28 Dec

Written by Dr. Sheila Littles, DNP, NP December 5, 2020 Based on peer reviewed studies, CDC, WHO and Pfizer Dedicated to everyone Safety of Pfizer Covid Vaccine Background: Covid 19 emerged in late 2019. The name COVID-19 was initiated by the world health organization (WHO) on February 11, 2020. COVID-19 stands for Corona (CO), Virus (VI), Disease (D) also called novel coronavirus. COVID-19 is a serious global health threat that to-date has affected 14.4 million people in the United States and caused 27.5 thousand deaths. The virus is an accumulation of earlier corona viruses, (MERS-COV and SARS-COV), which originated in bats. Best practices for reducing chances of getting or spreading the virus is to wash hands for at least 20 seconds (or sanitize), multiple times daily, wear mask on outings, and social distance preferrable 6 feet but at least 3 ft and last minimize groups. Vaccine  Clinical trials started early 2020, for evaluating investigational COVID 19 vaccines in thousands of study participants for the purpose of generating scientific data and other information for the food and drug administration (FDA) to determine the safety and effectiveness. “These clinical trials are being conducted according to the rigorous standards set forth by FDA in their June 2020 guideline documents” (CDC, 2020). The FDA makes the determination of safety and effectiveness for the vaccines. Once the vaccines are determined safe and effective, it will be further reviewed by the advisory committee on immunization practices (ACIP) before making recommendations to the CDC. The approval is still pending from the FDA. Although, long-term affects have not been studied, there will be extensive safety monitoring systems in-place ie. V-safe, national health care safety network (NHSN), and other claims-based data surveillance. Pfizer           Completed efficacy (effectiveness of vaccine) data from 170 confirmed cases of COVID-19, and safety data from a randomized subset of at least 8,000 participants 18 years and older (Pfizer, 2020). Also, they have included data on approximately 19,000 trial participants who have been followed for a median of 2 months following the second and final dose. **The efficacy of Pfizer vaccine derived from data on nearly 44,000 people and demonstrated the vaccine was 95% effective in helping to prevent COVID 19 (Pfizer, 2020). The effectiveness was consistent across race, age, ethnicity demographics according to Pfizer. The observed efficacy in adults age 65 years of age was over 94%. To-date, no serious safety concerns were found and has been well tolerated in the candidates. Pros verse Cons Cons: clinical research usually can take up to 10 years to test an intervention for both safety and effectiveness. Most trials go through 3 phases; testing interventions in in large groups until they determine safe and effectiveness (antidote, 2020). Pros: Pfizer processed through all 3 phases in warp speed and passed for safety and efficacy per Pfizer. Cons: still awaiting approval from FDA and ACIP Pros: based on limited data, currently benefits of vaccine outweigh the risk Cons: Unknown long term affect Conclusion           The effectiveness of Pfizer’s Corona virus vaccine is 95% effective in preventing the Corona virus. Health care workers and residents in long term care facilities will be the first to be offered the vaccine once approved. It will not be until early to mid-2021 until the rest of the public can get and may be done in other phases. References https://www.antidote.me/   https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations-process.html https://www.cdc.gov/coronavirus/2019-ncov/vaccines/faq.html https://covid.cdc.gov/covid-data-tracker/#cases_casesper100klast7days https://www.cdc.gov/coronavirus/2019-ncov/vaccines/effectiveness.html   https://www.nih.gov/research-training/medical-research-initiatives/activ https://www.pfizer.com/search/site?keys=when+is+last+vaccine+for+corona    

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