Two women at the laptop

Frequently asked Questions*

*This website is intended for a global audience

mRNA vaccines consist of messenger RNA, a blueprint that provides instructions for a human cell to make a target protein, or antigen, which activates the body’s immune response against the respective virus. What is unique is that mRNA vaccines utilise the genetic sequencing of the virus but not the virus itself. The goal of all vaccines – mRNA and conventional vaccines – is to stimulate the immune system to generate protective, long-lasting antibody and T cell responses against SARS-CoV-2 and prevent subsequent infection upon exposure to the virus.

We used our proprietary mRNA technology to develop our COVID-19 vaccine, as this technology allows new vaccine candidates to be designed and manufactured faster and more efficiently than conventional vaccine manufacturing methods would allow. BioNTech's mRNA vaccine technology enables rapid development and short manufacturing cycles, which is critical to getting a COVID-19 vaccine to market and to address urgent unmet medical needs. At BioNTech, we have over a decade of experience with our proprietary mRNA-based technology platforms.

Conventional vaccines usually contain weakened or inactivated disease-causing organisms or pathogen proteins to stimulate the immune response of the body.

SARS-CoV-2 is a member of a large family of coronaviruses consisting of spherically-shaped viral particles covered with spike proteins protruding from their surface, which give the virus its crown-like appearance. These spikes bind onto human cells, allowing the virus to infect them. Our vaccine consists of a short segment of genetic sequence, called messenger RNA, that delivers the instructions for a human cell to make a harmless version of a target protein, or antigen, which activates the body’s immune response against the SARS-CoV-2 virus. This means the immune system learns how to recognise the SARS-CoV-2 virus upon exposure and prevent subsequent infection.

mRNA vaccines contain only the information required to encode the selected viral protein. They do not contain full virus or parts of virus. Additionally, mRNA vaccines cannot induce production of a full virus, and therefore they pose no risk of vaccine-induced infection.

All vaccines must go through thorough testing (i. e., non-clinical and clinical trials). After non-human testing, vaccines have to pass successfully through three key phases of clinical trials before they can be licensed for use. In a Phase 1 study, a very small number of healthy volunteers receive the vaccine under carefully monitored conditions to identify potential side effects and preliminarily test the immune responses. The objective for a Phase 2 study is to find the right dose. 
 
Provided that the results of the Phase 1 and 2 studies are positive, a dose is selected, and if the vaccine appears to generate a relevant immune response with an acceptable initial safety profile, a Phase 3 study will be initiated. In a Phase 3 study, a large number of people receive the vaccine or a control substance, such as a placebo (a placebo is a substance or treatment which is designed to have no therapeutic effect). Comparisons between what happens to the individuals who receive the vaccine and what happens to those who receive the placebo control with regards to local and systemic side effects after vaccination and infection with COVID-19 allow scientists to check against the vaccine’s efficacy and safety. Approval from regulatory authorities to manufacture and distribute the vaccine will only be granted, if a phase 3 study is successful.  

For more information, check out a video from GAVI, the Vaccine Alliance:

Can vaccine clinical trials be sped up safely for COVID-19? (WHO)

Before a vaccine is given to humans, scientists normally spend many years developing it in the laboratory. BioNTech has built its development work on its decades-long experience in mRNA technology and its deep understanding of the immune system. Together with its partners, BioNTech is committed to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles, always making the safety and well-being of vaccinated individuals our top priority.

mRNA works by providing a blueprint for the cells' own machinery to produce the selected antigen inside the body, which enable new vaccine candidates using mRNA technology to be developed more quickly than conventional ones. This is the technology being used to develop our COVID-19 vaccine. In addition, we leveraged BioNTech's prior experience with mRNA products already used in clinical studies in different indications since more than one decade.

Since the beginning of its COVID-19 vaccine program, BioNTech engaged in discussions with regulatory authorities like the German Paul Ehrlich Institut (PEI), the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in order to reach an early alignment on the development strategy. Several regulatory authorities (e. g. in the EU, UK, Canada, Japan) are also implementing expedited pathways such as rolling submissions, which allow for data to be submitted at different stages of the clinical trial program and for ongoing evaluation, rather than the evaluation occurring at the end only. This approach allowed reaching conditional and full approvals for our vaccine in record time.

Regulatory Agencies that are responsible for reviewing and approving new vaccines are making all possible efforts to expedite review and evaluation procedures for products relating to treating or preventing COVID-19; this includes increasing the number of staff members and other resources to focus on COVID-19 efforts. Thus, because COVID-19 vaccine regulatory reviews are highly prioritized, review timelines are largely expedited by sheer manpower and resource allocation, and what would normally take months to review because of clashing priorities, now only takes days to weeks. While timelines are accelerated, however, the quality standards and the requirements for scientific data to support approval of new drugs or vaccines are not lowered, and regulatory agencies will request all the comprehensive data needed for a thorough evaluation of the benefit and risks of the new vaccine. Another way to speed up an approval process is through what is known as rolling review, a process used in e. g. EU, UK, Canada and Japan. This allows the company to submit portions of the regulatory application to the regulatory authorities as they become available. All these measures help to accelerate the application process without compromising the diligence of the assessment. An essential prerequisite for the use of vaccines in humans is to avoid risks as much as possible, therefore the full package regarding the safety of the vaccine is a key priority.

From a safety perspective, e. g. the U.S. FDA expects an EUA submission will include all safety data accumulated from Phase 1 and 2 studies conducted with the vaccine, with an expectation that Phase 3 data will include a median follow-up of at least 2-months (meaning that at least half of vaccine recipients in Phase 3 clinical trials have at least 2 months of follow-up) after completion of the full vaccination regimen. The Phase 3 study will continue to collect safety data for an additional two years. Long-term safety follow up will continue and surveillance of the vaccine after licensure will take place.

To ensure the quality of the vaccine, it has to be shipped and stored at very deep temperatures. Pfizer 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’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. So, this will minimize the need for long-term storage anywhere. Vaccination in a pandemic situation is expected to be rapid, with high demand, 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 COVID-19 mRNA vaccine candidate, which can maintain recommended storage conditions (-75°C ±15°C) for extended periods of time without any additional equipment but dry ice. Once thawed, the vaccine vial can be stored for up to five days at refrigerated (2-8°C) conditions. Prior to administration, the vaccine is brought to room temperature.

Read also

Stay up to date

Looking for our latest news, events or SEC filings?
Sign-up for our alerts here