Pfizer, BioNTech Submit Emergency Vaccine Authorization Request to FDA

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Allowing the world to breathe a sigh of relief after the numbing drumbeat of bad news in 2020, pharmacological companies Pfizer and BioNTech announced on Friday that they have submitted a request for emergency authorization to begin distributing a vaccine for Covid-19.

In addition to today’s submission to the Food and Drug Administration, the companies have already initiated rolling submissions across the globe including Australia, Canada, Europe, Japan and the UK, and they plan to submit applications immediately to other regulatory agencies around the world.

Based on current projections, the companies said in their Friday press release that they expect to produce globally up to 50 million doses in 2020 and up to 1.3 billion doses by the end of 2021.

Pfizer/BioNTech’s new coronavirus vaccine is now awaiting FDA approval. Credit: Pfizer/Twitter

Will be Released “Within Hours” After Approval

Pfizer CEO Dr. Albert Bourla stated yesterday that the companies will be ready to distribute the vaccine “within hours” after  they receive the necessary authorization from the FDA.

The vaccine, officially named “BNT162b2,” has demonstrated an efficacy rate of 95%, with no serious safety concerns observed to date, according to the companies.

After previously stating that the vaccine was 90% effective, the latest results, revealed on Wednesday, showed that it was even more effective in older populations, with a 94.5% effectiveness rate in those over 65. The approval will potentially enable the use of the vaccine in high-risk populations in the US by the middle to end of December, 2020.

The submission to the FDA is based on a vaccine efficacy rate of 95%, demonstrated in the companies’ Phase 3 clinical study in participants without prior coronavirus infection and also in participants with prior infection.

The first primary objective analysis was based on 170 confirmed cases of COVID-19. The 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.

The study also included data on approximately 100 children from 12-15 years of age. Approximately 42% of global participants and 30% of U.S. participants in the Phase 3 study come from racially and ethnically diverse backgrounds, and 41% of global and 45% of US participants are 56-85 years of age.

To date, the Data Monitoring Committee for the study has not reported any serious safety concerns whatsoever related to the vaccine.

“Our work to deliver a safe and effective vaccine has never been more urgent, as we continue to see an alarming rise in the number of cases of COVID-19 globally.

“Critical Milestone” — Bourla

Filing for the emergency authorization to the FDA “represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world — and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential,” said Pfizer CEO Bourla.

“We look forward to the upcoming Vaccines and Related Biological Products Advisory Committee discussion and continue to work closely with the FDA and regulatory authorities worldwide to secure authorization of our vaccine candidate as quickly as possible,” he added.

“Filing for Emergency Use Authorization in the U.S. is a critical step in making our vaccine candidate available to the global population as quickly as possible,” said Dr. Ugur Sahin, CEO and Co-founder of the German company BioNTech, which partnered with Pfizer in the vaccine’s development.

“We intend to continue to work with regulatory agencies worldwide to enable the rapid distribution of our vaccine globally. As a company located in Germany in the heart of Europe, our interactions with the European Medicines Agency (EMA) are of particular importance to us and we have continuously provided data to them as part of our rolling review process.”

The companies have already initiated rolling submissions with several regulatory agencies around the world, including the EMA and the Medicines & Healthcare Products Regulatory Agency (MHRA) in the United Kingdom, and intend to submit applications to other regulatory agencies worldwide in the coming days.

In some cases, governments may have regulatory pathways similar to the FDA’s Emergency Use Authorization. The companies will be ready to distribute the vaccine candidate within hours after they receive authorization.

In their Friday statement, Pfizer and BioNTech said that they were “extremely grateful 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

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 which will distribute the vaccine, subject to authorization or approval, to help ensure it can reach those most in need as quickly as possible.

In its statement Pfizer said that it is “bringing its leading in-house manufacturing capabilities to this effort, with the ability and experience to quickly scale, manufacture and distribute large quantities of vaccine at high quality, leveraging multiple sites in the US and Europe.”

It added that it will complement the mRNA manufacturing expertise of BioNTech, gained over almost a decade. Pfizer and BioNTech say that their 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).

Pfizer said in its statement that it also has vast experience and expertise in cold-chain shipping and has an established infrastructure to supply the vaccine worldwide, including distribution hubs that can store vaccine doses for up to six months.

The company has developed specially-designed, temperature-controlled shippers for the  vaccine, which can maintain the recommended ultra cold storage conditions needed (-70°C ±10°C) for 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 normal refrigerator temperatures.

From the start of the research program earlier this year, Pfizer and BioNTech have successfully used the vaccine at more than 150 clinical trial sites across the US, as well as Europe, Latin America, and South Africa.

About the Study

The Phase 3 clinical trials of the vaccine, which is based on BioNTech’s proprietary mRNA technology, began on July 27, 2020 and has enrolled 43,661 participants to date, 41,135 of whom had received a second dose of the vaccine as of November 13, 2020.

Participants will continue to be monitored for long-term protection and safety for an additional two years after their second dose.

Pfizer and BioNTech stated that they 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.

In a Tweet published on Friday, Dr. Bourla heaped praise on the work of all involved, including the more than 43,000 volunteers, who helped make the vaccine a reality, saying “248 long days and nights; 150 active clinical trial sites; 43,661 courageous volunteers; thousands of dedicated Pfizer and BioNTech group colleagues. And the hopes of billions, all leading to one historic moment. #PfizerProud of our FDA submission today.”