The Warp Speed operation (OWS), the Trump administration’s bold commitment to deliver at least 300 million doses of a safe and effective coronavirus vaccine by January, has taken another expensive step forward. On Fridays, Sanofi (NASDAQ: SNY) is GlaxoSmithKline (NYSE: GSK) signed a vaccine supply agreement with the United States government of up to $ 2.1 billion to help collaborative partners increase the production of a vaccine candidate – before there are clinical trial results showing which safely prevents SARS-CoV-2, the virus that causes the spread of COVID-1
Fundless spending accounts have enabled major vaccine candidates to advance at full speed. Here is a quick rundown to help you keep an eye on the top five programs and the funds that are pushing them forward.
|Company (symbol)||OWS financing||Phase 3 start date|
|Sanofi and GlaxoSmithKline||$ 2.1 billion||Late 2020|
|BioNTech SE (NASDAQ: BNTX) is Pfizer (NYSE: PFE)||$ 2 billion||July 27, 2020|
|Novavax (NASDAQ: NVAX)||$ 1.6 billion||Autumn 2020|
|AstraZeneca (NYSE: AZN)||$ 1.2 billion||June 20, 2020|
|Modern (NASDAQ: mRNA)||$ 955 million||July 27, 2020|
Who needs a name?
Sanofi and GlaxoSmithKline are committed to developing a candidate for the coronavirus vaccine at top speed, but have not yet bothered to name their protein-based vaccine candidate. Sanofi will partner with a protein that mimics part of SARS-CoV-2 and GlaxoSmithKline will contribute an adjuvant designed to trigger a stronger immune response to the Sanofi protein.
The government has promised partners up to $ 2.1 billion, about half of which will pay for clinical trials that are not expected to start until the fall. If a phase 1/2 study scheduled to begin in September produces encouraging results, a phase 3 study could start by the end of 2020.
Sanofi and GlaxoSmithKline will use the remainder of the committed funding to support the production of their candidate vaccine. Partners will produce 100 million doses long before it has a chance to prove effective. The government also has an option to supply an additional 500 million doses along the way.
BNT162 from BioNTech and Pfizer
In partnership with Pfizer, BioNTech is one of two biotechnologies in the clinical phase with vaccine programs supported by OWS that rely on messenger RNA (mRNA) strands that induce human cells to produce proteins that mimic SARS-CoV-2. Unlike Moderna’s other mRNA program, mRNA1273, BNT162 entered phase 1 of the test as multiple related candidates.
When the government issued an initial order for 100 million doses with an option to purchase an additional 500 million doses, the partners had not yet selected the specific candidate who would pass phase 3 tests. BioNTech’s shares rose higher when the company reported encouraging signs of efficacy from BNT162b1 in early July, but partners started a phase 2b / 3 study with BNT162b2 because patients who received it were less likely to report fever, fatigue and chills.
NVX-CoV2373 from Novavax
This Maryland-based biotechnology company has developed vaccines since the 1980s, but has not yet sent new drug applications to the Food and Drug Administration (FDA). Despite this troubling track record, the government has purchased 100 million doses of the company’s SARS-CoV-2 vaccine candidate NVX-CoV2373 for delivery in late 2020.
In July, OWS awarded Novavax a $ 1.6 billion prize that the company will use to complete the advanced stage development of NVX-CoV2373. This is an adjuvant-enhanced protein similar to the candidate Sanofi and GlaxoSmithKline they are testing.
During the first week of August, Novavax will share the results of a phase 1/2 clinical study of 130 patients started in May. The company plans to start a phase 3 study that will enroll up to 30,000 people in the fall.
AZD1222 by AstraZeneca
This is one of three OWS-supported vaccine candidates who use the sculpted shell of another virus to provide genetic material that cells use to produce proteins found on SARS-CoV-2. AstraZeneca partners at the University of Oxford have started a phase 3 trial with AZD1222 in Brazil until 20 June 2020.
The ongoing phase 3 study of 5,000 patients in Brazil has been fully sponsored by interested Brazilian entrepreneurs, but the United States government will fund a phase 3 study with 30,000 patients, which is expected to start soon. In addition to a giant pivotal study, AstraZeneca will also use $ 1.2 billion of taxpayer dollars to produce 400 million doses for the United States, making it the least expensive vaccine that OWS has claimed so far.
mRNA-1273 from Moderna
In April, Moderna received a $ 483 million commitment to support the development of its mRNA vaccine candidate, mRNA-1273. In July, the company received a $ 483 million top-up to perform a much larger test phase 3 than originally planned.
Before the results of the 30,000-participant Cove study are complete, the company will use the OWS award to increase production. Moderna believes it will be able to deliver up to 1 billion doses of mRNA-1273 every year in 2021.
It may seem like an eternity, but the COVID-19 pandemic will end in the near future, along with any cash flow that these vaccines could produce. Investing in one of these companies simply because there may be a great (but short) fortune in their near future is probably not a great idea.
While the amount of demand for an SARS-CoV-2 vaccine is unprecedented, so is the level of competition. In addition to these five well-funded programs, at least a dozen others will produce their first clinical trial results by the end of the summer.