BioNTech and Pfizer say their COVID-19 vaccine candidate is 90% effective

The vaccine announcement, in addition to the expected confirmation over the weekend that Joe Biden won the U.S. presidential election, sent U.S. stock-index futures soaring on Monday before the market opened.

“For the first time we can see a light at the end of the tunnel and a return to ‘normalcy’ seems likely within 2021,” Raymond James analyst Steven Seedhouse told investors, in response to the BioNTech/Pfizer announcement. “It all depends on scaling manufacturing for this and subsequent vaccines that we expect to work.”

There are four coronavirus vaccines in late-stage clinical trials in the U.S. BioNTech and Pfizer are the first companies to announce interim results for their vaccine from a Phase 3 clinical trial. (Moderna Inc. MRNA, +8.30%, which is also developing a mRNA vaccine, was the first company to announce interim clinical data from a Phase 1 study, back in May.)

BioNTech and Pfizer’s experimental mRNA vaccine, BNT162b2, has an efficacy rate of 90% when assessed seven days after the second dose was administered in the Phase 3 clinical trial, the companies said in a news release on Monday. This is significantly higher than the 60% threshold cited in the original study protocol for the vaccine.

“This early disclosure looks very promising and we think should beat expectations of most investors and the market, and should provide a welcome boost to sentiment going into an epidemiologically challenging winter season,” SVB Leerink’s Geoffrey Porges wrote in an investor note.

The companies did not share the actual clinical data from BNT162b2’s late-stage trial but said they plan to submit the data for publication in a peer-reviewed medical journal in the coming weeks.

BioNTech and Pfizer also said they updated the protocol for the Phase 3 study; instead of doing the first interim analysis when 32 cases of COVID-19 were reported among trial participants, they conducted the analysis at 62 events. “Upon making that decision (given the spiking cases in the U.S.) 94 events had already occurred, triggering the first interim analysis,” Seedhouse said.

The companies also said they expect to have enough safety data by the third week of November to submit an application to the Food and Drug Administration (FDA) for an emergency use authorization, which is a type of regulatory approval that is quicker and less rigorous than a full FDA approval. However, emergency authorization is considered an important tool to bring to market vaccines and COVID-19 treatments during the pandemic.

The trial has enrolled more than 43,000 people and is expected to continue until there are 164 confirmed cases of COVID-19 among participants. The FDA requires at least five cases of severe COVID-19 infections among trial participants who received the placebo as part of the regulatory process.

BioNTech and Pfizer did not receive funding from the U.S. government to support the development of their vaccine; however, they have a deal with the U.S. to supply at least 100 million doses of their vaccine for $1.95 billion, with current plans to produce 50 million doses in 2020. (This translates to 25 million vaccinations because BNT162b2 requires two doses, spaced several weeks apart.)

President-elect Biden said in a statement that “this news follows a previously announced timeline by industry officials that forecast vaccine approval by late November.” He also reminded Americans that even if a vaccine is authorized for use by the end of the year, “it will be many more months before there is widespread vaccination in this country.”

So far this year shares of BioNTech have soared 171.5%, Pfizer’s stock is down 7.1%. The S&P SPX, +3.35%  has gained 8.6% this year.