December 21, 2020: “Pfizer and BioNTech announced that the European Commission (EC) has granted a conditional marketing authorization (CMA) to Pfizer and BioNTech for COMIRNATY® (also known as BNT162b2), for active immunization to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 16 years of age and older.
This follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive opinion to authorize the vaccine earlier today.
The EC granted this CMA in the interest of public health to help address the COVID-19 pandemic. The CMA is valid in all 27 member states of the European Union (EU).
The vaccine will be marketed in the EU under the brand name COMIRNATY, which represents a combination of the terms COVID-19, mRNA, community, and immunity, to highlight the first authorization of a messenger RNA (mRNA) vaccine, as well as the joint global efforts that made this achievement possible with unprecedented rigor and efficiency – and with safety at the forefront – during this global pandemic.
COMIRNATY is the first COVID-19 vaccine to receive CMA in the EU. The distribution of COMIRNATY by the EU member states will be determined according to the populations identified in EU and national guidance.
“The conditional marketing authorization by the European Commission is an historic achievement.
It is the first vaccine which has been developed in a large-scale trial with more than 44,000 participants and approved in less than a year to address this pandemic.
This is based on the decade-long pioneering work by many scientists from all over the world. This achievement is also a testament to the successful collaboration with our partner Pfizer,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech.
“As a company founded and headquartered in the heart of Europe, we are looking forward to delivering the vaccine to Europeans in the upcoming days. We believe that vaccinations may help reduce the number of people in high-risk populations being hospitalized.
Moving forward, we will continue to collect efficacy and safety data in participants for an additional two years and test the vaccine against additional mutations that might occur.”
“With the pandemic still raging in many countries, we are continuing to work around the clock to bring this vaccine to the world as quickly, efficiently and equitably as possible,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “I am truly grateful for the collaboration with our partner BioNTech, and to the European Medicines Agency and European Commission for their thorough and efficient review to help us defeat a virus that has already claimed the lives of hundreds of thousands of people in Europe. We are grateful that this authorization is bringing hope to people across the continent, as we hopefully turn the corner of this crisis and approach the new year.”
The EU authorization is based on the totality of scientific evidence shared by the companies as part of the EMA’s rolling review process and the application for CMA, which the companies submitted on December 1, 2020.
This included data from a pivotal Phase 3 clinical study announced last month and published recently in The New England Journal of Medicine. The Phase 3 data demonstrated a vaccine efficacy rate of 95% 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 Data Monitoring Committee (DMC) for the study has not reported safety concerns related to the vaccine. Efficacy was consistent across age, gender, race and ethnicity demographics.
All trial participants will continue to be monitored to assess the duration of protection and safety for an additional two years after their second dose.
Following today’s CMA, Pfizer and BioNTech will initiate delivery of the first vaccine doses immediately across the EU based on a distribution plan defined by the EC and contract terms.
In November 2020, Pfizer and BioNTech reached an agreement with the EC to supply 200 million doses of a vaccine for COVID-19 in 2020 and 2021, with the option for up to 100 million additional doses, subject to agreement of the parties.
Delivery will begin immediately, and occur in stages, throughout 2020 and 2021, to ensure an equitable allocation of vaccines according to contract terms across the EU.
Vaccine doses for Europe will be produced in BioNTech’s manufacturing sites in Germany, and Pfizer’s manufacturing site in Puurs, Belgium.
Pfizer and BioNTech appreciate the continued participation of the more than 44,000 trial volunteers, and remain committed to the companies’ pledge to always make their safety and well-being the companies’ top priority.
The participants in the companies’ COVID-19 vaccine clinical trial are courageous volunteers who have made a personal and important choice to help make a difference during this pandemic.
Pfizer and BioNTech are providing a vaccine transition option that enables trial participants 16 years and over who received the placebo to receive the vaccine as part of the study.
This option is voluntary and is being implemented in a phased manner.
With this EU authorization in all 27 EU member states, the COVID-19 vaccine has now been granted a conditional marketing authorization, emergency use authorization or a temporary authorization in a total of more than 40 countries.1 Regulatory reviews are underway in several countries, with more authorizations anticipated in the coming weeks.
About the Phase 2/3 Study
The ongoing Phase 3 clinical trial of BNT162b2, which is based on BioNTech’s proprietary mRNA technology, has enrolled more than 44,000 participants, the vast majority of whom have received their second dose.
A breakdown of the diversity of clinical trial participants includes information from more than 150 clinical trials sites in the U.S., Germany, Turkey, South Africa, Brazil and Argentina.
The Phase 3 trial is designed as a 1:1 vaccine candidate to placebo, randomized, observer-blinded study to obtain safety, immune response, and efficacy data needed for regulatory review.
The trial’s primary endpoints are prevention of COVID-19 in those who have not been infected by SARS-CoV-2 prior to immunization, and prevention of COVID-19 regardless of whether participants have previously been infected by SARS-CoV-2.
Secondary endpoints include prevention of severe COVID-19 in those groups. The study also will explore prevention of infection by SARS-CoV-2, the virus that causes COVID-19.
Data from this study, including longer term safety, comprehensive information on duration of protection, efficacy against asymptomatic SARS-CoV-2 infection, and safety and immunogenicity in adolescents 12 to 17 years of age, will be gathered in the months ahead.
Additional studies are planned to evaluate BNT162b2 in pregnant women, children younger than 12 years, and those in special risk groups, such as the immunocompromised.
Manufacturing and Delivery Capabilities
Pfizer and BioNTech continue to work in collaboration with governments and Ministries of Health around the world that will distribute the vaccine, subject to country authorization or approval and terms of supply agreements, to help ensure it can reach those most in need as quickly as possible.
The companies are leveraging Pfizer’s leading vaccine manufacturing and distribution capabilities to quickly scale, manufacture and distribute large quantities of the vaccine at high quality, complementing BioNTech’s mRNA manufacturing expertise gained over almost a decade.
Pfizer has a 171-year track record of researching, developing, manufacturing and delivering innovative medicines and vaccines to patients in need. Pfizer and BioNTech are confident in their ability to deliver the vaccine to people in the EU.
Based on current projections, Pfizer’s and BioNTech’s combined manufacturing network has the potential to supply globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021 (subject to manufacturing capacity and regulatory approval or authorization).
Through its existing mRNA production sites in Germany, BioNTech is able to produce the Pfizer-BioNTech COVID-19 Vaccine for commercial supply after having already produced the vaccine candidate doses for the clinical trials.
BioNTech will also increase its manufacturing capacity in 2021, once a third site in Marburg, Germany will start manufacturing to provide further capacities for a global supply of the vaccine.
Critical to distribution in Europe will be Pfizer’s manufacturing site in Puurs, Belgium, one of Pfizer’s largest sterile injectable sites.
The Puurs site is being used primarily for European supply but will also serve as back up supply to Kalamazoo, Michigan, for the U.S. market.
Pfizer has vast experience and expertise in cold-chain shipping and has an established infrastructure to supply the vaccine worldwide, including distribution hubs where vaccine can be stored until its expiration.
The company’s distribution is built on a flexible just-in-time system that can ship the frozen vials quickly to designated points of vaccination at the time of need, minimizing the need for long term storage.
Vaccination in a pandemic situation is expected to be rapid, and we do not expect that the product will need to be stored at any location for more than 30 days.
To assure product quality, the companies have developed specially designed, temperature-controlled shippers for the vaccine, which can maintain recommended shipping conditions (-90ºC to -60ºC (-130ºF to -76ºF)) for extended periods of time with dry ice.
The shipper can maintain temperature for 10 days unopened which allows for transportation to markets globally.
Once open, a vaccination center may store the vaccine in an Ultra-Low Temperature freezer at (-70°C ±10°C) for up to six months, or use the specially designed shippers as a temporary storage solution to maintain the required temperatures for up to 30 days with re-icing every five days in accordance with the handling instructions.
Each shipper contains a GPS-enabled thermal sensor to track the location and temperature of each vaccine shipment 24 hours a day, seven days a week.
Once thawed, the vaccine vial can be stored safely for up to five days at refrigerated (2-8°C) 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 reaching more than 44,000 participants.
Based on their collective experience, the companies believe in their capability to distribute the vaccine globally upon approval or authorization. BioNTech will hold the regulatory authorization in the U.S., U.K., Canada, EU, and, if authorized, in other countries.
Pfizer will have marketing and distribution rights worldwide with the exception of China, Germany, and Turkey.
The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older.
The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564 (b) (1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.
AUTHORIZED USE IN THE U.S.:
The Pfizer-BioNTech COVID-19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.
IMPORTANT SAFETY INFORMATION FROM U.S. FDA EMERGENCY USE AUTHORIZATION PRESCRIBING INFORMATION:
- Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine.
- Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer-BioNTech COVID-19 Vaccine.
- Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine.
- The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.
- In clinical studies, adverse reactions in participants 16 years of age and older included pain at the injection site (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%), injection site swelling (10.5%), injection site redness (9.5%), nausea (1.1%), malaise (0.5%), and lymphadenopathy (0.3%).
- Severe allergic reactions have been reported following the Pfizer-BioNTech COVID-19 Vaccine during mass vaccination outside of clinical trials.
Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine. - Available data on Pfizer-BioNTech COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.
- Data are not available to assess the effects of Pfizer-BioNTech COVID-19 Vaccine on the breastfed infant or on milk production/excretion.
- There are no data available on the interchangeability of the Pfizer-BioNTech COVID-19 Vaccine with other COVID-19 vaccines to complete the vaccination series.
Individuals who have received one dose of Pfizer-BioNTech COVID-19 Vaccine should receive a second dose of Pfizer-BioNTech COVID-19 Vaccine to complete the vaccination series. - Vaccination providers must report Adverse Events in accordance with the Fact Sheet to VAERS at https://vaers.hhs.gov/reportevent.html or by calling 1-800-822-7967.
The reports should include the words “Pfizer-BioNTech COVID-19 Vaccine EUA” in the description section of the report. - Vaccination providers should review the Fact Sheet for mandatory requirements and Information to Provide to Vaccine Recipiipients/Caregivers and the Full EUA Prescribing Information for Requirements and Instructions for Reporting Adverse Events and Vaccine Administration Errors.”
https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-receive-authorization-european-union
