Pfizer Inc. and BioNTech SE announced they will submit a request today to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of their mRNA vaccine candidate, BNT162b2 against SARS-CoV-2, which will potentially enable use of the vaccine in high-risk populations in the U.S. by the middle to end of December 2020.
The submission is based on a vaccine efficacy rate of 95% (p<0.0001) announced Nov. 18 demonstrated in the companies’ Phase 3 clinical study in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose. The first primary objective analysis was based on 170 confirmed cases of COVID-19. This submission also is supported by solicited safety data from a randomized subset of approximately 8,000 participants ≥18 years of age and unsolicited safety data from approximately 38,000 trial participants who have been followed for a median of two months following the second dose of the vaccine candidate. The submission also includes solicited safety data on approximately 100 children 12-15 years of age. Approximately 42% of global participants and 30% of U.S. participants in the Phase 3 study have racially and ethnically diverse backgrounds, and 41% of global and 45% of U.S. participants are 56-85 years of age.
To date, the Data Monitoring Committee (DMC) for the study has not reported any serious safety concerns related to the vaccine.
In addition to today’s submission to the FDA, the companies have already initiated rolling submissions with regulatory agencies around the world including in Australia, Canada, Europe, Japan and the U.K., and plan to submit applications immediately to other regulatory agencies around the world
Both companies expressed their gratitude to the study volunteers and investigative site staff in the clinical trial program, “as their involvement was crucial to today’s important milestone in the companies’ efforts to address the COVID-19 global pandemic.”
Manufacturing and Delivery Capabilities
Pfizer and BioNTech’s combined manufacturing network has the potential to supply up to 50 million vaccine doses globally in 2020 and up to 1.3 billion doses by the end of 2021 (subject to clinical success, manufacturing capacity, and regulatory approval or authorization).
While Pfizer and BioNTech await potential authorization or approval from regulatory agencies, the companies continue to work in collaboration with governments and Ministries of Health around the world that will distribute the vaccine, subject to authorization or approval.
Pfizer has developed specially designed, temperature-controlled shippers for the BNT162b2 vaccine candidate, which can maintain recommended storage conditions (-70°C ±10°C) up to 15 days. Each shipper contains a GPS-enabled thermal sensor to track the location and temperature of each vaccine shipment. Once thawed, the vaccine vial can be stored for up to 5 days at refrigerated (2 – 8oC) conditions.
From the start of the research program earlier this year, Pfizer and BioNTech have successfully supplied and distributed their investigational vaccine to more than 150 clinical trial sites across the U.S., as well as Europe, Latin America, and South Africa. Based on their collective experience, the companies believe in their capability to distribute the vaccine globally upon approval or authorization.
About the Study
The Phase 3 clinical trial of BNT162b2, which is based on BioNTech’s proprietary mRNA technology, began on July 27 and has enrolled 43,661 participants to date, 41,135 of whom have received a second dose of the vaccine candidate as of November 13, 2020. A breakdown of the diversity of clinical trial participants can be found here from approximately 150 clinical trials sites in the U.S., Germany, Turkey, South Africa, Brazil and Argentina. Participants will continue to be monitored for long-term protection and safety for an additional two years after their second dose.
Pfizer and BioNTech plan to submit the efficacy and safety data from the study for peer-review in a scientific journal once analysis of the data is completed, according to a company press release.
Making the Data Public
The public’s first chance to see how strong the evidence really is will come in early December at a public meeting of the FDA’s scientific advisers.
So far, what’s known is based only on statements from Pfizer and BioNTech. Of 170 infections detected to date, only eight were among people who’d received the actual vaccine and the rest had received the placebo shot. On the safety side, the companies cite results from 38,000 study participants who’ve been tracked for two months after their second dose.
The 95% protection rate is based on people who developed symptoms and then were tested for the virus. Can the vaccinated get infected but have no symptoms, able to spread the virus? How long does protection last? That’s why the 44,000-person study needs to keep running — something difficult considering ethically, participants given dummy shots at some point must be offered real vaccine, complicating the search for answers.
Read more at the Associated Press
Early Data From Large Trial Indicate COVID-19 Vaccine Strongly Effective
Although early efficacy signs are a bright spot in the battle against the pandemic and a triumph for Pfizer and BioNTech, key information about the vaccine is not yet available. There is no information yet on whether the vaccine prevents severe cases, the type that can cause hospitalization and death.
Nor is there any information yet on whether it prevents people from carrying the virus that causes Covid-19, SARS-CoV-2, without symptoms.
Read more at STAT