Your Coronavirus Update for October 5; stay up to date with Elite.
More than 35.4 million cases of coronavirus (COVID-19) have been diagnosed worldwide as of Sunday evening, including at least 1.4 million deaths. Healthcare officials in the United States have reported more than 7.4 million positive COVID-19 cases and at least 210,000 deaths. Source: Johns Hopkins University & Medicine
FDA Hits Pause On Vaccine Candidate’s Trail
A planned Phase 2/3 trial of the COVID-19 vaccine candidate being produced by Pennsylvania-based INOVIO Pharmaceuticals has been placed on hold by the U.S. Food and Drug Administration (FDA). According to INOVIO officials, the FDA has questions about the drug and the CELLECTRA delivery device to be used in the trial. Until the FDA’s questions have been satisfactorily addressed, INOVIO’s investigational new drug application remains on partial clinical hold. The company is actively working to address the questions and plans to respond some time during October, after which the FDA will have up to 30 days to notify INOVIO of its decision as to whether the trial may proceed, INOVIO officials have confirmed.
This partial clinical hold is not due to the occurrence of any adverse events related to INOVIO’s ongoing expanded Phase 1 study of the vaccine candidate, the conduct of which may continue and is not impacted by the FDA’s notification, according to INOVIO officials. In addition, this partial clinical hold does not impact the advancement of INOVIO’s other product candidates in development, officials said. Preparations for the planned Phase 2/3 trial of the vaccine candidate will continue following resolution of the FDA’s partial clinical hold and will be subject to the receipt of external funding to conduct the trial, officials said.
WHO Finds Significant Impact On Mental Health
The COVID-19 pandemic has disrupted or halted critical mental health services in 93% of countries worldwide while the demand for mental health is increasing, according to a survey conducted by the World Health Organization (WHO). The survey of 130 countries provides the first global data showing the impact of COVID-19 on access to mental health services and underscores the urgent need for increased funding, say WHO officials.
The survey was published ahead of the WHO’s upcoming online advocacy event Oct. 10, which is intended to bring together world leaders, celebrities, and advocates to call for increased mental health investments in the wake of COVID-19.
Bereavement, isolation, loss of income, and fear are triggering mental health conditions or exacerbating existing concerns, WHO officials claim. Many people may be facing increased levels of alcohol and drug use, insomnia, and anxiety as a result of the pandemic. Additionally, COVID-19 can lead to neurological and mental complications such as delirium, agitation, and stroke. Those diagnosed with pre-existing mental, neurological, or substance use disorders are also more vulnerable to COVID infection and could stand a higher risk of severe outcomes and death.
“Good mental health is absolutely fundamental to overall health and well-being,” said Tedros Adhanom Ghebreyesus, PhD, MSc, director-general of the WHO, in a prepared statement. “COVID-19 has interrupted essential mental health services around the world just when they’re needed most. World leaders must move fast and decisively to invest more in life-saving mental health programs ̶ during the pandemic and beyond.”
The survey was conducted from June to August 2020 among 130 countries across WHO’s six regions, officials report. It evaluates how the provision of mental, neurological, and substance use services has changed due to COVID-19, the types of services that have been disrupted, and how countries are adapting to overcome these challenges.
Findings in the survey also include:
- More than 60% reported disruptions to mental health services for vulnerable people, including children and adolescents (72%), older adults (70%), and women requiring antenatal or postnatal services (61%).
- 67% saw disruptions to counseling and psychotherapy; 65% to critical harm reduction services; and 45% to opioid agonist maintenance treatment for opioid dependence.
- More than 35% reported disruptions to emergency interventions, including those for people experiencing prolonged seizures; severe substance use withdrawal syndromes; and delirium, often a sign of a serious underlying medical condition.
- 30% reported disruptions to access for medications for mental, neurological, and substance use disorders.
- Approximately three-quarters reported at least partial disruptions to school and workplace mental health services (78% and 75%, respectively).
While many countries (70%) have adopted tele-medicine or tele-therapy to overcome disruptions to in-person services, there are significant disparities in the uptake of these interventions, according to the WHO. More than 80% of high-income countries reported deploying tele-medicine and tele-therapy to bridge gaps in mental health, compared with less than 50% of low-income countries.
The WHO has issued guidance to countries on how to maintain essential during COVID-19 and recommends that countries allocate resources to mental health as an integral component of their response and recovery plans. The WHO also urges countries to monitor changes and disruptions in services so that they can address them as required.
CDC Again Announces Updates To How COVID Spreads
As of Oct. 5, officials with the U.S. Centers for Disease Control and Prevention (CDC) have issued updated guidance related to how COVID-19 spreads, which includes information about the potential for airborne spread of the virus.1
CDC officials said they continue to believe, based on current science, that people are more likely to become infected the longer and closer they are to a person diagnosed with COVID-19. The recent updated information acknowledges the existence of some published reports showing limited, uncommon circumstances where people with COVID-19 infected others who were more than 6 feet away or shortly after the COVID-positive person left an area. In these instances, transmission occurred in poorly ventilated and enclosed spaces that often involved activities that caused heavier breathing, such as singing or exercise. Such environments and activities may contribute to the buildup of virus-carrying particles, the CDC reports. Recommendations remain the same based on existing science and after a thorough technical review of the guidance.
- How COVID-19 Spreads. CDC. 2020. Accessed online: www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/how-covid-spreads.html