And in a few days, a US Food and Drug Administration (FDA) meeting may provide clues as to what will happen next. The Advisory Committee on Vaccines and Related Biological Products will meet on October 22nd to discuss studies that should be conducted to further confirm the safety and efficacy of the vaccine candidates (whether pre-approved or post-approved).
In an information document, the FDA emphasized that any Emergency Authorization (EUA) must be supported by phase 3 data. And the agency said the committee would hold an open meeting to review these dates before issuing an EEA. With the finish line on the horizon, investors may wonder which players have the best chance of winning the coveted EUA. Let’s take a closer look at where some of the leaders are.
Image source: Getty Images.
Pfizer and BioNTech
Pfizer (NYSE: PFE) and German biotech partner BioNTech (NASDAQ: BNTX) There are currently 37,000 volunteers in the Phase 3 study of their investigational vaccine, of which 28,000 have received their second of two doses of vaccine. In an October 16 update, Pfizer CEO Albert Bourla reiterated that companies may know by the end of October whether their vaccine candidate will be effective. Pfizer had previously said the companies could potentially file for a regulatory review by the end of October. But in the update, Bourla changed the timeline. He estimated that by the third week of November, companies would have FDA-required safety data for two months, and said Pfizer would apply for an EEA “soon after”.
In the meantime, Pfizer and BioNTech have started filing applications in both Canada and Europe through the European Medicines Agency (EMA). Continuous filings allow a company to submit data as it becomes available, allowing regulators to start the review process instead of waiting for the full submission when all results are in.
The data published so far has been encouraging. In Phase 1, volunteers ages 18-55 produced neutralizing antibody levels that were 3.8 times higher than those seen in patients with recovered coronavirus. Volunteers aged 65 to 85 produced 1.6 times as many values as recovered patients. Neutralizing antibodies are seen as a key element as they are designed to block infection.
Moderna Therapeutics (NASDAQ: MRNA) was the first to begin human trials with a coronavirus vaccine candidate. Competitors like Pfizer and BioNTech have since caught up, but this clinical-stage biotechnology still remains a front runner. CEO Stephane Bancel recently said Moderna was not ready to apply for an EUA before November 25th. By then, it should have generated enough test data. This is because only half of the participants in the company’s Phase 3 study had completed the second vaccination on the two-dose regimen by the end of September. Moderna designed the phase 3 study with a total of 30,000 volunteers.
Moderna has also started a rolling filing in Canada. And the EMA this month confirmed Moderna’s eligibility to request a review as part of its centralized process, meaning that only one filing and review is required for approval in all countries of the European Union.
The test results were favorable. In Phase 1, participants aged 18 to 55 who received the dose given in later studies produced more than four times higher levels of neutralizing antibodies than patients with recovered coronavirus. In phase 3, this type of antibody was two to three times higher in adults aged 56 to 70 and 71 years and older than in recovered patients.
Moderna and the Pfizer BioNTech team are on an equal footing in terms of schedule and data quality. Right now, they are the closest players to finding an EUA.
Novavax (NASDAQ: NVAX) Operation Warp Speed (OWS) was at the center of attention back in July when the U.S. government tried to bring a potential coronavirus vaccine to market and granted the company $ 1.6 billion. At the time, it was OWS ‘biggest award for a vaccine manufacturer.
Novavax has not yet reported any results from its studies of coronavirus vaccine candidates in older adults. In Phase 1, volunteers ages 18 to 59 produced neutralizing antibodies that were four to six times higher than in patients with recovered coronavirus.
Unless its competitors suffer a setback, this clinical-stage biotech is unlikely to be the first to receive EUA or regulatory approval for its vaccine candidate. While Pfizer and Moderna are well into the phase 3 study, Novavax started its phase 3 study in the UK late last month. The study will give 10,000 volunteers aged 18 to 84 years either a placebo or the two-dose vaccine over 21 days.
But Novavax has something else to offer that, over time, could keep it in the picture of the coronavirus vaccine. The company plans to study a combination of flu / coronavirus vaccine. Novavax has the expertise; The company’s flu vaccine NanoFlu met all primary endpoints in a Phase 3 study. The next step is to submit regulations. Novavax said a possible combination vaccine would be of use after the pandemic. Nobody likes the idea of getting multiple vaccines. So if Novavax is successful with a flu / coronavirus vaccine and can keep prices close to other flu vaccines, that could play a crucial role.
AstraZeneca (NYSE: AZN) AstraZeneca achieved a temporary roadblock last month due to an unexplained disease in a Phase 3 study in the UK. As a result, AstraZeneca has suspended all studies with the investigational coronavirus vaccine. Since then, they have been resumed in various locations around the world, although the U.S. study continues to pause as the FDA conducts further investigation.
Initially, AstraZeneca and partner Oxford University said Phase 3 efficacy results could not be available until this fall at the earliest. That could still happen. However, given the trial halt, it will be difficult for AstraZeneca to be the first to provide data to the FDA.
Johnson & Johnson
Johnson & Johnson This month, dosing was temporarily suspended in studies of its coronavirus vaccine candidate, including the Phase 3 study. The phase 3 study with 60,000 participants is the largest to date. The company stopped the process after an inexplicable illness of a participant.
While test breaks are frequent in large studies, Johnson & Johnson sets them back from a time perspective. That is, if the company can resume soon, it could still be among the winners. And it will take advantage of data from a large group.
Inovio Pharmaceuticals (NASDAQ: INO) was one of the first to start human trials with his vaccine candidate. However, a recent event could prove to be a major setback. The FDA has partially clinically suspended the company’s planned Phase 2/3 trial and withheld approval until Inovio answers additional questions, including about the device used to deliver the vaccine. Inovio said it will answer this month. The FDA will then have 30 days to let the company know if the study can begin.
Even if the FDA responds positively, Inovio has lost valuable time. Investors are also waiting for more details on Phase 1 data – including publication in a medical journal. Inovio previously reported that its vaccine candidate demonstrated an immune response as measured by neutralizing antibodies. However, unlike most of its competitors, the company did not deliver neutralizing antibody levels in relation to recovered coronavirus patients.
|Companies||Clinical trial phase||Any setbacks?||First phase 3 results expected|
|Pfizer and BioNTech||3||None||Third week of November|
|Moderna Therapeutics||3||None||November 25th at the earliest|
|AstraZeneca||3||Trial break in September||Possibly in autumn|
|Johnson & Johnson||3||Trial break in October||Unknown|
|Inovio Pharmaceuticals||1/2||Phase 2/3 study with partial clinical interruption||Unknown|
What does this mean for investors?
Pfizer-BioNTech, Moderna and Novavax seem to be on the smoothest path at the moment. However, it’s important to note that setback – or failure – can occur at any time during clinical trials. So it’s too early for a player to claim victory.
And the race can’t just lead to one victory. If studies are successful for more than one company, some vaccine manufacturers may be on the podium. With global demand there is room for multiple products.
Another important point: Investors should keep in mind that clinical-stage companies like Moderna, Novavax and Inovio pose 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 portfolio at this point. More cautious investors may want to buy shares in a player like Pfizer or AstraZeneca – both have extensive product portfolios – or watch the final laps of this race from the sidelines.
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