Algernon Pharmaceuticals Inc (AGNPF)

[medchem]

Part 2: Why people shouldn't worry about Pfizer vaccine

- Vaccine has to be supplied to various countries via advanced purchase agreements... pre-arranged with companies to purchase the vaccines in advance of knowing if they worked
- Canada and USA are examples that have advanced purchase agreements.
- Each country wanting to use vaccine need to provide the data to the regulators
- FDA and Health Canada will look at those results and rest of the data
- rolling submissions have been carried out (typically companies wait until they have all the info ready and then present it to the FDA and Health Canada as one package, and then FDA and Health Canada have very rigorous and laborious process of reviewing data) with FDA and health canada agreeing with a number of manufacturers, most advaanced to do a rolling submission
- ad data becomes available, companies submitted it to FDA and health canada so start reviewingf data on manufacturing and testing so that they can get ahead , but this takes MONTHS AND MONTHS AND MONTHS to review
- FDA and Health canada will then have to sign off, and THEN they can apply for emergency use authorization (or "interim order") so that public health could deliver vaccine and this would only be for use in "priority groups" determined by FDA and Health canada, to start
- NAC on Immunization said a week ago who priority groups are and laid out groundwork for doing this
- local regulators would then decide on distribution
- e.g. of priorrtity groups: frontline health care workers and indigenous populations, older individuals