Category: Federal Government Actions

CDC Issues Warning Over Invasive Strep A Cases (December 28, 2022)

The Centers for Disease Control and Prevention (CDC) is looking into an increase in invasive group A strep (iGAS) infections among children in the United States. iGAS infections include necrotizing fasciitis and streptococcal toxic shock syndrome.

Strep A is a type of bacteria that can cause a illnesses such as strep throat, scarlet fever, and skin infections. Strep A cases that involve an invasive form of strep A result in bacteria spreading to parts of the body that are not typically affected. In fact, according to a December 22, 2022 CDC warning cases in which the bloodstream becomes involved can cause severe and even fatal illness and must be immediately treated with antibiotics.

The CDC recommends that parents and other family members should:

To view the CDC warning, click here.

To view additional info from the CDC, click here.

FDA authorizes updated (bivalent) COVID-19 vaccines for children down to 6 months of age (December 8, 2022)

On December 8, 2022 the U.S. Food and Drug Administration (FDA) amended the emergency use authorizations (EUAs) of the updated (bivalent) Moderna and Pfizer-BioNTech COVID-19 vaccines to include use in children down to 6 months of age. 

“More children now have the opportunity to update their protection against COVID-19 with a bivalent COVID-19 vaccine, and we encourage parents and caregivers of those eligible to consider doing so – especially as we head into the holidays and winter months where more time will be spent indoors,” said FDA Commissioner Robert M. Califf, M.D. “As this virus has changed, and immunity from previous COVID-19 vaccination wanes, the more people who keep up to date on COVID-19 vaccinations, the more benefit there will be for individuals, families and public health by helping prevent severe illnesses, hospitalizations, and deaths.”

What parents and caregivers need to know:

  • Children 6 months through 5 years of age who received the original (monovalent) Moderna COVID-19 Vaccine are now eligible to receive a single booster of the updated (bivalent) Moderna COVID-19 Vaccine two months after completing a primary series with the monovalent Moderna COVID-19 Vaccine.
  • Children 6 months through 4 years of age who have not yet begun their three-dose primary series of the Pfizer-BioNTech COVID-19 Vaccine or have not yet received the third dose of their primary series will now receive the updated (bivalent) Pfizer-BioNTech COVID-19 vaccine as the third dose in their primary series following two doses of the original (monovalent) Pfizer-BioNTech COVID-19 Vaccine.
  • Children 6 months through 4 years of age who have already completed their three-dose primary series with the original (monovalent) Pfizer-BioNTech COVID-19 Vaccine will not be eligible for a booster dose of an updated bivalent vaccine at this time. Children in this age group who already completed their primary series would still be expected to have protection against the most serious outcomes from the currently circulating omicron variant. The data to support giving an updated bivalent booster dose for these children are expected in January. The agency is committed to evaluating those data as quickly as possible.
  • The Moderna and Pfizer-BioNTech bivalent COVID-19 vaccines include an mRNA component corresponding to the original strain to provide an immune response that is broadly protective against COVID-19 and an mRNA component corresponding to the omicron variant BA.4 and BA.5 lineages to provide better protection against COVID-19 caused by the omicron variant. 
  • Individuals who receive the updated (bivalent) vaccines may experience similar side effects reported by individuals who received previous doses of the original (monovalent) mRNA COVID-19 vaccines.
  • The fact sheets for both bivalent COVID-19 vaccines for recipients and caregivers and for healthcare providers include information about the potential side effects, as well as the risks of myocarditis and pericarditis. 

“Vaccines remain the best defense against the most devastating consequences of disease caused by the currently circulating omicron variant, such as hospitalization and death. Based on available data, the updated, bivalent vaccines are expected to provide increased protection against COVID-19,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “Parents and caregivers can be assured that the FDA has taken a great deal of care in our review, and we encourage parents of children of any age who are eligible for primary vaccination or a bivalent COVID-19 vaccine booster dose to consider seeking vaccination now as it can potentially help protect them from COVID-19 during a time when cases are increasing.”

Moderna COVID-19 Vaccine, Bivalent

The monovalent Moderna COVID-19 Vaccine is authorized as a two-dose primary series in individuals six months of age and older and as a third primary series dose for individuals 6 months of age and older who have been determined to have certain kinds of immunocompromise. With this authorization, the Moderna COVID-19 Vaccine, Bivalent is now authorized for administration in individuals 6 months through 5 years of age as a single booster dose at least 2 months after completion of primary vaccination with the monovalent Moderna COVID-19 Vaccine.  The Moderna COVID-19 Vaccine, Bivalent is also authorized for use in individuals 6 years and older as a single booster dose at least two months after completion of either primary vaccination with any authorized or approved COVID-19 vaccine, or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine.

For the authorization of a single booster dose of the Moderna COVID-19 Vaccine, Bivalent for children 6 months through 5 years of age, the FDA relied on immune response data that it had previously evaluated from a clinical study in adults of a booster dose of Moderna’s investigational bivalent COVID-19 vaccine that contained a component corresponding to the original strain of SARS-CoV-2 and a component corresponding to the omicron lineage BA.1. 

In addition, the FDA conducted an analysis of data from a clinical study that compared the immune response among 56 study participants 17 months through 5 years of age who received a single booster dose of monovalent Moderna COVID-19 Vaccine at least six months after completion of a two-dose primary series of the vaccine to the immune response among approximately 300 study participants 18 through 25 years of age who had received a two-dose primary series of monovalent Moderna COVID-19 Vaccine in a previous study which determined the vaccine to be effective in preventing COVID-19. The immune response to the booster dose of monovalent Moderna COVID-19 Vaccine in the 17 months through 5 years age group was comparable to the immune response to the two-dose primary series in the adult participants. 

The safety of a single booster dose of the Moderna COVID-19 Vaccine, Bivalent for children 6 months through 5 years of age is supported by safety data from a clinical study which evaluated a booster dose of Moderna’s investigational bivalent COVID-19 vaccine (original and omicron BA.1), safety data from clinical trials which evaluated primary and booster vaccination with the monovalent Moderna COVID-19 Vaccine, and postmarketing safety data with the monovalent Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine, Bivalent. 

In one clinical study, the safety of a single booster dose of monovalent Moderna COVID-19 Vaccine was evaluated in 145 clinical study participants 6 months through 5 years of age who received a booster dose of monovalent Moderna COVID-19 Vaccine at least six months after completion of the monovalent Moderna COVID-19 Vaccine two-dose primary series.  The most commonly reported side effects after a booster dose of the monovalent Moderna COVID-19 Vaccine across this age group included pain, redness and swelling at the injection site, swelling/tenderness of the lymph nodes of the injected arm or thigh, and fever. In clinical study participants 17 months through 36 months of age, other commonly reported side effects included irritability/crying, sleepiness, and loss of appetite. In clinical trial participants 37 months through 5 years of age, other commonly reported side effects included fatigue, headache, muscle pain, joint pain, chills, and nausea/vomiting.

The data accrued with the investigational Moderna bivalent COVID-19 vaccine (original and omicron BA.1) and with the monovalent Moderna COVID-19 Vaccine are relevant to the Moderna COVID-19 Vaccine, Bivalent because these vaccines are manufactured using the same process.

Pfizer-BioNTech COVID-19 Vaccine, Bivalent

With this authorization, children 6 months through 4 years of age who have not yet received the third dose of the three-dose primary series with the monovalent Pfizer-BioNTech COVID-19 Vaccine will now receive the Pfizer-BioNTech COVID-19 Vaccine, Bivalent as the third dose of the primary series. The Pfizer-BioNTech COVID-19 Vaccine, Bivalent is also authorized for administration in individuals 5 years of age and older as a single booster dose at least two months after completion of either primary vaccination with any authorized or approved COVID-19 vaccine, or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. 

With this action, the monovalent Pfizer-BioNTech COVID-19 Vaccine is no longer authorized for use as the third dose of the three-dose primary series in children 6 months through 4 years of age. The monovalent Pfizer-BioNTech COVID-19 Vaccine remains authorized for administration as the first two doses of the three-dose primary series in individuals 6 months through 4 years of age, as a two-dose primary series for individuals 5 years of age and older, and as a third primary series dose for individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise. 

The authorization of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent for administration as the third dose of a three-dose primary series following two doses of the monovalent Pfizer-BioNTech COVID-19 Vaccine in children 6 months through 4 years of age is supported by the FDA’s previous analyses of the effectiveness of primary vaccination with the monovalent Pfizer-BioNTech COVID-19 Vaccine in individuals 16 years of age and older and individuals 6 months through 4 years of age, and previous analyses of immune response data in adults greater than 55 years of age who had received a two-dose primary series and one booster dose with the monovalent Pfizer-BioNTech COVID-19 Vaccine and a second booster dose with the investigational Pfizer-BioNTech bivalent COVID-19 vaccine (original and omicron BA.1).

The safety of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent for administration as the third dose of a three-dose primary series following two doses of the monovalent Pfizer-BioNTech COVID-19 Vaccine in children 6 months through 4 years of age is based on safety data from a clinical study which evaluated a booster dose of Pfizer-BioNTech’s investigational bivalent COVID-19 vaccine (original and omicron BA.1) in individuals greater than 55 years of age, safety data from clinical trials which evaluated primary vaccination in individuals 6 months of age and older with the monovalent Pfizer-BioNTech COVID-19 Vaccine, safety data from clinical trials which evaluated booster vaccination in individuals 5 years of age and older with the monovalent Pfizer-BioNTech COVID-19 Vaccine and postmarketing safety data with the monovalent Pfizer-BioNTech COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent. 

The data accrued with the investigational Pfizer-BioNTech bivalent COVID-19 vaccine (original and omicron BA.1) and with the monovalent Pfizer-BioNTech COVID-19 Vaccine are relevant to the Pfizer-BioNTech COVID 19 Vaccine, Bivalent because these vaccines are manufactured using the same process.

The amendments to the EUAs were issued to Moderna TX Inc. and Pfizer Inc.

USDE, DOJ, and HHS Release First Report to Congress as Part of the Interagency Task Force on Sexual Violence in Education (December 6, 2022)

The Interagency Task Force on Sexual Violence in Education (Task Force), created by the Violence Against Women Act Reauthorization Act of 2022 (VAWA 2022 Reauthorization), presented its first report to Congress today. As required by the VAWA 2022 Reauthorization, the report focuses on recruiting, retaining, and training the U.S. Department of Education’s highly qualified workforce who investigate complaints and enforce Title IX of the Education Amendments of 1972 (Title IX) and section 485(f) of the Higher Education Act of 1965 (Clery Act). The reauthorization of VAWA and the work of this Task Force continue a long commitment to action by President Biden, who was the primary Senate sponsor of the original Violence Against Women Act, which was enacted in 1994.

The Task Force, which includes the USDE, U.S. Department of Health and Human Services (HHS), and U.S. Department of Justice (DOJ), was established on Sept. 1, 2022. The VAWA 2022 Reauthorization required the Task Force’s first report to be completed by Nov. 30, 2022, which is no later than 90 days after the Task Force’s establishment.

“The Department of Education is fully committed to ensuring that every student has the right to learn in a safe environment free from harassment and sexual violence,” said U.S. Secretary of Education Miguel Cardona.

“Sexual violence prevention, particularly in educational settings, is critical,” said U.S. Secretary of Health and Human Services Xavier Becerra. “This report is the first step to providing critical information about gaps in federal law enforcement and resources. HHS looks forward to working across the federal government to advance trauma-informed health care and advocacy services for survivors.”

As required by Congress, the report provides information from the USDE’s Office for Civil Rights (OCR) and the Clery Group within the office of Federal Student Aid on the following topics:

  1. An assessment to identify gaps or challenges in carrying out such investigation and enforcement, which may include surveying the current investigative workforce to solicit feedback on areas in need of improvement.
  2. An examination of issues of recruiting, retention, and the professional development of the current investigative workforce, including the possibility of providing retention bonuses or other forms of compensation for the purpose of ensuring the USDE has the capacity, in both personnel and skills, needed to properly perform its mission and provide adequate oversight of educational institutions.
  3. An assessment of the benefits of outreach and training with both law enforcement agencies and educational institutions with respect to such workforce.
  4. An examination of best practices for making educational institutions aware of the most effective campus sexual violence prevention, investigation, and response practices and identifying areas where more research should be conducted. And,
  5. Strategies for addressing such other matters as the Secretary of Education considers necessary to sexual violence prevention, investigation, and responses.

In addressing the USDE’s work on best practices and strategies for preventing campus sexual violence, the report highlights a range of the Department’s programs, including its National Center on Safe Supportive Learning Environments (NCSSLE)’s recent Lessons from the Field webinars on engaging school communities in preventing gender-based violence. Both featured leaders of prevention programming who provided practical, ready-to-use strategies for preventing sexual violence and other gender-based violence on college and university campuses and in secondary schools.

A full copy of the report can be found here.

USDE Seeks Public Comment on Bipartisan Safer Communities Act Stronger Connections (November 25, 2022)

The U.S. Department of Education (USDE) is seeking public comment on Draft Bipartisan Safer Communities Act Stronger Connections Frequently Asked Questions – Nonregulatory Guidance (2022). As indicated in its title, the final document will provide nonregualtor guidance.

In the FAQs, the USDE outlines school violence prevention options under $1B Stronger Connections grant program Schools should take a comprehensive approach to violence prevention that includes not only improved safety measures but meets students’ physical, social, emotional, mental health and academic needs, according to a draft FAQ issued by the U.S. Department of Education for the $1 billion Stronger Connections grant program.  

A September 15, 2022 letter  to Chief State School Officers by U.S. Education Secretary Miguel Cardona provided  information regarding the prioritization of funding for school districts that focuses on poverty levels, as well as other circumstances based on the need to address student vulnerabilities.

The FAQs also provide recommendations for allowable activities under the grant.

The public is invited to provide feedback on the draft document by December 19, 2022.

The USDE will consider all comments in making revisions, as appropriate, but will
not provide individual responses to comments.

Submission Instructions include:
Send comments to: [email protected]
Subject line: Stronger Connections Grant Program FAQs Comments: Please submit succinct, substantive comments regarding the draft Bipartisan Safer Communities Act Stronger Connections Grant Program FAQs, which may include:
• Identifying questions or answers in the document, by question number, that you think are not clear and provide a suggestion for enhancing clarity; or
• Providing suggestions for enhancing the document overall, such as an unanswered question.

Special Olympics Honors Daniel Boone HS as a 2022 National Banner Unified Champion School (November 25, 2022)

The Daniel Boone Area High School has been selected as a 2022 National Banner Unified Champion School by Special Olympics.  This is a prestigious distinction that celebrates the “best of the best” inclusive school communities.  Daniel Boone High School is one of 110 schools throughout the country to receive this national honor for its efforts to make sure all students feel included and respected. It is also one of only three schools in Pennsylvania to be selected as a 2022 National Banner Unified Champion School.

In an interview with WFMZ Hannah Huddleson, a junior at Daniel Boone,  stated, “Our big word is ‘inclusion. We choose to include and just make sure that everybody’s unified.”

In addition, Daniel Boone Superintendent Brett Cooper said, “We developed a district vision. That vision is five simple words: ‘Learning together, advocating for all.'”

The high school has unified sports, where students of different abilities can compete, including a bocce team and track-and-field team. There’s also a unified ambassadors group made up of more than 100 students.

Congratulations to longtime PAPSA member Robert Hurley, Assistant to the Superintendent at Daniel Boone.

For more from WFMZ, click here.