Pfizer on Monday announced the U.S. COVID-19 Immunization Pilot Program with four states, to help refine the plan for the delivery and deployment of the company’s COVID-19 vaccine candidate that is being co-developed with BioNTech.
To build on our coordination with the relevant U.S. agencies, Pfizer launched this pilot program to help better support the states’ planning, deployment, and administration of the COVID-19 vaccine candidate.
Learnings from this program will be adapted for usage across other states to help them create effective immunization programs for this vaccine. The four states – Rhode Island, Texas, New Mexico, and Tennessee – were selected for the program because of their differences in overall size, diversity of populations, and immunization infrastructure, as well as the states’ need to reach individuals in varied urban and rural settings.
The four states included in this pilot program will not receive vaccine doses earlier than other states by virtue of this pilot, nor will they receive any differential consideration.
Pfizer has been working with U.S. officials in Operation Warp Speed (OWS) and the U.S. Centers for Disease Control and Prevention (CDC) to help ensure that after potential authorization or approval, the Pfizer-BioNTech COVID-19 vaccine can reach those in most need as quickly and equitably as possible.
The company believes this ongoing coordination is critical to help ensure an efficient vaccine distribution as soon as possible after the vaccine receives regulatory authorization or approval, if received.
“This pilot program and our collaboration with U.S. and state officials will help us prepare for broader vaccine deployment in the near future, subject to authorization or approval, as we work to address this urgent public
health need,” said Angela Hwang, Group President, Pfizer Bio Group President, Pfizer Biopharmaceuticals Group. “We are hopeful that results from this vaccine delivery pilot will serve as the model for other U.S.
states and international governments, as they prepare to implement effective COVID-19 vaccine programs.”
In July, Pfizer and BioNTech announced the execution of an agreement with the U.S. Department of Health and Human Services and the Department of Defense to meet the U.S. government’s OWS program goal to begin delivering 300 million doses of a vaccine for COVID-19 in 2021. Under the agreement, the U.S. government will first receive 100 million doses of the Pfizer-BioNTech COVID-19 vaccine after Pfizer successfully manufactures and obtains approval or emergency use authorization from the U.S. Food and Drug Administration (FDA). The U.S. government will pay $1.95 billion for those first 100 million doses, with the option to acquire up to an additional 500 million doses.
Pfizer’s COVID-19 vaccine development and manufacturing costs have been entirely self-funded, with billions of dollars already invested at risk. The company will continue bearing all the costs of development
and manufacturing in an effort to help find a solution to this pandemic as fast as possible.
The BNT162b2 COVID-19 vaccine development program is a collaboration between Pfizer and BioNTech. It is not currently approved for distribution anywhere in the world. Both collaborators are committed to developing these novel vaccines with preclinical and clinical data at the forefront of all their decision making.
About the BNT162 Vaccine Candidate Program
The BNT162 program is based on BioNTech’s proprietary mRNA technology and supported by Pfizer’s global vaccine development and manufacturing capabilities. Two of the companies’ four investigational vaccine candidates – BNT162b1 and BNT162b2 – received Fast Track designation from the U.S. Food and Drug Administration (FDA), based on preliminary data from Phase 1/2 studies that are currently ongoing in the U.S. and Germany as well as animal immunogenicity studies. During preclinical and clinical studies,
BNT162b1 and BNT162b2 emerged as strong candidates based on assessments of safety and immune response.
On November 9, 2020, Pfizer and BioNTech announced 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. The
DMC reviewed 94 cases. 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. As the study continues, the final vaccine efficacy percentage may vary. The DMC has not reported any serious safety concerns and recommends that the study continue to collect additional safety and efficacy data as planned. The data will be discussed with regulatory authorities worldwide. Pfizer and BioNTech plan to submit data from the full Phase 3 trial for scientific peer-review publication.
On July 27, 2020, Pfizer and BioNTech announced that following extensive review of preclinical and clinical data from Phase 1/2 clinical trials, and in consultation with the FDA’s Center for Biologics Evaluation and
Research (CBER) and other global regulators, the companies selected the BNT162b2 vaccine candidate to move forward into a Phase 2/3 study. BNT162b2 encodes an optimized SARS-CoV-2 full-length spike
glycoprotein (S), which is the target of virus neutralizing antibodies.
About the Study
The Phase 3 clinical trial of BNT162b2 began on July 27, 2020 and has enrolled 43,661 participants to date, 41,135 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 SARSCoV-2, as well as vaccine prevention against severe COVID-19 disease. In addition to the primary efficacy endpoints evaluating confirmed COVID-19 cases accruing from 7 days after the second dose, the final analysis now will also include, with the approval of the U.S. Food and Drug Administration (FDA), new secondary endpoints evaluating efficacy based on cases accruing 14 days after the second dose. The companies believe that the addition of these secondary endpoints will help align data across all COVID-19 vaccine studies and allow for cross-trial learnings and comparisons between these novel vaccine platforms. The companies have posted an updated version of the study protocol at https://www.pfizer.com/science/coronavirus.
Pfizer and BioNTech are continuing to accumulate safety data and currently estimate that a median of two months of safety data following the second (and final) dose of the vaccine candidate – the amount of safety
data specified by the FDA in its guidance for potential Emergency Use Authorization – will be available by the third week of November. Additionally, participants will continue to be monitored for long-term protection and safety for an additional two years after their second dose. Along with the efficacy data generated from the clinical trial, Pfizer and BioNTech are working to prepare the necessary safety and manufacturing data to submit to the FDA to demonstrate the safety and quality of the vaccine product produced.
Assuming positive data and availability of the necessary safety and manufacturing data, and based on current projections, Pfizer and BioNTech expect to produce globally up to 50 million vaccine doses in 2020
and up to 1.3 billion doses in 2021. To meet those anticipated quantities and milestones, the companies have produced sufficient supply for their Phase 2/3 clinical trial and have begun to produce and stockpile their pandemic supply.