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WASHINGTON – (FDA) – 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, 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.”

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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.

The FDA granted this application Priority Review. The approval was granted to BioNTech Manufacturing GmbH.

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2 Teens Fatally Shot In A Houston Apartment Parking Lot

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Harris County police are investigating a shooting at a Houston apartment complex that left two teens dead and another injured.

The shooting happened Friday night around 10:40 p.m. on the 300 block of Airtex Drive when officers responded to a shooting call.

Upon arrival they found 3 males suffering from gunshot wounds. All three males were transported to an area hospital where two of the males succumbed to their injuries. They were 17 years old. The third victim is expected to survive.

During the preliminary investigation officers learned that multiple people were in the parking lot when numerous shots were fired.

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No suspect(s) have been arrested at this time.

This investigation remains ongoing.



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Previous article1 Person Dies, 22 Hospitalized As Listeria Outbreak Spreads To Ten States

2 Teens Fatally Shot In A Houston Apartment Parking Lot


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1 Person Dies, 22 Hospitalized As Listeria Outbreak Spreads To Ten States

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A Listeria outbreak has now infected 23 people throughout in 10 various states. One person from Illinois has died as a result. All but one of the individuals had to be hospitalized, states the Center for Disease Control and Prevention.

The agency reported that Listeria is a sickness that usually affects pregnant women, newborns, other adults, and people with weakened immune systems. It is unusual for those who aren’t in one of these groups to get the illness. To add, antibiotics are used if a person is infected.

Symptoms are different, depending on the person and where they have been affected in their body. A small percentage of cases can lead to a fever or diarrhea.

For those with severe cases, they may experience invasive listeriosis which means bacteria extends pass the gut. If a woman is pregnant, she may experience muscle aches and fatigue. Headache, stiff neck, confusion, loss of balance, and convulsions are also symptoms.

Although it usually doesn’t cause major symptoms in pregnant women, Listeria can cause fetuses and newborn babies to become very sick. It can result in miscarriage, stillbirth, premature delivery, or life-threatening infection in a newborn.

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During the recent outbreak, five pregnant women became ill and suffered a miscarriage.

For people who are 65 or older, they could develop an infection in the bloodstream or brain. They may also experience problems with their joints, bones, chest, and abdomen.

Listeria outbreaks are almost always related to food contamination products. The CDC hasn’t validated where the outbreak started. However, almost all of the people who had gotten sick reside in or had gone to Florida about a month prior to becoming ill. It’s uncertain if that is a coincidence.



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1 Person Dies, 22 Hospitalized As Listeria Outbreak Spreads To Ten States


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Rowlett Man Pleads Guilty To Stalking And Killing His Former Girlfriend

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35-year-old Andrew Charles Beard, from Rowlett, Texas, cyberstalked, shot, and fatally stabbed his ex-girlfriend. It occurred as the two were going through a custody battle.

Last week, Beard pleaded guilty to two violent federal crimes. He had been charged with cyberstalking using a dangerous weapon resulting in death and discharging a firearm during a crime of violence.

Beard will receive his punishment on October 6 and could receive two life sentences.

Authorities say that he admitted to stalking and killing his ex-girlfriend, Alyssa Burkett, 24. It happened in a parking lot in Carrollton on October 2, 2020. Beard wanted to have custody of the couple’s daughter who was a 1-year-old at the time.

Beard confessed to placing a GPS tracker inside of Burkett’s vehicle. He then trailed her to her apartment where he shot her in the head.

Burkett was able to get to a parking lot that was nearby. However, Beard found her and stabbed her 13 times.

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Burkett’s mother and colleagues informed authorities that she had been scared of Beard. She was worried that he had been following her and felt like he may kill her. Burkett’s boyfriend added that Beard seemed to be “overly obsessed” with Burkett and their daughter.

“This was a brutal, bloody crime. Ms. Burkett’s daughter is now suffering twin tragedies. Her mother is deceased, and her father is an admitted murderer. We pray for strength for this child and the rest of her family…” said U.S. Attorney Chad Meacham.



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Rowlett Man Pleads Guilty To Stalking And Killing His Former Girlfriend


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