Category: Government Actions

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.

PSSA Test Scores Continue to Fall Short of Pre-pandemic Levels (December 5, 2022)

On November 28th, the Pennsylvania Department of Education (PDE) released results from the 2021-2022 school year administration of state-level assessments: the Pennsylvania System of School Assessment (PSSA), Pennsylvania Alternate System of Assessment (PASA), and Keystone Exams. 

PSSA data from the 4th and 8th grades showed proficiency levels down between two and 10 points from 2019 to 2022 in language arts, math, and science. In 4th grade, proficiency in English and language arts was 52.2% compared to 63.3% in 2019. In science, proficiency was 73.7% compared to 77.8% in 2019. Math proficiency showed improvement, increasing to 42.3%. However, that is still below the 46.2% mark set in 2019.

In 8th grade, language arts proficiency was 55.6% compared to 57.9% in 2019. Science proficiency was 51.1% compared to 58.2% in 2019. Math proficiency was 22.6%, which is nearly 10 points below the 32.2% mark set in 2019.

The lower tests scores continue to be an effect of the pandemic.

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To view the PDE press release, click here.

Free COVID-19 Testing Offered at Select IUs in Preparation for Holiday Gatherings (November 29, 2022)

As people are preparing for holiday gatherings this season, the PA Department of Health (PDH) is offering free COVID-19 testing and take-home tests at nearly a dozen locations across the state.  

The testing is free and open to everyone. COVID-19 community-based testing sites are operated in partnership with AMI Expeditionary Healthcare (AMI) offering three forms of testing:    
-point of care tests where tests are performed and results are analyzed on-site,   
-distribution of at-home COVID-19 antigen tests, and   
-administration of the mid-nasal passage swab PCR testing.  

Individuals do not need to be experiencing symptoms of COVID-19 to be tested. Patients are encouraged to bring a photo ID, but ID is not required to be tested. Appointments are not necessary as registration will be completed on-site. 

Tests can be picked up at the following IUs: 1, 4, 5, 8, 10, 11, 14, 17, and 19

Gov. Wolf Announces $9 Million For Substance Use Disorder Crisis Stabilization Services (November 29, 2022)

On November 28, 2022, Governor Tom Wolf announced ​the availability of more than $9 million in state grant funding for Single County Authorities (SCAs) to establish or expand crisis stabilization services for individuals with co-occurring mental health and substance use disorders (SUD).

“The COVID-19 pandemic highlighted the need for enhanced and coordinated behavioral health services in Pennsylvania,” Gov. Wolf said. “This funding opportunity will make use of Pennsylvania’s share of the federal Opioid Distributor Settlement to build on our existing programs and initiatives.”

Grants of up to $3 million will be awarded to eligible SCAs and can be applied toward a range of activities including construction and building infrastructure, staffing, and programming.

“These grants will help expand or establish services to provide a much-needed component to the continuum of care; reduce the burden on first responders, law enforcement, and emergency departments, and provide timely care to individuals in need,” said state Department of Drug and Alcohol Programs (DDAP) Secretary Jen Smith.

The administration’s goal in offering this funding opportunity is to provide an additional mechanism for counties to invest in infrastructure, staffing, programming, and other necessary components to establish or expand crisis stabilization services.

SUD crisis stabilization services must have the capacity to recognize and manage individuals presenting with a wide range of SUD-related symptoms, mental health disorders, and developmental disabilities. Additionally, services include assessment and stabilization of acute physical and psychiatric symptoms which may include medical management and behavioral interventions, induction on medication-assisted treatment, level of care assessments, short-term stays, and connections to supportive services.

For more information on this Grant Initiative Funding Application, visit the Funding Opportunities page on the DDAP website. Applications must be submitted to [email protected] by 12 PM on Wednesday, December 28, 2022.

Questions regarding the funding and the application process should be emailed to [email protected]