August 6, 2021
Thank you for your continued partnership in responding to the COVID-19 pandemic. Please visit the Virginia Department of Health (VDH) website for current clinical and public health guidance, epidemiologic data, and other information. Updates on the following topics are included in this correspondence:
- Updates on the Delta (B.1.617.2) Variant and Guidance
- Monoclonal Antibody Therapy and Postexposure Prophylaxis
- Guillain-Barré syndrome after receiving Johnson & Johnson’s COVID-19 vaccine
- Updates about Non-COVID-19 Respiratory Viruses
- Burkholderia cepacia complex Infections Associated with Contaminated Ultrasound Gel
- Back-to-school Vaccinations and Updated Resources
Updates on the Delta (B.1.617.2) Variant and Guidance
Due to a surge in COVID-19 cases across the United States, the Centers for Disease Control and Prevention (CDC) released a health advisory, Vaccination to Prevent COVID-19 Outbreaks with Current and Emergent Variants — United States, 2021, urging for increased vaccination coverage and mask usage. Nationally, the Delta (B.1.617.2) variant is causing a surge in cases, hospitalizations, and deaths. In Virginia, cases have increased by 956% since mid-June, and the state is now at a substantial level of transmission. The majority of cases, hospitalizations, and deaths in the U.S. and Virginia are occurring in people who are not fully vaccinated. The percent of fully vaccinated adults in Virginia varies widely by locality, from 35% to 72%.
The Delta (B.1.617.2) variant is more infectious than previous circulating strains. It spreads more than two times the rate of earlier strains and now accounts for more than 90% of sequenced samples in the country. According to a non-peer reviewed publication, people infected with the Delta variant have higher viral loads than those infected with the wild-type SARS-CoV-2 virus during the initial wave in China.
Evidence shows that COVID-19 vaccines available in the U.S. are safe and protect against severe disease, hospitalization, and death. It is important that people receive both doses of the two-dose vaccines. The Pfizer-BioNTech and Moderna COVID-19 vaccines protect against known circulating variants, including the Delta variant; data about the effectiveness of the Johnson & Johnson/Janssen vaccine are being collected. COVID-19 infections in people who are fully vaccinated are uncommon, but are expected because no vaccine works 100% of the time. Some fully vaccinated people who are infected with the Delta variant might be able to spread the virus to others; one recent study demonstrated that when breakthrough cases occur, fully vaccinated people who are infected with the Delta variant have viral loads comparable to infected people who are not fully vaccinated. Given these concerning trends and emerging data, CDC continues to emphasize the need to improve vaccination coverage rapidly to control the pandemic.
Given the new evidence, CDC updated its Interim Public Health Recommendations for Fully Vaccinated People. VDH recommends the following:
- Fully vaccinated people should wear a mask in public indoor settings if they are in an area of substantial or high transmission.
- Fully vaccinated people might choose to mask regardless of the level of transmission, particularly if they or someone in their household is immunocompromised or at increased risk for severe disease, or if someone in their household is unvaccinated.
- Fully vaccinated people should get tested if they are experiencing COVID-19 symptoms and isolate if they have tested positive for COVID-19 in the prior 10 days or are experiencing COVID-19 symptoms.
- Fully vaccinated people should also get tested 3–5 days after exposure to someone with suspected or confirmed COVID-19 and wear a mask in public indoor settings for 14 days after exposure or until they receive a negative test result.
- All K-12 schools (including PreK classrooms) in Virginia should implement a requirement for students, teachers, and staff to wear masks indoors, regardless of vaccination status. For additional information, see Interim Guidance for COVID-19 Prevention in Virginia PreK-12 Schools for the 2021-2022 school year.
Monoclonal Antibody Therapy and Postexposure Prophylaxis
Outpatient monoclonal antibody (mAb) therapy for the treatment of mild to moderate COVID-19 is an underutilized resource, despite the wide availability of these drugs (REGEN-COV and sotrovimab). With the current increase in COVID-19 cases, VDH encourages medical providers to consider using point-of-care (POC) molecular or antigen tests to evaluate patients suspected of having COVID-19. Results from POC tests generally come back in 10–30 minutes, which allows for prompt individual and public health decision making. Patients with a positive POC test who meet Emergency Use Authorization criteria for monoclonal antibody therapy should be offered REGEN-COV or sotrovimab.
On July 30, FDA granted an Emergency Use Authorization (EUA) for REGEN-COV to be used for COVID-19 postexposure prophylaxis. To qualify for therapy, patients must be at least 12 years old and weigh at least 40 kg, AND be at high-risk for progression to severe COVID-19, AND not be fully vaccinated or not expected to mount an adequate immune response to complete vaccination, AND have been a close contact to a person with COVID-19, or be at high-risk of exposure to a person with COVID-19 (for example, residents in a congregate setting where cases of COVID-19 are known to be present). Please see the U.S. Department of Health and Human Services website or the VDH Monoclonal Antibody website for more information.
Guillain-Barré syndrome (GBS) after receiving Johnson & Johnson/Janssen COVID-19 Vaccine
On July 12, the Food and Drug Administration (FDA) announced a new warning for the J&J/Janssen COVID-19 vaccine, stating that reports suggest an increased risk of GBS, a serious but rare side effect, during the 42 days following vaccination. CDC’s Advisory Committee on Immunization Practices (ACIP) met on July 22 to discuss this issue. As of June 30, 100 preliminary reports of GBS were received in the Vaccine Adverse Event Reporting System (VAERS) after more than 12 million doses of J&J/Janssen COVID-19 had been administered. Among the 100 reported cases, 61 occurred in males and the median age was 57 years (range 24–76 years). The median time from vaccination to symptom onset was 13 days (range 0–75 days); 95 patients required hospitalization and one died.
Despite the higher than expected rate of GBS following J&J/Janssen vaccination, this event is still relatively rare (7.8 GBS cases per million doses administered among adults). Both CDC and VDH continue to strongly recommend this vaccine for anyone 18 years of age and older, given the greater risk of serious COVID-19 complications, even death. Although patients with a history of GBS can receive any of the authorized vaccines, they should talk with their healthcare provider about the availability of mRNA vaccines to offer protection against COVID-19. FDA has updated the J&J/Janssen COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers), and J&J/Janssen COVID-19 Fact Sheet for Recipients and Caregivers. CDC plans to update its Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States and J&J/Janssen materials soon.
Updates about Non-COVID-19 Respiratory Viruses
VDH disease surveillance systems are detecting a significant increase of non-COVID-19 respiratory illness, including respiratory syncytial virus (RSV), human parainfluenza virus 3 (HPIV-3), and other human coronaviruses among 0 to 9 year-old children. All healthcare professionals, especially pediatricians, should re-familiarize themselves with pediatric-specific clinical presentations of RSV, HPIV-3 and other common respiratory illnesses, and can review weekly updates about these viruses of concern via CDC’s NREVSS website. Patients at highest risk for developing severe respiratory illness include infants and young children, adults aged 65 years and older, those with chronic medical conditions, and those taking immunosuppressive drugs or with weakened immune systems. Clinicians should consider if prophylaxis with palivizumab (SYNAGIS) is indicated in children at high risk of RSV disease. VDH recommends clinicians consider testing patients with a negative SARS-CoV-2 test and acute respiratory symptoms for other respiratory pathogens; real-time RT-PCR is the preferred testing method for respiratory viruses. Clinicians should report clusters of laboratory-confirmed RSV and HPIV-3 cases, as well as suspected outbreaks of severe respiratory illness to the local health department.
Burkholderia cepacia complex Infections Associated with Contaminated Ultrasound Gel
An investigation is ongoing of Burkholderia stabilis infections in healthcare facilities across multiple states. Patients have developed infections, including bloodstream infections, after undergoing ultrasound-guided procedures in which a MediChoice M500812 ultrasound gel was used. Unopened bottles of the non-sterile gel have been determined to be contaminated with high levels of bacteria that genetically match the bacteria identified in patient isolates.
On August 4, the manufacturer (Eco-Med Pharmaceutical, Ontario, Canada) recalled multiple lots of the ultrasound gel. All healthcare facilities should immediately destroy or return recalled products, and should immediately stop use and quarantine all lots of ultrasound gels distributed under a long list of brand names. It is unknown how many and what types of facilities in Virginia currently have products from the recall list, but it has been confirmed that the MediChoice product is used in Virginia. For more information, see FDA’s link to product recall as well as the manufacturer press release and recall information. Please notify your local health department if a cluster of Burkholderia cepacia complex infections is identified among patients with exposure to the recalled products.
Back-to-School Vaccinations and Updated Resources
School-required vaccines have changed for the 2021–2022 school year. Starting this school year, students in Virginia will need vaccines to protect against meningococcal disease, human papillomavirus (HPV), and hepatitis A, in addition to previously required immunizations. Without these vaccinations, children will not be able to start school on time or go to daycare. For more information, please review the updated Virginia Childhood Vaccination Schedule. Visit VDH’s Healthy Back to School Campaign website for more details on this and COVID-19, child well visits, routine oral health, and mental health resources for children.
VDH and the Virginia Department of Education released updated Interim Guidance for COVID-19 Prevention in Virginia PreK-12 Schools.
On behalf of VDH, I thank you for your tireless efforts and sacrifices these many months to protect Virginians from COVID-19. If you have questions about COVID-19, please contact your local health department.
M. Norman Oliver, MD, MA
State Health Commissioner