News not Good for Approval this YearIn my opinion, there will be no approval this year if an additional test is required. It seems that they will need to inject a variety of species of animals (mice, rats, guinea pigs, monkeys might be considered) with the vaccine and then the animals are observed for a period of time to see if they develop any symptoms. Designing and conducting such studies is a specialized science and it is difficult to rush these. The steps involved include the following:
1) Design the study and hopefully submit the protocal for review to the regulatory agencies.
2) Once comments are received and protocol is appropriately amended, you have to find a contract research organization (CRO) to complete the study. Studies for chemicals can range from 2 weeks to 2 years. The partial good news is that I am not sure how long the study will need to be for a vaccine (hopefully it would be the shorter variety).
3) Once the study results are obtained, they need to be interpreted (as to the relevance to humans) and reported and then submitted to the regulatory agency (hopefully the study finds no unacceptable risks from accidental injection).
4) Regulatory agency then reviews and reports their findings.
5) Submission review continues.
Cost is not huge (could range from $50 k to 1 million depending on length of study and animal species evaluated). However, the big thing is the time. I don't know how long this will take but I would be surprised if tasks 1 -3 could be completed by the summer (especially if the animal study is longer than a month of observations). I hope I am wrong about this but it does not look good for approval this year.
One question: if BNC knew about this requirement last year (as has been suggested by Ric6565), why weren't these studies initiated then?