Tag Archives: FDA

News

FDA Expands Eligibility For COVID Booster Shot

November 19, 2021 Mike Smith

(Washington D.C.) — The U.S. Food and Drug Administration has amended the emergency use authorizations (EUA) for both the Moderna and Pfizer-BioNTech COVID-19 vaccines authorizing use of a single booster dose for all individuals 18 years of age and older after completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine. The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices was expected to meet Friday afternoon to discuss further clinical recommendations.

“Throughout the course of the COVID-19 pandemic, the FDA has worked to make timely public health decisions as the pandemic evolves. COVID-19 vaccines have proven to be the best and highly effective defense against COVID-19. Authorizing the use of a single booster dose of either the Moderna or Pfizer-BioNTech COVID-19 vaccine for individuals 18 years of age and older helps to provide continued protection against COVID-19, including the serious consequences that can occur, such as hospitalization and death,” said Acting FDA Commissioner Janet Woodcock, M.D.

Prior to Friday’s authorizations, a single booster dose of the Moderna and Pfizer-BioNTech COVID-19 vaccines was authorized for administration to individuals 65 years of age and older, individuals 18 through 64 years of age at high risk of severe COVID-19 and individuals 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2. Today’s action expands the use of booster doses of both vaccines to include all individuals 18 years of age and older at least six months after completion of the primary vaccination series of the Moderna COVID-19 Vaccine or Pfizer-BioNTech COVID-19 Vaccine or at least two months after completion of primary vaccination with the Janssen COVID-19 Vaccine.

“The FDA has determined that the currently available data support expanding the eligibility of a single booster dose of the Moderna and Pfizer-BioNTech COVID-19 vaccines to individuals 18 years of age and older,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “Streamlining the eligibility criteria and making booster doses available to all individuals 18 years of age and older will also help to eliminate confusion about who may receive a booster dose and ensure booster doses are available to all who may need one.”

Data Supporting Effectiveness

The EUA for a single booster dose for individuals 18 years of age and older for the Moderna (administered as half of the dose of a primary series dose) and Pfizer-BioNTech COVID-19 vaccines is based on the FDA’s analysis of immune response data that supported use in the previously authorized populations for boosters.

For the Moderna COVID-19 Vaccine booster dose, the FDA analyzed the immune response data from 149 participants 18 years of age and older from the original clinical studies who received a booster dose at least six months after their second dose and compared it to the immune responses of 1,055 study participants after completing their two-dose series. The antibody response against the SARS-CoV-2 virus 29 days after a booster dose of the vaccine demonstrated a booster response.

For the Pfizer-BioNTech COVID-19 Vaccine booster dose, the FDA analyzed the immune response data from approximately 200 participants 18 through 55 years of age who received a single booster dose about six months after their second dose. The antibody response against the SARS-CoV-2 virus one month after a booster dose of the vaccine when compared to the response one month after the two-dose primary series in the same individuals demonstrated a booster response.

FDA Evaluation of Benefits and Risks

Since Moderna and Pfizer-BioNTech initially submitted safety and effectiveness data on a single booster dose following primary vaccination to the FDA, additional real-world data have become available on the recently increasing number of cases of COVID-19 in the U.S. and on the risk of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the outer lining of the heart) following vaccination with these vaccines. These additional data enabled the FDA to reassess the benefits and risks of the use of these vaccines in the general adult population. The FDA has determined that the benefits of a single booster dose of either the Moderna or Pfizer-BioNTech COVID-19 vaccines outweigh the risks of myocarditis and pericarditis in individuals age 18 years of age and older when used following completion of primary vaccination to provide continued protection against COVID-19 and the associated serious consequences that can occur including hospitalization and death.

Both Pfizer and Moderna are conducting post-authorization/post-marketing studies to assess known serious risks of myocarditis and pericarditis. In addition, the FDA and the CDC have several systems in place to continually monitor COVID-19 vaccine safety and allow for the rapid detection and investigation of potential safety concerns.

The fact sheets for both vaccines for recipients and caregivers and for healthcare providers contain information about the potential side effects, including the risk of myocarditis and pericarditis. The most commonly reported side effects by individuals who received a booster dose of the vaccines were pain, redness and swelling at the injection site, as well as fatigue, headache, muscle or joint pain and chills. Of note, swollen lymph nodes in the underarm were observed more frequently following the booster dose than after the primary two-dose series.

The FDA did not hold a meeting of the Vaccines and Related Biological Products Advisory Committee on these actions as the agency previously convened the committee for extensive discussions regarding the use of booster doses of COVID-19 vaccines and, after review of both Pfizer’s and Moderna’s EUA requests, the FDA concluded that the requests do not raise questions that would benefit from additional discussion by committee members.

The amendments to the EUAs were granted to ModernaTX Inc. and Pfizer Inc.

News

COVID Booster Eligibility Update

November 16, 2021 Mike Smith

Presented By Classic Brands

As many of the first people to take the COVID-19 vaccinations approach the one year mark, questions arise as to when or if those fully vaccinated people should receive a booster shot.

The Centers For Disease Control along with U.S. Food & Drug Administration of approved the booster for some age groups and health risk groups.

The Ohio Department of Health has provided a chart that goes along with current CDC guidelines as of November 16th, 2021.

(See Guideline Graph Below)

Contact your local health department or physician if you have questions on the current booster recommendations.

The FDA could expand this booster shot recommendation to lower age groups, but has not made a determination on that as of the date of this report.

Uncategorized

FDA Gives Full Approval To Pfizer COVID-19 Vaccine For Age 16 & Up

August 23, 2021 Mike Smith

Presented By Hometown-Motors, Inc.

(Washington D.C.) — The U.S. Food and Drug Administration has given full approval of 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.

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.

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.

Uncategorized

FDA Pauses Use of Johnson & Johnson COVID-19 Vaccine

April 13, 2021 Mike Smith

Presented By Atomic Speedway

UPDATED 3pm (4/13/21)

(COLUMBUS)—Today (4/13/21) Governor Mike DeWine, Ohio Department of Health Director Stephanie McCloud, and Ohio Department of Health Chief Medical Officer Bruce Vanderhoff, M.D., are advising all Ohio vaccine providers to temporarily pause using the Johnson and Johnson (Janssen) vaccine.

This is in response to a statement by the Food and Drug Administration (FDA) and the Centers for Disease Control (CDC) recommending a pause in the use of the Johnson and Johnson vaccine following extremely rare blood-clotting events of six people in the U.S. after receiving the vaccine. Those problems occurred within 6-13 days of the six individuals receiving the shot.

Over 200,000 Ohioans have already received the J&J shot, and the Governor says he’s been told by the White House that the pause on using the Johnson & Johnson vaccine will likely be “days instead of weeks.”

The CDC will convene a meeting of the Advisory Committee on Immunization Practices Wednesday to further review these cases.

Officials with the Ohio Department of Health are following this situation closely.

The directive from the FDA and CDC appeared on FDA’s Twitter.

“We are recommending a pause in the use of this vaccine out of an abundance of caution.”

Federal officials say further “As of 4/12, 6.8m+ doses of the J&J vaccine have been administered in the U.S. CDC & FDA are reviewing data involving 6 reported U.S. cases of a rare & severe type of blood clot in individuals after receiving the vaccine. Right now, these adverse events appear to be extremely rare. Treatment of this specific type of blood clot is different from the treatment that might typically be administered.”

CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance. FDA will review that analysis as it also investigates these cases.

“Until that process is complete, we are recommending this pause. This is important to ensure that the health care provider community is aware of the potential for these adverse events and can plan due to the unique treatment required with this type of blood clot.”

In Ross County, Adena Health System is stopping its Johnson & Johnson COVD-19 vaccines following Food and Drug Administration (FDA), Centers for Disease Control (CDC) and the Ohio Department of Health (ODH) guidance.

Spokeperson Jason Gilham said “We will be continuing our mass vaccination clinic appointments for this week Wednesday through Friday using the Moderna vaccine and scheduling those individuals for their second appointments. Anyone scheduled at the Adena PACCAR Medical Education Center mass vaccination clinic this week will receive a call from ODH regarding the change from Johnson & Johnson to Moderna vaccines with the option if they want to keep their appointment.”