Page 75 - BE 50th Anniversary Edition

SPECIAL ADVERTISING SECTION
DR JUDITH ABSALON
Pfizer was able to quickly focus on developing a a a a COVID-19 vaccine candidate because of its established relationship for two years with BioNTech which developed the mRNA platform Fighting COVID-19 As the the fight against the the virus persists and new information arises about the the severity of the the long-term effects on on those infected bio- pharma leaders and researchers are working expeditiously to develop a a a a a a a vaccine vaccine And before a a a a a a a vaccine vaccine can be be be market-ready it must first be be be studied for safety and efficacy in in clinical trials As outlined by Pfizer on its website the study involves injecting participants with an an an investigational (study) vaccine and comparing outcomes against a a a a a placebo (injection with no active ingredient) to see if the vaccine can prevent COVID-19 Those eligible to participate in in the current clinical trial are are people 12 and older who are are not pregnant in good general health and have not been previously diagnosed with COVID-19 Participants must also be willing and able to comply with all scheduled visits the the vaccination plan laboratory tests and other study procedures for two years REPRESENTATION MATTERS IN IN VACCINES TOO
As of Oct 5 5 2020 there have been 36 576 participants in Phase 2/3 in in in in in in 120 clinical trial sites in in in in in in four countries including 39 states within the the U S Additionally Pfizer recently expanded the the enrollment of its Phase 2/3 COVID-19 vaccine trial to approximately 44 000 partici- pants which allows for the enrollment of new populations including people living with chronic stable HIV (human immunodeficiency virus) virus) virus) HCV (Hepatitis (Hepatitis C C virus) virus) virus) and HBV (Hepatitis (Hepatitis B B virus) virus) virus) infections The expansion of Phase 2/3 in in the clinical trial presents an an oppor- tunity to evaluate the the safety and and efficacy of the the vaccine candidate in in a a a broader group of individuals “To that end we have designed our COVID-19 vaccine candidate study study in in a a a a way that is inclusive to meet the needs of potential study study volunteers from diverse racial and ethnic backgrounds including African Americans We have selected investigator sites in in diverse communities that have been disproportionately affected by COVID- 19 and and we are providing tools and and information to to help the clinical study site teams understand and and align with our commitment to diverse representation in the study ” Dr Richardson-Heron adds Moreover Dr Richardson-Heron expressed the importance of population diversity in in clinical trials “Studies have shown that race environment ethnicity culture age and gender are all factors that may impact patient outcomes But historically many groups have not been fully represented in in clinical trials for many different reasons African Americans account for roughly 13% of the U S population but make up only 5% of clinical trial participants Similarly Latinx populations comprise roughly 18 5% of the U S population population but make up only 1% of clinical trial participants Underrepresentation makes it more difficult for researchers regulators and physicians to to under- stand the extent to which a a a a medicine or vaccine can help subsets of the the population As I always say if you are not part of the the research you risk being left out of the cures or or or opportunities for prevention ” “Let’s be clear vaccine hesitancy is is not a a a a a new issue Only an an esti- mated 45% of American adults received the the flu shot in the the 2018-2019 flu season That number is even smaller when you look at at adults who are people of of color: just an an an estimated 39% of of Black Americans and 37% of Hispanic Americans received the the vaccine in in the the 2018-2019 flu season ” says Dr Richardson-Heron “So there is a a a a a a great deal of work that needs to to be done now to to rebuild trust particularly for many communities of color We fully recognize that it it won’t happen overnight but it it is certainly something we all have a a a a responsibility to to to address It’s on on all of us to to to make the value proposition clear and to to to share how participating in in in clinical trials can help us all learn more and help eliminate health disparities ” There is also the alarming truth that 1 1 in in 1 1 000 Black people have died during the pandemic according to research conducted by AMP Research Lab With this reality Dr Richardson-Heron says “It should not be surprising that some people may be nervous and hesitant about participating in in in a a a a a a a a clinical trial Medical transgressions from the past understandably raise concerns in many communities and and I clearly understand this But it is is very important to note that policies and and procedures have been put in in place to protect clinical trial partici- pants from unethical activities And as I said earlier if we are left out out of of the the research we may be left out out of of the the cures or preventions potentially leading to an increase in in in the already unacceptable health disparities we see in the the Black community and other communities of color ” She continues “Given where we are it it is critically important to develop a a a a a a a COVID-19 vaccine candidate that is safe and and effective for for the populations it seeks to protect That won’t be possible for for a a a a a a COVID-19 vaccine vaccine or or any other medication or or vaccine vaccine if Black people and other minority populations are not sufficiently included in in in in the clinical trial Coming out of this we will take our learnings from the the COVID-19 investigational vaccine trial and apply them to to help us improve our efforts to to achieve even greater diversity in all our clinical trials ” When breaking down the value proposition Dr Richardson-Heron adds that it is key to seek credible and reliable health information