Ten days after filing for Emergency Use Authorization (EUA), Pfizer has already put its plan into action, enlisting some interesting partners. According to the Wall Street Journal, as of Friday, United Airlines has begun flying Pfizer’s BNT162b2 vaccine to an from the U.S. and Europe in anticipation of regulatory approval.
Pfizer has final vaccine assembly centers in Kalamazoo, Mich., and in Puurs, Belgium, and runs distribution storage sites in Pleasant Prairie, Wis., and Karlsruhe, Germany, the paper said.
"As a result of the historic pace of vaccine development through Operation Warp Speed and careful logistics planning, the FAA is supporting the first mass air shipment of a vaccine," the Federal Aviation Administration said in a statement to major news outlets on Friday.
In October, the agency established a COVID-19 air transport team to ensure safe, efficient and successful transportation of COVID-19 vaccines, especially ones that have uncommon temperature demands. This includes around-the-clock air traffic services to keep air cargo moving and prioritizing flights carrying COVID-19 vaccines and essential personnel. In Pfizer’s case, these efforts also include granting exceptions to normal aircraft regulations.
The amount of dry ice needed to keep Pfizer’s vaccine at -70˚C—as required to ensure efficacy—is about 5x more than usually permitted on aircraft. The FAA told the WSJ it has granted United Airlines permission to fly 15,000 pounds of dry ice per flight, rather than 5.5 pounds. While United flew the first mass air shipment of BNT162b2, the aviation agency said it will continue to work with other airlines on vaccine transportation.
Moderna to file EUA today
Today, Moderna said it will request EUA from the FDA, as well as conditional approval from the European Medicines Agency (EMA). Two weeks ago, Moderna released preliminary data that said its vaccine candidate is 94.5% effective, as shown in the randomized, double-blind Phase 3 trial called COVE.
However, due to the FDA’s new rule requiring at least two months of follow-up safety data, Moderna had to wait to file for an EUA. That milestone was just reached after analysis of 196 cases, of which 185 cases of COVID-19 were observed in the placebo group versus 11 cases observed in the mRNA-1273 vaccine group (94.1% efficacy).
The trial also analyzed the vaccine’s effect on severe COVID-19 cases. Of the 30 cases of severe illness seen during the trial, all occurred in the placebo group, indicating 100% vaccine efficacy against the worst of COVID-19.
Efficacy was consistent across age, race and ethnicity and gender demographics, and no serious side effects have been reported. mRNA-1273 is a two-dose vaccine.
The biotechnology company said it expects the FDA’s Vaccines and Related Biological Products Advisory Committee to review the safety and efficacy data package for mRNA-1273 during a meeting scheduled for December 17. Shipping to designated distribution points throughout the U.S. will shortly after EUA approval, Moderna said.
As opposed to Pfizer, Moderna’s mRNA-based vaccine only requires -20°C storage— a temperature common in doctor’s offices and pharmacies. Additionally, mRNA-1273 remains stable at 2° to 8°C for 30 days. That temperature range is the same as an everyday refrigerator, making the vaccine easy—and familiar—to distribute and maintain.
No vaccine for children
On Sunday, Anthony Fauci told NBC News the process for approving COVID-19 vaccines for children will likely begin in January 2021.
The news is not unexpected or surprising as normal vaccine development for children requires additional safety data and studies. New vaccine safety is always established in adult populations first, particularly “adult normal populations,” Fauci said.
In late October, Pfizer expanded its trial to include children as young as 12. Moderna has not done so yet.
The next steps would be a Phase I/Phase II trial in children to assess vaccine safety and see if it induces the same immune response as demonstrated in adults. If a vaccine candidate does indeed show immunogenicity, scientists could turn to a bridge study to gain rapid approval for children. This route would be quicker than a trial with 30,000 children.
When COVID-19 emerged at the beginning of 2020, it didn’t take long for researchers to determine that children are significantly less affected by SARS-CoV-2 than their adult and especially elderly counterparts. Some cases of COVID-19-induced multisystem inflammatory syndrome (MIS-C) have been seen, but the sample size is limited. The most recent study of pediatric patients at two New York Hospitals found that children and adults produce different types and amounts of antibodies in response to the novel virus.
While the findings strongly suggest the course of infection is different among the two populations, it’s still not known how children are able to avoid and clear the virus so much more easily than adults.
Photo: A Boeing 777-300ER taking off. Credit: United Airlines