Understanding the FDA Fast Track

ComirnatyPfizers, recently rebranded as COVID-19 vaccine, recently became the name heard around the world after full FDA approval.

Many celebrated the news, thankful to see the official thumbs up for the public’s path through the pandemic and back to normalcy. Others saw it as their cue to get vaccinated, leading to a 17% increase in Americans receiving their first dose.

Others became curious, if not concerned. A history-making vaccine gained approval to fight a history-making pandemic in history-making time.

Of these reactions, celebration, curiosity and concern about Comirnaty’s approval, one seems the most appropriate: trust.

How can the public be sure that the vaccine’s approval did not come with budget cuts or overlooked risks?

The FDA has a proven approval process to ensure a new vaccine is safe, effective, and available when it’s most needed, such as a pandemic: the fast track.

Move with Operation Warp Speed

On May 15, 2020, President Trump announced: Operation Warp Speed. Against the backdrop of a pandemic that is gaining momentum and no approved vaccines are available, the announcement suggested nothing less than its name: accelerated efficiency. More specifically, the effort challenged agencies and companies to fight the pandemic in record time by preparing to deliver 300 million doses of a safe, effective vaccine in less than a year.

Getting a safe, effective vaccine for a new virus in Americans’ immune systems in less than a year seemed implausible. But advances in vaccine technology; the worldwide collaboration of scientists, researchers and innovators; and the readiness of the federal agencies have collectively accepted the challenge.

Like dr. Nancy Pook, Network Emergency Medical Director at Kettering Health, shared: As our world moved quickly to eradicate the tangible threat of the pandemic, the FDA and other organizations had to adapt while ensuring quality measures were taken.

And in December, the FDA approved the Pfizer-BioNTechs vaccine for emergency use. The emergency use (EUA) authorization, while not an approval, meant that the FDA determined that the vaccines’ benefits outweighed the risks.

The fight against the pandemic had begun. And between January and June 2021, COVID-19 cases, hospitalizations and deaths dropped.

Transition from emergency to fully approved

In May, a year after the launch of Operation Warp Speed, Pfizer filed for FDA approval.

Although Pfizers’ vaccine had already given the FDA the green light for emergency use, the potential approval still required the full measure of the FDA’s investigation. The agency, Dr. Pook, takes a comprehensive approach to the efficacy and safety data initially provided in the early vaccine studies.”

The approval process includes teams of FDAs experts who analyze all clinical and testing data from vaccines, communicate with vaccine development leaders, inspect companys facilities, and determine a vaccine’s safety and effectiveness.

However, most approval applications are not filed during a nearly two-year pandemic with countless lives at stake.

For Pfizers vaccine, if the FDA were to process the thousands of piles of data (including data collected from the millions of fully vaccinated U.S. citizens), inspect the facilities where it was manufactured, and determine the vaccine’s safety and efficacy, and do so to help the US respond to the pressures of the pandemic, it would need to engage every available hand to help.

To do that, the FDA may grant an accelerated designation.

Moving to the FDA’s fast lane

In 1997, Congress affirmed the need for the FDA to speed up their approval process when needed through the Food and Drug Administration Act (FDAMA).

Because viruses don’t wait for the conventional vaccine approval process, the FDA can assign certain designations to a vaccine that is still going through clinical trials through FDAMA when

1. There is no approved alternative that identifies what the FDA calls an unmet medical need.
2. The available data on the vaccine show that the benefits outweigh the risks, both known and observed.

Pfizer has applied for and received a fast track designation in july 2020, as Operation Warp Speed ​​gained momentum.

When a vaccine receives the fast track process from the FDA, it ensures:

• The possibility of a rolling review. A company can submit parts of their application throughout the process instead of waiting to complete the application and wait for it to be reviewed.
• Early and frequent communication between the FDA and the company developing the vaccine during the application process.
• The ability to add other approaches such as: priority rating, which received Pfizers vaccine in July 2021, expediting the approval of the completed application.

The accelerated designation ensures secure implementation and ongoing monitoring, said Dr. Poker.

With the swift designation of FDAs, followed by its priority review, the vaccine from Pfizers (now called Comirnaty) received the full volume of FDAs funds.

It was really a hands-on-deck approach, said an FDA representative.

On the way to tomorrow

The mix of celebration, curiosity and concern for Comirnaty’s approval makes sense. A global venture took place in record time, and just as hospitals are once again finding their rooms full of patients on ventilators.

At the top of that list, however, is confidence.

A necessary step has been taken towards a tomorrow where a nearly two-year-long pandemic is yesterday’s news. Granted, it’s only one step. But it’s a monumental step at warp speed.

(Have questions about Comirnaty? Email the FDA at: vog.shh.adf@doco)