Coronavirus Breaking News

Sanofi and GSK jointly announced on September 3, 2020, they are launching a Phase 1/2 clinical trial for their adjuvanted COVID-19 vaccine candidate. This protein-based adjuvanted vaccine development uses the same technology as one of Sanofi’s seasonal influenza vaccines, with GSK’s established pandemic adjuvant technology.

The Phase 1/2 clinical trial is designed to evaluate the safety, reactogenicity, and immunogenicity of the COVID-19 vaccine candidate with a total of 440 healthy adults, who are being enrolled in the trial across 11 investigational sites in the USA. The companies anticipate first results early December 2020 which will support the initiation of a Phase 3 trial in December 2020.

If data from these studies are sufficient for licensure application, these companies plan is to request regulatory approval in the first half of 2021.

The development of the adjuvanted COVID-19 vaccine candidate is being supported through funding and a collaboration with the Biomedical Advanced Research and Development Authority, part of the office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.

A WHO panel announced 2 recommendations regarding the use of steroids to treat severely and critically ill patients on September 2, 2020. A strong recommendation was issued for systemic (i.e. intravenous or oral) corticosteroid therapy (6 mg of dexamethasone orally or intravenously daily or 50 mg of hydrocortisone intravenously every 8 hours) for 7 to 10 days in patients with severe and critical COVID-19 disease.

And, a conditional recommendation, not to use corticosteroid therapy in patients with non-severe COVID-19.

These WHO recommendations mean 'Given the moderate certainty evidence of an important reduction in the risk of death, the panel concluded that all or almost all fully informed patients with severe or critical COVID-19 would choose treatment with systemic corticosteroids. Moreover, the panel believed that other perspectives (i.e. costs, equity, the feasibility of implementation), and patient values and preferences would not alter decisions.

In contrast, the panel concluded that fully informed patients with non-severe COVID-19 would mostly not choose to receive this treatment given that current data indicated they would not likely derive benefit and may derive harm.

According to McClatchy reporting on September 2, 2020, ‘the U.S. Department of Health and the Centers for Disease Control and Prevention (CDC) are rapidly making preparations to implement the large-scale distribution of COVID-19 vaccines in the Fall of 2020.’

A letter from the CDC’s Director Robert Redfield told the governors of the US states on August 27, 2020: "This vaccine distribution is expected to be a public health effort of significant scale, potentially involving hundreds of millions of vaccine doses to be distributed across the U.S. The CDC urgently requests your assistance in expediting applications for these distribution facilities.”

Dr. Redfield continued: “and, if necessary, asks that you consider waiving requirements that would prevent these facilities from becoming fully operational by November 1, 2020.”

Google and Apple jointly created the Exposure Notifications System out of a shared sense of responsibility to help governments and our global community fight this pandemic through contact tracing, stated Google on September 1, 2020. 'Technology can support and augment these efforts by allowing public health authorities to quickly notify people who may have been exposed to a person who has contracted COVID-19, including those the person might not know directly.'

'This starts with Exposure Notifications on your smartphone. These will help your public health authority alert you if you’ve been exposed to COVID-19.'

'Once you opt-in to the notification system, the Exposure Notifications System will generate a random ID for your device. To help ensure these random IDs can’t be used to identify you or your location, they change every 10-20 minutes. Your phone and the phones around you will work in the background to exchange these privacy-preserving random IDs via Bluetooth. You do not need to have the app open for this process to take place.'

On Android, you can find the app on Google Play.

Researchers measured antibodies in serum samples from 30,576 persons in Iceland, using 6 assays, and the results indicate that antiviral antibodies against SARS-CoV-2 did not decline within 4 months after diagnosis. Published in JAMA on September 1, 2020, these researchers estimate that the risk of death from infection was just 0.3% in Iceland.

Furthermore, these researchers stated: 'A relationship between a humoral immune response to SARS-CoV-2 infection and protection against reinfection by this virus has been shown in rhesus macaques, but has yet to be established in humans.'

'Regardless of the relationship or lack thereof between seropositivity against SARS-CoV-2 and protection against reinfection, the low SARS-CoV-2 antibody seroprevalence in Iceland indicates ... that the Icelandic population is vulnerable to a potential 2nd wave of coronavirus infections.'

On September 2, 2020, the US Department of Health and Human Services (HHS) announced that 'the national stockpile of ventilators has now reached its maximum capacity, with nearly 120,000 units available for deployment to state and local health officials, if and when needed.'

One source of these ventilators was General Motors and Ventec Life Systems, which announced they delivered its 30,000th V+Pro critical care ventilator to the HHS on September 1, 2020.

Additionally, HHS confirmed it was terminating contracts with ventilator manufacturers Hamilton Medical and Vyaire Medical for 38,000 additional ventilators that had been scheduled for delivery to the National Strategic Stockpile by the end of 2020, reported the AP.

During the early stages of the COVID-19 pandemic, there was a worldwide shortage of ventilators that were used to treat severe, hospitalized patients. Since then, the U.S. CDC has determined how best to allocate ventilators to optimize patient care.