Pfizer Seeking Emergency Approval by the FDA

Pfizer pushes for Emergency Use Authorisation
Photo by Jakub Porzycki/NurPhoto via Getty Images
  • Last week, Pfizer and BioNTech released the first interim analysis results of their vaccine’s phase III trials.
  • On Wednesday, Pfizer announced the results from their final analysis and found the vaccine to have a 95% efficacy rate.
  • They plan to submit their data to the FDA today and, seek Emergency Use Authorization for their vaccine.

Pfizer and BioNTech are the first to submit their vaccine to the U.S Food and Drug Administration (FDA) for an Emergency Use Authorization (EUA). The news comes after the companies announced data from the final analysis of their phase 3 clinical trials on Wednesday.

The study results mark an important step in this historic eight-month journey to bring forward a vaccine capable of helping to end this devastating pandemic.

Dr. Albert Bourla, Pfizer Chairman and CEO

What is Emergency Use Authorization?

Under emergency use authorization the FDA allows the use of unapproved medical products during times of emergencies, such as pandemics. This allows for timely access to medications during the unavailability of other options.

However, a EUA is not the same as full approval of a medical product.  

Using the data available from the clinical trials, the FDA then makes a decision. That is, whether the drug is effective at preventing or treating the condition. The approval is, therefore, based on a risk-benefit analysis of the drug. 

According to Pfizer’s statement, they have achieved the safety data milestone required by the FDA. And, therefore plan to submit their data for a EUA. FDA is expected to announce its decision by the second week of December.

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. We intend to continue to work with regulatory agencies worldwide to enable the rapid distribution of our vaccine globally.

Dr. Ugur Sahin, M.D., CEO and Co-founder of BioNTech
Emergency Use Authorization
Credit: FDA

Phase III Trials Reveal a 95% Efficacy Rate

Pfizer’s phase III trials began in late July. It included over 40,000 volunteers. All of whom belonged to racially and ethnically diverse backgrounds. 

Initial results of its first interim analysis had found an efficacy rate of 90%. However, earlier this week the company released a statement about their final analysis.

Out of the almost 44,000 study volunteers, 170 contracted the infection. Only 8 of these belonged to the vaccine group. 10 of the 170 diagnosed cases developed a severe infection. Only one of which belonged to the vaccination group. 

Therefore, suggesting the vaccine may help reduce the severity of the infection. Furthermore, the vaccine showed an efficacy of over 94% even in adults aged 65 years and above.

The researchers did not report any adverse reactions to the vaccine. Moreover, the elderly faced much milder side-effects from the vaccine.

Any Complications?

Pfizer and BioNTech plan to produce 50 million doses of their vaccine by end of December. And, a further 1.3 billion doses by the end of 2021.

Upon receiving FDA approval, the vaccine will first be given to high-risk individuals. These include frontline workers, the elderly, and those with co-morbids. 

However, the storage and transportation of Pfizer’s vaccine can present a real struggle for pharmacies and doctors. Unlike the Moderna vaccine, Pfizer’s vaccine requires storage at minus 75 degrees Celsius. Thus, to combat this, Pfizer is currently working on creating temperature-controlled thermal shippers that utilize dry ice.

The clinical trial is set to continue for the next two years. During this, researchers will determine whether there are any long-term side effects of the vaccine. Moreover, they will assess how long immunity from the vaccine will last.

Reference:

Pfizer and BioNTech to Submit Emergency Use Authorization Request Today to the U.S. FDA for COVID-19 Vaccine. 20 Nov. 2020, www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-submit-emergency-use-authorization

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