2021 Biopharma Update on the Novel Coronavirus: March 2

CV Update_March 2_2021

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

Diagnostics

The FDA issued EUA for the QuickVue At-Home COVID-19 test. The at-home antigen test allows individuals to collect and test their sample at home, without needing to send a sample to a laboratory for analysis.

 

Testing Therapies, Antivirals and Vaccines

As expected, the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) to Janssen Pharmaceutical of Johnson & Johnson’s single-shot COVID-19 vaccine. The EUA covers individuals 18 years of age and older.

Two days after receiving Emergency Use Authorization from the FDA, millions of doses of Johnson & Johnson’s COVID-19 vaccine are being transported to vaccination sites across the country. The Wall Street Journal reports McKesson Corp. is working with FedEx and UPS to ship the doses nationwide.

A clinical trial is a gold standard for determining the safety and efficacy of drugs and vaccines, but it’s not quite the same as the real world. As the vaccines against COVID-19 are being rolled out worldwide, numerous studies are being conducted to evaluate how the vaccines do under less controlled situations. Here’s a look.

Researchers at the University of Exeter developed a fast and simple way to evaluate the potential risk of water-borne transmission of the COVID-19 virus from sewage spills into open and closed freshwater networks. It studied the risk across 39 different counties, and leveraged environmental data, a population’s infection rate, and water usage.

University of California-San Diego investigators found that a repurposed arthritis drug, tocilizumab, did not significantly improve patients with severe COVID-19 pneumonia, clinical status or mortality rate at 28 days compared to placebo. They published the results of the Phase III trial in The New England Journal of Medicine. They did observe some benefits, including improvement in length of stay and fewer days on a mechanical ventilator.

A study by Public Health England (PHE) found that a single dose of either the Pfizer-BioNTech or Oxford-AstraZeneca vaccines decreased the risk of hospitalization from COVID-19 by more than 80% in people 80 years of age or older. The effect was observed three to four weeks after receiving the shots. People over the age of 70 also showed up to 61% protection against symptomatic disease from the Pfizer-BioNTech vaccine and up to 73% from the Oxford-AstraZeneca shot.

The World Health Organization (WHO) strongly advises against using malaria drug hydroxychloroquine to prevent COVID-19. The advice was based on a review of all existing studies on the subject. The recommendation was announced in the BMJ medical journal as part of the first version of WHO’s living guideline for drugs to prevent COVID-19. They concluded with high certainty that the drug does not prevent hospitalization or death from COVID-19.

Cerecor announced final efficacy data including 60-day mortality from their U.S.-based Phase II trial of the human anti-LIGHT (TNFSF14) monoclonal antibody CERC-002. All patients in the trial were hospitalized with COVID-19 associated pneumonia and mild-to-moderate acute respiratory distress syndrome (ARDS). The trial hit its primary efficacy endpoint, the proportion of patients alive and free of respiratory failure over the 28-day study period, compared to placebo in COVID-19 patients with ARDS treated with a single dose of CERC-002.

The Center for Infectious Disease Research and Policy at the University of Minnesota reported that patients who used statins prior to COVID-19 hospitalization were almost 50% less likely to experience 30-day in-hospital mortality compared with those that didn't. Clinical studies could show that statins may prove to be a low-cost and effective therapeutic strategy for COVID-19.

A study from the Earlham Institute is conducting a study of cytokine storms associated with COVID-19 in order to help clinicians “identify interventions that have successfully alleviated cytokine storm in other diseases, and evaluate whether they could be effective in treating certain COVID-19 cases.”

A study coordinated by UZ Gent in Belgium shows the drug Leukine can play an important role in healing hospitalized COVID-19 patients.  Leukine promotes oxygen absorption from the lungs to the blood and stimulates the immune system. Because the T-cells are specific to the virus present in the individual, Leukine would be effective against all variants of the disease, researchers said.

 

Organizational Announcements

Novavax Chief Executive Officer Stanley Erck believes the U.S. Food and Drug Administration (FDA) could grant Emergency Use Authorization (EUA) for its COVID-19 vaccine by May.

Chinese fusion protein company Clover Biopharmaceuticals raised a $230 million series C round co-led by GL Ventures and Temasek, which will push its COVID-19 vaccine into Phase II/III testing and production planning.

 

Other Industry News

Now that the Johnson & Johnson COVID-19 vaccine has been authorized in the U.S., along with the Pfizer-BioNTech and Moderna vaccines, and manufacturing and distribution ramps up, the debate over herd immunity is heating up. Currently, vaccination efforts are resulting in fewer new cases, hospitalizations and deaths. Herd immunity is the point where enough people are protected from a disease, whether by having had it or by vaccination, that it can’t spread through the population. It tends to be more commonly discussed in terms of vaccinated populations.

As scientists and vaccine manufacturers continue to test their products against the variants, researchers are seeing new variants cropping up that originated in the U.S. Click here for more information

The development, clinical trials and authorization of several COVID-19 vaccines within about one year is an amazing and historic scientific achievement. But manufacturing and distribution problems have cast a light on other difficulties. Although problems with actually getting shots into arms have been described thoroughly, manufacturing problems and scale-up haven't been the focus of much reporting. However, with supply lagging, COVID-19 manufacturers pledge to ramp up. 

 

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