Coronavirus COVID-19 Update for January 5, 2022

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Clinical Reports

CDC Updates and Shortens Recommended Isolation and Quarantine Period for General Population
Given what is currently known about COVID-19 and the Omicron variant, CDC is shortening the recommended time for isolation for the public. People with COVID-19 should isolate for 5 days and if they are asymptomatic or their symptoms are resolving (without fever for 24 hours), follow that by 5 days of wearing a mask when around others to minimize the risk of infecting people they encounter. The change is motivated by science demonstrating that the majority of SARS-CoV-2 transmission occurs early in the course of illness, generally in the 1-2 days prior to onset of symptoms and the 2-3 days after. Additionally, CDC is updating the recommended quarantine period for anyone in the general public who is exposed to COVID-19. For people who are unvaccinated or are more than six months out from their second mRNA dose (or more than 2 months after the J&J vaccine) and not yet boosted, CDC now recommends quarantine for 5 days followed by strict mask use for an additional 5 days. Alternatively, if a 5-day quarantine is not feasible, it is imperative that an exposed person wear a well-fitting mask at all times when around others for 10 days after exposure. Individuals who have received their booster shot do not need to quarantine following an exposure, but should wear a mask for 10 days after the exposure. For all those exposed, best practice would also include a test for SARS-CoV-2 at day 5 after exposure. If symptoms occur, individuals should immediately quarantine until a negative test confirms symptoms are not attributable to COVID-19.

Children and COVID-19: State-Level Data Report
State-level reports are the best publicly available and timely data on child COVID-19 cases in the United States. The American Academy of Pediatrics and the Children’s Hospital Association are collaborating to collect and share all publicly available data from states on child COVID-19 cases. The definition of “child” case is based on varying age ranges reported across states (see report Appendix for details and links to all data sources). COVID-19 cases among US children have reached the highest case count ever reported since the start of the pandemic. For the week ending December 30th, over 325,000 child COVID-19 cases were reported. This number is a 64% increase over the 199,000 added cases reported the week ending December 23rd and an almost doubling of case counts from the two weeks prior. Nearly 7.9 million children have tested positive for COVID-19 since the onset of the pandemic, representing over 1 in 10 US children. For the 21st week in a row child COVID-19 cases are above 100,000. Since the first week of September, there have been over 2.8 million additional child cases.

Antiviral Therapeutics and Vaccines

Coronavirus (COVID-19) Update: FDA Authorizes Additional Oral Antiviral for Treatment of COVID-19 in Certain Adults
The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Merck’s molnupiravir for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate. Molnupiravir is available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset. Molnupiravir is not authorized for use in patients younger than 18 years of age because molnupiravir may affect bone and cartilage growth. It is not authorized for the pre-exposure or post-exposure prevention of COVID-19 or for initiation of treatment in patients hospitalized due to COVID-19 because benefit of treatment has not been observed in people when treatment started after hospitalization due to COVID-19.

COVID-19 Vaccine Safety in Children Aged 5–11 Years — United States, November 3–December 19, 2021
In preauthorization trials for Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, vaccinated children aged 5–11 years reported mild to moderately severe local and systemic reactions; no serious vaccination-related events were noted. After authorization of Pfizer-BioNTech COVID-19 vaccine for children aged 5–11 years during October 2021, and administration of approximately 8 million doses, local and systemic reactions after vaccination were commonly reported to VAERS and v-safe for vaccinated children aged 5–11 years. Serious adverse events were rarely reported. Parents and guardians of children aged 5–11 years should be advised that local and systemic reactions are expected after vaccination with Pfizer-BioNTech COVID-19 vaccine and are more common after the second dose.

Texas Children’s Hospital and Baylor College of Medicine COVID-19 Vaccine Technology Secures Emergency Use Authorization in India
Texas Children’s Hospital and Baylor College of Medicine announced today that CORBEVAX^™, a protein sub-unit COVID-19 Vaccine, whose technology was created and engineered at its Center for Vaccine Development (CVD), has received Emergency Use Authorization (EUA) approval from the Drugs Controller General of India (DCGI) to launch in India with other underserved countries to follow. Dubbed “The World’s COVID-19 Vaccine”, it uses a traditional recombinant protein-based technology that will enable its production at large scales making it widely accessible to inoculate the global population. The initial construct and production process of the vaccine antigen was developed at Texas Children’s Hospital CVD, led by co-directors Drs. Maria Elena Bottazzi and Peter Hotez and in-licensed from BCM Ventures, Baylor College of Medicine’s integrated commercialization team, to Hyderabad-based vaccine and pharmaceutical company Biological E. Limited (BE). CORBEVAX^™ after completing two Phase III clinical trials involving more than 3000 subjects was found to be safe, well tolerated and immunogenic

COVID-OUT, an at-home clinical trial to determine if Ivermectin, Fluvoxamine, and Metformin may treat COVID symptoms and long COVID
This study is being done to understand if these medications prevent severe Covid and long-Covid symptoms. COVID-19 increases inflammation in the body, which causes harm. The medications Metformin, Ivermectin, and Fluvoxamine are known to decrease inflammatory proteins (cytokines) in the body. They also appear to possibly stop the proteins inside cells that help viruses reproduce and spread. Reviews of persons who developed COVID-19 while taking metformin suggest they were less likely to be hospitalized or die from the infection. Smaller, prospective studies showed patients given fluvoxamine or ivermectin were similarly less likely to be hospitalized or die from COVID-19. If we give metformin, ivermectin, fluvoxamine, or a combination of these medications to individuals soon after they develop COVID-19, will it decrease the severity of their symptoms? Will it prevent them from needing hospitalization? This study hopes to answer these questions.

Diagnostics

Omicron Variant: Impact on Antigen Diagnostic Tests (As of 12/28/2021)
Throughout the ongoing COVID-19 pandemic, the FDA has been monitoring and evaluating the potential impact of genetic variants on antigen tests. The FDA is collaborating with the National Institutes of Health's (NIH) RADx program to study the performance of antigen tests with patient samples that have the omicron variant. RADx recently performed preliminary studies evaluating the performance of some antigen tests using patient samples containing live virus, which represents the best way to evaluate true test performance in the short-term. Early data suggests that antigen tests do detect the omicron variant but may have reduced sensitivity. Prior to completing these live virus tests, RADx conducted initial laboratory tests using heat-inactivated samples for some of the currently available antigen tests, which were able to detect the omicron variant, with similar performance when detecting other variants. Heat-inactivated samples are patient samples with omicron variant that have been heat-treated so that the virus is no longer live. Heat-inactivated samples are the best available option when patient samples with live virus are not available. It is important to note that these laboratory data are not a replacement for clinical study evaluations using patient samples with live virus, which are ongoing. The FDA and RADx are continuing to further evaluate the performance of antigen tests using patient samples with live virus.

Epidemiology

Investigation of a SARS-CoV-2 B.1.1.529 (Omicron) Variant Cluster — Nebraska, November–December 2021
The B.1.1.529 (Omicron) variant of SARS-CoV-2 (the virus that causes COVID-19) was first detected in specimens collected on November 11, 2021, in Botswana and on November 14 in South Africa; the first confirmed case of Omicron in the United States was identified in California on December 1, 2021. On November 29, the Nebraska Department of Health and Human Services was notified of six probable cases^† of COVID-19 in one household, including one case in a man aged 48 years (the index patient) who had recently returned from Nigeria. Given the patient’s travel history, Omicron infection was suspected. Specimens from all six persons in the household tested positive for SARS-CoV-2 by reverse transcription–polymerase chain reaction (RT-PCR) testing on December 1, and the following day genomic sequencing by the Nebraska Public Health Laboratory identified an identical Omicron genotype from each specimen. Phylogenetic analysis was conducted to determine if this cluster represented an independent introduction of Omicron into the United States, and a detailed epidemiologic investigation was conducted. This activity was reviewed by CDC and was conducted consistent with applicable federal law and CDC policy.^§

SARS-CoV-2 Omicron VOC Transmission in Danish Households
The Omicron variant of concern (VOC) is a rapidly spreading variant of SARS-CoV-2 that is likely to overtake the previously dominant Delta VOC in many countries by the end of 2021. Authors estimated the transmission dynamics following the spread of Omicron VOC within Danish households during December 2021. Authors used data from Danish registers to estimate the household secondary attack rate (SAR). Among 11,937 households (2,225 with the Omicron VOC), we identified 6,397 secondary infections during a 1-7 day follow-up period. The SAR was 31% and 21% in households with the Omicron and Delta VOC, respectively. Authors found an increased transmission for unvaccinated individuals, and a reduced transmission for booster-vaccinated individuals, compared to fully vaccinated individuals. Comparing households infected with the Omicron to Delta VOC, authors found an 1.17 (95%-CI: 0.99-1.38) times higher SAR for unvaccinated, 2.61 times (95%-CI: 2.34-2.90) higher for fully vaccinated and 3.66 (95%-CI: 2.65-5.05) times higher for booster-vaccinated individuals, demonstrating strong evidence of immune evasiveness of the Omicron VOC. These findings confirm that the rapid spread of the Omicron VOC primarily can be ascribed to the immune evasiveness rather than an inherent increase in the basic transmissibility.