Thread by @iheartkidneys

1/ Have you ever wondered how a vaccine💉 is made and how long it takes before it reaches your arm 💪? #medtwitter #tweetorial #NKFClinicals #COVID19

2/ How long does it take for a #vaccine to reach the general public from the initial development phase?#medtwitter

3/ Making a vaccine is not an easy task, it is a tedious process from its initial planning phase. Let’s go over what a general process looks like for vaccine development.

4/ The general stages of the development cycle of a vaccine are displayed below. #medtwitter
cdc.gov/vaccines/basic…

5/ The first stage is Exploratory🧪 & Preclinical🧑‍🔬- which is where the safety and immunogenicity of a target antigen is assessed. Also this is where a safe starting dose for human clinical studies is determined.
ncbi.nlm.nih.gov/pmc/articles/P…

6/ Next step is to get authorization and approval for a clinical trial from the U.S. Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research (CBER), which is responsible for regulating vaccines in the United States.
fda.gov/vaccines-blood…

7/ This step includes submission of an application for an Investigational New Drug - which describes the vaccine, the method of manufacture and quality control tests for release.

8/ Phew, once that’s done, the clinical trials begin. There are three phases in clinical trials.
cdc.gov/vaccines/paren…

9/ Phase 1⃣- goal is to assess safety of the vaccine and determine the type and extent of immune response that the vaccine provokes. In this phase, the vaccine is tested in a small number (20-100) of healthy volunteers🙋‍♂️🙋‍♀️.
ncbi.nlm.nih.gov/pmc/articles/P…

10/ Phase 2⃣- if no serious side effects are found in Phase 1 - expands to several hundred volunteers to get more information on the vaccine’s safety, immunogenicity, and short-term side effects.

11/ Phase 3⃣- enrolls 1000's of volunteers to again assess the vaccine's safety and effectiveness. Vaccinated volunteers are compared with those that receive another vaccine or a placebo, to learn more about the vaccine’s safety, effectiveness and side effects associated with it.

12/ If there are concerns for safety or effectiveness of the vaccine at any stage of the clinical trial, then the FDA may request additional information/studies and may stop ongoing trials.🤯

13/ 💥Let’s say a vaccine makes it this far and has promising results in phase 3 of the clinical trials, what is next? Wait, there is more?

14/ The company behind the vaccine prepares a Biologics License Application (BLA) - a comprehensive application that gives the FDA information on the efficacy and safety of the vaccine to make a risk/benefit assessment -> leading to recommend/oppose the approval of the vaccine.

15/ Also during the BLA process, the proposed manufacturing facility, where the vaccine is being produced, is inspected for approval.

16/ Once FDA reviews the license application, the findings from this review are presented to FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC).

17/ This committee (VRBPAC) of scientists 👨‍🔬👩‍🔬, physicians 👩‍⚕️, biostatisticians and a consumer representative provides advice to the FDA regarding the safety and efficacy of the vaccine for the proposed indication.

18/ If the vaccine’s benefits are fond to outweigh its potential risks, the FDA may grant a license for the vaccine, allowing its use by the public! 🎉🎊

19/ Does that mean the FDA is done with the vaccine? No! The FDA continues to oversee the vaccine’s production to ensure continuing safety - they also have periodic inspections of the manufacturing facility.

20/ Then there is Phase 4⃣ - Post-Licensure Monitoring - which is where there is continued monitoring to watch for any additional adverse effects, that were not identified in earlier phases due to smaller number of volunteers.

21/ So THAT is a brief outline of what a vaccine💉goes through before it reaches the general population.

Let’s not wait for a #COVID19 vaccine and follow the recommendations of the health care professionals, such as CDC and WHO. #StayHome #StaySafe #FlattentheCurve #medtwitter