed, just half of the participants in the Company’s Phase 3 trial had completed the second vaccination in the two-dose regimen by the end of September. Moderna designed the Phase 3 trial to include a total of 30,000 volunteers.
Moderna has also launched a continuous submission in Canada. And the EMA this month confirmed Moderna’s eligibility to request a review through its centralized procedure, meaning that only one submission and one review is required for approval in all countries in the world. ‘European Union.
The results of the trials were favorable. In phase 1, participants aged 18 to 55 who received the dose to be administered in later stage trials produced levels of neutralizing antibodies more than four times higher than those of recovered coronavirus patients. And in phase 3, for adults aged 56 to 70 and 71 and older, this type of antibody was two to three times higher than in recovered patients.
Moderna and the Pfizer-BioNTech team remain on a level playing field in terms of timing and data quality. At present, they are the closest players in the search for an EUA.
Novavax (NASDAQ: NVAX) In July, Operation Warp Speed (OWS) took center stage, the U.S. government’s effort to bring a potential coronavirus vaccine to market, awarded the company $ 1.6 billion . At the time, it was the biggest award given by OWS to a vaccine manufacturer.
Novavax has yet to report the results of its coronavirus candidate vaccine trials in the elderly. But in phase 1, volunteers aged 18 to 59 produced levels of neutralizing antibodies four to six times higher than those found in recovered coronavirus patients.
Unless its rivals face a setback, this clinical-stage biotech company is unlikely to become the first to receive an EUA or regulatory approval for its vaccine candidate. While Pfizer and Moderna are well into their Phase 3 studies, Novavax just launched its Phase 3 study in the UK at the end of last month. The study will administer either a placebo or vaccination to 10,000 volunteers aged 18 to 84 with two doses over 21 days.
But Novavax has something else to offer that could keep it in the picture of the coronavirus vaccine over time. The company plans to start exploring a combined flu and coronavirus vaccine. Novavax has the expertise; The company’s investigational influenza vaccine, NanoFlu, has met all primary endpoints in a Phase 3 trial. The next step is regulatory submission. Novavax said a potential combination vaccine would be useful after the pandemic. No one likes the idea of having multiple vaccines, so if Novavax is successful with a flu / coronavirus vaccine and is able to keep the price close to that of other flu vaccines, that could be a game-changer.
AstraZeneca (NYSE: AZN) hit a temporary roadblock last month due to unexplained illness in a participant in a UK Phase 3 trial. As a result, AstraZeneca has suspended all trials of the investigational coronavirus vaccine. They have since resumed at various sites around the world, although the US study remains on hold as the FDA further investigates.
Initially, AstraZeneca and its partner at the University of Oxford said Phase 3 efficacy results could be available this fall at the earliest. It could still happen. But given the end of the trials, it will be difficult for AstraZeneca to be the first to submit data to the FDA.
Johnson & Johnson
Johnson & Johnson this month, temporarily suspended all assays in trials of its coronavirus vaccine candidate, including the Phase 3 trial. The Phase 3 study, which is expected to involve 60,000 participants, is the largest in this day. The company halted the trial due to unexplained illness in one participant.
While trial breaks are common in large studies, this one puts Johnson & Johnson chronologically behind. That said, if the company can pick up again soon, it could still be among the winners. And it will have the benefit of data from a large group.
Inovio Pharmaceuticals (NASDAQ: INO) was among the first to launch human trials of its vaccine candidate. But a recent event can turn out to be a big setback. The FDA has placed a partial clinical suspension on the company’s planned Phase 2/3 trial, refusing to allow it until Inovio answers further questions about, among other things, the device used to administer the vaccine. Inovio said he would respond this month. The FDA then has 30 days to notify the company of the possibility of starting the trial.
Even if the response from the FDA is positive, Inovio will have wasted precious time. Investors are also awaiting more details on the Phase 1 data – including publication in a medical journal. Inovio reported earlier that its vaccine candidate exhibited an immune response as measured by neutralizing antibodies. But unlike most of its rivals, the company has not provided neutralizing antibody levels for recovered coronavirus patients.
|Company||Clinical trial phase||Setbacks?||Expected results of the initial phase 3|
|Pfizer and BioNTech||3||No||Third week of November|
|Moderna Therapeutics||3||No||November 25 at the earliest|
|AstraZeneca||3||Trial break in September||Maybe in the fall|
|Johnson & Johnson||3||Trial break in October||Unknown|
|Inovio Pharmaceuticals||1/2||Phase 2/3 trial with partial clinical hold||Unknown|
What does this mean for investors?
Right now, Pfizer-BioNTech, Moderna and Novavax seem to be on the smoothest path. That said, it’s important to note that a setback – or failure – can happen at any time during clinical trials. It is therefore too early for a player to win.
And the race may not end with just one victory. If the trials are successful for more than one company, we might see a few vaccine manufacturers on the podium. Considering the global demand, there is room for several products.
Finally, another important point: Investors should keep in mind that companies at the clinical stage, such as Moderna, Novavax and Inovio, present a higher risk than companies that already have other products in the market. These marketed products provide a source of income even if the company’s coronavirus program fails. For this reason, only aggressive investors should consider adding clinical stage biotech players to their portfolios at this stage. More cautious investors may want to buy shares in a player like Pfizer or AstraZeneca – both have large product portfolios – or watch the final laps of this race on the sidelines.