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About Cottage Grove sentinel. (Cottage Grove, Or.) 1909-current | View Entire Issue (Aug. 26, 2021)
COTTAGE GROVE SENTINEL | AUGUST 26, 2021 | 3A FDA approves first COVID-19 vaccine product,” said Acting FDA Commissioner Janet Woodcock, M.D. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vac- cine may now instill ad- ditional confi dence to get vaccinated. Today’s mile- stone puts us one step clos- er to altering the course of this pandemic in the U.S.” Since Dec. 11, 2020, the Pfi zer-BioNTech COVID-19 vaccine has been available under EUA in individuals 16 years of age and older, and the au- thorization was expand- ed to include those 12 through 15 years of age on May 10, 2021. EUAs can be used by the FDA during public health emergencies to provide access to medical prod- ucts that may be eff ective in preventing, diagnosing, or treating a disease, pro- vided that the FDA de- termines that the known and potential benefi ts of a product, when used to prevent, diagnose, or treat the disease, outweigh the known and potential risks of the product. Discover the True Power of Teamwork! VOTED F O T S E B SO U T vaccine and is adminis- tered as a series of two dos- es, three weeks apart. “Our scientifi c and med- ical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evalu- ated scientifi c data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and eff ectiveness, and performed a detailed assessment of the manu- facturing processes, in- cluding inspections of the manufacturing facilities,” said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Eval- uation and Research. “We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and eff ec- tive vaccines. Th e public and medical community can be confi dent that al- though we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.” Th e fi rst EUA, issued Dec. 11, for the Pfi zer-Bi- oNTech COVID-19 Vac- cine for individuals 16 years of age and older was based on safety and eff ectiveness data from a randomized, controlled, blinded ongoing clinical trial of thousands of indi- viduals. To support the FDA’s ap- proval decision on Aug. 23, the FDA reviewed updated data from the clinical trial which supported the EUA and included a longer du- ration of follow-up in a larger clinical trial popu- lation. Specifi cally, in the FDA’s review for approval, the agency analyzed eff ective- ness data from approxi- mately 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have evidence of the COVID-19 virus infection within a week of receiving the second dose. Th e safety of Comirnaty was evaluated in approxi- mately 22,000 people who received the vaccine and 22,000 people who re- ceived a placebo 16 years of age and older. Based on results from the clinical trial, the vac- cine was 91 percent ef- fective in preventing COVID-19 disease. More than half of the clinical trial participants were followed for safety outcomes for at least four months aft er the second dose. Overall, approxi- mately 12,000 recipients have been followed for at least six months. Th e most commonly re- ported side eff ects by those clinical trial participants who received Comirnaty were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever. Th e vaccine is eff ective in preventing COVID-19 and potentially serious outcomes includ- ing hospitalization and death. Additionally, the FDA conducted a rigorous eval- uation of the post-authori- zation safety surveillance data pertaining to myo- carditis and pericarditis following administration of the Pfi zer-BioNTech COVID-19 vaccine and has determined that the data demonstrate in- creased risks, particularly within the seven days fol- lowing the second dose. Th e observed risk is higher among males under 40 years of age compared to females and older males. Th e observed risk is high- est in males 12 through 17 years of age. Available data from short-term follow-up sug- gest that most individu- als have had resolution of symptoms. However, some individuals required inten- sive care support. Information is not yet available about potential long-term health out- comes. Th e Comirnaty Prescribing Information includes a warning about these risks. Th e FDA and Centers for Disease Control and Pre- vention have monitoring systems in place to ensure that any safety concerns continue to be identifi ed and evaluated in a timely manner. In addition, the FDA is requiring the company to conduct postmarketing studies to further assess the risks of myocarditis and pericarditis following vaccination with Comir- naty. Th ese studies will in- clude an evaluation of long-term outcomes among individuals who develop myocarditis fol- lowing vaccination with Comirnaty. Also, although not FDA requirements, the compa- ny has committed to ad- ditional post-marketing safety studies, including conducting a pregnancy registry study to evalu- ate pregnancy and infant outcomes aft er receipt of Comirnaty during preg- nancy. Enjoy the ease of 0 202 Y Contact the Cottage Grove Area Chamber of Commerce (541) 942-2411 info@ cgchamber.com NT Are you a Chamber Member? Ask us how you can become a member today! FDA-approved vaccines undergo the agency’s stan- dard process for review- ing the quality, safety and eff ectiveness of medical products. For all vaccines, the FDA evaluates data and in- formation included in the manufacturer’s submission of a biologics license appli- cation (BLA). A BLA is a comprehensive document that is submitted to the agency providing very spe- cifi c requirements. For Comirnaty, the BLA builds on the exten- sive data and information previously submitted that supported the EUA, such as preclinical and clini- cal data and information, as well as details of the manufacturing process, vaccine testing results to ensure vaccine quality, and inspections of the sites where the vaccine is made. Th e agency conducts its own analyses of the infor- mation in the BLA to make sure the vaccine is safe and eff ective and meets the FDA’s standards for ap- proval. Comirnaty contains messenger RNA (mRNA), a kind of genetic materi- al. Th e mRNA is used by the body to make a mim- ic of one of the proteins in the virus that causes COVID-19. Th e result of a person receiving this vac- cine is that their immune system will ultimately re- act defensively to the virus that causes COVID-19. Th e mRNA in Comir- naty is only present in the body for a short time and is not incorporated into - nor does it alter - an in- dividual’s genetic material. Comirnaty has the same formulation as the EUA U On Aug. 23, the U.S. Food and Drug Admin- istration (FDA) approved the fi rst COVID-19 vac- cine. Th e vaccine has been known as the Pfi zer-BioN- Tech COVID-19 vaccine, and will now be marketed as Comirnaty (koe-mir’- na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. Th e vaccine also contin- ues to be available under emergency use authoriza- tion (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immuno- compromised individuals. “Th e FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vac- cines have met the FDA’s rigorous, scientifi c stan- dards for emergency use authorization, as the fi rst FDA-approved COVID-19 vaccine, the public can be very confi dent that this vaccine meets the high standards for safety, ef- fectiveness, and manu- facturing quality the FDA requires of an approved H L A N E CO Showering Safely So you can stay in the home you love! Introducing the ALL NEW Walk-In Shower! 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