Regulatory

-80 Freezers and Regulatory Compliances

As the COVID19 Vaccine reach the final phase, a few questions arise. Pfizer demonstrated 94 percent of positive data from Phase III, and unlike many vaccines, they need -80 degrees for storage. How hard is it to validate these -80 freezers? How do they plan to deliver? Regulatory guidelines governing developed countries, such as FDA (21 CFR part 11) & EU Annex 11, are stringent and self-sufficient to ensure safety. What about developing or poor countries? Do you think local quality guidelines are good enough for safety? Does adhere to FDA/EU guidelines make the vaccine expensive?

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