John Parkinson

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), B.1.1.7, or otherwise known as VOC 202012/01, which was discovered in the United Kingdom back in December may lead to a large increase in the number of COVID-19 cases in the US and may become the dominant strain of the virus in the coming months, according to a Centers for Disease Control and Prevention (CDC) report released last week.

“The increased transmissibility of this variant requires an even more rigorous combined implementation of vaccination and mitigation measures (e.g., distancing, masking, and hand hygiene) to control the spread of SARS-CoV-2,” the CDC wrote in its report. “These measures will be more effective if they are instituted sooner rather than later to slow the initial spread of the B.1.1.7 variant.”

The B.1.1.7 variant has been spreading across the globe, but has been limited in the United States, thus far. The variant has been reported in 76 cases and discovered in 10 states. However, it is believed that the number of cases is actually much higher. Investigators have said B.1.1.7 is more contagious than the original virus, but no determination has been made that this variant can lead to severe cases and higher mortality. The CDC said the UK variant is spreading faster than other variants and points to B.1.1.7 potentially becoming the dominant virus in just a matter of weeks. The agency pointed to projections in its modeling data.

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B.1.1.7, or otherwise known as VOC 202012/01, may lead to a large increase in the number of COVID-19 cases in the United States and may become the dominant strain of the virus in the coming months.

Highly Contagious UK COVID-19 Variant May Become Dominant Strain by March

Johnson & Johnson’s (J&J) JNJ-78436735 COVID-19 vaccine was shown to be 90% efficacious in interim results, according to findings published in the 

The single dose investigational vaccine, which is being developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, is more commonly referred to as the Ad26.COV2.S vaccine, and is a recombinant, replication-incompetent adenovirus serotype 26 (Ad26) vector encoding a full-length and stabilized SARS-CoV-2 spike (S) protein.

After a single dose vaccination, data showed neutralizing antibodies against COVID-19 were detected in over 90 percent of study participants at Day 29 and 100% of participants aged 18-55 years at Day 57. These neutralizing antibodies remained stable through Day 71, currently the latest timepoint available in this ongoing study, in all participants aged 18-55 years. The company plans to release data in participants 65 years and older in late January.

The phase 1/2a analysis showed that the company’s COVID-19 vaccine candidate was generally well-tolerated across all study participants. While the vaccine is being studied as a single dose administration shot, the trial did evaluate 2 dose administration. The data showed that a second dose of JNJ-78436735, administered 56 days apart, was less reactogenic while it triggered more than a two-fold increase in antibodies against COVID-19.

“Although all ongoing phase 3 studies of other Covid-19 vaccines have assessed two-dose schedules, a single dose of Ad26.COV2.S elicited a strong humoral response in a majority of vaccine recipients, with the presence of S-binding and neutralizing antibodies in more than 90% of the participants, regardless of either age group or vaccine dose,” the investigators wrote.

The single dose investigational vaccine being developed by the Janssen Pharmaceutical Companies of Johnson & Johnson is a recombinant, replication-incompetent adenovirus serotype 26 vector encoding a stabilized SARS-CoV-2 spike protein.

Interim Results of Johnson & Johnson Single-Dose COVID-19 Vaccine Shows 90% Efficacy

The FDA will review a Biologics License Application (BLA) for V114, Merck’s investigational 15-valent pneumococcal conjugate vaccine, for the prevention of invasive pneumococcal disease in adults 18 years of age and older. The FDA set a Prescription Drug User Fee Act (PDUFA) date for July 18, 2021.

“Building on our nearly 40 years of experience with PNEUMOVAX 23, Pneumococcal Vaccine Polyvalent, we have developed V114 as another potentially important option to help protect more adults from invasive pneumococcal disease, especially those who are at increased risk," Roy Baynes, MD, PhD, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, said.. "We look forward to working with the FDA during the review of this application.”

The BLA and priority review designation are supported by results from phase 2 and phase 3 clinical studies in a variety of adult populations, including healthy adults and those at increased risk, such as adults with chronic medical conditions, adults with HIV, and those 65 years of age and older. Back in September, 

The FDA will review a Biologics License Application for V114, Merck’s investigational 15-valent pneumococcal conjugate vaccine, for the prevention of invasive pneumococcal disease.

FDA to Review BLA for Merck’s Novel 15-Valent Pneumococcal Conjugate Vaccine

Novavax announced today the FDA had granted the company fast track status for its investigational COVID-19 vaccine, NVX-CoV2373.

“The FDA’s decision to grant Fast Track Designation for NVX-CoV2373 reflects the urgent need for a safe and effective vaccine to prevent COVID-19, and we look forward to working closely with the agency to accelerate access to this vaccine,” Gregory Glenn, MD, president of Research and Development, Novavax, said. “While the regulatory review of this clinical program will be expedited, Novavax remains committed to a data-driven and scientifically rigorous approach in demonstrating safety and efficacy, which we believe will support confidence in the vaccine in the U.S. and globally.”

The company is looking to begin a phase 3 trial in the US and Mexico at the end of this month. Data from the event-driven trial could support global authorization and approval, including in the US. Back in September, the company announced it had initiated a phase 3 trial for the vaccine in the United Kingdom. That trial is evaluating the efficacy, safety, and immunogenicity of NVX-CoV2373, and is expected to be fully enrolled by the end of November. Depending on the overall COVID-19 attack rate, interim data in the UK trial, which is event-driven, are expected as soon as early first quarter 2021.

Trial that is evaluating the efficacy, safety, and immunogenicity of NVX-CoV2373 in COVID-19 is expected to be fully enrolled by the end of November. 

Novel COVID-19 Vaccine NVX-CoV2373 Gets FDA Fast Track Designation

Adult patients living with HIV that were virologically suppressed remained virologically stable with optimal adherence and retention in care when willingly chose to refill prescriptions in Community Pharmacies (Co-Pharm) after transistioning away from hospital settings, according to a new study.

An overwhelming majority (98%) of the participants were retained in care, and 85% had optimal adherence.  

“Patients remained virologically stable with optimal adherence and retention in care,” the investigators wrote.

These findings were presented at the International AIDS Society (IAS) AIDS 2020 Virtual Sessions. In developing countries with overcrowded hospitals, community pharmacies can relive burden, help patients adhere to their regimen, thus offering a viable alternative to patients who need to maintain their medication and keep stable.

In developing countries with overcrowded hospitals, community pharmacies can relive burden, help patients adhere to their regimen, thus offering a viable alternative to patients who need to maintain their medication and keep stable.