FDA to Approve Pfizer Vaccine Following Green Light from Advisory Panel

 The Food and Drug Administration says it will approve the coronavirus vaccine developed by Pfizer and its partner BioNTech. This comes just a day after the agency’s Vaccine Advisory Committee recommended that the drug receive emergency use authorization. The announcement is some much-needed good news as new infections continue to soar across the country.

Our coverage begins below, with updates and analysis posted in reverse chronological order.

Companies Prepare for First Shipments of Pfizer Vaccine

3:00 PM PT:

As the U.S. gets ready for the FDA to approve the Pfizer vaccine for emergency use, new details are emerging regarding how the drug will be shipped.

The “first wave” will include 2.9 million doses, which will be shipped directly from the company’s facilities in Michigan and Wisconsin. Officials say they plan to increase this number week after week, while ensuring that every patient receives two doses exactly 21 days apart. Of the first 100 million doses, half will be reserved for the second round of immunization.

FedEx and UPS say they have been planning for the rollout of the vaccine since April. They will use custom shipping boxes designed by Pfizer to transport the drug via “hundreds of flights per week.” Each container can hold anywhere from 975 to 5,000 doses, which must be stored at -70°C. To keep the vaccines cold, every box comes with an initial layer of dry ice, a thermal container to hold the vaccines, with another layer of dry ice on top of that. They are then fitted with a GPS tracking device and temperature monitor for additional safety.

“The preparation for this has been intense. We have been at this for months – planning; putting the right people, the right technology in place. At this point, UPS is 100% ready to go,” said Jim Mayer, a spokesman for the company.

The FDA could grant an Emergency Use Authorization (EUA) to the drug as soon as later tonight. The first wave of doses will likely go out within 24 hours of that authorization. 

U.S. Seeks to Increase Production of Pfizer Vaccine

2:00 PM PT:

As the FDA gets closer to authorizing the Pfizer vaccine for emergency use, the U.S. government is trying to secure more doses of the drug as demand continues to rise.

Operation Warp Speed, the program responsible for accelerating the development and distribution of a coronavirus vaccine, is requesting 100 million additional doses of the drug by July 2021, on top of the 100 million it ordered last summer. 

Every patient must receive two doses for the vaccine to be effective. The government paid $2 billion for the first 100 million doses in July 2020, which will be used to vaccinate 50 million people. The additional request would double this figure by the second half of next year, in addition to the vaccines being developed by Moderna and Astra-Zeneca.

The government is using the Defense Production Act to secure vital materials used to make and distribute the drug, including lipid nanoparticles, the fat bubbles which deliver the genetic code into the body, as well vials used to administer the drug, both of which have been in short supply in recent months.

Pfizer and its partner BioNTech say they have the resources to manufacture 1.3 billion doses of the vaccine in 2021, but the company has contracts to distribute the drug all over the world, promising 40 million doses to the U.K., 120 million to Japan, and 200 million to the European Union, with the option to buy 100 million more.

FDA Vaccine Advisory Board Member Explains Her “No” Vote

1:00 PM PT:

Yesterday, the FDA’s Vaccine Advisory Committee approved the Pfizer vaccine for emergency use. The final vote passed on a 17-4 decision, with one member abstaining. Some have wondered why four of the committee members voted against authorizing the drug. Now, Dr. Archana Chatterjee, Dean of the Chicago Medical School, is explaining why she voted “no”.

Dr. Chatterjee told CNBC earlier today that she voted “no” because she didn’t believe the drug should be administered to 16- and 17-year-olds. The question posed to the committee asked whether the drug should be recommended for individuals 16 years and up. Members were only allowed to vote yes or no. 

Dr. Chatterjee said she wants to see more information regarding how the drug affects people under the age of 18 before she approves it for younger patients, but that doesn’t mean the drug is unsafe.

“I want to be very clear that I am fully supportive of the emergency use authorization for the use of this vaccine from Pfizer and BioNTech for adults 18 years and older,” she said. 

White House Issues Warning to FDA Commissioner 

12:00 PM PT: 

An anonymous source has revealed that White House Chief of Staff Mark Meadows allegedly told the commissioner of the FDA, Stephen Hahn, on Friday to submit his resignation if the agency does not approve the Pfizer vaccine by the end of the day. Sources familiar with the situation say the FDA was originally planning to approve the drug for emergency use on Saturday. The warning has accelerated the approval process as FDA officials rush to complete all the paperwork required for authorization.

The threat came just a few hours after President Trump referred to the FDA as “a big, old, slow turtle” on Twitter, while demanding that commissioner Hahn “get the dam vaccines out NOW,” adding, “Stop playing games and start saving lives!!!”

Based on these developments, the Pfizer vaccine could receive final authorization by the end of the day instead of Saturday.

FDA to Probe Allergic Reactions Before Clearing the Vaccine

10:25 AM PT: 

One of the last things the FDA needs to do before it approves the Pfizer COVID-19 vaccine is clarify the guidelines for people with existing food and medicine allergies.

There have been several reports of people coming down with severe allergic reactions in the U.K. where the drug is already being distributed. That prompted the U.K.’s National Health Service to issue a warning that people with a significant history of allergies shouldn’t receive the shots.

The FDA has requested more information regarding possible allergic reactions to the drug. Health and Human Services Secretary Alex Aza commented during an interview with Fox Business, “That’s something we’re working with Pfizer right now on is the appropriate language for the doctors, is if you have a pre-existing serious allergic reaction to anything in these vaccines or medical allergies, you should exercise caution in getting these vaccines initially.”

The FDA will use this information to include specific instructions for doctors administering the drug to patients. These issues will likely be resolved within a matter of days as the agency gets ready to approve the drug for emergency use.

FDA “Will Work Rapidly Toward Finalization”

10:00 AM PT:

A spokesperson for the FDA told Health and Human Services Secretary Alex Azar on Friday that the agency plans to approve the drug now that the Advisory Committee has weighed in. In a press release, the agency says, “it will rapidly work toward finalization and issuance of an emergency use authorization.”

“Just a little bit ago, the FDA informed Pfizer that they do intend to proceed toward an authorization for their vaccine.” Azar said on ABC’s Good Morning America. That means the first doses could go out to states as soon as Monday or Tuesday.

Discussing the Merits of the Vaccine

On Thursday, the FDA Vaccine Advisory Committee discussed the safety and efficacy of the Pfizer vaccine, based on the data collected during the clinical trials process. The group sat for over eight hours of presentations and debate before finally making its decision. Disease experts posed the ultimate question, “Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech COVID-19 Vaccine outweigh its risks for use in individuals 16 years of age and older?”

17 members voted yes, four voted no, and one abstained from the vote.

The committee sent its findings to the FDA and now the agency says it will approve the drug for emergency use. The drug will start being distributed as quickly as possible to states all over the country. It’s still not clear if the FDA will include 16- and 17-year-olds in the emergency use authorization.

What Happens Next?

Federal officials say the initial shipment will contain around 6.4 million doses. Sources say half of these doses will go out right away, while the other half will stay in storage until the first patients are ready to receive their second shot several weeks later.

Distributing the vaccine will likely prove to be a challenge as the virus continues to accelerate. The Pfizer vaccine must be stored at ultra-low temperatures, which means the first shipments will likely go to large hospitals with the resources necessary to store the drug.

Kathrin Jansen, a senior vice president and the head of vaccine research and development at Pfizer, shared her concerns with the committee during the meeting, “With the high efficacy and good safety profile shown for our vaccine, and the pandemic essentially out of control, vaccine introduction is an urgent need.”

The Long Road to Success

Getting the green light from the FDA Vaccine Advisory Panel is considered a major breakthrough for Pfizer and its partner BioNTech. They began working on the drug 11 months ago when the virus first hit the U.S. The drug is shattering records in terms of the speed with which it was developed. The company invested millions of dollars to develop the drug before conducting a massive clinical trial of nearly 40,000 participants. The federal government agreed to buy 100 million doses of the drug back in July before it was finished, which gave Pfizer the money it needed to quickly scale up its operations.

The FDA is also being hailed for independence during this difficult time. Political leaders have been pressuring the agency to approve a vaccine as quickly as possible, but it held off until it had all the related safety information. FDA employees have been working around the clock, vetting crucial safety data and analyzing information related to thousands of clinical trial participants.

Public health experts and providers have welcomed the news as they continue to limit the spread. The drug has proven to be around 95% effective at preventing new infections of the coronavirus, and nearly 100% effective at preventing serious illness.

With a safe, effective vaccine coming soon, we are now one step closer to putting this dark chapter behind us.