Pfizer Submitted an EUA Request for Its COVID-19 Vaccine - What’s Next?
Pfizer and BioNTech announced that they have submitted a request to the U.S. Food and Drug Administration (FDA) for an Emergency Use Authorization (EUA) of their COVID-19 vaccine candidate. If authorized by the FDA, then the investigational vaccine could be used in high-risk populations in the U.S. by the end of December 2020. On our path toward making a potential vaccine publicly available, we want to make sure that the public is updated on our progress and next steps in our development process.
Now that Pfizer and BioNTech have filed an EUA, what happens next?
Now that we have filed for an EUA, the FDA’s scientists will review the data on our COVID-19 vaccine candidate collected to date. Per the guidance from the FDA, this evidence also will be reviewed by an external panel of independent experts, known as the Vaccines and Related Biological Products Advisory Committee (VRBPAC). There will be a public meeting where Pfizer and BioNTech will present to the VRBPAC the safety and efficacy data that were submitted to the FDA and answer questions from the Committee members. We expect this meeting will be scheduled for December.
What data will Pfizer and BioNTech present to VRBPAC?
We are presenting all the data included in our EUA submission. This includes efficacy data from the total 170 confirmed cases of COVID-19 accrued in our Phase 3 trial, and safety data from a randomized subset of at least 8,000 participants 18 years and older. We also have data on approximately 19,000 trial participants who have been followed for a median of two months following the second and final dose of the vaccine candidate as well as data on our manufacturing processes.
What is VRBPAC’s role in approving the EUA?
As with any FDA advisory committee, the VRBPAC will provide a recommendation to the FDA on whether or not to authorize the vaccine candidate for emergency use. The FDA takes the VRBPAC’s recommendation into consideration, though the FDA makes the final decision.
Why is this VRBPAC meeting important?
The VRBPAC meeting is a standard part of the vaccine development process. This committee is made up of independent scientific experts that the FDA selects to review and evaluate evidence regarding whether a vaccine or other biological product is safe and effective for its intended use. This meeting is an important milestone in the FDA’s scientific review process to ensure that any investigatoional COVID-19 vaccine it authorizes for use has been adequately evaluated for safety, efficacy and quality.
What happens if VRBPAC does not recommend that the FDA authorize the COVID-19 vaccine for emergency use? Does that mean the FDA won’t approve it?
Ultimately the FDA makes the decision whether or not to approve or authorize any medical therapy, including an investigational vaccine against COVID-19. No matter the outcome of this meeting, we will continue working closely with the FDA as part of our ongoing commitment to making a potential vaccine available quickly and safely.
Pfizer and BioNTech announced that the ongoing Phase 3 study for our COVID-19 vaccine candidate has met all of its primary efficacy endpoints.
Analysis of the data shows the vaccine candidate was effective in helping to prevent COVID-19 with an overall favorable safety profile. On our path toward making a potential vaccine available, we want to make sure that the public is updated on our progress and next steps.
Now that Pfizer and BioNTech have efficacy and safety data, what happens next to get your COVID-19 candidate vaccine approved for use?
We are looking to submit within days an application to the U.S. FDA for Emergency Use Authorization (EUA). An EUA gives the FDA the authority to allow unapproved medical products to be used during a public health emergency when there are no other adequate, approved, or available alternatives. Our EUA application will include all the data on our COVID-19 vaccine candidate collected to date. This evidence will then be reviewed by the FDA’s own scientists, as well as by an external panel of independent experts, known as the Vaccines and Related Biological Products Advisory Committee (VRBPAC).
Before the FDA authorizes any COVID-19 vaccine for emergency use, VRBPAC will review and discuss the data in a publicly-held meeting, likely to be held in December. As with any FDA advisory committee, VRBPAC will provide a recommendation to the FDA on whether or not to authorize the vaccine for emergency use, though the FDA makes the final decision.
What are the criteria for a COVID-19 vaccine candidate to receive an EUA?
The FDA may issue an EUA after it has determined that the following requirements are met:
- Based on available scientific evidence, including data from clinical trials, it is reasonable to believe that the product may be effective to prevent, diagnose, or treat such serious or life-threatening disease or condition that can be caused by SARS-CoV-2 (the virus that causes COVID-19)
- The identified and potential benefits of the product, when used to diagnose, prevent, or treat the identified serious or life-threatening disease or condition, outweigh the identified and potential risks of the product
- There is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating the disease or condition
If the vaccine candidate being developed by Pfizer and BioNTech for the prevention of COVID-19 is authorized for emergency use, then who will receive it first?
If the vaccine candidate is authorized for emergency use, the government and health authorities would first offer the vaccine to those that they determine are appropriate and have the greatest need. In the U.S., we expect the EUA to be specific to certain high-risk populations as defined by the U.S. Centers for Disease Control and Prevention (CDC) and based on the data that will be provided in the EUA application. We believe the priority will be front line health care workers, essential workers, immunocompromised individuals, nursing homes, and public safety officials, but ultimately it is the governments that will make this determination.
Does your COVID-19 candidate vaccine work for everyone, including different age groups and ethnicities?
Data from our large Phase 3 study of nearly 44,000 people has demonstrated that our vaccine candidate was 95% effective in helping to prevent COVID-19. Efficacy was consistent across age, race and ethnicity demographics. The observed efficacy in adults over 65 years of age was over 94%. View our press release for more information.
Is the Pfizer and BioNTech COVID-19 candidate vaccine safe? What are the potential risks and side effects?
To date, an independent, external data monitoring committee has not observed any serious safety concerns, and the data from our Phase 3 study has demonstrated that our COVID-19 candidate vaccine has been well tolerated. View our press release for more information.
Are Pfizer and BioNTech able to manufacture enough vaccine doses?
We have ramped up manufacturing capabilities across the globe in an effort to meet the high demand due to the COVD-19 pandemic. Based on current projections, the companies expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021.
We have confidence in our vast experience, expertise and existing cold-chain infrastructure to distribute the vaccine around the world. With BioNTech, we have developed specially designed, temperature-controlled thermal shippers. They can be used be as temporary storage units for 15 days by refilling with dry ice. Each shipper contains a GPS-enabled thermal sensor to track the location and temperature of each vaccine shipment across their pre-set routes leveraging Pfizer’s broad distribution network.
What if the SARS-CoV-2 virus mutates? Will the Pfizer and BioNTech COVID-19 candidate vaccine still work?
Only through testing will we know whether the vaccine works against a mutated form of the SARS-CoV-2 virus. However, we think that mRNA vaccine technology has the ability to be easily adapted and potentially modified relatively quickly to address new mutations of the virus. Because this technology does not include all or a portion of the actual pathogen, but instead utilizes the pathogen’s genetic code, we could potentially modify the genetic code of the vaccine candidate to address any changes in the virus.
For more on SARS-CoV-2, our scientific efforts, and what you can do now to stay safe and prevent the spread, visit www.pfizer.com/health/coronavirus.
For additional information about Pfizer, please see our filings with the U.S. Securities and Exchange Commission, including the information provided in the sections captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results” and the press release issued by Pfizer and BioNTech on November 18, 2020.