President Trump believes a COVID-19 vaccine could be ready before the end of the year. In fact, he’s optimistic that a vaccine could be available by the time of the November 3, 2020 US election. Is this just wishful thinking? Maybe not.
The US Food and Drug Administration (FDA) recently scheduled an Advisory Committee meeting for October 22, 2020 to “discuss the general issue of the development, approval and / or approval of vaccines to prevent COVID-19.” The agency also said it “stands ready to quickly schedule additional meetings of this committee after any requests have been made”. In addition, FDA Commissioner Stephen Hahn stated in an interview with the Financial Times that he is ready to expedite the Emergency Authorization (EUA) for a COVID-1
Add all of this together and we have a real possibility that one or more coronavirus vaccines could be available in the US by the end of 2020. But which?
Pfizer (NYSE: PFE)together with his German partner BioNTech (NASDAQ: BNTX)Seems to be the most likely company to launch a coronavirus vaccine within the next four months. The two companies began Phase 2/3 clinical trials of their lead candidate BNT162b2 on July 27.
This central study will not be completed by the end of 2020. However, Pfizer and BioNTech have publicly stated that they are on the right track to file a regulatory review “as early as October 2020”. Pfizer CEO Albert Bourla said The Washington Post“We’ll apply for regulatory approvals in October.”
Don’t expect full FDA approval for BNT162b2 this year. However, based on comments from FDA Commissioner Hahn, it wouldn’t be surprising if the Pfizer and BioNTech vaccine were given emergency approval – provided the Phase 2/3 trial goes well. The two companies are expected to deliver up to 100 million cans by the end of 2020.
AstraZeneca (NYSE: AZN) stands out as another major drug company with a pretty good chance of getting its COVID-19 vaccine in the US before the end of the year. The British pharmaceutical company and its partner, the University of Oxford, recently initiated a US phase 3 study with the vaccine candidate AZD1222 for all age groups of adults.
Last week the Financial Times reported that the Trump administration was exploring the possibility of rapid emergency approval for AstraZeneca’s COVID-19 vaccine candidate. The company has denied any talks with the US government regarding approval for AZD1222, calling it “premature” speculation.
However, this scenario doesn’t seem unrealistic. AstraZeneca signed a contract earlier this year to supply at least 300 million doses of its COVID-19 vaccine to the US from October 2020. The company has also committed to delivering 100 million cans to the UK from September.
Modern (NASDAQ: MRNA) is the only other company with a late-stage COVID-19 vaccine candidate that is not based in China or Russia. On July 27, biotechnology started a phase 3 study with mRNA-1273.
How soon could mRNA-1273 be ready to receive FDA approval for an emergency? Moderna CEO Stephane Bancel stated in an interview with CNBC in July that the late-stage results could be in October under a “really bullish scenario” or possibly in November. If he’s right, the company could get an FDA-EUA before the end of the year.
Moderna has teamed up with Catalytic to produce the first 100 million doses of mRNA-1273 for the US market. The company expects shipping of these cans to begin in the third quarter of 2020.
The biggest winner?
If any of these COVID-19 vaccine candidates prove safe, effective and rolled out in the United States, the Americans ready to end the pandemic will be the biggest winner of all.
Which company will be the biggest winner, however, depends on how you define winning.
Pfizer and BioNTech get the most money initially. The US government will pay the two drug companies $ 1.95 billion for 100 million doses if BNT162b2 receives FDA or emergency clearance. That sum is more than the $ 1.525 billion Moderna will receive from the US for the delivery of 100 million cans. AstraZeneca has already received up to $ 1.2 billion in pledge from the U.S. government that included the delivery of at least 300 million doses of AZD1222, despite the company promising not to benefit from its vaccine during the pandemic.
However, the biggest winner in terms of stock performance will most likely be Moderna. The company is much smaller than Pfizer and AstraZeneca. While Moderna is bigger than BioNTech, it doesn’t have a partner who takes a large chunk of the money out of its vaccine. Sure, biotech stock has risen sharply this year. However, if mRNA-1273 launches in the US in the next few months, Moderna stocks will almost certainly rise much higher.