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The Vaccine Review Process and why you should know it

Nov 16, 2020 2:48 pm

There is much controversy regarding vaccine safety and efficacy in the United States. Prior to COVID19, there were populations who lacked confidence in vaccination for any number of reasons. Dr. Grace Lee presented a great overview of the vaccination recommendation to adoption framework that is worth review in light of the ongoing COVID-19 vaccine trials. 

The first steps for any vaccine candidate is development and testing monitored by Data Safety Monitoring Boards. Once patients begin enrolling into phase three clinical trials, vaccine candidates submit a FDA Biologics Licensing Application.  Specifically for COVID-19 vaccines, there is an additional level of licensing approval required for emergency use prior to distribution. The Vaccines and Related Biologic Products Advisory Committee (VRBPAC) then reviews all safety and efficacy data. Upon review, they provide recommendation information, from a regulatory standpoint, to the FDA commissioner. After this step approval, the vaccine candidate goes on to the Advisory Committee for Immunization Practices (ACIP) which advises the CDC directory on potential use in the US civilian population. If all of these prior steps are approved, then the vaccine candidate is published in the Morbidity and Mortality Weekly Report (MMWR) and then subsequently financed and distributed to the general population. 

As you can see, this is a lengthy process, and it should be. Due to the severity of the pandemic, COVID-19 candidates are working on a compressed timeline. However, ALL of these steps listed above are still required for implementation. In fact, as I mentioned above, these vaccine candidates will have to go through an additional layer of review for emergency use prior to approval and implementation. The evidence based recommendations framework has not changed, only the length of time requested due to the severity of the pandemic. 

In terms of the COVID-19 vaccine candidate trials, these are some of the largest trials we've ever seen for any potential vaccine. Between 30,000 to 60,000 individuals are enrolled per trial. This is in stark difference to the traditional 3,000-10,000 individuals per vaccine candidate trial in the pre-COVID-19 era. We will likely have much more safety and efficacy data available to us prior to approval than ever before. 

We need to educate ourselves in order to promote confidence in the vaccine candidate approval process and to reinforce trust about the medical and scientific communities with our patients. Through transparency, education, and advocacy, I am hopeful we will end the pandemic through vaccine implementation. 

 

 

 

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