Drugmaker Pfizer Inc. announced in a press release that early data from its COVID-19 vaccine trial indicates that the vaccine candidate has demonstrated high efficacy. The Phase 3 vaccine candidate’s early results were found in an interim analysis by an independent data monitoring board to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection. Pfizer developed this two-dose vaccine candidate in partnership with German drugmaker BioNTech.
The clinical trials for this vaccine candidate included over 43,000 participants, with 94 confirmed cases of COVID-19. According to the press release, no serious safety concerns have been reported. While the limited data from these initial results is positive, Pfizer has cautioned that results could change by the time the study is complete.
According to National Institute of Allergy and Infectious Diseases (NIAID) Director Dr. Anthony Fauci, this early data suggesting 90% effectiveness is “just extraordinary” and higher than expected.
Although these early results are an advancement toward an approved vaccine, this announcement does not mean that a vaccine is imminent. This vaccine candidate still has required steps to take before receiving approval, as the study has not yet met safety milestone criteria. Pfizer intends to achieve sufficient safety data later in November, and plans to then submit the vaccine for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA). Pfizer’s projection is to produce globally up to 50 million vaccine doses in the remainder of 2020, and up to 1.3 billion doses in 2021.
COVID-19 Vaccine Development and Planned Distribution
This vaccine candidate is among 10 late-stage candidates globally, with four companies currently conducting extensive studies in the United States. The effectiveness of these vaccines remains in question, as scientists have expressed skepticism about the effectiveness of a vaccine once it is approved. Once a vaccine does arrive, there will likely still be a substantial amount of time before being ready for public use. Likely, vaccine distribution would prioritize specific populations, such as health care professionals and other designated essential employees.
COVID-19 Cases Continue to Surge
This early vaccine data arrives as the number of COVID-19 cases in the United States continues to rise. According to the Centers for Disease Control and Prevention (CDC), the United States is averaging over 100,000 new COVID-19 cases per day. According to CDC guidance, the public should continue to take steps to help prevent the spread of COVID-19 with practices such as avoiding large crowds, social distancing, wearing a mask and frequent hand-washing.