US FDA on COVID19 vaccine approval at record speed

The Vaccine Challenge

This episode of The Vaccine Challenge is hosted by Priyanka Asera and features Peter Marks, Director, Director Center for Biologics Evaluation and Research, Food & Drugs Administration.

We’ve asked Peter some really important questions around how FDA has been giving vaccine approval at record speed, why the embargo on vaccine raw materials to rest of the world, their relationship with other regulatory bodies, and whether there will be permanent changes in how the FDA functions, development and approval timelines given the speed at which these vaccines have come to market.

If you want to hear more from Peter, he is a speaker this year at the Disease Prevention & Control Summit, a two-day virtual event taking place on July 20-21st, focusing on some of the most important topics across the COVID-19 space, including vaccines, therapeutics, diagnostics, and health equity. Priyanka will also be moderating a panel on vaccine distribution, so make sure not to miss it! Link to register for free is below. Link to free registration: https://bit.ly/2Qzvjpy

Summary of the podcast interview:

How do you think the rollout has been going on under the two different administrations?

• Three vaccines have been authorised for emergency use.
• Despite speedbumps, the rollout has gone as well as expected

How does FDA collaborate with regulatory bodies of other countries?

• FDA is a global lead in the area and has been working closely with WHO.
• If the entire world doesn't get inoculated, we would not be in a position to suppress COVID

Has the collaboration between different regulatory authorities been deeper due to COVID?

• FDA has been working in close collaboration with agencies like CDC in the US
• They have a weekly meeting with CDC, and a deep personal relationship between the two agencies has developed.
• Around the world, regulators have come closer to handle the emergency

What is FDA's role in the Vaccine process?

• To ensure safety around the vaccine, however they do not have a say on how the vaccine is used
• Currently, FDA is closely monitoring the adverse events around the vaccine and what the risks are
• FDA has made the vaccines available under emergency use authorization, this is different from regular use
• Despite the streamlined approval process, care has been maintained to ensure the same safety information is available to the public
• 8 months is the regular approval process, this was possible because they were working with the Pharma companies when they were developing the vaccine

With the new COVID variants coming in, does the vaccine strategy change?

• FDA has developed a playbook to quickly tackle strain changes
• The current batch of vaccines should take us through the current wave
• This might look similar to influenza

With the vaccine rollout in full swing, how does the FDA keep track of possible adverse effects of the Vaccine?

• FDA has collaborated with CDC and has an overlapping set of safety surveillance
• FDA has developed an active system through Medicare and Medicaid system which helps them keep track of 100 million lives
• Currently, fifteen different adverse events are being monitored

Follow up to that: The J&J vaccine is being re-examined, can you shed some light on the process of how it could be reintroduced to the public

• Once the relevant information was gathered, CDC and FDA came together to re-approve the vaccine
• Providers were sensitized to treat the adverse effects should something crop up

About Peter

Peter Marks is an American hematologist oncologist serving as the Director of the Center for Biologics Evaluation and Research within the Food and Drug Administration. He was appointed to the position in 2016 after previously serving as deputy director.

In May 2020, he was selected to serve as a member of the White House Coronavirus Task Force, although he left a few days later over concerns that his participation would represent a conflict with his position at FDA. Marks also played a role in establishing Operation Warp Speed, a partnership between the federal government and various private companies to develop a COVID-19 vaccine.