Infectious Disease

Pfizer and BioNTech announced today that European authorities approved storage of their COVID-19 vaccine at a new temperature. Based on data showing stability in standard pharmaceutical freezers, the European Medicines Agency (EMA) approved storage of the vaccine at -25°C to -15°C for a total of two weeks. The FDA’s requirements include two-week storage at the same temperatures,…

Influenza viruses are a moving target, forcing drug developers to modify their products annually based on the strains most likely to dominate a given season. SARS-CoV-2 could follow a similar trajectory in the first few years of the pandemic, according to a study published in Virus Evolution. SARS-CoV-2 is likely to continue to accumulate changes…

The World Health Organization has a leading theory regarding the origins of the COVID-19 pandemic but is considering three others in a forthcoming report, according to a recent AP article. The most likely scenario is that the virus, which many scientists believe first appeared in bats, infected humans through an intermediary animal. Less likely is that…

Following allegations of sexual harassment, former head of Operation Warp Speed Moncef Slaoui has left roles at two more companies. Yesterday, Slaoui was terminated as the Galvani board of directors’ chair, GlaxoSmithKline’s board of directors announced. The same day, Vaxcyte confirmed in an SEC filing that it had axed Slaoui as its chairman of the…

The Korean biopharma Medytox and Jupiter, Fla.–based Dyadic International are partnering to develop vaccines that would protect against multiple COVID-19 variants. The companies plan on using Dyadic’s C1-cell protein production platform in the development of the vaccines. The vaccines would use a similar strategy to flu vaccines, which are often trivalent or quadrivalent. The former…

Some of the first commercially available doses of Pfizer-BioNTech COVID-19 vaccine had lower levels of intact mRNA than anticipated, according to leaked documents reviewed by BMJ. The documents in question relate to a December breach of the European Medicines Agency (EMA), which was one of the many victims of pharma-related cyber breaches in 2020. The cybercriminals…

A multicenter study involving a substantial number of minorities indicated that remdesivir supported clinical improvement in the majority of patients. The hospitalized remdesivir group had an average time to clinical improvement of five days versus seven days for those not receiving the drug. Remdesivir recipients had a 28-day mortality rate of 7.7% compared with a…

The duration of immunity from COVID-19 infections is still not well understood. But a recent longitudinal study indicates that the presence of SARS-CoV-2 neutralizing antibodies could range from about 40 days to decades, depending on the severity of infection. The study followed 164 patients infected with the novel coronavirus for up to 180 days after…

  GlaxoSmithKline’s board of directors announced today that it terminated Moncef Slaoui as the chair of the Galvani board of directors. Slaoui, who served as the head of Operation Warp Speed — the Trump administration’s program to accelerate COVID-19 vaccine development — was terminated effective immediately, according to a news release from GSK, the majority…

An experimental oral antiviral from Pfizer will be the focus of a Phase 1 study involving healthy adults. Known as PF-07321332, the drug has shown promise during in vitro studies against SARS-CoV-2. PF-07321332 belongs to a class of drugs known as protease inhibitors, which are commonly used to treat HIV/AIDS and hepatitis C. Protease inhibitors bind to…

Regeneron Pharmaceuticals (NSDQ:REGN) announced today that its COVID-19 antibody drug reduced hospitalization and death risk by 70% in clinical trials. The definitive Phase 3 outcomes trial in high-risk, non-hospitalized COVID-19 patients met its primary endpoint in displaying that the REGEN-COV (casirivimab with imdevimab) significantly reduced the risk of hospitalization or death by 70% (1,200 mg…

The National Institute of Allergy and Infectious Diseases (NIAID) has announced concerns with data from AstraZeneca’s COVID-19 vaccine trial. NIAID, a wing of the National Institutes of Health (NIH), said in a statement today that it was concerned that information the company released from its AZD1222 vaccine clinical trial may be outdated.In turn, that may…

Two separate teams of scientists in Germany and Norway concluded that the AstraZeneca vaccine could cause an autoimmune reaction, which in turn causes thrombosis in a small number of patients. The problem could be treated using a  blood thinner and immunoglobulin, the German research team determined. The Norwegian researchers claim to have identified an antibody…

AstraZeneca announced today that its COVID-19 vaccine demonstrated statistically significant efficacy in preventing COVID-19 in a U.S. trial. AZD1222, developed in a collaboration between London-based AstraZeneca and Oxford University, was 79% effective in preventing symptomatic COVID-19 and 100% effective in preventing severe disease and hospitalization, according to a news release. Efficacy was consistent across ethnicity…

A significant number of people obtaining COVID-19 vaccines have complained of dizziness. Some 11.8% of the reports associated with COVID-19 vaccines in the Vaccine Adverse Event Reporting System (VAERS) cite dizziness as a possible side effect. An additional 0.80% list vertigo as a complaint while 1.27% reported syncope (fainting).  Several adverse events are common among…

COVID-19 vaccines launched BioNTech and Moderna into the limelight, making these once little-known companies prominent companies. But neither wants to be pigeonholed as a COVID-19 vaccine company. BioNTech cofounder Özlem Türeci stressed in a recent interview with AP that the mRNA vaccine technology that is its focus could be a powerful weapon against cancer. “We have several different…

The number of SARS-CoV-2 variants with enhanced transmissibility and resistance to antibodies is increasing, prompting the U.S. government to issue guidance on how to classify them. The criteria divide variants into three categories including the following: Variant of interest: This virus type has genetic markers that have been linked to a potentially increased risk. Examples…

Oramed Pharmaceuticals (NSDQ:ORMP) announced today that it is forming a joint venture to develop novel oral COVID-19 vaccines. New York-based Oramed entered into definitive agreements to form Oravax Medical, which is based on Oramed’s proprietary POD (protein oral delivery) technology and Premas Biotech’s novel vaccine technology, according to a news release. Get the full story…

Emulate has debuted what it terms a “colon intestine chip” targeted at pharma and biotech companies, academics and other researchers. The company believes the system will accelerate the identification of drug candidates to treat inflammatory damage in the colon. The technology could be a boon for understanding inflammatory bowel disease, which approximately 1.6 million people in…

HRS Heat Exchangers announced that it received orders for pharmaceutical heat exchangers for use with the manufacturing of COVID-19 vaccines. Orders were placed by subcontractors working with Pfizer and Moderna, which both have vaccines authorized in the U.S., and Oxford/AstraZeneca, which has been approved across Europe but not yet in the U.S. The orders are…

The ChAdOx1 COVID-19 vaccine jointly developed by AstraZeneca and the University of Oxford is not effective against the B.1.351 variant first identified in South Africa, according to a recent study published in NEJM. In a five-month study involving HIV-negative adults, 23 of 717 placebo recipients developed mild-to-moderate COVID-19 while 19 of 750 vaccine recipients did. Based…

Sudden onset sensorineural hearing loss — sometimes referred to as sudden deafness — occurs in anywhere from 11 to 77 per 100,000 people per year in the U.S.  There have been a handful of case reports of COVID-19 patients having such hearing loss, including a report in BMJ. But as more COVID-19 vaccines become available, there are a…

Moderna (Nasdaq: MRNA) announced today that it has started dosing the first participants in its Phase 2/3 KidCOVE study evaluating its COVID-19 vaccine among children between the ages of 6 months and 12 years. The NIH’s National Institute of Allergy and Infectious Diseases (NIAID) and HHS’s Biomedical Advanced Research and Development Authority (BARDA) are collaborating…

While the origins of the COVID-19 remain unknown, a likely theory is that wildlife farms in southern China are most likely to blame for seeding the pandemic, according to a World Health Organization member (WHO). While most scientists believe bats were the source of the virus that would later infect humans, it was unclear how humans contracted the…

Although no causal link has been found between blood clots and the AstraZeneca COVID-19 vaccine, several European nations have decided to suspend its use out of an abundance of caution. Germany, France, Italy, and Spain recently halted the use of the vaccine following reports of blood clots in vaccinated people’s brains. There have been 37…