N.J. pharmaceutical company’s COVID vaccine could be a game-changer. Here’s why.

January 20, 2021 Pharma

As the nation struggles to scale up its COVID-19 immunization rollout, another vaccine in the works could soon help bridge the gap.
The two vaccines available now — one by Pfizer/BioNTech and another by Moderna — require two doses: a priming shot and then a booster three or four weeks later, depending on which company’s injection you get.
But another vaccine on the horizon — developed by Johnson & Johnson — would require only a single dose. It could be a game-changer for distribution, which continues to drag in New Jersey and beyond.
The vaccine is still in development, but the New Brunswick-based company is expected to release the findings of its Phase 3 clinical trial — known as “Ensemble” — later this month, the company says.
“We hope to have that information very soon,” Johnson & Johnson CEO Alex Gorsky said Monday at J.P. Morgan’s annual health care conference.
The company aims to meet the necessary benchmarks by as early as Jan. 21, according to reports. Johnson & Johnson did not respond to a request for comment regarding its timeline.
“We need to ensure all aspects of our COVID-19 vaccine development program meet our safety and quality standards, and that all of our manufacturing and distribution processes comply with all applicable regulations,” said Dr. Mathai Mammen, global head for Janssen Research & Development at Johnson & Johnson, in a statement on the company’s website.
He added, “This includes our raw materials and other components; procedures; manufacturing facilities; testing laboratories, including equipment and analytical methods; shipping and routes; and shelf life and stability.”
Once the clinical trial data is ready, Johnson & Johnson will likely take the same step as Pfizer and Moderna and apply for an emergency use authorization with the U.S. Food and Drug Administration.
It’s unclear how long it will take before people can receive the Johnson & Johnson vaccine once it’s approved.
What is clear is that the additional doses would greatly boost distribution in the U.S. and around the globe.
“We’ve committed to not-for-profit pricing during the pandemic period if we are granted EUA (or its equivalent) in any region of the world,” Mammen said in the statement. “We want to bring an affordable vaccine to the public, with the goal of providing 1 billion doses in 2021 and more after that.”
New Jersey has administered 264,681 Pfizer and Moderna vaccine doses so far — including 236,503 first-dose shots and 28,045 boosters, according to the state dashboard. New Jersey has received 654,900 doses to date, according to the Centers for Disease Control and Prevention.
In August, Johnson & Johnson entered into an agreement with the federal government to deliver 100 million doses after it received “approval or Emergency Use Authorization by the U.S. Food and Drug Administration.”
The vaccine — developed by the company’s Belgian division, Janssen Pharmaceutica — differs from the Pfizer and Moderna vaccines, which use mRNA technology.
“Unlike mRNA vaccines, which use messenger RNA to create a protein that prompts an immune response in the body, our investigational COVID-19 vaccine uses an adenovirus — a type of virus that causes the common cold — that has been made unable to replicate,” Mammen said in the online statement. “The adenovirus carries a gene from the coronavirus into human cells, which then produce the coronavirus spike protein, but not the coronavirus itself. This spike protein is what primes the immune system to fight off a subsequent infection by the virus.”
The University of Oxford and AstraZeneca used a similar method to develop its vaccine in the United Kingdom.
Like Oxford/AstraZeneca, Johnson & Johnson’s vaccine also doesn’t require ultra-cold storage like Pfizer’s version does.
“The vaccine technology we’ve used can remain stable for two years at -4° F, and at least three months at 35 [to] 46° F, which is about the temperature of your home refrigerator,” Mammen said in the statement.
Many experts believe vaccines like the Johnson & Johnson and AstraZeneca doses can be more rapidly scaled up and more easily delivered, as they don’t require special freezers.
Johnson & Johnson has full enrollment in its Phase 3 trial with 45,000 participants.

Source : nj

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