Shares of BioNTech (NASDAQ:BNTX) were up by 6.7% as of 2:51 p.m. EDT Tuesday after the company announced that it started a rolling submission to the European Medicines Agency (EMA) for its coronavirus vaccine candidate, BNT162b2, which it is developing in partnership with Pfizer (NYSE:PFE). Shares of Pfizer were trading slightly lower, but close to flat, which isn't particularly surprising given the companies' relative sizes and how much the potential revenue from the vaccine could affect their respective bottom lines.
The rolling submission will allow BioNTech and Pfizer to submit parts of the application as they are complete, which should reduce the time between the final submission of data from their ongoing phase 3 clinical trial and the potential approval of BNT162b2. The early data submissions will likely include manufacturing and quality control data, preclinical safety data from animals, and data from the earlier clinical trials. The EMA is even willing to look at interim data from ongoing studies, which should help it make its decision on approval more quickly once the final data is available.
In normal times, a rolling submission might allow a company to get a candidate approved a few months early. But given the pressing need for a COVID-19 vaccine amid this pandemic, it isn't clear exactly how much time the accelerated procedure might save. The benefit may also be limited if regulators are juggling multiple applications because several vaccine-makers complete their phase 3 clinical trials at around the same time. Last week, AstraZeneca started a rolling submission for its coronavirus vaccine candidate, AZD1222.
It's hard to see how a rolling submission is really worth a 7.5% bump in BioNTech's valuation. Most likely, the rally -- which has been going on for a couple of days -- is more a result of biotech investors jumping in ahead of the phase 3 data, which Pfizer and BioNTech have said could come as early as the end of this month.