Your Coronavirus Update for November 18; stay up to date with Elite.
More than 54.8 million cases of coronavirus (COVID-19) have been diagnosed worldwide as of Monday evening, including at least 1.32 million deaths. Healthcare officials in the United States have reported more than 11.2 million positive COVID-19 cases and at least 246,000 deaths. Source: Johns Hopkins University & Medicine
Moderna Vaccine Trial Reports Effective Results
Officials at Moderna Inc. have announced that their independent Phase 3 study of a vaccine candidate against COVID-19 has met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5%. The COVE study enrolled more than 30,000 participants in the United States and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases and the Biomedical Advanced Research and Development Authority.
The primary endpoint of the Phase 3 COVE study is based on the analysis of COVID-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine, officials said. This first interim analysis was based on 95 cases, of which 90 cases of COVID-19 were observed in the placebo group versus five cases observed in the vaccine group, resulting in a point estimate of vaccine efficacy of 94.5% (p <0.0001).
A secondary endpoint analyzed severe cases of COVID-19 and included 11 severe cases (as defined in the study protocol) in this first interim analysis. All 11 cases occurred in the placebo group, officials said. The 95 COVID-19 cases included 15 older adults (ages 65 and older) and 20 participants identifying as being from diverse communities.
Other findings from the study include:
- The interim analysis included a concurrent review of the available Phase 3 COVE study safety data by the DSMB, which did not report any significant safety concerns.
- A review of solicited adverse events indicated that the vaccine was generally well tolerated.
- The majority of adverse events were mild or moderate in severity.
- Grade 3 (severe) events ≥ 2% in frequency after the first dose included injection site pain (2.7%), and after the second dose included fatigue (9.7%), myalgia (8.9%), arthralgia (5.2%), headache (4.5%), pain (4.1%), and erythema/redness at the injection site (2.0%). These solicited adverse events were generally short-lived.
These data are subject to change based on ongoing analysis of further Phase 3 COVE study data and final analysis, officials said. Preliminary analysis suggests a broadly consistent safety and efficacy profile across all evaluated subgroups.
As more cases accrue leading up to the final analysis, officials expect the point estimate for vaccine efficacy could change.
“This is a pivotal moment in the development of our COVID-19 vaccine candidate,” said Stéphane Bancel, Moderna’s chief executive officer, in a prepared statement. “We look forward to the next milestones of submitting for an emergency use authorization (EUA) in the U.S., and regulatory filings in countries around the world, while we continue to collect data on the safety and efficacy of the vaccine in the COVE study. We remain committed to and focused on doing our part to help end the COVID-19 pandemic.”
Based on these interim safety and efficacy data, Moderna intends to submit for an EUA with the U.S. Food and Drug Administration in the coming weeks and anticipates having the EUA informed by the final safety and efficacy data (with a median duration of at least two months), officials said. Applications for authorizations to global regulatory agencies are also in process.
CDC Releases Updated Guidance on Mask Use
Experimental and epidemiological data support community masking to reduce the spread of the virus that causes COVID-19, according to officials with the Centers for Disease Control & Prevention (CDC). New findings also claim that prevention benefit is derived from a combination of source control and personal protection for the mask wearer.1
Multilayer cloth masks are said to block release of exhaled respiratory particles into the environment, along with the microorganisms these particles carry. Cloth masks effectively block most large droplets and can block the exhalation of fine droplets and particles that increase in number with the volume of speech and specific types of phonation. Multi-layer cloth masks can block up to 50-70% of droplets and particles while limiting the spread of those that are not captured. Upwards of 80% blockage has been achieved in human experiments that have measured blocking of all respiratory droplets, according to CDC findings, with cloth masks in some studies performing on par with surgical masks as barriers for source control.1
A recent report from the CDC1 also claims that studies have demonstrated that cloth mask materials can reduce exposure to infectious droplets through filtration. The relative filtration effectiveness of various masks has varied widely across studies due to mask design and particle sizes. Multiple layers of cloth with higher thread counts have demonstrated superior performance compared to single layers of cloth with lower thread counts. Materials such as polypropylene may enhance filtering effectiveness by generating triboelectric (static electricity) charges that enhance capture of charged particles while silk may help repel moist droplets and reduce fabric wetting.
Philadelphia Mobile Units Traveling Across U.S. To Test
A company based in a Philadelphia suburb is trying to help mitigate the spread of coronavirus by bringing its mobile testing services to locations of patients experiencing the most need. According to a recent report,2 Aardvark Mobile Health, Conshohocken, PA, has sent trucks with staff to administer tests to individuals in Philadelphia, Texas, Florida, and New York. The vehicles are reportedly equipped with heat and air conditioning systems and a generator for electricity. There are also “labs” for nurses to administer tests and gather results in separate locations within the vehicles.
1. Scientific Brief: Community Use of Cloth Masks to Control the Spread of SARS-CoV-2. CDC. 2020. Accessed online: www.cdc.gov/coronavirus/2019-ncov/more/masking-science-sars-cov2.html
2. Dickerson B. Conshohocken-based Aardvark Mobile Health Helping Fight the Spread of COVID-19. MontcoToday. 2020. Accessed online: https://montco.today/2020/11/conshohocken-based-aardvark-mobile-health-helping-fight-the-spread-of-covid-19