Research published in JAMA found the Moderna’s COVID-19 vaccine drove an antibody response that was more than two times greater than that of Pfizer’s. Specifically, the Moderna mRNA-1273 vaccine generated post-second-dose antibody levels of 2,881 units per milliliter. Those who received the Pfizer-BioNTech BNT162b2 vaccine had antibody levels measuring 1,108 units per milliliter. The study involved 1,647…
BioAegis announces promising data in case study involving critical COVID-19 patient
BioAegis (North Brunswick, NJ) is evaluating data from a Phase 2 clinical trial related to recombinant human plasma gelsolin (rhu-pGSN) along with standard of care in treating patients with severe COVID-19 pneumonia. In the interim, the company has announced the results of a compassionate use case study involving a hospitalized patient with critical COVID-19 pneumonia.…
Pardes Biosciences launches first-in-human trial for SARS-CoV-2 antiviral
A handful of companies may have a lock on COVID-19 vaccines, but competition is heating up in antivirals targeting the novel coronavirus. One of the latest entrants is Pardes Biosciences (Carlsbad, Calif.), which recently announced a Phase 1 trial for PBI-0451, an oral antiviral targeting SARS-CoV-2. Other companies developing antivirals for COVID-19 include Pfizer as well as…
How Delta could change the COVID-19 landscape
Delta is “an extremely transmissible variant and has taken us all for a loop,” said Dr. Monica Gandhi, a professor of medicine and associate division chief of the division of HIV, infectious diseases and global medicine at University of California, San Francisco. But despite Delta’s hurricane-like ascent, the volume of infections it drives are likely…
REGEN-COV lowers risk of symptomatic COVID-19 infections by 81% in study
Regeneron’s (NSDQ:REGN) REGEN-COV remains one of the most effective monoclonal antibody therapies in reducing the risk of serious COVID-19 infections and resulting hospitalizations and deaths. A study recently published in the New England Journal of Medicine found that the drug effectively prevented COVID-19 disease in household contacts of individuals infected with the novel coronavirus. When…
Europe orders another 150 million doses of Moderna’s COVID-19 vaccine
Moderna (NSDQ:MRNA) has announced that the European Commission has reserved an additional 150 million doses of its COVID-19 vaccine for delivery in 2022. To date, the European Commission has reserved 460 million Moderna vaccine doses. The new deal gives the European Commission the ability to purchase new COVID-19 vaccines. The company is currently testing various…
Moderna vaccine highly effective two weeks after first dose
A study published in JAMA involving healthcare workers found that the first dose of Moderna’s (NSDQ:MRNA) COVID-19 vaccine was highly effective at reducing the risk of COVID-19 infections. In the study, participants received two doses of the vaccine at the recommended 28-day interval. Clinical effectiveness reached 95% for days 15 through 42 of the study.…
Recent study finds Pfizer vaccine effective against Delta variant
The BNT162b2 COVID-19 vaccine from Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) leads to a strong neutralizing antibody response to the B.1.617 variant, according to a recent study published in Nature. The study focused on the B.1.617.2 subtype of the virus. Two others exist, known as B.1.617.1 and B.1.617.3. The study did acknowledge that the antibody…
FDA authorizes lower dose of REGEN-COV COVID-19 antibody cocktail
Regeneron (NSDQ:REGN) has announced that the FDA has signed off on a 1,200 mg subcutaneous or intravenous dose of its REGEN-COV antibody cocktail. The quantity is half of the initially authorized dose. The agency had previously authorized a 2,400 mg dose of the vaccine, including a combined dose of 1,200 mg of Casirivimab and 1,200…
COVID-19 lab-leak theory re-emerges as U.S. intelligence report surfaces
A previously undisclosed U.S. intelligence report revealed that three scientists from China’s Wuhan Institute of Virology became sick enough in November 2019 to seek hospital care, according to the Wall Street Journal. The illnesses were consistent with both COVID-19 and common seasonal illnesses, but the report fuels speculation that the scientists at the Wuhan lab…
FDA OKs Pfizer-BioNTech COVID-19 vaccine for younger adolescents
The FDA has authorized the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) for adolescents as young as 12. The agency had previously authorized the vaccine for people 16 and older in December 2020. The FDA came to its decision after Pfizer demonstrated in a Phase 3 trial that the vaccine showed 100% efficacy in preventing symptomatic…
On ePRO and ensuring data integrity
As clinical trials have become more decentralized, there has been an increased focus on the need for more patient-centric drug development. This focus has led to a variety of eClinical applications. Electronic patient-reported outcomes (ePRO) and other electronic clinical outcome assessment (eCOA) approaches can transform trials to make them more pragmatic, patient-centric and efficient. Such…
A quick history of the tech behind J&J, AstraZeneca’s COVID-19 vaccines
Regulatory authorities in the U.S. and Europe have either paused or constrained the use of COVID-19 vaccines from AstraZeneca (LON:AZN) and Johnson & Johnson (NYSE:JNJ), causing some to wonder why the adenoviral-vector vaccines have been potentially linked to similar blood clotting events. Researchers have observed blood clotting events associated with adenoviral vectors since the late-1990s…
Annual COVID-19 vaccines likely, according to Pfizer CEO
The public may require annual vaccines to protect against SARS-CoV-2, Pfizer (NYSE:PFE) CEO Albert Bourla said today. “It is extremely important to suppress the pool of people that can be susceptible to the virus,” Bourla said in a CNBC interview. While the details of Pfizer-BioNTech boosters are not yet clear, COVID-19 boosters will likely be based…
Pfizer asks FDA to authorize its COVID-19 vaccine for younger teens
Pfizer (NYSE:PFE) and its German partner BioNTech (NSDQ:BNTX) have asked FDA to extend the authorization of their COVID-19 vaccine to the ages of 12 to 15. FDA authorized the vaccine for people 16 and older on Dec. 11, 2020. The agency will likely extend its prior authorization to younger adolescents “if the data submitted support…
Johnson & Johnson to test COVID-19 vaccine in adolescents
Mass-vaccination efforts are ramping up, and prominent COVID-19 vaccine developers are working to lower the eligibility age for their products. Johnson & Johnson (NYSE:JNJ), for instance, has begun vaccinating adolescents in a Phase 2a clinical trial for its COVID-19 vaccine candidate. Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) recently announced that their vaccine was 100% effective in…
GSK and Vir Biotechnology seek EUA for COVID-19 monoclonal antibody
GlaxoSmithKline and Vir Biotechnology have filed for emergency use authorization (EUA) for VIR-7831 (GSK4182136), a dual-action SARS-CoV-2 monoclonal antibody. VIR-7831 is designed to stop SARS-CoV-2 viral entry into cells and accelerate the clearing of infected cells. VIR-7831 would have a similar indication to other monoclonal antibodies that have won an EUA. It is intended for…
Forthcoming WHO report could provide multiple theories of COVID-19 pandemic’s origins
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…
Pfizer launches trial for novel oral COVID-19 therapeutic
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…
EU and US take steps to battle coronavirus mutations
The EU recently added clauses to COVID-19 vaccine contracts to prioritize vaccines that are effective against emerging SARS-CoV-2 variants. Meanwhile, a U.S. House bill that would provide $1.75 billion for genomic sequencing of coronavirus samples is scheduled for floor debate and the Senate is considering similar legislation. The UK variant (B.1.1.7) that is spreading across…
South Africa pauses rollout of AstraZeneca COVID-19 vaccine
South Africa has scrapped its plans to vaccinate a portion of its population with the COVID-19 vaccine from Oxford University and AstraZeneca (LON:AZN) after a small study showed it was ineffective against a variant widely circulating there. In the interim, South Africa will rely on vaccines from Johnson & Johnson (NYSE:JNJ) and Pfizer (NYSE:PFE). Researchers at Oxford University…