A: It’s a big process with lots of steps and players! These include clinical development and testing, review by the FDA, review by the Advisory Committee on Immunization Practices, distribution to communities, and finally, vaccination. Let’s run down the process.
The Covid vaccine is on the horizon! Hooray! The FDA is meeting TODAY (watch it here) to discuss the application for Emergency Use Authorization for the Pfizer vaccine. This is big news. How did they achieve this?
First step in vaccine development is pinning down the virus. Thanks to incredible scientific collaboration, the genetic sequence of the virus was determined and shared widely with other scientists. This gave vaccine developers a head start on a process that usually takes a long time.
Once a vaccine is developed, the next step is testing. Phase 1 of testing is looking for general safety and the vaccine is only given to a small number of volunteers (around 20-100). Phase 2 still looks at safety but has more people and is starting to test different doses to see what impact that has on immune response and side effects. In Phase 3, thousands of people get the trial vaccine to look at effectiveness at preventing the illness, the immune response, and safety. Did I mention that they keep looking at safety throughout?
This brings us to the here and now. The data from these trials will be presented to the FDA independent advisory committee called the VRBPAC (again, today!) and the Moderna vaccine will be discussed on Dec 17th. The FDA will decide whether to authorize each vaccine with an Emergency Use Authorization. The vaccine developers will continue to study the trial vaccines and will submit for full licensure in the future.
Next step: The Advisory Committee on Immunization Practices is meeting on December 11 and 13th (watch it here) to review and vote on vaccine recommendations. The ACIP is a group of medical and public health experts that develop recommendations on the use of vaccines. This would include who should be vaccinated, when, and how often.
Once the vaccine is authorized and the ACIP gives recommendations on vaccination, it’s off and running! Fortunately, the vaccine developers were manufacturing the vaccine at the same time they were testing the vaccine so they would be ready to go with doses as soon as approval was in place. They were prepared to have to throw everything away if the vaccine didn’t work or didn’t get approved. This parallel process of manufacturing and testing helped us beef up vaccine readiness during the pandemic without sacrificing safety!
Now it’s down to local jurisdictions to vaccinate their communities. This typically means states and counties figure out how to get the vaccine to people and who should get it first. The ACIP recommended that healthcare workers and people who live in long-term care facilities get the vaccine first (https://www.cdc.gov/mmwr/volumes/69/wr/mm6949e1.htm). These groups represent some of the highest risk people and some of the highest risk of death from Covid. However, states and counties can choose who and how they want to vaccine their communities. Check with your state public health department to see what your state plan is for vaccination or look here. Many places plan on starting vaccines in high-risk groups starting next week!
It’s super important to note that though vaccine development was quick, safety standards were not side stepped! Thousands of people received the trial vaccines in a short period of time. Vaccine developers were able to do this faster than normal because there was funding for research, commitment from partnering organizations, enthusiastic study volunteers, and (sadly) lots of people getting sick which speeds up the determination of vaccine efficacy. Look for a future post talking about vaccine safety monitoring strategies.
Here are way too many links about vaccine development. Enjoy!
CDC Vaccine Testing and Approval Process
Role of the ACIP in CDC’s Vaccine Recommendations
Description of FDA Emergency Use Authorizations
