Pharmaceutical giant Pfizer Inc. (PFE:NYSE) and immunotherapy and MRNA-based vaccine developer BioNTech SE (BNTX:NASDAQ) today announced that their "mRNA-based vaccine candidate, BNT162b2, against SARS-CoV-2 has demonstrated evidence of efficacy against COVID-19 in participants without prior evidence of SARS-CoV-2 infection, based on the first interim efficacy analysis conducted on November 8, 2020, by an external, independent Data Monitoring Committee (DMC) from the Phase 3 clinical study."
Pfizer's Chairman and CEO Dr. Albert Bourla remarked, "Today is a great day for science and humanity. The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine's ability to prevent COVID-19...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. We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks."
The companies reported that they have been involved in ongoing discussions with the U.S. Food and Drug Administration (FDA) and decided to base the first interim analysis data after the evaluable case count reached 94 and the DMC performed its first analysis on all cases. The data received from the review demonstrated that "the case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate above 90%, at 7 days after the second dose. This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule."
BioNTech's co-founder and CEO Prof. Ugur Sahin commented, "The first interim analysis of our global Phase 3 study provides evidence that a vaccine may effectively prevent COVID-19. This is a victory for innovation, science and a global collaborative effort...When we embarked on this journey 10 months ago this is what we aspired to achieve. Especially today, while we are all in the midst of a second wave and many of us in lockdown, we appreciate even more how important this milestone is on our path towards ending this pandemic and for all of us to regain a sense of normality. We will continue to collect further data as the trial continues to enroll for a final analysis planned when a total of 164 confirmed COVID-19 cases have accrued."
The firms explained that the Phase 3 BNT162b2 clinical study has enrolled 43,538 participants to date beginning in July 2020 and that as of November 8, 2020, 38,955 of the trial participants had already received a second and final dose of the vaccine candidate. The report stated that that "the trial is continuing to enroll and is expected to continue through the final analysis when a total of 164 confirmed COVID-19 cases have accrued." Going forward, the study plans are also designed to evaluate the potential for the vaccine candidate to provide protection against COVID-19 in people having had prior exposure to SARS-CoV-2 and it will also seek to evaluate the potential for a preventative vaccine for addressing severe COVID-19 disease.
The two companies noted that they are continuing to accumulate safety data for a period of two months following the second of two vaccine candidate doses, as was specified in the FDA's recommendations for potential Emergency Use Authorization (EUA), that the firms are optimistic will be available by the third week of November 2020. All study participants will be monitored for two years after their second dose to verify safety and long-term protection. Pfizer and BioNTech explained that they are presently working on preparing the required safety and manufacturing data to submit to the FDA to demonstrate the vaccine product's quality and safety. The firms indicated that they intend to submit the full Phase 3 trial data for scientific peer-review publication.
The companies advised that current projections are that together Pfizer and BioNTech expect to be able to produce up to 50 million vaccine doses globally in 2020 and that in 2021, the number will increase up to as high as 1.3 billion doses.
BioNTech is based in Mainz, Germany, and is focused on providing next generation immunotherapies for cancer and other serious diseases. The firm noted that "its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules." The firm is highly engaged in mRNA vaccine development activities for COVID-19 and infectious diseases and claims to have significant in-house manufacturing capabilities.
Pfizer is a research-based global biopharmaceutical firm based in New York that is engaged in the discovery, development and manufacture of healthcare products. Its global portfolio is comprised of many household name brand prescription medications including Celebrex, Eliquis, Lipitor, Prevnar 13, Pristiq, Viagra and Xeljanz. The company's shares trade on the NYSE and it has a market cap of greater than $200 billion.
Pfizer started the day with a market capitalization of around $202.3 billion with approximately 5.56 million shares outstanding. PFE shares opened 15% higher today at $41.86 (+$5.46, +15.00%) over Friday's $36.40 closing price and reached a new 52-week high price this morning of $41.99. The stock has traded today between $38.38 and $41.99 per share and is currently trading at $39.61 (+$3.21, +8.82%).[NLINSERT]
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