Before the market opened on Monday, Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX) announced interim efficacy results from a late-stage study of COVID-19 vaccine candidate BNT162b2. The drugmakers reported that BNT162b2 was found to be more than 90% effective in preventing COVID-19 in participants who had not been previously infected by the novel coronavirus SARS-CoV-2. Shares of Pfizer were soaring 12.5% as of 9:32 a.m. EST on Monday while BioNTech stock was up 18.2%.
Today's announcement from Pfizer and BioNTech is arguably the most important news since the COVID-19 pandemic began earlier this year. The potential for a COVID-19 vaccine to be available in the near future could mean that the world now can see a light at the end of the tunnel with the pandemic.
What's especially exciting is the 90% or greater efficacy of BNT162b2. The U.S. Food and Drug Administration (FDA) established a minimum threshold of 50% for coronavirus vaccines to win authorization or approval.
Pfizer CEO Albert Bourla stated, "Today is a great day for science and humanity." He added: "We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen. With today's news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis."
Bourla is exactly right about the great timing of the positive interim efficacy results for BNT162b2. Many people were anxiously awaiting these results. The big jumps for Pfizer's and BioNTech's shares today underscore how excited (and relieved) investors are with the great news. It makes sense that BioNTech delivered a bigger gain because the biotech stock is much smaller than Pfizer is. However, this is still a huge win for Pfizer as well.
All eyes will now be on the safety results for BNT162b2. Pfizer and BioNTech expect to have enough safety data to potentially file for emergency use authorization with the FDA by the third week of November. The two drugmakers are also continuing to enroll participants in the late-stage study of BNT162b2. They will evaluate the potential for the experimental vaccine to protect against COVID-19 in individuals with prior exposure to SARS-CoV-2 and in preventing against severe cases of COVID-19.