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Since July, Pfizer and its German biotech partner, BioNTech have been working on getting a highly effective mRNA pandemic vaccine to the market as quickly as possible. That work and science has paid off.
Pfizer announced on November 9 that their coronavirus vaccine was more than 90% effective in preventing COVID-19 among those without evidence of prior infection. Scientists are hoping for a coronavirus vaccine that is at least 75% effective, while Dr. Anthony Fauci has said one that is at least 50% or 60% effective would be acceptable.
At a time when there is much to disagree about, scientists concur that the preliminary results on the vaccine – which uses a previously unproven mRNA technology – vastly exceeded expectations.
What’s more, the independent Data Monitoring Committee that reviewed the results did not report any serious safety concerns.
The positive results brought Pfizer and BioNTech one step closer to getting cleared for widespread use. The next step was to meet two more milestones before Pfizer could apply for an Emergency Use Authorization (EUA):
- Pfizer had to produce manufacturing data to demonstrate the vaccine can be produced with consistency and quality.
- The company had to provide a median of two months of safety data following the second dose.
On December 12, the Pfizer and BioNTech vaccine became the first in the U.S. authorized for emergency use by the US Food and Drug Administration. On December 14, the first shots were given to the American public.
Still, it will take months for the companies to make enough doses for the general population.
An Injection of Hope
The progress has come when the world needs it most – amid record breaking infection rates as we head into the winter flu season, hospitals nearing capacity, and economies struggling to reopen. It is a promising development to help bring an end to the pandemic that has killed more than 1.2 million people.
“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,” said Dr. Albert Bourla, Pfizer Chairman and CEO after the company's November 9 announcement of the efficacy results.
The Phase 3 clinical trial of BNT162b2 began on July 27 and has enrolled 43,538 participants to date, 38,955 of whom have received a second dose of the vaccine candidate as of November 8, 2020.
Approximately 42% of global participants and 30% of U.S. participants have racially and ethnically diverse backgrounds. 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. The study also will evaluate the potential for the vaccine candidate to provide protection against COVID-19 in those who have had prior exposure to SARS-CoV-2, as well as vaccine prevention against severe COVID-19 disease.
Based on current projections, Pfizer and BioNTech expect to produce up to 50 million vaccine doses in 2020, and up to 1.3 billion doses in 2021. The vaccine requires two doses per person. In July, the companies reached a nearly $2 billion agreement with the U.S. government to supply 100 million doses.
“I think we can see light at the end of the tunnel,” Pfizer Chairman and CEO Dr. Albert Bourla told CNBC’s Meg Tirell on “Squawk Box.” “I believe this is likely the most significant medical advance in the last 100 years, if you count the impact this will have in public health, global economy.”
For more insight and analysis into the global effort to identify effective treatments and vaccines for COVID-19, visit the U.S. Chamber Global Innovation Policy Center’s Discover & Deliver page.
The Global Innovation Policy Center is also tracking the progress of COVID-19 vaccine clinical trials across the United States. Explore the interactive map to see what kind of COVID-19 research is going on in your community.