Infectious Disease

Moderna (Nasdaq:MRNA) recently announced that an investigational version of its COVID-19 vaccine for potential use in children 6 months to 6 years met its primary endpoint in a Phase 2/3 study. Two doses of the vaccine were 43.7% effective at preventing infection during the omicron wave in children aged 6 months to 2 years old.…

Pfizer (NYSE:PFE) and BioNTech (Nasdaq:BNTX) recently asked FDA to allow individuals 65 and older to receive a second booster of their BNT162b2 COVID-19 vaccine. Now, Moderna (Nasdaq:MRNA) is filing for FDA authorization to permit a fourth dose of its Spikevax (mRNA-1273) COVID-19 vaccine for adults 18 and older. In its submission, Moderna included data gathered…

Moderna’s mRNA Access program (Nasdaq: MRNA) enables researchers to use its mRNA technology platform for research projects related to emerging and neglected infectious diseases. “It takes a community of scientists and disease experts to develop novel vaccines to tackle our greatest public health threats,” said Hamilton Bennett, Moderna’s senior director, vaccine access and partnerships. “mRNA Access was…

Pfizer Inc. (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) have filed an application to the FDA for Emergency Use Authorization (EUA) for an additional COVID-19 vaccine booster dose in adults 65 years of age and older. The two companies submitted two real-world data sets from Israel while the omicron variant was widespread. Pfizer notes that an additional dose…

The National Institute of Allergy and Infectious Diseases (NIAID) has announced a Phase 1 clinical study of HIV vaccines using mRNA sequences. The study will test the safety and immunogenicity of three investigational HIV mRNA vaccines known as BG505 MD39.3 mRNA, BG505 MD39.3 gp151 mRNA and BG505 MD39.3 gp151 CD4KO mRNA. The three HIV vaccine…

French vaccine company Valneva SE (Nasdaq:VALN; Euronext Paris:VLA) has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has sent the company a “small set” of questions related to its VLA2001 COVID-19 vaccine candidate. The firm announced on February 25 that CHMP had sent the company a…

Everest Medicines (HKEX:1952.HK) has announced that its licensing partner, Venatorx Pharmaceuticals, reported positive results from a Phase 3 study investigating the use of cefepime-taniborbactam in hospitalized adults with complicated urinary tract infections (cUTI), including acute pyelonephritis. The study pitted cefepime-taniborbactam against meropenem. First approved in 1996, meropenem is used to treat various bacterial infections. In the…

The Pfizer-BioNTech COVID-19 vaccine lowered the incidence of omicron-based SARS-CoV-2 infection by 31% in children aged 5 to 15 in a recent study. The vaccine was more effective in children between the ages of 12 and 15, lowering the risk of omicron infection by 59%, according to the study from CDC and Abt Associates. Participants…

Researchers from the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) are conducting a clinical trial on allergic reactions to mRNA-based COVID-19 vaccines. The single-site trial will enroll up to 100 people between 16 and 69 years old who had an allergic reaction to a first dose of COVID-19 mRNA vaccines. NIAID seeks participants…

Pfizer (NYSE:PFE) is looking to expand the use of the  antiviral Paxlovid, which FDA has authorized to treat mild-to-moderate COVID-19 in individuals who are at least 12 years of age who weigh at least 40 kg. The authorization covers individuals with a risk of developing severe disease. A recently launched Phase 2/3 study will test…

COVID-19 vaccine heavyweight Pfizer (NYSE:PFE) will soon provide data related to the fourth dose of its COVID-19 vaccine, according to Bloomberg. The company and its partner BioNTech (Nasdaq: BNTX) are also developing an omicron-specific version of the vaccine. Pfizer CEO Dr. Albert Bourla said that the data to be shared with FDA involve the fourth dose…

AstraZeneca’s (LON:AZN) and Sanofi‘s (Nasdaq:SNY) nirsevimab had 75% efficacy against lower respiratory tract infections resulting from rr (RSV) in a Phase 3 study. There are currently few treatment options for lower respiratory tract infections stemming from RSV. Two antivirals, palivizumab and ribavirin, are available, while new vaccines are currently authorized. RSV is the most common…

Before Alexander Fleming discovered penicillin, another more selective antibacterial agent rose to popularity in the early 1900s: bacteriophage. In 1917, microbiologist Felix d’Herelle was tasked with identifying the cause of a dysentery outbreak impacting French troops. From his research, he noticed that Shigella bacteria was the primary culprit of this affliction. He then discovered an…

A recent editorial in the British Medical Journal (BMJ) criticized the decisions of British and U.S. health regulators to authorize the use of the antiviral molnupiravir, the COVID-19 antiviral. The developers of the drug, Merck & Co. (NYSE:MRK) and Ridgeback Biotherapeutics, had announced that molnupiravir lowered the risk of hospital admissions or death by roughly 50% in…

GlaxoSmithKline plc (LSE/NYSE:GSK) has announced that it has chosen to stop enrollment and vaccination of studies testing its respiratory syncytial virus (RSV) maternal vaccine candidate in women. The company had announced a voluntary pause of the trials NCT04605159, NCT04980391 and NCT05229068 on February 18. GSK did not elaborate on the reason for halting the trials.…

Researchers at MIT are touting a novel method to synthesize a natural compound that has shown potential as an antibiotic. The chemists produced himastatin using the synthesis method and also managed to generate variants of the molecule, some of which showed antimicrobial activity, according to a news story from the university’s website. The compound appears…

GlaxoSmith Kline (NYSE:GSK) and Sanofi (NYSE:SNY) recently announced their intent to seek regulatory authorization for an adjuvanted recombinant protein-based COVID-19 vaccine. Now, GSK and its partner Medicago have received approval from Health Canada for another COVID-19 vaccine, which combines the former’s adjuvant technology with the latter’s plant-derived vaccine.  Known as Covifenz, the vaccine makes use of plant-based virus-like…

Moderna (NSDQ:MRNA) shares are on the rise on fourth-quarter results that came in ahead of the consensus forecast. MRNA shares were up 11.7% at $161.51 per share in midday trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was up 1.1%. The Cambridge, Massachusetts-based company posted…

The CDC has recommended extending the interval between the first and second doses of the Pfizer (NYSE:PFE) and Moderna (NASDAQ:MRNA) COVID-19 vaccines up to eight weeks for some individuals. The guidance for those vaccines was formerly 21 and 28 days, respectively.  CDC notes that an eight-week interval could be preferred for some individuals 12 and…

In the U.S., Moderna (NASDAQ:MRNA) and Pfizer (NYSE:PFE) continue to dominate the COVID-19 landscape while demand for Johnson & Johnson’s (NYSE:JNJ) vaccine remains limited. Now, Sanofi (NASDAQ:SNY) and GSK (NYSE:GSK) are preparing to get into the game by preparing their regulatory submissions for their COVID-19 vaccine. The companies are currently communicating with the FDA and…

The Data and Safety Monitoring Board for Moderna’s (NASDAQ:MRNA) respiratory syncytial virus (RSV) vaccine program has backed the launch of a Phase 3 clinical study of the mRNA-1345 vaccine candidate. The study will focus on adults 60 years and older. RSV leads to approximately 177,000 hospitalizations and 14,000 deaths among adults aged 65 years or…

Officials at the Food and Drug Administration are considering potentially authorizing an additional booster of the COVID-19 vaccines from Moderna (NASDAQ:MRNA) as well as Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX), according to the Wall Street Journal. At present, individuals 12 and older who are moderately or severely immunocompromised are eligible for four COVID-19 vaccine doses. Before the…

Pfizer (NYSE:PFE) and its partner BioNTech SE (NSDQ:BNTX) have launched a clinical trial to test an omicron-specific version of their COVID-19 vaccine. The two companies initially vowed to launch the updated vaccine by the end of March, but that goal may shift depending on the volume of clinical data regulators demand, according to BioNTech. In…

Pardes Biosciences (NSDQ:PRDS) said its PBI-0451 twice-daily COVID-19 pill candidate had favorable tolerability and good oral bioavailability, based on interim data from an ongoing Phase 1 trial. The company also said the drug candidate lacked clinically significant drug-drug interactions. “We’re very encouraged by the safety profile and bioavailability profile we’re seeing to date,” Brian Kearney,…

PharmaJet announced today that its partner, Technovalia, reported positive interim safety results from a needle-free COVID-19 vaccine trial. Golden, Colorado-based PharmaJet’s needle-free injection systems are being studied with Covigen, a DNA-based vaccine developed by French-Thai pharmaceutical company BioNet-Asia in collaboration with Melbourne, Australia-based Technovalia. Enrollment for the trial began in June 2021. Get the full story at…