Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech 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. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved 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 vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”
Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA in individuals 16 years of age and older, and the authorization was expanded 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 products that may be effective in preventing, diagnosing, or treating a disease, provided that the FDA determines that the known and potential benefits of a product, when used to prevent, diagnose, or treat the disease, outweigh the known and potential risks of the product.
FDA-approved vaccines undergo the agency’s standard process for reviewing the quality, safety and effectiveness of medical products. For all vaccines, the FDA evaluates data and information included in the manufacturer’s submission of a biologics license application (BLA). A BLA is a comprehensive document that is submitted to the agency providing very specific requirements. For Comirnaty, the BLA builds on the extensive data and information previously submitted that supported the EUA, such as preclinical and clinical 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. The agency conducts its own analyses of the information in the BLA to make sure the vaccine is safe and effective and meets the FDA’s standards for approval.
Comirnaty contains messenger RNA (mRNA), a kind of genetic material. The mRNA is used by the body to make a mimic of one of the proteins in the virus that causes COVID-19. The result of a person receiving this vaccine is that their immune system will ultimately react defensively to the virus that causes COVID-19. The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into – nor does it alter – an individual’s genetic material. Comirnaty has the same formulation as the EUA vaccine and is administered as a series of two doses, three weeks apart.
“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,” said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation 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 effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.”
FDA Evaluation of Safety and Effectiveness Data for Approval for 16 Years of Age and Older
The first EUA, issued Dec. 11, for the Pfizer-BioNTech COVID-19 Vaccine for individuals 16 years of age and older was based on safety and effectiveness data from a randomized, controlled, blinded ongoing clinical trial of thousands of individuals.
To support the FDA’s approval decision today, the FDA reviewed updated data from the clinical trial which supported the EUA and included a longer duration of follow-up in a larger clinical trial population.
Specifically, in the FDA’s review for approval, the agency analyzed effectiveness data from approximately 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. The safety of Comirnaty was evaluated in approximately 22,000 people who received the vaccine and 22,000 people who received a placebo 16 years of age and older.
Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease.
More than half of the clinical trial participants were followed for safety outcomes for at least four months after the second dose. Overall, approximately 12,000 recipients have been followed for at least 6 months.
The most commonly reported side effects 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. The vaccine is effective in preventing COVID-19 and potentially serious outcomes including hospitalization and death.
Additionally, the FDA conducted a rigorous evaluation of the post-authorization safety surveillance data pertaining to myocarditis and pericarditis following administration of the Pfizer-BioNTech COVID-19 Vaccine and has determined that the data demonstrate increased risks, particularly within the seven days following the second dose. The observed risk is higher among males under 40 years of age compared to females and older males. The observed risk is highest in males 12 through 17 years of age. Available data from short-term follow-up suggest that most individuals have had resolution of symptoms. However, some individuals required intensive care support. Information is not yet available about potential long-term health outcomes. The Comirnaty Prescribing Information includes a warning about these risks.
Ongoing Safety Monitoring
The FDA and Centers for Disease Control and Prevention have monitoring systems in place to ensure that any safety concerns continue to be identified 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 Comirnaty. These studies will include an evaluation of long-term outcomes among individuals who develop myocarditis following vaccination with Comirnaty. In addition, although not FDA requirements, the company has committed to additional post-marketing safety studies, including conducting a pregnancy registry study to evaluate pregnancy and infant outcomes after receipt of Comirnaty during pregnancy.
Recall Alert-McCormick & Company recall 3 of its seasoning due to possible Salmonella contamination.
McCormick & Company, Inc. is initiating a voluntary recall of McCormick Perfect Pinch Italian Seasoning, McCormick Culinary Italian Seasoning and Frank’s RedHot Buffalo Ranch Seasoning due to possible contamination with Salmonella.
Salmonella is an organism that can cause serious and sometimes fatal infections in young children, elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea, nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses.
No illnesses have been reported to date in connection with this problem.
The four products subject to this recall include:
McCormick Perfect Pinch Italian Seasoning 1.31 oz bottle
UPC NUMBER: 052100049731
MCCORMICK ITEM NUMBER: 901582629
AFFECTED DATE CODES: BEST BY MAY 26 24 K, BEST BY MAY 27 24 K, BEST BY JUN 04 24 K, BEST BY JUN 05 24 K
McCormick Perfect Pinch Italian Seasoning 2.25 oz bottle
UPC NUMBER: 052100038254
MCCORMICK ITEM NUMBER: 901455463
AFFECTED DATE CODES: BEST BY JUN 30 24 H, BEST BY JUL 01 24 H
McCormick Culinary Italian Seasoning 1.75 lbs. bottle
UPC NUMBER: 52100325743
MCCORMICK ITEM NUMBER: 932574
AFFECTED DATE CODES: BEST BY Jun 12 24 H
Frank’s RedHot Buffalo Ranch Seasoning 153g bottle
UPC NUMBER: 066200021047
MCCORMICK ITEM NUMBER: 901543520
AFFECTED DATE CODES: BB / MA 2022 SEP 06
The four products were shipped to the following locations:
SHIPPING DATES: June 20, 2021 through July 21, 2021
STATES SHIPPED TO: AL, CA, CO, CT, DE, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NY, OH, OK, PA, SC, TN, TX, VA, WI
INTERNATIONALLY SHIPPED TO: Bermuda, Canada
The potential risk was brought to McCormick’s attention by FDA during routine testing. This recall affects cases that were shipped of the affected date codes.
McCormick has alerted customers and grocery outlets to remove the product with the affected date codes from store shelves and distribution centers immediately, and to destroy this product in a manner that would prevent any further consumption
Consumers do not need to return the product to the store where it was purchased. Instead, consumers are urged to dispose of the recalled product and its container. Please contact McCormick Consumer Affairs at 1-800-635-2867, weekdays from 9:30 AM to 8:00 PM (Eastern Time), for a replacement or full refund, and with general inquires.
Hungry for a taste of the Caribbean right here in Palm Bay, or maybe you’ve always wanted to try traditional favorites like Jerk Chicken or Pork, Curried Goat of Chicken, Oxtail, and then wash it down with one of Jamaica’s traditional sodas or juices? Then you should definitely try Palm Bay’s JamRock Grill, a casual restaurant with a laid back and friendly Caribbean vibe, where you can find all of your favorites and maybe discover some new ones. We spoke with JamRock’s owners Garth and Michelle Williams via telephone to learn more about them and their restaurant.
What brought you to Palm Bay?
“We were in Washington D.C. and we wanted a better place for our kids to grow up. My wife’s family was here, and when I visited, I fell in love with Palm Bay! And I knew this was a good place to do business,” Garth said.
Where did the idea for JamRock come from?
“We opened a music venue called Sugar Kane Lounge, and I grew tired of the party scene, and I had always wanted to open a place where people could come and enjoy good, authentic jamaican food. So I went back to the drawing board and we opened JamRock.” Garth explained.
Tell us about your menu, which items are most popular, and if there are any secret or family recipes?
Mr Williams explained that he’s always loved cooking and that all of the recipes are his own that he has put together over the years. Michelle added, “The most popular item we’re doing right now is the Jerk Chicken. Garth loves to grill, and we put the chicken on the grill outside so it gets that smokiness and tastes just like the chicken you would get in Jamaica. And people love our signature rum punch.” “I do the chicken on authentic Jamaican Jerk drum like it’s supposed to be, and the oxtail and the Curry Chicken are popular, too. The restaurant is a few blocks from Winn-Dixie, and people walking to Winn-Dixie smell the chicken and come into the restaurant!” Garth said.
How would you describe the vibe/atmosphere of JamRock Grill?
“The vibe is a love vibe, the colors are the colors of the Jamaican flag, and I love the look of wood, and it’s pretty much my design. The atmosphere is really good, and when you walk into JamRock you just feel love, and we get a lot of compliments on our customer service,” Mr. Williams said. Said Mrs. Williams, “Our daughter is our head cashier and she is really good at customer service, which we really strive for. We want people to leave smiling.”
What’s running a business in Palm Bay like, have you been well received by the community?
Garth answered, “I love my community and Palm Bay is a great place to run the kind of business that I am running. The people that I meet, all kinds of people from different cultures, and I get to talk to them, that’s really special for me. So yes, Palm Bay is definitely a great place for the kind of business we have. The majority of our clients are not from the Caribbean, we have a very diverse clientele.”
You opened your current location in July of 2020, during the heart of COVID. What was that like?
“It actaully gave me a lot of time to think and reflect on my plan. We were going so fast before the pandemic and then the pandemic hit really slowed us down. The slow time really helped to clear my mind and focus on the plan and the things that I could control,” Mr. Williams explained.
What’s in the future for JamRock Grill?
Garth explained. “We definitely want to expand and put in a full bar in, maybe bring in Caribbean comedians and bands for live entertainment, and we really want to turn this into a Caribbean sports bar where folks can come in and watch their soccer or football or cricket or whatever, and drink some beer and shoot some pool. We want to expand what we offer so people will want to come for a happy hour and just enjoy themselves, maybe have some rum punch and good food. When I get this one just the way we want it, we definitely want to open the next location and we are thinking about franchising.”
160 Malabar Rd SW
Palm Bay, FL 32907
7.14.2021- New update- Our city clerk has just confirm that the cost for the special election will be $253,628.04
Palm Bay- A change to the method by which Palm Bay fills vacant Council seats will be considered at the City of Palm Bay Regular Council meeting on Thursday, July 15, taking place in Council Chambers beginning at 7:00 P.M. The proposed change calls for vacant council seats to be filled by a majority vote of Council members rather than a special election, as the ordinance currently calls for.
This amendment to Chapter 50, Elections, of the City Code, was proposed by and the result of a collaboration of the Palm Bay Charter Officers, according to Terese Jones, Palm Bay City Clerk. According to Ms. Jones, the cost of the election to replace outgoing Councilman Jeff Bailey is unknown at this time.
For additional information about Thursday’s Regular Council meeting and to download the meeting agenda, click https://www.palmbayflorida.org/government/agendas-minutes/-folder-6003#docan1526_8367_2078
West Melbourne-Randall Keith Kearse was arrested this afternoon after a crime spree through West Melbourne and Melbourne today. Just after 10AM, Kearse entered the Walmart on Palm Bay Rd and filled up two carts of merchandise totaling over $1,500.00. He then exited the store without paying and was confronted by an employee. After a brief struggle over the merchandise, Kearse punched the employee and leaves prior to police arriving.
Unable to leave with the merchandise, Kearse made his way to the Home Depot on US 192. Once at the store, Kearse again selected multiple items and attempts to leave the without paying. A Home Depot associate identified Kearse due to his priors and attempted to stop him from leaving with the merchandise. Kearse once again became violent. He punched a 74 year old female cashier, knocking her to the ground and stabbed another associate with a screw driver. He then is seen getting into a white 4 door vehicle and leaving the area. Officers from West Melbourne, Melbourne and Brevard Sheriff’s Office conducted an extensive search for Kearse and the vehicle. Kearse then went to the Best Buy in Melbourne where he was able to steal several high dollar pieces of electronics and fled the area. Just before 12:30PM, the vehicle and Kearse were located by Melbourne Police department on Reddick St. where Kearse was taken into custody.
West Melbourne Police have charged Kearse with armed robbery, robbery, aggravated battery with a deadly weapon, two counts of felony battery, grand theft, resisting a merchant and violation of probation. He will be held at the Brevard County Jail on no bond.
Kearse has an extensive criminal history in Brevard County:
Attempted Robbery Burglary Felony Battery
Grand Theft (Multiple)
Dealing in Stolen Property
Giving False Verification of Ownership to Pawnbroker
Violation of State Probation (Multiple) Violation of State Community Control
Criminal Mischief Retail Theft (Multiple) Trespass Fail Leave Property Upon Warning By Owner
Driving while License Suspended (Multiple)
Resisting Arrest without Violence (Multiple)
West Melbourne– During the late evening hours of Friday, June 26th a large party of 50 to 100 people gathered near the end of Columbia Lane. While at the party, Gregory Stefan Alan Barr II (07/08/1994) and another individual engaged in a verbal argument which escalated to Barr pulling a knife and placing it to the individual’s throat.
Andre Deloria Hutchinas (11/27/2001) went over in an attempt to break up the altercation. That is when Barr turned the knife towards Hutchinas. Hutchinas punched Barr striking him in the face. Barr then retrieved a Glock 19 9MM handgun from his waistband and shot Hutchinas one time, striking him in the neck.
West Melbourne Officers, with the assistance of Brevard County Sheriff’s Office responded the area. Upon arrival Barr surrendered to Officers and was taken into custody. Hutchinas was taken to a local hospital where he later succumbed to his injuries. Barr was arrested and charged with Second Degree Murder and Aggravated Assault with a Deadly Weapon. He is currently being held at the Brevard County Jail on no bond status.
Watch the video of the arrest here:
PALM BAY, FLORIDA – On behalf of the Brevard County Association of Chiefs of Police, Chief Nelson Moya, current president of the association, announced the winners of the 2020 Officer of the Year and 2020 Communications Officer of the Year. The awards ceremony was held yesterday, June 23rd, 2021.
For more information on those award recipients, please contact their respective agency directly.