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John Parkinson

The Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) panel voted to recommend the Pfizer-BioNTech vaccine in the 5 to 11 year old pediatric population.

The panel voted on the following question:

Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech COVID-19 vaccine when administered as a 2-dose series (10 µg each dose, three weeks apart) outweigh its risk for use in children 5-11 years of age.

Seventeen members voted yes and 1 member voted to abstain. 

The VRBPAC recommendation today was the first step in paving the way for younger children to get the first series of COVID-19 vaccines as this population has not been eligible for any vaccines yet.

Although no timetable has been set for the FDA to decide on an official EUA, recent history demonstrates a decision will happen soon.

 to the FDA prior to today’s meeting showed that 2 10 µg doses of the Pfizer-BioNTech vaccine to be 90.7% effective in children older than 5 and younger than 12.

There were no cases of severe COVID-19 and no cases of MIS-C reported as of the 3-month follow-up period after the second vaccine.

The reactogenicity profile of this age group was mild to moderate; most events arose 1-2 days after vaccination and dissipated soon after. The most common side effects were injection site pain, fatigue, headache, muscle pain, and chills. The adverse event (AE) profile post-vaccination mostly reflected reactogenicity. No serious AEs related to the vaccine were reported.

The meeting today highlighted the data and safety concerns associated with myocarditis risks.

In the morning, the Centers for Disease Control and Prevention (CDC) presented on the epidemiology of COVID-19 in children, followed by the known safety signals of vaccines in adolescents and young adults.

Mathew Oster, MD, MPH, CDC COVID-19 Response CDC Center on Birth Defects and Developmental Disabilities Pediatric Cardiologist, Sibley Heart Center, Children’s Healthcare of Atlanta Emory University School of Medicine and Rollins School of Public Health, presented on the known safety signals (Myocarditis in adolescents and young adults). During his presentation, Oster said most myocarditis was seen in MIC-S cases due to COVID-19. He also pointed out that not all myocarditis cases are the same when looking at patients who presented with myocarditis during the pre-COVID-19 era, patients with MIC-S, and patients with COVID-19 vaccine-related myocarditis.

In one study looking at COVID-19 vaccination-associated myocarditis in adolescents there were 54 cases with the mean age being 15.6 years old and 92% were male. Seven of them had persistent symptoms. Electrocardiogram showed 80% were normal.

Oster pointed out that myocarditis overall is a “rare but important adverse event following COVID-19 vaccination.” He said medical providers are following-up and early follow-up results of COVID-19 vaccine-associated myocarditis is sparse.

William Gruber, MD, FAAP, FIDSA, FPIDS senior vice president, Vaccine Clinical Res. And Development, Pfizer, presented findings of their data looking at administration of their COVID-19 vaccine. Gruber said immunobridging success criteria were met. The Pfizer-BioNTech vaccine “effectively neutralized both the USA-WA12020 (reference strain) and the highly transmissible B.617.2 (Delta) variant of concern.” He went on to say in the presentation that the vaccine as a 2-dose series, “is highly protective against COVID-19 in 5 to <12 year-olds when Delta variant was prominent.”

In terms of safety, there were no cases of anaphylaxis, 

/pericarditis, Bell’s palsy, or appendicitis were witnessed in the this study through the 3 months of follow-up after the second dose.

Reactogenicity was mostly mild to moderate, and short lived. The investigators observed mild to moderate local reactions (redness, swelling) captured by e-diary were more common and system reactions (including fever) less common than those 16-25 year olds.

Gruber said the observed AE profile in this study, “did not suggest any safety concerns for BNT162b2 vaccination in children 5 to <12 years of age.”

The FDA reviewed the Pfizer-BioNTech vaccine submission and presented post-authorization evaluation and a benefit-risk analysis.

There was a public comment portion of the meeting and a question and answer session for the committee in the afternoon.

In the committee discussion there was a debate about whether to modify the question to possibly look at just offering the EUA to kids within specific populations within this age group.  

After this, the committee voted on whether or not to recommend the EUA.

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This recommendation was based off of data showing the vaccine was 90% efficacious in this population, and sets the stage for the first COVID-19 vaccine in the age group. 

FDA VRBPAC Votes to Recommend Pfizer-BioNTech COVID-19 Vaccine in 5 to 11 Year Olds

The Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) panel is meeting today to discuss whether or not to recommend an Emergency Use Authorization (EUA) for the Pfizer-BioNTech vaccine in the 5 to 11 year old pediatric population.

The meeting will include a presentation by Pfizer who will be discussing data on their COVID-19 vaccine series in this age group.

The Centers for Disease Control and Prevention (CDC) will be presenting on the epidemiology of COVID-19 in children, followed by the known safety signals of vaccines in adolescents and young adults.

The FDA will review the Pfizer-BioNTech vaccine submission and present post-authorization evaluation and a benefit-risk analysis.

There will be a public comment portion of the meeting and a question and answer session for the committee in the afternoon.

After this, the committee will take a vote on whether or not to recommend the EUA. Check back later today when the committee votes.

The committee is meeting today to review the data presented to them, and will vote to either recommend or not an Emergency Use Authorization in this pediatric population. 

FDA VRBPAC Meeting Today to Discuss the Pfizer-BioNTech COVID-19 Vaccine in 5 to 11 Year Olds

The Biden Administration announced today it had secured enough of the Pfizer-BioNTech vaccine for the US pediatric population to roll out vaccinations to 5 to 11-year-old children.

“Today the Biden Administration is announcing a plan to ensure that, if a vaccine is authorized for children ages 5-11, it is quickly distributed and made conveniently and equitably available to families across the country,” the White House said in a statement.

The timeline for upcoming meetings by the Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) have been set and both will discuss and review data regarding this age group. The FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting is set for October 26 and open to the public.

The CDC is planning back-to-back meetings on November 2-3 to weigh the FDA’s recommendations.

Assuming the FDA approves the Pfizer-BioNTech vaccine in this age group and the CDC also recommends it, the rollout for vaccinations in children ages 5 to 11 years could begin in early November.

“Millions of adolescents ages 12-17 have been safely vaccinated, and we know vaccines work,” the White House said in a statement. “Fully vaccinated individuals are 10 times less likely to be hospitalized with COVID-19 and have a high degree of protection, including against the Delta variant. The consequences of a pediatric COVID-19 case can be serious and potentially last months.”

The White House said it has secured enough of the Pfizer-BioNTech vaccine supply to offer vaccinations for everyone in this age group. 


Biden Administration Announces Plans for COVID-19 Vaccines for 5 to 11 Year Olds

During the early days of the COVID-19 pandemic, some hospitalized patients with severe cases of the virus had their medical conditions deteriorate badly to the point it created massive inflammation and they experienced the cytokine storm.

When these patients began to suffer the effects of this overwhelming inflammation, they might succumb to it. Since the emergence of the COVID-19 related cytokine storm, clinicians have tried avoiding it and biotechnology companies have been trying to address it with therapies and medical devices.

San Diego-based Sigyn Therapeutics has developed its Sigyn Therapy, which is a novel blood purification technology, to address the viral pathogens and bacterial toxins of the cytokine storm in concert with the depletion of inflammatory cytokines from the bloodstream. Sigyn is looking to addressing the cytokine storm that underlies sepsis, especially as clinicians understand the gravity of sepsis because it remains the greatest cause of inpatient mortality. 

Sigyn Therapy is a single-use (blood-in-blood-out) disposable device designed for use on the existing infrastructure of hemodialysis and continuous renal replacement therapy machines currently being deployed in care facilities. The device does not require additional infrastructure such as pumps or separation cartridges, and is compatible with industry-standard connectors and blood tubing sets.

Sigyn Therapeutics Co-founder and CEO Jim Joyce believes blood purification devices can either be designed to go beyond the reach of medications, or in some cases, augment the benefits of drug therapies.

Prior to starting his current company, Joyce founded another company in the field and has testified before Congress on issues related to Project BioShield legislation and the deployment of broad-spectrum blood devices as countermeasures against biological weapons. His efforts were instrumental in expanding the definition of treatment countermeasure in Project BioShield legislation to include medical devices.

 spoke to Joyce who provided further insights about his company's medical device, results from their studies thus far, and his work on Project BioShield legislation. 

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The company’s current investigational medical device, Sigyn Therapy, is a novel medical device that is being studied for addressing viral pathogens and bacterial toxins to avoid this massive inflammation onslaught and the potential of sepsis.