Infectious Disease

Sanofi (NYSE:SNY) and Glaxo Smith Kline’s (NYSE:GSK) have confirmed a delay in their adjuvanted recombinant protein-based COVID-19 vaccine owing to an inadequate immune response in older adults in a Phase 1/2 trial.  Sanofi and GSK now plan to launch a Phase 2b study in February 2021 to investigate a new vaccine formulation.  If that study reaches primary endpoints,…

Vaccinating against the flu is like shooting at a moving target. Influenza strains continuously mutate, and it is difficult for researchers to identify the three or four strains most likely to post the most significant risk in any given season. As a result, developing flu vaccines is something of a guessing game. According to the…

Today, an FDA advisory panel recommended that the COVID-19 vaccine candidate from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) be granted emergency use authorization (EUA). A total of 77% of the 22 panelists voted “yes” to issue an EUA for the vaccine. In the past week, three countries — UK, Canada and Bahrain — granted emergency use…

The United Arab Emirates has approved a COVID-19 vaccine from Sinopharm (OTCMKTS:SHTDY). The China-based pharma company concluded that that the vaccine was 86% effective, putting it ahead of the vaccine performance of the vaccine candidate from AstraZeneca (LON:AZN) but behind the vaccines from Pfizer (NYSE:PFE) and Moderna (NYSE:MRNA). Both of the latter two vaccines were 95% efficacious.  The UAE Ministry of…

President Trump unveiled his latest executive order, which aims to distribute COVID-19 vaccines to American citizens before sending them abroad.  “It is the policy of the United States to ensure Americans have priority access to free, safe, and effective COVID-19 vaccines,” reads part of the order. After the HHS Secretary has determined that the U.S. public…

FDA staff released data today confirming the performance of the BNT162b2 COVID-19 vaccine candidate from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX).  The vaccine appears to be on track to receive emergency use authorization to inoculate Americans at least 16 years old based on its Phase 3 trial involving roughly 44,000 participants.  The average efficacy rate for the vaccine in…

The U.S. intends to order enough Pfizer’s COVID-19 vaccine for 50 million people, but the volume of COVID-19 vaccines the U.S. can procure could be limited until June 2021, according to the New York Times. The cause of the potential shortfall stems from the Trump administration officials’ decision to pass on an offer from Pfizer…

The FDA today said that the COVID-19 vaccine candidate made by Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) meets success criteria. Ahead of an advisory meeting on Thursday, Dec. 10, to review the vaccine candidate, the FDA found that data from Pfizer and BioNTech’s trials was “consistent” with its recommendations for emergency use authorization and that the candidate was…

Eli Lilly (NYSE:LLY) and UnitedHealth Group (NYSE:UNH) are partnering on a pragmatic study of bamlanivimab (LY-CoV555) in high-risk patients with COVID-19 infections.  Lilly recently won emergency use authorization from the FDA to use the monoclonal antibody bamlanivimab to treat mild to moderate COVID-19 infections in patients at risk of severe infections.  The study will evaluate the…

Dr. Paul Offit is one of the most notable vaccine experts in the U.S. A member of the FDA’s Vaccines and Related Biological Products Advisory Committee for COVID-19 vaccines, Offit is the co-inventor of a rotavirus vaccine. In a conversation with JAMA editor-in-chief Dr. Howard Bauchner, Offit shared his opinion on a range of subjects…

In pharmacovigilance, detecting risks linked to new medicine can be a slow process. The typical procedures for doing so, known as signal detection and assessment, involves probing hypothetical risks tied to a medicine based on at least some degree of supporting evidence.  The U.S. government aims to speed the process by combining routine signal detection…

A Centers for Disease Control and Prevention (CDC) advisory panel voted 13 to 1 to prioritize COVID-19 vaccines for healthcare workers and residents of long-term facilities after FDA authorizes their use.   The panel’s recommendations include three-tiers — Phases 1A, 1B and 1C — for early vaccinations. Officials with the federal government’s Operation Warp Speed have…

Throughout much of the world, SARS-CoV-2 infections are seemingly spiraling out of control. Still, there is reason for optimism as a trio of COVID-19 vaccines seems to be on the cusp of winning emergency use authorization in the U.S.  At least 10 vaccines have entered or completed Phase 3 trials. And by the second half…

On the face of it, AstraZeneca (LON:AZN) seems to have a competitive COVID-19 vaccine. Its vaccine, which it has jointly developed with the University of Oxford, promises to be up to 90% effective — far higher than the FDA’s requirement of 50%. It is also inexpensive, costing $2.50 per dose.  But the company finds itself…

Moderna (NSDQ:MRNA) announced today that it will apply for emergency authorization from U.S. FDA and the European Medicines Agency for its COVID-19 vaccine candidate. The company said it has already initiated the rolling review process with the EMA, Health Canada, SwissMedic, the United Kingdom Medicines and Healthcare products Regulatory Agency, Ministry of Health in Israel, and…

Merck (NYSE: MRK) recently announced that it will pay $425 million in cash to acquire privately-held biopharmaceutical company OncoImmune and its potential COVID-19 treatment. OncoImmune’s CD24Fc is a first-in-class recombinant fusion protein that targets the innate immune system. OncoImmune recently announced positive top-line findings from an interim efficacy analysis of a Phase 3 study evaluating…

U.S. Health and Human Services Dept. Secretary Alex Azar confirmed that HHS is working with president-elect Joe Biden on a presidential transition. Speaking during a press briefing, Azar said HHS is in contact with the transition team after the General Services Administration formally recognized Biden as the president-elect, having previously sidestepped questions regarding the potential…

An estimated 21 million U.S. healthcare workers should be among the first to receive a COVID-19 vaccine, according to a CDC advisory committee. The Advisory Committee on Immunization Practices (ACIP) within the CDC met yesterday to discuss how to best allocate COVID-19 vaccines. Members of the group will formalize their recommendations by voting after FDA…

Once enough people receive effective vaccines against the novel coronavirus, experts say, the end of the pandemic may be in sight. But a new poll of older adults — one of the highest-priority groups for vaccination — suggests an uphill climb lies ahead to reach that goal. In all, 58% of adults aged 50 to…

Regeneron Pharmaceuticals (NSDQ:REGN) has announced that the FDA has granted emergency use authorization (EUA) for the combination of casirivimab and imdevimab to treat COVID-19.  The monoclonal antibody cocktail is reportedly the first treatment to show “statistically significant anti-viral activity” against COVID-19, according to its developer. In a trial, the combination of drugs cut hospitalization or emergency…

Biotechnology traces its roots to the Neolithic era when early civilizations discovered how to ferment grains to prepare alcoholic brews and bread. It wasn’t until genetic engineering became mainstream in the mid-1970s, however, that biotechnology, as we know it today, was launched. The field continues to evolve today. The advent of new technology has revolutionized the market…

Until recently, the most rapidly developed vaccine was for mumps, which took four years. Now, Pfizer (NYSE:PFE) and Moderna (NSDQ:MRNA) appear to be on the cusp of commercializing COVID-19 vaccines under emergency use authorization. It was only a year ago that physicians in China identified unusual pneumonia cases that would later be associated with the novel coronavirus. As impressive…

AstraZeneca (NYSE:AZN) announced today that one of its COVID-19 vaccine candidate dosing regimens is up to 90% effective in preventing the virus. Cambridge, United Kingdom-based AstraZeneca, working in collaboration with Oxford University, found the vaccine to be highly effective in preventing COVID-19 for subjects in the UK and Brazil, with no hospitalizations or severe cases of…

Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) announced that they will submit a request today with FDA for an EUA of their mRNA vaccine candidate, BNT162b2, against SARS-CoV-2. If all goes as planned, the companies predict that high-risk populations in the U.S. could start receiving the vaccine by mid- to late-December. Vaccine distribution could start within…

Thermo Fisher Scientific (NYSE: TMO) has debuted a cryogenic transmission electron microscope (cryo-TEM) that it claims “democratizes” the technique. In 2017, a trio of international researchers won the Nobel Prize in Chemistry for the microscopy method, which enables high-resolution imaging of biomolecules in a solution.  The technique enables researchers to see proteins in high resolution…