Two companies that are developing a vaccine against the deadly coronavirus have signed a new collaboration agreement that is designed to expedite completion of a late-stage clinical trial while mitigating the risks to their stakeholders and patients as well as the need for a FDA approval process.
Vaccine developers are required to complete pre-clinical trials to ensure they are safe for humans before beginning the active-vaccine phase of the research. A partnership is made if the study design conforms to standards approved by the Food and Drug Administration (FDA).
Further, there are certain assumptions that must be made about the current knowledge about the human immune system to help the researchers reduce the time required to obtain the required data. These are known as immunogenicity and virulence factors that are important when evaluating the effectiveness of a vaccine. These factors, such as surface antigens, targets, antigen binding to the cell surface, and antigen-specific entropion, are important as the clinical trials proceed.
Researchers at Connecticut-based Alnus and Bulgaria-based Antara informally agreed over summer that they would develop a vaccine against Middle East Respiratory Syndrome Coronavirus, better known as MERS-CoV, in collaboration with fellow researchers at the Children’s Hospital in Philadelphia (CHOP).
Once certain technical questions are resolved between Alnus and Antara, this project team will proceed to the next step.
Between January and May, Alnus placed an additional $6.5 million into its MERS-CoV vaccine development program to ensure that the process is going forward.