Fast Tracking a COVID-19 Vaccine
Fast Tracking a COVID-19 Vaccine
Several vaccine candidates have been approved for early testing. Industry collaboration and coordination is proving positive in our race to a vaccine.
As our nation’s top scientists work tirelessly to develop a COVID-19 vaccine, the federal government, R&D groups and the pharmaceutical industry are working collaboratively to ensure our supply chain is ready to scale up production to meet the tremendous demand. Creating billions of doses of a COVID-19 vaccine is a herculean task.
The process of identifying and testing a new antigen that triggers immune response includes a detailed research process, whereby the development of the substance into a final vaccination can take several years and over $1 billion dollars. The National Institutes of Health (NIH) is bringing together several leading biopharmaceutical companies, the FDA, the CDC and the European Medicines Agency to develop an international strategy for a coordinated research response to the COVID-19 pandemic.
Collaborative Framework for prioritizing COVID-19 Vaccine Candidates
The NIH partnership otherwise known as ACTIV (Accelerating COVID-19 Therapeutic Interventions and Vaccines) will provide a collaborative framework for prioritizing COVID-19 vaccine candidates, streamlining clinical trials, and coordinating regulatory processes. Collaboration and open innovation are essential in fighting this global pandemic.
“Battling the COVID-19 pandemic is far too great a challenge for any one company or institution to solve alone,” said Mikael Dolsten, M.D., Ph.D., Chief Scientific Officer and President, Worldwide Research, Development and Medical, Pfizer. “We are seeing an unprecedented level of collaboration across the innovation ecosystem to address this global health crisis, and this potentially powerful NIH initiative may allow us to further accelerate the delivery of much needed therapies to patients around the world.”
The FDA is actively monitoring the medical product supply chains, addressing imbalances and screening and monitoring the millions of domestic and international products in the medical supply chain. The FDA strives to help ensure COVID-19-related medical products coming into the U.S. are safe and distributed appropriately.
Another current key focus of the FDA is to Accelerate the Availability of Medical Equipment and Products for COVID-19 treatments. The FDA is currently Monitoring nearly 80 COVID-19 drug development programs that are in progress, with multiple candidates under investigation that may be able to effectively treat patients before a COVID-19 vaccine is developed.
Precision Cleanrooms is currently designing and building cleanroom facilities to house the development and manufacturing processes of pharmaceutical and medical products. Specializing in cGMP cleanroom environments for pharmaceutical and biopharmaceutical production and packaging, Precision Cleanrooms’ turnkey cleanroom offering covers the entire cleanroom implementation process, from concept to certification.
Our CGMP pharmaceutical cleanrooms are compliant to all FDA, EU and Japanese regulations. They are also 21CFR Part 11 compliant, when applicable. These cleanrooms are designed and built to eliminate cross-contamination and bio-growth by using the highest quality materials.
Contact us to see how Precision Cleanrooms® can partner with you on your next cleanroom project.