COVID-19 Update
The World at a Glance: The number of daily deaths attributed to COVID-19 continues to decline, with a daily average of 1,696 deaths across the world. In the past two weeks, there has been a slight uptick in global cases as the virus spreads across Australia, Central America, and Europe. More specifically, Papua New Guinea, Mexico, and Namibia have all seen a 14-day change of greater then 1,000%. This is a concern, as many countries across the globe continue to approach a vaccinated population greater than 50%, except for Papua New Guinea and much of Africa.
United States at a Glance: The US has surpassed 1 million COVID deaths, the highest known total of any country. In May alone, the US accounted for almost 2 million more active COVID cases, and 6,000 deaths attributed to the disease. Currently, 91% of the US population ages 65+, 73% of those ages 18-64, and 59% of those ages 12-17 have been fully vaccinated. While only 29% of those ages 5-11 have been fully vaccinated in the US, the recently authorized emergency use authorization for a booster dose for individual ages 5-11 will encourage more parents to vaccinate their children.
U.S. residents can order eight more free at-home tests for COVID-19, the White House announced on May 17. People who have difficulty accessing the internet or need additional support can order the test by phone.
Emergency Use Operations News
The Food and Drug Administration (FDA) has amended the EUA for the Pfizer-BioNTech COVID-19 Vaccine, authorizing the use of a single booster dose for administration to individuals aged 5-11 at least 5 months after completion of the primary series vaccination. Additionally, the FDA has authorized the first COVID-19 Test available without a prescription that also tests for seasonal flu and RSV.
The FDA released a security communication urging not to use Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test, as it is not authorized, cleared, or approved by the FDA for distribution or use in the US.
Finally, the FDA has also limited the authorized use of the Janssen COVID-19 vaccine to patients 18 years and older for whom other authorized COVID-19 vaccines are not accessible or clinically appropriate, or those that choose to have the Janssen vaccine and would otherwise not receive the vaccine.
Therapeutics Update
As of May 4, the FDA has authorized the shelf-life extension for the monoclonal antibody (mAb) bamlanivimab from 18 to 24 months. The use of bamlanivimab and etesevimab are not currently authorized for use in the treatment or prevention of COVID-19 due to the high frequency of the Omicron variant. It is recommended that the product is retained for future use in the event that future variants are susceptible to bamlanivimab and etesevimab. Similarly, the FDA has previously authorized the shelf-life extension for sotrovimab from 12 to 18 months on September 21, 2021, and evaluation for future extensions are ongoing.
On May 10, the FDA approved Olumiant (baricitinib) for the treatment of COVID-19 in hospitalized adults that require supplemental oxygen. This is the first immunomodulatory treatment for COVID-19 to receive FDA approval, and the use of Olumiant for hospitalized patients 2 to 18 years of age is still under emergency use authorization status.
Supply Chain Update
The US Department of Health and Human Services released a report on May 9, 2022 titled, "Essential Medicines Supply Chain and Manufacturing Resilience Assessment." The report was compiled by HHS’s Office of the Assistant Secretary for Preparedness and Response (ASPR) and the Advanced Regenerative Manufacturing Institute (ARMI) / the Next Foundry for American Biotechnology (NextFAB). The report includes a prioritized list of medicines that the government can target for increased resilience and provides an assessment of current pharmaceutical supply chain challenges and vulnerabilities. The report is a byproduct of the Biden-Harris Administration’s 100-day supply chain review report. This report is also available for download here.
The US has experienced a shortage of infant formula supply since February 2022, due to several factors including ongoing supply chain constraints, product recalls and inflation concerns, as well as a limited manufacturing capacity by the nation’s three formula manufacturers, Abbott, Gerber, and Reckitt. In the past month, the US Government (USG) has taken several steps to assist in alleviating this issue. On Tuesday May 17, 2022, the FDA moved to temporarily allow manufacturers to import certain infant formula products into the US, as well as shifting the use of products that are manufactured in the U.S. but intended for the international market to assist in alleviating the shortage. On Wednesday May 18, 2022, President Biden invoked the Defense Production Act to compel suppliers to prioritize the production of infant formula. On Thursday May 19, the Senate approved the Access to Baby Formula Act by unanimous consent, ensuring low-income families can buy more types of formula.
Public Health and Community Engagement
Public Health
Monkeypox, a poxvirus which has symptoms including fever, body aches, chills, and swollen lymph nodes similar to those observed in smallpox cases, has been observed in countries that do not normally report the disease. These countries include the UK, Portugal, Spain, and other European countries, as well as the US. The strain of the disease in Europe is milder than expected, with a fatality rate of less than 1%. As of May 31, 2022, one case has been identified in Massachusetts, Virginia, and Washington, two cases have been identified in Utah, New York, and Colorado, and three cases have been identified in both California and Florida. This data was taken from the CDC Monkeypox Tracker, which is updated daily. At this time, the CDC says the risk to the general public remains low and there is no evidence that the virus has evolved to be more transmissible.
On Monday May 23, 2022, the CDC announced that the government is in the process of releasing some of its stock of over 1,000 JYNNEOS vaccines from the Strategic National Stockpile to be used by high-risk contacts of early patients. The JYNNEOS vaccine is approved by the FDA for “prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection.” The CDC is urging healthcare providers to be on alert for patients who have rash illnesses regardless of the patient’s recent travel, specific risk factors, including gender or sexual orientation.
The Federal Emergency Management Agency (FEMA) has released a new “Guide to Expanding Mitigation - Making the Connection to Older Adults” this past month, a guide on to connecting to more age-friendly communities during mitigation planning. Mitigation planning typically relies on technical data, and requires emergency managers, local officials and civic organizations to work together with the impacted communities. This guide is meant to support local leaders in developing more age-friendly communities, and to engage older adults in the planning process, as they can bring long term perspectives and longstanding relationships to the table.
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