Science

Lonza : Pfizer to outsource some drug production, focus on coronavirus vaccine

During the clinical development stage, BioNTech will provide clinical supply of the vaccine from its GMP-certified mRNA manufacturing facilities in Europe.

Clinical trials in the United States began this week, Smith said.

Missouri's Department of Health & Senior Services confirmed 9,341 cases of COVID-19 and 418 deaths Thursday.

This week, Pfizer and its partner BioNTech, a German pharmaceutical company, began human trials for the BNT162 vaccine program to prevent COVID-19.

"The elements of the technology, as well as adapting the technology to the new disease, are the challenge", he said, adding that regulators will be extra wary to ensure it is fit for public use.

"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.

One participant in the trial noted that joining the study was a "no brainer" because it was a way to be helpful to humanity at this time.

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Pfizer is far from alone in its search for a vaccine, working among other companies, and universities. Each of the four vaccine candidates is potentially being tested in three different doses and two different age populations in a single Phase 1/2 study.

Pfizer also has production plants in Massachusetts, Missouri, and Puurs in Belgium, which have all been identified as manufacturing centers for COVID-19 vaccine production. RNA-based vaccines also by nature avert risks of infection and immune challenges that come with older vaccine types based on live, weakened versions of a virus.

Scientists say the vaccine instructs a person's cells to make proteins associated with the coronavirus without making the person sick. In some viruses, including the new coronavirus, RNA serves as the primary genetic material instead of DNA.

"First, you got to get it out there and even make it available", he said. For this reason two of the study vaccines feature RBDs.

Over this study period, the participants will be divided into four groups to compare the four variations of the vaccines. Once the protein is made, it triggers the body's immune system to make antibodies - essentially tricking the body into protecting itself against the coronavirus before it ever encounters it. The first immunized at stage 1 of the study will be healthy adults aged 18 to 55 years. 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.

She said many steps are being done in parallel fashion, rather than the usual sequential manner, which gives the potential - "subject to technical success and regulatory approvals" - to supply millions of vaccine doses by the end of 2020, and "rapidly scale up to produce hundreds of millions of doses in 2021".



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