IN-DEPTH

COVID-19 Update

The World at a Glance: According to the World Health Organization (WHO) Director-General Tedros Adhanom Ghebreyesus, Omicron variants BA.4 and BA.5 is spreading in 110 countries. Per the New York Times, 57 countries are reporting a 14-day increase in reported case counts above 100% with Bangladesh, the Maldives, Albania, and Kosovo reporting the greatest percentage increase as of June 30. The number of daily COVID-19 related deaths has decreased 15% since last month with an average of 1,470 deaths per day.

The World Trade Organization (WTO) adopted a Vaccine-Patent waiver to limit intellectual property restrictions for the manufacturing of COVID-19 vaccines.

The United States at a Glance: According to the Centers for Disease Control and Prevention’s (CDC’s) COVID-19 weekly reports, as of June 22, the seven-day moving average of new cases (97,430) decreased slightly (5.6%) compared to the previous seven-day moving average (103,175). This trend is consistent with data from earlier this month and May, with reported cases remaining relatively stable. Similar trends can be seen for hospitalizations (4,375 seven-day average for June 15-21; 1.0% increase from the prior seven-day average), and deaths (255 7-day moving average; 10.4% decrease from the prior seven-day moving average). COVID-19 community levels have been declining in the Northeast as well as Midwest and is on the rise in the Southeast and the West, with cases in Mississippi having doubled over June.

On June 8, the White House announced the redirection of $5 billion dollars previously earmarked for testing and protective equipment to go towards the procurement of COVID-19 vaccines. An additional $4.9 billion will be redirected to purchase courses of Paxlovid and another $300,000 will be used for monoclonal antibody treatments.

The Biden administration laid out a plan for the distribution of low-dose vaccines on June 9, for children age six months to five years, the last major group of Americans to get inoculated. The CDC’s Public Health Communications Collaborative (PHSCC) has updated its messaging toolkit on COVID-19 vaccination for children six months and older.
 

Therapeutics Update

On June 7, the US Federal Food and Drug Administration’s (FDA's) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted to recommend Novavax's vaccine (two doses, 21 days apart) for use in the US. Novavax had informed the agency of changes to its manufacturing process on June 3 days before the committee was scheduled to review its vaccine's safety and efficacy data. The FDA will consider VRBPAC’s recommendation when authorizing the Novavax vaccine, which may delay authorization of the Novavax vaccine. VRBPAC's June 28 meeting included a presentation by Novavax, whose materials can be accessed here.

Laboratory Corporation of America's (Labcorp) newest COVID-19 test, VirSeq SARS-CoV-2 NGS Test on the PacBio Sequel II sequencing system, was issued an Emergency Use Authorization (EUA) by the FDA on June 10. The new test is authorized for the identification and differentiation of global strains of the virus. It is intended for use by clinical laboratory personnel trained in the operation of the PacBio Sequel 2 sequencing system and should be used in conjunction with patient medical history and other diagnostic information to determine appropriate clinical management. 

The Office of Assistant Secretary for Preparedness and Response (ASPR) and the FDA announced an authorization of an extension to the shelf-life from 18 to 24 months on June 28 for specific lots of the refrigerated AstraZeneca monoclonal antibody therapy, Evusheld  (tixagevimab co-packaged with cilgavimab), which is currently authorized for emergency use for pre-exposure prophylaxis of COVID-19 in certain adults and pediatric individuals. As a result of the extension, some batches of Evusheld may be stored for an additional six months from the labeled expiration date. The FDA and ASPR have also announced the authorization of an extension to the shelf-life from 24 months to 30 months for specific lots of refrigerated Regeneron monoclonal antibody therapy, REGEN-COV (casirivimab and imdevimab, administered together). Due to the high frequency of the omicron variant and sub-variants, REGEN-COV is not currently authorized for the treatment or prevention of COVID-19.
 

Supply Chain Update

On June 2, the Biden Administration announced $368 million in government grants to strengthen and boost rail-based transport. Under the Consolidated Rail Infrastructure and Safety Improvement (CRSI) grant program, funds will be routed to support 46 projects in 32 states and the District of Columbia (DC), as confirmed by the Federal Railroad Administration (FRA).
  
GE Healthcare, a subsidiary of American conglomerate General Electric, has stabilized the production of Iodinated (IV) Contrast Media at its Shanghai, China, facility as of June 6 and is resuming normal production and shipping. GE plans to work with affected customers as supply progressively recovers.
 
On June 7, MITRE unveiled its new "System of Trust" (SoT) Framework to provide a comprehensive knowledge of the supply chain and security-risk assessment process at the RSA Conference 2022. The open-source framework will help entities identify, discuss, and quantify the risks in major supply chains, including risk assessment of suppliers and software. 
 
On June 21, President Biden signed the Ocean Shipping Reform Act into law. This bars imports in part or in full from Xinjiang unless companies prove that their supply chain and manufacturing capacity do not include elements of forced labor practices. The law may present a risk of supply chain disruption as reduced imports into the US from China may lead to price surges of products as companies seek alternate sources of manufacturing, or from certain product shortages on the US market. The second part of the law regulates the bi-directional movement of goods, requiring shippers to load up on China-bound exports instead of returning to China empty-handed, a practice that may further affect maritime trade and the movement of goods.
 

Public Health and Community Engagement  

Public Health
On June 24, the Supreme Court overturned Roe v. Wade ending the federal protection of abortion access. This historic ruling has widespread implications to the public health system by shifting decisions around abortion access to state and local governments, limiting safe access to healthcare.

The WHO ruled that the Monkeypox outbreak does not yet classify as a global health emergency.  Nevertheless, as monkeypox continues to spread, the CDC is maintaining a Level 2 Alert asking individuals to practice enhanced precautions. As of June 30, there are 396 confirmed cases of monkeypox in the US as the global count rises above 5,300. The monkeypox virus is present in 49 countries, an eight-location increase since June 17. The WHO started creating a new smallpox vaccine-sharing platform in mid-June to better contain the outbreak of monkeypox. In more than 30 countries out of Africa that are reporting cases the smallpox vaccines are 85% effective against monkeypox.

On June 30, the Supreme Court limited the Environmental Protection Agency’s ability to regulate carbon emissions from power plants. With a 6 to 3 vote, the court diminished the Biden administration’s work to set emissions standards and caps. According to CNN, anthropogenic climate change causes deadlier extreme weather events, worsened water crises, increases in food insecurity, and higher rates of disease spread.


 

Public Health and Community Engagement Continued 

The Senate passed the first major federal gun safety legislation allocating money for mental healthcare and altering age requirements and background checks for those looking to purchase guns. As a newly classified public health issue, gun violence and safety has not been federally regulated in such a way until now. The goals are to implement red flag laws and other safety measures to cut down on gun death rates.

The tampon and period product shortage, coupled with rising inflation, remains a concern as it continues to affect menstrual hygiene and public health.

Community Engagement 
On June 10, the Secretary of US Department of Health and Human Services (HHS) Xavier Becerra restated HHS’ commitment to support and protect the LGBTQI+ community from discrimination in certain states. Several action documents were released earlier this year that includes a guidance on child welfare systems to support LGBTQI+ youth, and a notice on gender affirming care, civil rights, and patient privacy.

LOOKING BACK

Earlier this year, Trust for America’s Health (TFAH) released their Ready or Not 2022: Protecting the Public’s Health from Diseases, Disasters, and Bioterrorism report, which measures states’ level of preparedness to effectively respond to various emergencies or disasters. In late April, TFAH gave a congressional briefing and national webinar to present key findings and recommendations. 

Earlier this month, the US Government Accountability Office (GAO) released a report titled COVID-19, Pandemic Lessons Highlight Need for Public Health Situational Awareness Network. This report reflects on the challenges associated with real-time situational awareness experienced during the pandemic and provides recommendations on ways to support national information sharing.
 

LOOKING AHEAD

On July 1, under Title 32 of the US Code, the federal funding for the National Guard to support the whole-of-America response to COVID-19 is transitioning to State Active Duty (SAD). After July 1,  governors may still activate National Guard personnel to SAD as necessary for ongoing COVID-19 response and may receive reimbursement from FEMA's Public Assistance (PA) program at a 90 percent federal cost-share.

July is Extreme Heat Safety Month. Last year, the National Oceanic and Atmospheric Administration (NOAA) reported that July was the world’s hottest month ever recorded. Be sure to prepare for the anticipated upcoming heat and read how you can stay safe.

The National Association of Community Health Centers is hosting their 2022 Community Health Institute in August. The event is one of the largest gatherings of health center clinicians, executives, consumer board members, and State/Regional Primary Care Associations, many of whom are being called upon to assume a larger role in the nation’s health care system. Registration is now open.  

On June 28, FDA announced they are working with Abbott Nutrition in Ireland to ship approximately 35,000 pounds of infant formula (Similac Advance 2’-FL Stage 1) to the US by mid-July. FDA continues to leverage flexibilities in order to bolster the supply of formula products.

On Tuesday, June 21, House Speaker Nancy Pelosi and Senate Majority Leader Chuck Schumer released a statement mentioning that COMPETES/USICA should pass in July. Both COMPETES and USICA contain significant sections related to the pandemic and other disaster preparedness, as well as supply chain resilience including the reimbursable transfers, efforts to enhance medical supply chain elasticity, efforts to maintain domestic reserves of critical medical supplies, and more.

IN CASE YOU MISSED IT

COVID-19

• FDA recommends including omicron subvariants BA4 and BA5 in fall COVID booster (NBC News)
• CDC clears the way for vaccinations for children 6 months to 5 years old (NPR)
• Advisor to the FDA back COVID vaccines for the youngest children (NPR)

Preparedness

• Beyond the pandemic: mitigated supply chain risk and disruption (NBC News)
• President Joseph R. Biden, Jr. approves major disaster declaration for Oklahoma (FEMA)
• FEMA modernizes mobile app to increase accessibility and improve user experience (FEMA)
• President Joseph R. Biden approves major disaster declaration for South Dakota (FEMA)

Disaster Response & Recovery

• Biden says FEMA will cover 100% of wildfire recovery costs during trip to New Mexico (CBS News)
• US officials announce more steps to combat monkeypox outbreak (CBS News)
• Improving weather aids fight against Sierra Nevada wildfire (US News)
• Some cities nix July 4 fireworks for shortages, fire dangers (US News)

Public Health

• Monkeypox outbreak in US is bigger than the CDC reports. testing is 'abysmal' (NPR)
• WIC benefits not able to be used to purchase baby formula online (CNN)

UPCOMING EVENTS

FY 2022 Regional Catastrophic Preparedness Grant Program Outreach Webinar (FEMA)