Human Trials of Experimental COVID-19 Vaccine Begin in U.S.

Pfizer sign

Pfizer sign

Older adults will only be immunized with a given dose level of a vaccine candidate once testing of that candidate and dose level in younger adults has provided initial evidence of safety and immunogenicity.

A Pfizer pharmaceuticals laboratory in Chesterfield, Missouri, has produced a COVID-19 vaccine on an accelerated timeline, which started human trials last week. The company is planning to zero in on three sites in the United States and one in Belgium for the early stages of the launch, provided its Covid-19 vaccine candidate in collaboration with BioNTech gets green light from the Food and Drug Administration (FDA).

"With our unique and robust clinical study program underway, starting in Europe and now the USA, we look forward to advancing quickly and collaboratively with our partners at BioNTech and regulatory authorities to bring a safe and efficacious vaccine to the patients who need it most", said Albert Bourla, chair and CEO of Pfizer. "We are proud the Pfizer facility right here in Chesterfield, Missouri, is helping lead the charge on this critically important global development".

The trial is part of a global development program. Moreover, it is also seen that these vaccines are faster to produce than conventional ones.

A Pfizer facility in Chesterfield is working to develop a COVID-19 vaccine.

Parson noted that hospitalizations are down 17% since peaking in Missouri in early April, though he noted there has yet to be "a steep decline in St. Louis" but said there's a noticeable flattening. "This is promising news not just for our region but for our world".

The company's BNT162 Vaccine Program manufactures the synthetic template for Pfizer's Messenger RNA Vaccine at the St. Louis-area research and development facility.

The Portage site is a supplier of sterile injectable, liquids and semi-solid medicines, for Pfizer and produces more than 150 products.

The phase I/II study is created to determine the safety, immunogenicity and optimal dose level of four mRNA vaccine candidates evaluated in a single, continuous study.

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Contract manufacturers Lonza and Catalent are also working with other drugmakers to help produce potential treatments and vaccines for the coronavirus. "We are leveraging our decades of scientific expertise in pioneering vaccine discovery and development to respond to this global health crisis".

Pfizer and BioNTech are now investigating whether the vaccine candidates will be safe and effective against COVID-19.

The Missouri site is one of three owned by Pfizer in the US that's been selected as an initial manufacturing center for a vaccine. Including the spikes in vaccines has the potential to make proteins required for viral survival (ability to infect) visible to the human immune system, said the study investigators.

She said each of four vaccine candidates is being tested at three different doses, and among two different age populations.

It could distribute up to 20 million doses by the end of 2020, and potentially hundreds of millions next year, it said.

BioNTech is preparing to ramp up its production capacity at its existing mRNA production sites in Mainz and Idar-Oberstein, Germany, as well.

Pfizer's R&D Building at its facility in Chesterfield.

In addition to Parson's press briefing Thursday, the governor also visited HyVee and Orscheln Farm & Home in Jefferson City to meet with leadership and discuss the state's "Show Me Strong Recovery" Plan.

HyVee's Aisles Online program has also seen a 400-percent increase, allowing shoppers to order groceries online and pick them up at the store without leaving their vehicle.

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