COVID-19 News: Test for Asymptomatic People, Bemcentinib in Hospitalized COVID-19 Patients and More

CV Update_May 18_2021

News information is not all-inclusive and updates are published once a week on Tuesdays.

Here's a look at some of the top COVID-19 news over the past week. 

U.S. Shipping 20 Million Surplus COVID-19 Vaccines Internationally

The Biden Administration plans to ship approximately 20 million surplus COVID-19 vaccines to countries in need. These include Moderna, Pfizer-BioNTech and Johnson & Johnson vaccines, although most will be the AstraZeneca-Oxford vaccine, which has yet to be submitted for Emergency Use Authorization (EUA) in the U.S. These additional doses will bring the total to about 80 million distributed internationally by the end of June. About 60 million will be the AstraZeneca vaccine, with the remaining 20 million from Moderna, Pfizer-BioNTech and J&J.

“Our nation is going to be the arsenal of vaccines for the world,” President Biden told reporters. “We need to help fight the disease around the world. It’s the right thing to do, it’s the smart thing to do, it’s the strong thing to do.”

Convalescent Plasma from Recovered COVID-19 Patients Ineffective

A study out of the U.K., Randomised Evaluation of COVID-19 Therapy (RECOVERY) of convalescent plasma—that is, plasma from people who recovered from COVID-19—was found to be ineffective in hospitalized COVID-19 patients. The results were published in The Lancet, and found the plasma did not improve survival or hospitalization rates within 28; nor did it decrease the need for mechanical ventilation or decrease the rates of death.

Clinical Trials for COVID-19 Vaccines in Children 5 Years and Older Starting

Both Pfizer and Moderna are running clinical trials in young children. Pfizer expects to apply to the FDA for Emergency Use Authorization in children ages 2 to 11 in September. Moderna is currently running trials of its vaccine in children 6 months to less than 12 years. COVID-19, comparatively, is not as lethal for children as it is for older people. In the U.S., it has resulted in the deaths of 300 children, a far lower rate than in adults.

However, “that actually represents one of the top 10 causes of death in children right now,” said Yvonne Maldonado, a pediatric infectious disease expert at Stanford Medicine who is running the Pfizer trial. “And there have been thousands of children hospitalized.”

Extending Time Between Pfizer Doses Increases Efficacy

The Pfizer-BioNTech vaccine is designed to be given in two doses about three weeks apart. However, a study in the UK led by the University of Birmingham and Public Health England found that extending that gap by months resulted in stronger protection. Britain had adopted the strategy of extending the second dose by up to 12 weeks in order to get at least a single dose into more people early—as of Sunday, they reported that more than 20 million people have received two doses. The study indicated that after 12 weeks, antibody levels were three-and-a-half times higher than in the 3-week cohort.

“We’ve shown that peak antibody responses after the second Pfizer Vaccination are really strongly boosted in older people when this is delayed to 11 to 12 weeks,” said Helen Parry, senior author of the study at Birmingham. “There is a marked difference between these two schedules in terms of antibody responses we see.”

A Pfizer spokesperson, Jerica Pitts, told Fox News, “Pfizer can only comment on the dosing regime and outcomes outlined in our Phase III clinical trial, which demonstrated that two doses administered 21 days apart resulted in vaccine efficacy of 95%. However, we are encouraged by the increasing wealth of evidence from independent studies and real-world data which reinforces the effectiveness of the Pfizer-BioNTech vaccine in real-world settings.”

BerGenBio Updates Bemcentinib Program in Hospitalized COVID-19

BerGenBio ASA provided an update from its Phase II trial of bemcenetinib in hospitalized COVID-19 patients. It is 96% enrolled, with a total of 115 patients, 60 in India and 55 in South Africa, with 58 receiving the drug. The ACCORD2-002 study halted enrollment at 50% because of a drop in UK COVID-19 cases and to allow a speedy analysis. Both trials have the same design and endpoints. In both studies, bemcentinib was well tolerated and at day 29, there was a numerically lower number of deaths in the bemcentinib arm. The drug is a selective AXL kinase inhibitor.

FDA Authorized Roche’s Cobas SARS-CoV-2 Test for COVID-19

The FDA granted Emergency Use Authorization to Roche for its cobas SARS-CoV-2 Test on its cobas 6800/8800 Systems for testing people without symptoms or reasons to suspect COVID-19. This supports guidance from the U.S. Centers for Disease Control and Prevention (CDC) to expand testing to include asymptomatic people in hopes of decreasing the spread of COVID-19. It also applies to pooled samples with up to and including six individual samples.

Master Protocols for COVID-19

The U.S. Food and Drug Administration (FDA) issued final guidance Monday on master protocols for evaluating prevention and treatment options for COVID-19. The guidance takes effect immediately and will remain in effect throughout the pandemic. The document, COVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention Guidance for Industry, brings industry best practices learned during the pandemic to bear on the design and execution of clinical trials.

COVID-19 and Airborne Pathogens

Since the 1800s, scientists have pushed governments to overhaul water supply systems for cleaner, safer water to stop the outbreak of waterborne pathogens. Today, researchers are calling for a similar “paradigm shift” in indoor ventilation systems to combat COVID-19 and other airborne pathogens. Scientists have warned of the deadly virus spreading through the air for over a year, nothing has widely addressed the need for air quality control.  Air-quality expert Professor Lidia Morawska and 39 researchers from 14 countries published a call for change in Science

To Mask Or Not to Mask 

The U.S. Centers for Disease Control and Prevention (CDC) issued new pandemic guidelines that nearly eliminate mask-wearing requirements for fully vaccinated people. The announcement was met with mixed reaction.

A Vaccine Misconception

With the varying and often changing guidelines about COVID-19 vaccines, one could be forgiven for believing the recent rumors running rampant on social media proclaiming that the inoculations can cause infertility or harm an existing pregnancy. The good news is that reputable scientific sources continue to debunk this concern. Click here to read more

Humanigen on Track 

In its first-quarter reportHumanigen announced it had “recently held a meeting with FDA” to discuss plans for filing an Emergency Use Authorization (EUA) for its lenzilumab for hospitalized, hypoxic COVID-19 patients by the end of May.

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