By Frank Long, MS, Editorial Director
It’s been frothy times for Pfizer and BioNTech, two pharmaceutical companies that have jointly created four COVID-19 vaccine candidates. Two of those candidates have been granted Fast Track designation by the US Food & Drug Administration, and one is expected to move forward as the single candidate for a global study.
That worldwide study could begin by the end of July, according to Pfizer, and if testing is successful the company is prepared to seek Emergency Use Authorization as early as October 2020.
Pfizer details these developments in a media release the company issued Wednesday, July 22.
You Can’t Beat Free
As testing moves into its final phases healthcare consumers will have many questions about a new vaccine. Two that will loom particularly large will be how to access the vaccine and how much it will cost.
In response to those questions Pfizer’s response is succinct:
“Americans will receive the vaccine for free consistent with US government’s commitment for free access for COVID-19 vaccines.”— Pfizer Media Release, July 22, 2020
Pfizer does not lay out the details of how the vaccine will flow into consumer hands at no cost. It does, however, report that once the FDA authorizes the vaccine’s use the United States government will pay $1.95 billion for the first 100 million doses. That deal was made July 22 between the two companies and the U.S. Department of Health and Human Services and Department of Defense
Alexa Azar, Secretary of Health and Human Services, says that wrapping Pfizer and BioNTech’s vaccine candidates into the federal government’s Operation Warp Speed will hedge the operation’s chances of success.
“Depending on success in clinical trials, today’s agreement will enable the delivery of approximately 100 million doses of this vaccine to the American people,” Azar says.
Meanwhile, at Moderna
Pfizer is only one of several pharmaceutical giants working to cross the finish line first in the race for a COVID-19 vaccine. The lead position has changed several times, and AstraZeneca and Moderna are two other companies that have been at or near the head of the pack.
“There are more things you can do to compress the timelines. I’m not sure this is the vaccine you want to do that with.”
Moderna, which has worked on its vaccine collaboratively with the National Institutes of Health, had a Phase 2 study fully enrolled as of July 14. The company is poised to begin a Phase 3 study by the end of July and believes that positive results from its Phase 1 testing portend success in the final phase of development.
“The Moderna team continues to focus on starting our Phase 3 study this month,” says Stéphane Bancel, Moderna’s chief executive officer. “And, if successful, filing a biologics license application (BLA).”
A BLA is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce in the United States.
The month of October seems, perhaps coincidentally, a month when pharmaceutical manufacturers as well as the United States government are expecting big developments in the vaccine race. For example, the US government has reportedly pledged as much as $1.2 billion to Cambridge, UK-based AstraZeneca, in exchange for a promise of 300 million doses of its vaccine by October.
AstraZeneca currently has a vaccine candidate in Phase 3 testing that may slingshot past its competition. That candidate has not entered final phase testing in the United States, but it is currently in late-stage Phase 2 and Phase 3 trials in the UK, Brazil, and South Africa. Should those Phase 3 tests be successful, the company reports that it has a commitment to supply more than 2 billion doses to various nations around the world.
With human health as well as global economic health staked to the development of an effective vaccine, there is little question that time is of the essence in determining a winner for this race. It is one race in which there can scarcely be too many competitors, and for which the winner is likely to be cheered in virtually every language.