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Healthcare giants race to the finish in vaccine trials
August 5, 2020
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Last week, 150 global healthcare companies gathered for Morgan Stanley’s Global Healthcare Conference. The COVID vaccine was one of the most popular themes of the week, with giants like Moderna, Novavax, and Johnson & Johnson discussing the progress of their trials.
Below, we have compiled executive commentary and conference quotes to outline when we can anticipate a COVID vaccine and how current trials are progressing.
For an overview of timelines, potential hurdles, and likely efficacy of a COVID-19 vaccine, check out The Great Vaccine Race, our most recent expert briefing with Barclays’ U.S. Biopharma Analyst Carter Gould.
Here are the takeaways:
- Five major players are leading the charge toward a COVID-19 vaccine. Moderna and Pfizer are completing their Phase 3 trials, anticipating launches in late October or November.
- AstraZeneca’s vaccine was paused in the United States during their Phase 3 due to one case with transverse myelitis.
- 150 companies presented at Morgan Stanley’s Global Healthcare Conference, discussing data privacy, new strides in technology, supply chain, and more. Click here to read through the full list of transcripts.
COVID-19 Vaccine: Coming Soon?
Since Summer, the COVID-19 vaccine has been widely anticipated. There are five major players in the COVID-19 vaccine race: Pfizer, Moderna, AstraZeneca, Johnson & Johnson, and Novavax. Each giant is moving through Phase 3 of trials, with some (Moderna and Pfizer) anticipating a faster launch and others (AstraZeneca) falling behind due to adverse reactions.
|Moderna||Phase 3||Q4 2020 or Q1 2021||The final trial is enrolling 30,000 healthy people at about 89 sites around the
|Pfizer||Phase 3||Late 2020||BioNTech, Pfizer, and the Chinese drugmaker Fosun Pharma to develop an mRNA vaccine
to be given in two doses.
|AstraZeneca||Phase 3 (Paused in U.S.)||TBD||On Sept. 6, AstraZeneca halted global
trials of the vaccine to investigate one volunteer, who developed a form of inflammation called
transverse myelitis. The British and Brazilian trials
Sept. 12. But, as of now, trials in other countries remain on hold.
|Johnson & Johnson||Phase 3||Late 2020 or early 2021||Johnson & Johnson began Phase 1/2 trials in July and launched a Phase 3
trial with up to 60,000 participants in September.
|NovaVax||Phase 3||2021||Novavax launched a
Phase 3 trial enrolling
10,000 volunteers in the United Kingdom. It could potentially deliver results by the start of 2021. A larger
Phase 3 trial is in development to launch in the United States in October.
Pfizer (Conference Transcript – 9/29)
“Today, we are done with 30,000, and we continue with the 44,000, but we have already recruited the 30,000 patients. This is an event-based study.”
“… We calculate that we should be able to have a conclusive readout of the efficacy before the end of October. A lot of people are focusing because the end of October is 3 days before the election. For me, this is a completely artificial date, right? I couldn’t care less when we are speaking about COVID-19. Can it be a week earlier? If we have more events, yes. Can it be a week later?”
Novavax (Conference Transcript – 9/30)
We had a very successful Phase III trial. We have a tremendous amount of data on this program — on this product for showing improved efficacy — sorry, improved immunogenicity in multiple trials. We have accelerated approval pathway from the FDA to support a pathway to BLA. This year has been a tough year from the perspective of ability to do anything else other than pay attention to COVID vaccine development.
Johnson & Johnson (Press Release – 9/15)
Johnson & Johnson has begun final-stage testing of its COVID-19 vaccine candidate. The company will trial the vaccine with 60,000 volunteers from around the world including participants from the US, South Africa, Brazil, Argentina, Columbia, and Chile. Johnson & Johnson’s vaccine joins candidates developed by Moderna, Pfizer and BioNTech, and AstraZeneca, and the University of Oxford in beginning the final stage of development.
The company has committed to manufacturing a billion doses of the vaccine on a not for profit basis if proven effective. In contrast to other vaccine candidates that require at least two doses, J & J’s candidate requires just one dose. It also does not require freezing and can remain viable in its liquid form for several months. If the phase 3 trial is successful, both factors could have significant practical advantages for mass vaccination programs.
How Much ($) Has Been Invested in the Vaccine, and How Many Doses will be Developed?
Out of the five major players for the COVID vaccine, Pfizer and Moderna are deemed the furthest along—both companies started Phase 3 studies on the same date.
Although timelines to data could be impacted by the pace of enrollment, dosing schedules, and trial design, Pfizer expects initial data in October and Moderna in November.
|Company||$ Invested||# Anticipated Doses||Notes|
|Moderna||$2.5 billion||– 100 million doses globally in 2020
– 1.3 billion doses globally in 2021
|Pfizer||$1.9 billion||– 100 million doses globally in 2020
– 1.3 billion doses globally in 2021
|AstraZeneca||$1.2 billion||– 400 million||Trials remain on hold after adverse reaction|
|Johnson & Johnson||– $456 million
– $1 billion promised when the vaccine is approved
|– > 1 billion doses in 2021|
|NovaVax||– ~ $2 billion||– 100 million by Q1 2021
– 2 billion per doses per year
How are companies handling manufacturing and distribution?
Since the beginning of Q2, Pfizer and Moderna have made strides in their manufacturing. By the end of 2020, Pfizer will have 100 million available doses; by the end of 2021, they will have created over 1.3 billion COVID-19 vaccine doses. Similarly, Moderna anticipates that they will have 20 million doses by the end of 2020 and 1 billion doses available in 2021.
Even will millions of doses available, distribution will be narrow in 2020 and will broaden out in late Q1 2021. In the meantime, scientists and virologists are working to determine the durability of COVID immunity. One huge unknown right now is whether COVID will look like influenza (annual vaccine), tetanus (multi-year vaccine), or childhood vaccines (long-lived.)
Pfizer (Company Presentation – 9/20)
Pfizer has had a strong track record of vaccine development and commercial distribution that has led to the successful registration and launch of multiple vaccines over the years.
For our potential COVID vaccine, I see a pandemic phase first that could last until the end of 2021 into 2022, where we will need high volumes of doses to be provided to governments for large-scale vaccinations. For this pandemic period, we’re pricing the vaccine for broad access rather than using the typical value-based pricing framework and supplying it mainly through government contracts. We expect to supply up to 100 million doses globally in 2020, 1.3 billion doses in 2021 and we expect to have agreements covering all of these doses. To date, we have already gained commitments for over 450 million doses with options for 600 million more.
Moderna (Conference Transcript – 9/29)
“On the manufacturing front, every time we’ve increased the size of our manufacturing lots, we filed PPQs, documented it, filed into the IND of 1273, so the FDA has it in real time. So we’re doing everything we do, and the FDA is being extremely helpful to make sure that manufacturing will not be in a critical path.
Answer – Stéphane Bancel: Yes. So let’s be very clear that the Moderna vaccine and the Pfizer vaccines are very different from logistics distribution and use at the site of injection where people will get their vaccines. So let me describe ours first, and I can give you a sense for what Pfizer assets so far. So all vaccines do not have to be stored at minus 70. We have stored at a minus 20 Celsius. That is a temperature where already there are some products approved. And so it means that in all the big distributors, the McKesson of this world, the Walgreens and so on, they have minus 20 fridge — freezer capability. It’s not a special fancy freezer. It has the same temperature that you literally have at home for your ice creams and so on.
For the — what I call the last mile, which is the last 7 days, so far, we are still doing a lot of analysis to see how much we can stretch that or not without losing potency because it’s important everybody understands, if you play with temperatures too hard, you impact the potency of a product, and we don’t want to do that because it will impact the efficacy of our product.
So we currently have data that for 7 days or the last mile, the product can be stored at 2 to 5 Celsius, which is a regular fridge temperature, which, of course, there is everywhere because even products like insulin and regular vaccines are stored at that temperature. And then, we have up to 12 hours, and we’re trying to also figure out that world mix, where you can stay at room temperature when you administer it and so on.”
To dig in further to Morgan Stanley’s Global Healthcare Conference, login to AlphaSense for the full list of participants or sign up for a free trial.
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