As the world continues to battle the coronavirus pandemic, our scientists and experts are working determinedly, and with unprecedented partnership and speed, to bring forth a vaccine. In collaboration with German biotech company BioNTech, we announced that the first participants in the United States were dosed in the Phase 1/2 study of our COVID-19 mRNA vaccine program. Learn more about the science and this milestone below:
What is a vaccine?
Vaccines are designed to prevent disease. A vaccine stimulates your immune system to respond and produce antibodies – like it would be if you were exposed to the virus. After getting vaccinated, you develop immunity to that disease, without having to get the disease first.1
What is the difference between a vaccine and a treatment?
Vaccines are designed to prevent disease, while treatments help to manage or cure a disease or condition.1
Are vaccines safe?
Yes – vaccines undergo extensive testing to make sure they are safe and effective. Once a vaccine is licensed, regulatory authorities routinely monitor its use and investigate any potential safety concerns.2
How long does a vaccination last?
The immunity conveyed by a vaccine varies. For some vaccines, like polio vaccines, immunity can last a lifetime, while for other vaccines, like for influenza, vaccines are needed annually.3
How could a vaccine for COVID-19 work?
Researchers and scientists globally are working to develop a potential vaccine to prevent COVID-19. Different groups are using various methods, or technologies, to design possible COVID-19 vaccines. Pfizer and BioNTech are focusing on a technology called mRNA. The program includes four experimental vaccines in different mRNA formats. These four candidates were selected based on pre-clinical studies, which indicated the vaccine candidates are potentially effective and safe in protecting against COVID-19.
Any successful vaccine stimulates the immune system to produce antibodies against a specific foreign body, so that after getting vaccinated, a person develops immunity to a specific infection.1
What is the difference between a conventional vaccine and an mRNA vaccine?
mRNA vaccines potentially offer greater flexibility and quicker development timelines than traditional vaccines development.
How exactly do mRNA vaccines work?
mRNA – or messenger RNA – is a molecule, composed of nucleotides linked in a unique order to convey genetic information for the cells to produce the proteins or antigens encoded by the mRNA. Once mRNA in a vaccine is inside of the body’s cells, the cells use their genetic machinery to translate the genetic information and produce the antigens encoded by the mRNA vaccine. The antigens are then displayed on the cell surface, where they are recognized by the immune system which generates a response, including the production of antibodies against the antigen.4
Are mRNA vaccines safe?
mRNA vaccines have demonstrated a favorable safety profile in pre-clinical studies.v Unlike traditional vaccines, they do not use an inactivated virus, but rather a portion of the viral sequence encoding for one or more viral antigens.
How long does it take to develop a vaccine?
The development of a novel vaccine is a complex and lengthy process that generally takes 10 to 15 years.vi Given the current global scale of the COVID-19 pandemic, we are working at an unprecedented speed to develop a potential vaccine in a safe and responsible way, collaborating closely with regulatory and health authorities around the world – compressing stages that have taken years into months, and those that have taken months into weeks.
If all goes well, when will a vaccine be available?
By the end of 2020, we have the potential to supply millions of vaccines, subject to success of the development program and regulatory approval.
Who will be able to get the vaccine? Is it appropriate for everyone?
We will collaborate closely with regulatory and health authorities around the world to provide a potential vaccine to areas in greatest need and assuming success of the development program and regulatory approval, based on patient demographic data being produced in real time and being monitored throughout our clinical development process.
How can I volunteer to be a part of a vaccine trial?
To learn more about potentially becoming involved in a Pfizer vaccine clinical trial, please visit our Clinical Trials and Clinical Research page.
References:
1. https://www.cdc.gov/vaccines/vpd/vpd-vac-basics.html
3. https://www.cdc.gov/vaccines/adults/rec-vac/index.html
4. https://www.phgfoundation.org/briefing/rna-vaccines
5. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5906799/
6. https://www.ifpma.org/wp-content/uploads/2019/07/IFPMA-ComplexJourney-2019_FINAL.pdf
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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. Please see EUA Fact Sheet at www.cvdvaccine.com.
