Please check out the biopharma industry’s COVID-19 stories that are trending for June 22, 2021.
COVID-19 MultiSystem Inflammatory Syndrome Seen in Adults
Multisystem inflammatory syndrome (MIS-C), a rare side effect to COVID-19 in children, has been diagnosed in a 60-year-old Canadian man. The study, which was published in the Canadian Medical Association Journal, suggests that age should not limit MIS-C as a potential diagnosis. His symptoms were prolonged shortness of breath, high fever, swelling and severe fatigue. Subsequent testing detected an enlarged heart and lung swelling.
2 Studies Say Post-COVID Syndrome Therapy in Kids Tricky to Treat
Two real-world studies that looked at the use of intravenous immune globulin (IVIG) therapy plus glucocorticoids for treatment of post-COIVD-19 MIS-C in children were someone inconclusive. One found a lower risk of new or persistent cardiovascular problems while the other showed no effect. An accompanying editorial suggested that although they had conflicting conclusions, they were on very different populations and used data from two different periods in the pandemic. There may also have been shortcomings in the statistical modeling methods used.
Moderna Increases Overall Production
While the COVID-19 pandemic has been the worst we’ve seen in over 100 years, the crisis has brought out the best in the life sciences as companies around the world continue to answer the call. Moderna, the second company to have its COVID-19 vaccine approved by the FDA, is adding two new production lines at its rebuilt former Polaroid plant to increase overall production capacity by 50%. With the 350,000 square foot site expansion comes a continued hire flurry for the area. Originally employing 150 workers in 2018, Moderna has created more than 650 new jobs at the Norwood, Massachusetts site.
Use of Anti-Parasitic Drug Ivermectin for COVID-19
Use of the anti-parasitic drug ivermectin could reduce COVID-19-related deaths, data from a peer-reviewed study shows. The study, published last week in the American Journal of Therapeutics, analyzed data from multiple clinical studies assessing ivermectin as a potential treatment for COVID-19. Ivermectin, which is approved by the U.S. Food and Drug Administration (FDA) as a treatment for intestinal strongyloidiasis and onchocerciasis, which are two conditions caused by parasitic worms, has anti-inflammatory properties.
COVID-19 and Lingering Neurological Effects
The COVID-19 pandemic may be lessening, but for patients, the after-effects may linger for months. Researchers at the virtual 7th Congress of the European Academy of Neurology (EAN) consistently report significant, lingering cognitive and behavioral problems in multiple studies. The problem of neurological sequelae often is under-recognized, and may increase the burden of COVID-19 on patients, according to neurologists R. Garcia Santos, M.D., and M. Rodriguez Rodriguez, M.D., of Mexico City.
Guidance for Long COVID
Long COVID, or long-haulers syndrome, is a puzzling range of lingering symptoms and complications after COVID-19 infection. Last week, the U.S. Centers for Disease Control and Prevention (CDC) issued new guidance for long COVID, loosely defined as illness at least four weeks after acute infection. The guidance notes that primary care physicians can typically handle post-COVID conditions, but objective laboratory or imaging results “should not be used as the only measure or assessment of a patient’s well-being; lack of laboratory or imaging abnormalities does not invalidate the existence, severity, or importance of a patient’s symptoms or conditions.”
Pfizer’s Oral Rheumatoid Arthritis
Treatment with Pfizer’s oral rheumatoid arthritis drug Xeljanz (tofacitinib) was associated with a reduction in death or respiratory failure in hospitalized patients with COVID-19-related pneumonia, according to findings from a study in Brazil. Findings from the placebo-controlled STOP-COVID study, published in the New England Journal of Medicine, suggest the oral Janus kinase (JAK) inhibitor tofacitinib could be a potential contender in the race to identify benefit for COVID-19 in already approved therapies. The therapy is currently approved for rheumatoid arthritis but not for COVID-19 or COVID-19-related pneumonia.
CureVac’s COVID-19 Vaccine Only 47% Effective
CureVac’s COVID-19 vaccine candidate CVnCoV has shown to be only 47% effective against COVID-19 disease of any severity, according to an interim analysis of the international pivotal Phase IIb/III HERALD study. The new findings likely throw a wrench in the company’s plans to deliver millions of much-needed vaccine doses to the European Union soon. Following news of the findings, U.S. traded shares in CureVac fell 50.6% to $46.81 in after-hours trading. Shares in the company also plunged more than 52% in German trading, as reported by Bloomberg, which reportedly wiped out nearly $9.6 billion in market value.
COVID-19 Origin
While the science regarding the novel coronavirus responsible for COVID-19 hasn’t changed, some virologists and public officials call for more investigation into the origin of the virus, particularly regarding a China-based lab-leak theory bolstered by former President Donald Trump. Last month, a group of 18 scientists published an open letter in Science asking heads of global health organizations to investigate the origin of SARS-CoV-2 further. The scientists asked to examine theories surrounding the natural occurrence of the virus as well as laboratory spillovers.
Regeneron’s COVID-19 Antibody Cocktail
Regeneron’s COVID-19 antibody cocktail REGEN-COV continues to demonstrate efficacy against the coronavirus. Data from a new British study shows REGEN-COV reduced the risk of death in hospitalized patients unable to mount their own immune response by 20%.
Intranasal Therapy for COVID-19
Another company developing an intranasal therapy for COVID-19 has risen up from down under, as ENA Respiratory announced AU$32 million in funding and the appointment of COPD Foundation president and chief scientific officer, Dr. Ruth Tal-Singer, Ph.D., to help shepherd its nasal spray to the market.
Repurposed Drug for COVID-19
Repurposed drugs became the front-line defense against COVID-19 within a few months of the pandemic’s emergence. Now bucillamine, currently in Phase III trials in the U.S., may be poised to join them. Used in Japan and South Korea as an arthritis treatment for the past 30 years, Canadian firm Revive Therapeutics is putting it through its paces as a possible oral, at-home therapy for mild to moderate COVID-19.
COVID-19 Vaccines and the Delta Variant
New data shows COVID-19 vaccines are effective against the Delta variant, a strain of concern driving infections in India, England, Scotland, and other countries across the globe and causing governments to pause re-opening plans. A recent study conducted by Public Health England found that the available vaccines were “highly effective” at preventing hospitalization. The government report found that the mRNA vaccine developed by Pfizer and BioNTech is 96% effective against hospitalization after two doses and the AstraZeneca vaccine is 92% effective against hospitalization after two doses.
Pfizer’s Preparation for Next Pandemic
A sense of urgency, powerful science, relentless ingenuity, hope and trust drove the development of Pfizer and BioNTech’s mRNA vaccine during the height of the COVID-19 pandemic. As the crisis appears to lessen, Pfizer is preparing for the next pandemic. “The scenario that a viral variant will evade the vaccine, one day, is real,” Pfizer CEO and Chairman Albert Bourla, DVM, Ph.D., said while speaking at BIO Digital 2021. “We have tested our vaccine against almost all of the SARS-CoV-2 variants, including the latest one (from India and dubbed Delta), and no variant escapes our vaccine.”
AstraZeneca’s Antibody Failed to Meet Primary Endpoint
Shares of AstraZeneca have dipped in premarket trading after the company announced its COVID-19 antibody therapeutics failed to provide high levels of protection for individuals who have had contact with a symptomatic COVID-19 patient. AstraZeneca said the Phase III STORM CHASER trial assessing AZD7442, a long-acting antibody (LAAB) combination, failed to meet the primary endpoint of post-exposure prevention of symptomatic COVID-19 compared to placebo. The failure marks a setback in the hunt for means other than vaccines to provide protection against the novel coronavirus and its variants.
