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VDH
- (Updated, 5/10) Vaccination FAQs: Revisions involved adding a new question in the healthcare provider section about if providers can order the Janssen (J&J) COVID-19 and updating existing questions about FDA's further limiting the use of the J&J COVID-19 vaccine and the status of vaccines for younger children.
- (Updated, 5/9) Health Professionals: Under Hot Topics, added these 2 new items: FDA's further limits the use of the Johnson & Johnson (Janssen) COVID-19 vaccine and the recent MMWR entitled Effectiveness of additional or booster doses of COVID-19 vaccine in preventing COVID-19 in nursing home residents.
FDA
- (NEW, 5/4/22) On Wednesday, May 4, 2022, the U.S. Food and Drug Administration (FDA) authorized an extension to the shelf-life from 18 months to 24 months for specific lots of the refrigerated Eli Lilly monoclonal antibody bamlanivimab. Due to the high frequency of the Omicron variant, bamlanivimab and etesevimab are not currently authorized in any U.S. region. Therefore, these drugs may not be administered for treatment or post-exposure prevention of COVID-19 under their Emergency Use Authorization until further notice by the FDA. However, it is the recommendation of the U.S. Government that these products be retained in the event that future SARS-CoV-2 variants, which may be susceptible to bamlanivimab and etesevimab, emerge and become prevalent in the U.S.
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FDA Limits Use of Janssen COVID-19 Vaccine to Certain Individuals - On Thursday, May 5, 2022, the FDA limited the authorized use of the Johnson & Johnson (J&J)/Janssen COVID-19 Vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the J&J/Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine. The FDA:
- Has determined that the risk of thrombosis with thrombocytopenia syndrome (TTS), a syndrome of rare and potentially life-threatening blood clots in combination with low levels of blood platelets with onset of symptoms approximately one to two weeks following administration of the J&J/Janssen COVID-19 Vaccine, warrants limiting the authorized use of the vaccine;
- Has determined that the known and potential benefits of the vaccine for the prevention of COVID-19 outweigh the known and potential risks for individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and for individuals 18 years of age and older who elect to receive the J&J/Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine; and
- Has provided the Fact Sheet for Healthcare Providers Administering Vaccine and now reflects the revision of the authorized use of the J&J/Janssen COVID-19 Vaccine and includes a warning statement at the beginning of the fact sheet for prominence which summarizes information on the risk for TTS. Additionally, information on the revision to the authorized use of the vaccine and updated information on the risk of blood clots with low levels of blood platelets has been added to the Fact Sheet for Recipients and Caregivers.
- (New, 5/10) On Tuesday, May 10, the FDA approved a new indication for Olumiant (baricitinib) for the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Olumiant is the first immunomodulatory treatment for COVID-19 to receive FDA approval. The FDA first issued an emergency use authorization (EUA) for Olumiant in combination with remdesivir to treat COVID-19 in hospitalized adults and pediatric patients on November 19, 2020. On July 28, 2021, the FDA revised the EUA to authorize Olumiant as a standalone treatment. Olumiant remains under EUA status for hospitalized pediatric patients 2 to less than 18 years of age requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. The FDA has revised the Letter of Authorization and associated fact sheets for healthcare providers and recipients to remove the population covered under the approved indication. Common side effects of Olumiant and the recommended dosage for the approved population are included in the prescribing information. The FDA continues to work with developers, researchers, manufacturers, and partners to help expedite the development and availability of therapeutic drugs and biological products to prevent or treat COVID-19 through its Coronavirus Treatment Acceleration Program.
- FDA Safety warnings about certain COVID-19 tests:
- (New, 5/10) - On Tuesday, May 10 the FDA issued a warning for people to not use the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold). This test is not authorized, cleared, or approved by the FDA for distribution or use in the United States. The FDA is concerned about the risk of false results when using this test because SML Distribution LLC has not provided the FDA with adequate data to show the test works correctly. SML Distribution LLC is recalling the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Tests (Colloidal Gold), and the FDA has identified this issue as a Class I recall, the most serious type of recall.The FDA has not received reports of injuries or death associated with use of the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold).
- (New, 5/9) - On Monday, May 9, FDA issued a Class 1 recall (the most serious type of recall) regarding the Mesa Biotech Accula SARS-CoV-2 Test. The Accula SARS-CoV-2 Test is a polymerase chain reaction (PCR) test intended to detect the presence of SARS-CoV-2, the virus that causes COVID-19, based on a nasal swab sample from patients. It can be performed in a CLIA-waived setting, or a medium or high-complexity CLIA-certified lab. Mesa Biotech is recalling the Accula SARS-CoV-2 Test because certain lots of the test have an increased risk of giving false positive results due to contamination at the manufacturing facility. Although there have been no reports of injuries, adverse health consequences, or death associated with the use of these affected products, false positive results could lead to further exposure of uninfected individuals to SARS-CoV-2 virus. Manufactured dates of affected lots are: December 30, 2021 to January 1, 2022; January 15, 2022 to January 23, 2022.
- (Updated, 5/10) Is It Really 'FDA Approved'?: FDA updated this website. Although not specific to COVID-19, it highlights the many ways the FDA is responsible for protecting the public health by regulating human drugs and biological products, animal drugs, medical devices, tobacco products, food (including animal food), cosmetics, and electronic products that emit radiation.
Update from the Virginia Department of Health (VDH) Therapeutics Team
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VDH COVID-19 Treatment Locator tool - As of Monday, May 2, 2022, the VDH COVID-19 Treatment Locator tool was deactivated from the VDH website. There are two main reasons for this change:
- There are now two federal government COVID-19 treatment locator tools which provide information about availability of therapeutics across the entire U.S., and
- There is no longer a shortage of COVID-19 therapeutics, therefore, the vast majority of pharmacies in Virginia carry the oral antiviral medications (Paxlovid and/or Lagevrio) used for the treatment of patients with mild to moderate COVID-19 who are at high-risk for severe illness.
- The two federal websites are:
Get medication for COVID-19 which is designed for patients and healthcare providers to find nearby Test to Treat locations. This is primarily focused on oral antiviral therapy.
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Planning for Pediatric Vaccine Ordering and Storage
- Moderna has submitted a request for emergency use authorization (EUA) for its COVID-19 vaccine in children aged 6 months to under 2 years and children aged 2 years to 5 years of age to the FDA.
- Moderna is also in the process of requesting authorization of its COVID-19 vaccine for children aged 6 to 11 years and 12 to 17 years.
- Pfizer has not yet submitted a request for EUA or data for younger children, but will submit if clinical trial data supports.
- They have submitted a request for authorization and related data for a booster shot for children aged 5 to 11 years.
- Pending submission and review of all data and EUA authorization, release of these products may coincide with normal back-to-school and seasonal influenza vaccination activities resulting in the need to increase pediatric vaccine inventory when available vaccine storage space is limited. We encourage providers and jurisdictions to consider their available storage capacity prior to ordering and avoid stockpiling vaccine inventory beyond what can be efficiently and safely stored. Consider the following (based on what we know now) as you make plans for ordering pediatric COVID-19 vaccines:
- Both Moderna and Pfizer pediatric vaccines will have a minimum order quantity of 100 doses.
- Moderna can be stored frozen between -50oC and -15oC until the expiration date.
- Moderna vials can be moved to the refrigerator as needed for a maximum of a 30-day shelf life (unpunctured).
- Pfizer vials may be stored in an ultra-cold temperature (ULT) freezer between -90oC and -10oC until the expiration date.
- If you do not have an ULT freezer, Pfizer vials may be kept in the refrigerator for up to 10 weeks.
- We encourage providers to order “just in time” deliveries, ordering smaller amounts more frequently. Monitor your inventory on hand and as always, dispose of expired vaccine in a timely manner to ensure the availability of storage space and avoid accidental administration of expired vaccine.
- Planning for COVID-19 Vaccination of Younger Children
- Planning is underway to prepare for COVID-19 vaccination for children under 5 (or 6) years of age and will include many of the same strategies used to communicate the existing vaccination recommendation for children ages 5 through 11 years.
- CDC will continue with an “all of the above” approach, aiming to have vaccine available and accessible to all children who are eligible in a variety of settings.
- CDC is encouraging jurisdictions to identify sites and settings most likely to reach children younger than 5 (or 6) years of age to allow for the most equitable access and efficient reach of all children.
- More information will be shared as soon as it is available on the pediatric vaccination planning website: COVID-19 Vaccination for Children | CDC.
- As children of all ages enroll in early care and education programs, plan to attend summer or sports camps, and eventually prepare to return to school, there are times when they will visit their pediatrician or healthcare professional, offering opportunities for those clinicians to provide messages or answer questions about COVID-19 vaccination. The ultimate aim is to encourage that all people are up-to-date on their COVID-19 vaccines and provide information to build confidence in COVID-19 vaccines. In addition, CDC also offers resources to encourage routine childhood vaccination and strategies with its “Let’s Play Catch-up” resources.
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For questions about VaxMaX and its functionality, please visit the VaxMaX Help website, which includes reference guides and tutorial videos.
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Upcoming Events
- CDC’s next PHEP Connects webinar, “National Syndromic Surveillance Program (NSSP): Integrated Surveillance for Response,” is scheduled for 1 p.m. to 2 p.m. EDT on Wednesday, May 11. Presenter Karl Soetebier, acting program lead for CDC’s National Syndromic Surveillance Program (NSSP), will share key aspects of the program’s support for enabling local, state, and federal surveillance of automated near real-time data from emergency departments and other key data sources. He will also discuss NSSP’s BioSense Platform, its data sources, and examples of its use. Participant Information:
- National Academies of Sciences, Engineering, and Medicine (NASEM). “Lessons from COVID-19 for the Public Health Emergency Enterprise: What Happened to the Plans?” May 17-18, 9 to 4 PM.
- NASEM's Forum on Medical and Public Health Preparedness for Disasters and Emergencies is hosting a workshop exploring the nation’s Public Health Emergency (PHE) preparedness enterprise through the lens of COVID-19 in the U.S. The workshop will explore key components, success stories, and failure points throughout the entire PHE preparedness and response enterprise. Participants will also identify opportunities for more effective catastrophic disaster, pandemic, and other large scale PHE planning at the federal, state, local, tribal, and territorial levels. Register for this workshop here.
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CDC
- Guidance on Prevention and Management of Coronavirus Disease 2019 (COVID-19) in Correctional and Detention Facilities
- CDC separated the previous version of this guidance document into two sections:
- Framework to Assess COVID-19 Risk and to Select Prevention Strategies in Correctional and Detention Facilities – guidance on designing a flexible COVID-19 prevention plan based on COVID-19 Community Levels and facility-level factors.
- Appendix – detailed guidance on implementing specific prevention strategies in correctional and detention facilities
- CDC separated COVID-19 prevention strategies into two categories and provided guidance on when to apply each category in correctional and detention facilities.
- Strategies for Everyday Operations
- Enhanced COVID-19 Prevention Strategies.
- CDC also added modified post-exposure quarantine options for facilities to consider to reduce the impact of quarantine on residents’ mental health and access to services.
- Removed COVID-19-specific PPE recommendations for persons handling laundry or used food service items from people with COVID-19 or their close contacts.
- CDC recently resolved a critical functionality issue with the Quarantine and Isolation Calculator that occurred on Tuesday, May 3 and Wednesday, May 4, 2022. During this time frame, the calculator provided incorrect calculations on all pathways. The error resulted in recommendations that were one day short of the correct time frames for isolation, quarantine, testing, and wearing a well-fitting mask. The issue has been corrected andthe updated version of the calculator went live on May 4, 2022 at 3:32 EDT. People who used the calculator when it was not working correctly should go to the tool again to obtain accurate recommendations. Please note that prior to May 3, 2022 the calculator was functioning properly and provided correct CDC guidance for people with COVID-19 and close contacts.
Mask & Travel Resources
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CDC Recommendation for Masks and Travel - At this time, CDC recommends that everyone aged 2 and older – including passengers and workers – properly wear a well-fitting mask or respirator over the nose and mouth in indoor areas of public transportation (such as airplanes, trains, etc.) and transportation hubs (such as airports, stations, etc.). Wearing a well-fitting mask or respirator is most beneficial in crowded or poorly ventilated locations, such as airport jetways.
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Wearing Masks in Travel and Transportation Settings - CDC notes that it is especially important to wear a mask:
- During times when public transportation or transportation hubs are crowded,
- In areas that are poorly ventilated,
- If you are at high risk for getting very sick from COVID-19, or if you live with or have social contact with someone at high risk,
- During long-distance domestic travel, and
- When the COVID-19 Community Level in the area you are located in is high (applies to US locations only)
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Domestic Travel During COVID-19 and US Citizens, US Nationals, US Lawful Permanent Residents, and Immigrants: Travel to and from the United States - CDC recommends getting tested for current infection before traveling, regardless of the destination (domestic or international), vaccination status, Passengers should consider getting tested for current infection with a viral test as close to the time of departure as possible (but no more than 3 days before travel). After domestic travel, regardless of vaccination status, get tested if your travel involves situations with a greater risk of exposure.
FDA
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(NEW, 5/5/22) On Thursday, May 5, 2022, through the American Rescue Plan Act of 2021, Congress provided temporary funding for the FDA to develop the capacity to sequence SARS-CoV-2 RNA from wastewater samples and to conduct a sampling and sequencing project through 2022. To facilitate sharing of information about progress on this sequencing effort, the FDA published a public dashboard that graphically presents information from the project. Studies have shown that SARS-CoV-2 (COVID-19) variants of concern from wastewater can be identified 1-2 weeks prior to being detected in clinical samples from the same area, making wastewater surveillance useful for detecting and monitoring SARS-CoV-2 in the population.
- Note that VDH is listed as a participant in this, but Virginia data are not currently shown in the map.
VDH External Web Updates
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Masks: Updates posted on 5/5/22 involved adding a link to CDC's recommendations for mask use during travel and adding sport scenarios where wearing a mask is not recommended.
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Variants of COVID-19: Updates posted on 5/6/22 involved removing information about the Delta variant under the section "About Variants of Concern" and making general language edits
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General FAQs -
- Removed questions and consolidated information from the infection control, long term care facilities, animals and covid, and vet sections.
- New questions were added about monitoring COVID-19 in Virginia and counterfeit COVID-19 at-home tests
- Revised questions include breakthrough infections, ventilation best practices, COVID-19 Treatment Locator, remdesivir age expansion, and information on BA.4 and BA.5.
- Proper Masking Tips (Retired) - Retired VDH page and linked to CDC's Types of Masks and Respirators page
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Healthcare Professionals web page - Updated the Feeling Sick/COVID-19 symptoms fact sheet to be more in line with the Omicron variant and redesigned the overall sheet (non-content updates).
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Exposure web page - Removed repetitive information, removed information about Sara Alert and removed information about the VDH COVID-19 treatment locator tool.
- Feeling Sick Comparison Chart - The Spanish translation was uploaded to What To Do If You Are Sick under COVID-19 or Flu Section, uploaded to Resources and Support page under VDH Resources, and uploaded to the Health Professionals page under Resources for Patients
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