While these numbers are remarkable, most of these experimental vaccines are nowhere near ready for Americans to receive. There are only two vaccines for the coronavirus that could potentially meet the US Food and Drug Administration’s emergency use authorization guidelines by the end of 2020.
Normally, vaccines have to go through a lengthy review process to gain FDA approval. However, the FDA may allow the use of unapproved vaccines in an emergency, such as an emerging infectious disease. The COVID-19 pandemic is considered a biological threat for which the FDA can grant emergency use authorization.
While the EUA process is not as strict as a full FDA approval, the agency still wants to ensure that the vaccines used to treat Americans meet the thresholds for safety and efficacy. Earlier this month, the FDA released rules the biopharmaceutical industry must follow when EUA researches for coronavirus vaccines.
The FDA has stated that it “does not expect to be able to make a favorable benefit-risk determination that would support an EUA” without phase 3 data including, among other factors, “a high proportion of subjects enrolled (counting well over 3000 recipient vaccines) followed for serious adverse events and adverse events of special interest for at least one month after the end of the full vaccination schedule. In addition, the FDA guidelines have stated that advanced clinical data for coronavirus vaccine candidates “should include a median follow-up time of at least two months after completion of the full vaccination regimen.” ”
An advisory committee of infectious disease experts outside the FDA will first review all EUA filings for coronavirus vaccines. This committee will recommend whether or not the agency should grant the EUA based on the safety and efficacy data contained in the regulatory submissions. The FDA is not obligated to follow the advisory committee’s recommendations, although it seems likely that this is the case due to fears that the EUA process may be politicized.
Only two suitors
A drugmaker is expected to file an EUA application for a coronavirus vaccine candidate by the end of November for a realistic chance of getting FDA clearance by the end of this year. At this stage, only two vaccine candidates could meet this deadline: Pfizerof (NYSE: PFE) and BioNTechof (NASDAQ: BNTX) jointly produced BNT162b2 and Modernof (NASDAQ: ARNM) MRNA-1273.
Pfizer and BioNTech have repeatedly stated that they plan to release preliminary results from a Phase 3 study on BNT162b2 this month. Moderna CEO Stephane Bancel said in September that his company will have enough data to submit for the mRNA-1273 EUA on November 25, 2020.
What about the other eight COVID-19 vaccines in late stage studies? Five are investigational vaccines developed by Chinese and Russian drugmakers that are not being tested in the United States Novavax has launched a Phase 3 study in the UK of its coronavirus vaccine candidate, but has yet to start an advanced stage clinical trial in the US.
This only leaves AstraZenecaof (NYSE: AZN) AZD1222 and Johnson & Johnsonof (NYSE: JNJ) JNJ-78436735. However, the two advanced US studies of these candidate vaccines are on hold while potential safety concerns are examined.
In September, Pascal Soriot, CEO of AstraZeneca, said he believed his company might still have data before the end of the year to submit for regulatory review, but he likely expected the American study is now resuming. The quoted timeline still would not have allowed AstraZeneca to actually secure the EUA from the FDA before the end of the year.
J&J began its Phase 3 study on September 23, 2020 – later than the other late-stage candidates. It is unlikely that the company would have been able to meet FDA guidelines for submitting the EUA even if its advanced stage study had taken place.
Should investors assume that Pfizer, BioNTech and Moderna will automatically be the biggest winners in the coronavirus vaccine market? No. First, companies’ COVID-19 vaccine candidates must first demonstrate that they are safe and effective in their respective late stage studies. They will then have to earn the EUA from the FDA. BNT162b2, mRNA-1273, or both could stumble along the way.
More importantly, there will likely be waves of coronavirus vaccines. The first vaccines on the market will not necessarily be the best. Others could follow and offer better safety or efficacy profiles, or more convenient administration, distribution and storage.
Additionally, keep in mind that smaller biotech stocks could be bigger winners in terms of stock performance than large pharmaceutical stocks. This could happen even if small biotech coronavirus vaccines do not capture as much market share as vaccines from large drugmakers.
For now, however, Pfizer, BioNTech, and Moderna are clearly the leaders in the coronavirus vaccine race. If their vaccine candidates get EUA from the FDA before the end of 2020, all three stocks should post solid gains.