Oct 30, 2020 • 6:56 pm CDT
Canadian Biopharmaceutical Leading COVID-19 Antiviral Approval in the USA
An expanding consortium is bringing together globally coordinated clinical development, commercialization, cGMP manufacturing, and logistics expertise to accelerate the deployment and availability of Avigan® tablets for the potential treatment and prevention of COVID-19.
Announced on October 30, 2020, Nova Scotia-based Appili Therapeutics Inc., stated it has signed a collaboration, development, and supply agreement with Dr. Reddy’s Laboratories Ltd., Global Response Aid, and FUJIFILM Toyama Chemical Co., Ltd., the originator of Avigan® tablets.
In joining the global consortium, Appili said in a press release 'it will assume key responsibilities for the design and implementation of multiple pivotal Phase 3 trials to enable regulatory submission, review, and, if supported by data, approvals for the use of Avigan in the USA, Canada and internationally.
Dr. Armand Balboni, CEO at Appili added: “We look forward to the timely outcomes of our ongoing and soon-to-be initiated late-stage clinical trials to evaluate Avigan as the first orally available antiviral treatment option for COVID-19.”
Oct 30, 2020 • 11:35 am CDT
Very Few Flu Cases Reported in the USA
The U.S. CDC's Weekly U.S. Influenza Surveillance Report for Week 43, ending October 24, 2020, found 1.2% of patient visits reported through the U.S. Outpatient Influenza-like Illness Surveillance Network were due to influenza-like illness. This percentage is below the national baseline of 2.6%.
Oct 30, 2020 • 6:18 am CDT
Vaccination Schedule Changes for 2021 Approved
The U.S. CDC's vaccine committee, the Advisory Committee on Immunization Practices (ACIP), voted 14-0 to adopt the new vaccination schedules for adults and children for 2021, reported Molly Walker, Associate Editor, MedPage Today, late on October 29, 2020. Many of the ACIP changes related to specific language within the recommendations themselves.
This ACIP digital meeting's agenda and presentation 'Recommendations from the Combined Immunization Schedule WG for the 2021 Immunization Schedules for Children/Adolescents and Adults' are attached. The ACIP develops recommendations on how to use vaccines to control disease in the USA, and are forwarded to CDC’s Director for approval.
During the June 2020 meeting, the ACIP recommended annual flu shots for all persons aged 6 months and older who do not have contraindications.
Oct 29, 2020 • 5:48 pm CDT
Vaccine Candidate Addressing G4 EA H1N1 Swine Influenza Virus Announced
Cincinnati-based Blue Water Vaccines, Inc., announced that the Company is accelerating the development of a new vaccine candidate to combat the potential pandemic influenza strain, G4 EA H1N1, which is similar to the 2009 A(H1N1)pdm09 swine flu, which was extremely lethal.
This universal influenza vaccine candidate provides protection from H1, H3, and Flu B.
The Company has completed the initial design and in vivo analysis of the H1 vaccine candidate design. The H3 and Flu B constructs are entering into the final in vivo stage of testing prior to moving the universal program into manufacturing.
Joseph Hernandez, Chairman, and CEO of Blue Water Vaccines stated in a press release issued on October 29, 2020: "Our H1 construct has shown significant in vivo cross-reactivity with all previous pandemic strains, including the 1918 H1N1 and 2009 pandemic H1N1, and produces neutralizing antibodies in animal challenge studies."
Oct 29, 2020 • 12:01 pm CDT
Cell-Based Quadrivalent Flu Shot Found Effective For Children
New Jersey-based Seqirus presented absolute efficacy data on the company's cell-based quadrivalent influenza vaccine (QIVc) (FLUCELVAX QUADRIVALENT) from a randomized controlled trial which met its primary endpoint in children and adolescents between ≥2 to <18 years of age. QIVc is currently licensed for use in people 4 years of age and older in the USA.
This study (Fortanier, A.C., Põder, A., Bravo, L.C., et al. (2020)), was presented at the European Society for Paediatric Infectious Diseases virtual conference on October 29, 2020, represents the first absolute efficacy study of a cell-based seasonal influenza vaccine in this age population.
Jonathan Edelman, M.D., Vice President, Clinical Development at Seqirus, and study author stated in a press release: "This study reinforces our commitment to addressing this very serious public health threat by utilizing our advanced influenza vaccine technologies to help protect as many people as possible, including populations such as children between the ages of 2 and 18."
Oct 29, 2020 • 7:02 am CDT
Over $1 Billion in Coronavirus Vaccine Orders Confirmed
Massachusetts based Moderna, Inc. announced it has received $1.1 billion of customer deposits in Q3 2020 for the future supply of its mRNA-1273 vaccine candidate.
"We now have four programs in Phase 2 studies, in addition to the Phase 3 study of our COVID-19 vaccine, mRNA-1273, which is fully enrolled," said Stéphane Bancel, CEO of Moderna, in a press release issued on October 29, 2020. “We look forward to our expected first review of our interim efficacy data, which is expected in November 2020.”
Oct 28, 2020 • 4:36 pm CDT
Influenza A Dominates in 2020
The World Health Organization (WHO) reported on October 26, 2020, of 82,257 respiratory specimens tested at WHO network labs, only 172 were positive for influenza viruses. Of the positive samples, 62.8% were influenza A, and, of subtyped influenza A samples, 93.9% were found to be H3N2.
Globally, despite continued or even increased testing for influenza in some countries, the WHO said 'influenza activity remained at lower levels than expected for this time of the year.'
An updated listing of U.S. CDC authorized vaccines for the 2020-2021 flu season are published on this PrecisionVaccinations webpage.
Oct 28, 2020 • 2:04 pm CDT
Dentists Now Delivering Flu Shots
Dentists working for Kaiser Permanente near Portland, Oregon will soon begin a pilot program at Grand and Eastmoreland offices, where patients over the age of 12 can receive an annual flu shot during their dental appointment. Oregon dentists are authorized to administer vaccines based on the passage of House Bill 2220.
“Oregon dentists are always looking for ways to improve our patients’ health and well-being,” said Oregon Dental Association President James McMahan, D.M.D., in a 2019 press statement. “We sponsored HB 2220 to increase access to care, providing additional opportunities for patients to receive life-saving vaccines from highly trained practitioners they already know and trust.”
This Oregon legislation aligns with the American Dental Association policy Res. 53H-2018 approved by the House of Delegates in 2018, which supported the use and administration of the human papillomavirus vaccine.
Oct 28, 2020 • 1:38 pm CDT
US Military Will Deliver, Not Administer, COVID-19 Vaccines
U.S. military personnel won't be administering any COVID-19 vaccine to the American people once a vaccine has been approved for use. However, military personnel will lend its extensive logistic expertise to ensure vaccines are available across the USA, said Paul Mango, the deputy chief of staff for policy at the Department of Health and Human Services.
"The overwhelming majority of Americans will get a vaccine that no federal employee, including the Department of Defense, has touched," Mango said during an October 23, 2020 teleconference regarding the US Operation Warp Speed. "That said ... we have the best logisticians in the world... for things such as needles, syringes, swabs, adhesive bandages, dry ice, and trucks, for instance."
Operation Warp Speed includes the U.S. CDC, Food and Drug Administration, National Institutes of Health, and the Biomedical Advanced Research and Development Authority.
Oct 28, 2020 • 7:02 am CDT
11 Year Old Children To Make Vaccination Decisions
If the Minor Consent for Vaccinations Amendment Act is signed into law by the Washington D.C. Mayor, it would give 11-year-old children the authority to make decisions about vaccinations without their parents’ approval, reported MIC.com on October 22, 2020.
The D.C. Council passed the "Minor Consent for Vaccinations Amendment Act" in a 12-to-1 vote, which was initially introduced by council member Mary Cheh in March 2019.
Under B23-0107, doctors would make sure that each kid is "capable of meeting the informed consent standard." To assist in this, the Department of Health would provide age-appropriate information about vaccines to children.
Oct 28, 2020 • 6:23 am CDT
$10 Assay Targets 5 Viral Genomes
California based Agena Bioscience announced that its MassARRAY® SARS-CoV-2 Panel for the qualitative detection of the SARS-CoV-2 coronavirus has been granted Emergency Use Authorization (EAU) from the U.S. FDA. Clinical laboratories can process thousands of samples each day for less than $10 per sample running the assay on a single MassARRAY instrument, making it one of the highest throughput SARS-CoV-2 tests authorized.
“The MassARRAY SARS-CoV-2 Panel is the only assay on the market with 5 viral genome targets multiplexed into a single reaction, making it robust against potential mutations arising in the viral genome,” said Dr. Darryl Irwin, Vice President of Scientific Affairs, in a press release issued on October 27, 2020. “Most real-time qPCR-based assays target only two or three targets on the viral genome.”
Oct 28, 2020 • 5:49 am CDT
France and UK Pharma Companies Join COVID-19 Vaccine Facility
France-based Sanofi and England-based GlaxoSmithKline announced they have agreed to provide 200 million doses of their potential COVID-19 vaccine to the COVAX Facility, a collaboration designed to give countries around the world equal access to coronavirus vaccines.
Through the COVAX Facility’s efforts, COVID-19 vaccines will be distributed in participating countries through the WHO’s recently published Allocation Framework, and the WHO’s Strategic Advisory Group of Experts on Immunization Values Framework.
Roger Connor, President of GSK Vaccines said in a press statement on October 28, 2020: “We are proud to be working with Sanofi to make this adjuvanted recombinant protein-based vaccine available to the countries signed up to the COVAX Facility as soon as possible."
Previously, the U.S. government announced on July 31, 2020, it will provide funding up to $2.1 billion to Sanofi and GSK for the development of a SARS-CoV-2 recombinant protein-based vaccine and the delivery of an initial 100 million doses.
Oct 27, 2020 • 3:39 pm CDT
Needle-Free System to Deliver COVID-19 Vaccine
PharmaJet announced that its Needle-free Injection System will be used to deliver a vaccine against SARS-CoV-2 in a clinical trial. The vaccine developed by DIOSynVax, a spinoff company supported by the University of Cambridge in the UK, recently received multi-million dollar funding from the UK government to move forward with a clinical trial.
The PharmaJet System was chosen due to its record of increasing the efficacy of nucleic acid-based vaccines and therapeutics, said the company on October 27, 2020.
DIOSynVax’s innovative approach uses computer modeling of the virus’s structure to identify the distinct genetic code. The combined artificial intelligence and synthetic biology approach allow for the development of a vaccine that is specific to developing antibodies against the SARS-CoV-2 coronavirus.
Oct 27, 2020 • 3:02 pm CDT
US Defense Department Awards $26.7 Million For Coronavirus Vaccine Research
IAVI announced the award of US$26.7M from the Defense Threat Reduction Agency (DTRA) to support IAVI’s recombinant vesicular stomatitis virus vectored SARS-CoV-2 vaccine candidate.
DTRA’s award will facilitate the vaccine candidate’s clinical development path to licensure by supporting work at IAVI’s Vaccine Design and Development Laboratory in Brooklyn, New York, to characterize immune responses in animals and demonstrate the safety and efficacy profile of rVSVΔG-SARS-CoV-2 vaccination in animals, stated the company's press release issued on October 27, 2020.
Oct 27, 2020 • 1:07 pm CDT
South Korea Expands Flu Shot Support
South Korea authorities reported they found no direct link between the deaths and the vaccines against influenza, reported Reuters. “Do trust the health authorities’ conclusion...reached after a review with experts,” President Moon Jae-in stated. The Korean CDC reported on October 24, 2020, there have been (56) influenza-related fatalities.
“There is a need to expand the influenza vaccination this year not only to prevent the seasonal flu but also to ward off concurrent infection and spread of flu and COVID-19."
To meet consumer demand, South Korea ordered 20% more influenza vaccines for this flu year.
Oct 27, 2020 • 9:11 am CDT
US Government May Eliminate COVID-19 Vaccination Related Costs
According to Politico reporting, the U.S. administration may soon announce a plan to cover the out-of-pocket costs of COVID-19 vaccines that receive emergency use authorization from the FDA, for Americans who receive insurance coverage from Medicare or Medicaid, said people with knowledge of the pending CMS announcement.
Oct 27, 2020 • 9:03 am CDT
COVID-19 Vaccine Candidates Prepare CDC Authorization Presentations
Novavax’ Senior Vice President and Chief Medical Officer, Filip Dubovsky, M.D., announced he will present an update focused on the NVX-CoV2373 vaccine candidate during a public meeting of the U.S. CDC’s ACIP meeting on Friday, October 30, 2020. This ACIP Meeting will be a virtual meeting with no in-person attendance. For more information, please visit www.cdc.gov/vaccines/acip/meetings/index.html.
Oct 27, 2020 • 5:33 am CDT
COVID-19 Impacts Nurses Most Often
The majority of healthcare workers hospitalized with the SARS-CoV-2 coronavirus are nurses, according to a US Centers for Disease Control and Prevention (CDC) report published on October 26, 2020. This CDC report found that nearly 6% of all patients hospitalized with COVID-19 were healthcare workers, with 36.3% of those patients being nurses.
And, about 4.2% of nurses died from COVID-19 related issues while hospitalized.
The median age of those hospitalized was 49 years, and 89.8% had at least (1) underlying medical condition, of which obesity was most commonly reported (72.5%), reported the CDC.
Oct 26, 2020 • 9:15 pm CDT
Which Lessons Were Learned During New Zealand's Flu Season?
The BMJ reported on October 26, 2020, that various counties in the Southern Hemisphere, such as New Zealand, “skipped” the 2020 flu season. New Zealand's influenza fatality rates at the height of winter were the lowest absolute figure since 2016, and when accounting for population growth, it is the lowest death rate per 100 000 people in at least 10 years.
Flu cases were almost non-existent with a peak of 0.8% of people self-reporting flu-like symptoms, and GP surveillance has found no confirmed cases.
“Because influenza is transmitted in much the same way as COVID-19, the steps used to control the new disease are likely to be even more effective against flu, given the lower R-value for seasonal flu, and because of pre-existing population immunity,” says Paul Hunter, a professor in medicine at the University of East Anglia.
And, Vanessa Saliba, head of flu at Public Health England, told The BMJ, “We cannot be complacent, the southern hemisphere’s season doesn’t necessarily imply that the UK will have a similar experience and many factors are at play. For example, other strains of flu could still emerge, and the actual impact may be modified depending on what type of social distancing is in place.”
Oct 26, 2020 • 5:48 pm CDT
284 Coronavirus Diagnostic Tests Now Authorized
The U.S. FDA has authorized 284 coronavirus diagnostic tests, which include 221 molecular tests, 56 antibody tests, and 7 antigen tests, as of October 26, 2020. And, there have been over 140 million coronavirus related tests reported by the U.S. CDC's COVID Tracker, with an overall virus positivity rate of 7%.
Oct 26, 2020 • 4:33 pm CDT
US Government Licenses Patents To Create Modified Vaccinia Ankara Virus-Virus Like Particle Vaccine
Atlanta-based GeoVax Labs, Inc. announced the signing of a Patent and Biological Materials License Agreement with the US National Institute of Allergy and Infectious Diseases (NIAID), in support of GeoVax’s development of a vaccine against SARS-CoV-2, the virus that causes COVID-19. The Patent License Agreement to GeoVax includes access to NIAID’s patent rights in the stabilized SPIKE protein, which is the protein that SARS-CoV-2 uses to gain entry into human tissue.
The License Agreement enables GeoVax to create a preventive Modified Vaccinia Ankara Virus-Virus Like Particle (MVA-VLP) vaccine that primes and/or boosts the immune system against COVID-19.
Oct 26, 2020 • 1:15 pm CDT
Ever Wonder How a COVID-19 Vaccine is Developed?
Stephen M. Hahn, M.D., the U.S. FDA Commissioner, said in a video published on October 23, 2020: “We are committed to expediting the development of COVID-19 vaccines, but not at the expense of sound science and decision making. We will not jeopardize the public’s trust in our science-based, independent review of these or any vaccines. There’s too much at stake.”
This 2-minute video message can be found at this Twitter link.
Oct 26, 2020 • 12:38 pm CDT
Very Few Flu Cases Confirmed in the Southern Hemisphere
According to the World Health Organization (WHO) report #378, influenza activity remained at lower levels than expected for this time of the year, though increased detections were reported in some countries. In the temperate zones of the Southern Hemisphere, the influenza season remained low or below baseline.
Despite continued or even increased testing for influenza in some countries in the Southern Hemisphere, very few influenza detections were reported, as of October 12, 2020.
As an example, countries in the Caribbean and Central American did not report influenza outbreaks to the WHO.
Oct 26, 2020 • 9:48 am CDT
Only COVID-19 Treatment Study Launches Addressing African Americans Health Issues
Austin, Texas-based Nitric Oxide Innovations (NOI) announced it received Investigational New Drug clearance from the U.S. FDA to begin a Phase 2b/3a outpatient clinical study testing the safety and efficacy of its new drug, NOviricid dosing in an oral lozenge.
NOviricid is the first oral Nitric Oxide generating drug to be clinically tested to treat African Americans or anyone who is symptomatic with COVID-19.
Dr. Nathan S. Bryan, CEO of NOI stated in a press release published on October 26, 2020: "Everything we have learned about COVID-19 reveals that diminished nitric oxide production in patients is what is thought to be responsible for the increased risk of infection and rapid disease progression. Restoration of nitric oxide appears to be a very safe and effective solution."
"This applies directly to the African American population, which often suffers from diminished nitric oxide production. A lack of nitric oxide explains the multi-system disease and dysfunction that persists long after the active infection is gone, including increased risk of blood clots, endotheliitis, kidney, and lung dysfunction."
Oct 26, 2020 • 9:23 am CDT
COVID-19 Vaccine Reactogenicity Found Lower in Seniors
CNBC reported UK based AstraZeneca digitally stated 'its COVID-19 vaccine candidate (AZD1222) has produced a similar immune response in older and younger adults, and adverse responses to the vaccine among the elderly were also found to be lower.'
“It is encouraging to see immunogenicity responses were similar between older and younger adults and that reactogenicity was lower in older adults, where the COVID-19 disease severity is higher,” an AstraZeneca spokesman told CNBC via email on October 26, 2020.
Oct 26, 2020 • 1:50 am CDT
COVID-19 Vaccine Candidates Continue Phase 3 Studies
The COVID-19 vaccine development efforts include innovative platforms such as nucleic acid, virus-like particle, peptide, viral vector, recombinant protein, live attenuated virus, and inactivated virus development approaches. As of October 25, 2020, the US Food and Drug Administration had not approved any COVID-19 vaccine candidates.
Oct 25, 2020 • 7:57 am CDT
Infant Vaccination Rates Defeat COVID-19
The Morbidity and Mortality Weekly Report published by the US Centers for Disease Control and Prevention (CDC) on October 23, 2020, found the national coverage in the USA of recommended vaccines has remained high and stable during the COVID-19 pandemic, with recent increases for several vaccines for children born during 2016–2017 compared with those born during 2014–2015.
More than 90% of children 2 years and younger who were born in 2016 and 2017 received the recommended MMR, poliovirus, hepatitis B, and varicella vaccines, according to this new CDC report.
The CDC and its Advisory Committee recommend vaccinations for 14 illnesses by the time infants are 2-years old.
Oct 24, 2020 • 11:52 am CDT
Canada Provides $5 Million For Domestic COVID-19 Vaccine Development
Canada-based Entos Pharmaceuticals announced it is receiving advisory services and funding of up to $5 million from the National Research Council of Canada Industrial Research Assistance Program (NRC IRAP) as part of the Government of Canada’s continuing support for the development of domestic COVID-19 vaccine candidates.
NRC IRAP’s support will help progress Entos’ COVID-19 DNA vaccine research to phase 1 human clinical trial to assess its safety at the Clinical Trials Research Center at the Canadian Center for Vaccinology in Nova Scotia, Canada.
Entos stated in a press release published on October 23, 2020, that it developed a Fusogenix DNA vaccine called Covigenix, that in preclinical studies, induces a strong neutralizing antibody response plus a potent and balanced T cell response against SARS-CoV-2, the virus that causes COVID-19.
Oct 24, 2020 • 8:09 am CDT
2nd Generation Adenovirus Vaccine Candidate Launches Study
California based ImmunityBio announced that the first patient has been dosed in Phase 1 clinical trial of hAd5-COVID-19, a novel, 2-dose COVID-19 vaccine candidate that targets the inner nucleocapsid (N) and the outer spike (S) protein, engineered to activate both T cells and antibodies against the SARS-CoV-2 coronavirus.
This COVID vaccine candidate uses a second-generation adenovirus that delivers multiple proteins of SARS-CoV-2 with the potential for long-term immunity through memory T cells.
Oct 23, 2020 • 2:33 pm CDT
COVID-19 Vaccine Candidate Restarts Studies in the USA
The US Food and Drug Administration (FDA) has authorized clinical studies for the AZD1222 vaccine candidate to relaunch on October 23, 2020. The FDA reviewed all safety data from trials globally and concluded it was safe to resume the trial, said the company in a press statement.
By vaccinating people with AZD1222 (ChAdOx1 nCoV-19), researchers are hoping to make the body recognize and develop an immune response to the Spike protein that will help stop the SARS-CoV-2 virus from entering human cells and therefore prevent infection.
Oct 23, 2020 • 1:03 pm CDT
Standalone Universal Influenza Vaccine Candidate Misses Endpoints
Israel based BiondVax Pharmaceuticals announced topline data from the Company’s pivotal, phase 3 clinical trial of M-001 as a standalone universal flu vaccine candidate. Results did not demonstrate a statistically significant difference between the vaccinated and placebo groups in the reduction of flu illness and severity and therefore failed to meet both the primary and secondary efficacy endpoints.
However, the study’s primary safety endpoint was met.
Dr. Ron Babecoff, Founder and CEO stated in a press release issued on October 23, 2020: “Unfortunately, this study did not have the efficacy outcomes that we anticipated for M-001 on a standalone basis. We have observed in (7) previous studies that M-001 safely provoked an immune response to a broad range of flu strains, but ultimately this was not sufficient on a standalone basis to show protection.”
Oct 23, 2020 • 7:53 am CDT
Pharmacy Staff Authorized to Administer COVID-19 Tests
The U.S. Department of Health and Human Services (HHS) issued guidance on October 22, 2020, under the Public Readiness and Emergency Preparedness Act authorizing qualified pharmacy technicians and State-authorized pharmacy interns to administer COVID-19 tests.
This HHS guidance also authorizes qualified pharmacy technicians and State-authorized pharmacy interns to administer COVID-19 tests, including serology tests, that the U.S. FDA has approved, cleared, or authorized.
Oct 23, 2020 • 7:45 am CDT
UK Authorizes Recombinant Flu Vaccine For 2020
The influenza vaccine Flublok has been given authorization for temporary supply by the UK Department of Health and Social Care and the Medicines and Healthcare products Regulatory Agency (MHRA) for immunization against flu in this year’s seasonal flu program to meet public health need. The MHRA assessment was based in part on evidence from another closely related Sanofi flu vaccine, Supemtek.
This was recommended for approval by the European Medicines Agency in September 2020.
Flublok is made by Sanofi and is licensed for use in the USA by the Food and Drug Administration (FDA). It has been used there since 2016 and has been distributed to over 9 million people. The FDA considers the vaccine safe and acceptable for use.
Oct 22, 2020 • 1:57 pm CDT
Texas Secures 2.8 Million Flu Shots For Children and Adults
Texas Governor Greg Abbott announced that the Texas Department of State Health Services has secured 2.8 million doses of flu vaccine for the Texas Vaccines for Children Program and the new Adult Influenza Vaccine Initiative.
"The flu vaccine is an effective way to prevent the spread of influenza, and expanding access to this vaccine is especially important this year so that our healthcare systems can focus on treating COVID-19 patients," said Governor Abbott, in a press release issued on October 22, 2020.
U.S. FDA authorized influenza vaccines for the 2020-2021 flu season are listed on this PrecisionVaccinations webpage.
Oct 22, 2020 • 12:51 pm CDT
Efficacy of Tocilizumab in Patients Hospitalized with COVID-19 Questioned
The New England Journal of Medicine reported 'Tocilizumab was not effective for preventing intubation or death in moderately ill hospitalized patients at seven Boston hospitals with Covid-19. Some benefit or harm cannot be ruled out, however, because the confidence intervals for efficacy comparisons were wide.'
'Our data do not provide support for the concept that early interleukin-6 receptor blockade is an effective treatment strategy in moderately ill patients hospitalized with Covid-19,' stated these researchers on October 21, 2020.
Oct 22, 2020 • 9:54 am CDT
U.S. Vaccine Committee Delays Authorizing COVID-19 Vaccines
The U.S. FDA’s Vaccine and Related Biological Products Advisory Committee (VRBPAC) announced during its digital meeting held on October 22, 2020, that the VRBPAC agency decided not to approve any experimental COVID-19 vaccines for use in the USA, at this time.
Oct 22, 2020 • 7:31 am CDT
Do Ad5 Vector Coronavirus Vaccine Candidates Pose Risks for HIV-1 Patients?
A group of researchers led by Susan Buchbinder, a University of California San Francisco professor who runs the HIV Prevention Research in the San Francisco Department of Public Health, stated in an article published by The Lancet on October 19, 2020: 'We are writing to express concern about the use of a recombinant adenovirus type-5 (Ad5) vector for a COVID-19 phase 1 vaccine study, and subsequent advanced trials.'
'Over a decade ago, we completed the Step and Phambili phase 2b studies that evaluated an Ad5 vectored HIV-1 vaccine administered in three immunizations for efficacy against HIV-1 acquisition.'
'Both international studies found an increased risk of HIV-1 acquisition among vaccinated men.'
'This important safety consideration should be thoroughly evaluated before further development of Ad5 vaccines for SARS-CoV-2, and informed consent documents of these potential risks should reflect the considerable literature on HIV-1 acquisition with Ad5 vectors.'
Oct 22, 2020 • 6:14 am CDT
CEPI Aims to Progress Three COVID-19 Vaccines to Meet Demand
Gavi, the Vaccine Alliance, published an updated editorial by Nick Jackson, Head of Programmes and Innovative Technology at Coalition for Epidemic Preparedness Innovations (CEPI), which states: 'Most vaccine candidates in early development fail: this is the stark reality of vaccine development.'
CEPI, alongside Gavi and the World Health Organisation, launched COVAX in 2020 with the aim of ending the acute phase of the pandemic by the end of 2021.
'Historically, it takes 10 years or more and requires hundreds of millions of dollars of investments to progress each vaccine candidate through to licensure.'
'CEPI responded swiftly to the threat of the COVID-19 pandemic. In the space of just 8 months, CEPI has built one of the largest and most advanced COVID-19 vaccine portfolios in the world, comprising (9) promising vaccine candidates. CEPI aims to progress at least (3) vaccine candidates through clinical trials to licensure, which is vital if we are to meet global demand and protect vulnerable populations.'
Oct 21, 2020 • 5:43 pm CDT
Phase 1 Influenza Vaccine Candidate Demonstrated Potential for Once-Per-Season Dosing
California-based Vir Biotechnology, Inc. announced the presentation of preclinical and Phase 1 data demonstrating the broad neutralizing ability, high-level effector function, extended half-life, and tolerability of the VIR-2482 vaccine candidate in the prevention of influenza A.
Phil Pang, M.D., Ph.D., chief medical officer of Vir Biotechnology, stated in a press release on October 21, 2020, “The data also suggest that VIR-2482, because of its broad influenza A strain coverage, potency, and prolonged half-life, has the potential to be the first neutralizing monoclonal antibody to address this large unmet need.”
Oct 21, 2020 • 5:30 pm CDT
COVID-19 Infectiousness Period Found Less Than 10-Days
A study published by the Infection Control & Hospital Epidemiology on October 20, 2020, reported that individuals with mild or no COVID-19 symptoms may be infectious for no more than about 10-days, while those with severe illness may be able to spread the virus for as long as 20-days. The overall pooled median duration of RNA shedding from respiratory sources was 18.4 days.
"Even though people can shed virus for a prolonged period of time, the studies we reviewed indicated that live coronavirus, which may predict infectiousness, was only detected up to 9-days in people who had mild symptoms," said co-author Monica Sikka, M.D.
Oct 21, 2020 • 4:16 pm CDT
35% of Americans Purchase Medicines Online
The new poll published on October 19, 2020, shows that 35% of Americans have now used an online pharmacy to purchase medication, up from 23% in 2013.
The poll also reveals that, while most Americans turn to their healthcare professionals (38% doctor, 28% pharmacist, 12% nurse) for help locating online pharmacies, only half of the survey respondents report that they have talked with their provider about the potential risks associated with buying medicines online.
Oct 21, 2020 • 3:58 pm CDT
In-Hospital Use of Hydroxychloroquine Unlikely to Yield Beneficial Effects
This new report is the third update of a previously published living systematic review published by the Annals of Internal Medicine on October 21, 2020, which focuses on the treatment (not prophylaxis) of COVID-19 with hydroxychloroquine or chloroquine. The first and second updates covered evidence available through 1 July 2020 (2) and 1 August 2020 (3), respectively.
'It is becoming increasingly unlikely that in-hospital use of hydroxychloroquine (Plaquenil) will yield beneficial effects.'
This update evaluates evidence published through September 21, 2020.
Oct 21, 2020 • 12:47 pm CDT
COVID-19 Peptide Vaccine That Shows Broad T Cell Response in Pre-Clinical Tests
London-based PepTC Vaccines Limited announced the publication of positive preclinical results of its investigational PolyPEPI-SCoV-2 peptide vaccine. The non-peer-reviewed study was published on the preprint service bioRxiv and showed that PolyPEPI-SCoV-2 defines natural CD8+ and CD4+ T cell responses observed in asymptomatic/mild COVID-19 patients one to five months after symptom onset.
And, in tests of blood samples from 17 donors, the PolyPEPI-SCoV-2-specific CD8+ T cell repertoire used for recovery from COVID-19 was extremely diverse: donors recognized on average seven different vaccine peptides out of nine; 87% of donors had multiple vaccine-specific T cells against three SARS-CoV-2 structural proteins and 53% against all four.
Oct 21, 2020 • 10:59 am CDT
New FDA Podcast Discussing COVID-19 Vaccine Approval Meeting
The Food and Drug Administration (FDA) posted a new “FDA Insight” podcast featuring Deputy Commissioner Anand Shah, M.D., and Dr. Peter Marks, the Director of FDA's Center for Biologics Evaluation and Research, discussing the upcoming Vaccines and Related Biological Products Advisory Committee meeting on October 22, 2020.
Oct 21, 2020 • 10:14 am CDT
Adjuvanted Trivalent Influenza Vaccines Found Effective in Seniors
New Jersey-based Seqirus announced new real-world evidence indicating that an MF59®-adjuvanted trivalent seasonal influenza vaccine (aTIV) was more effective than standard, non-adjuvanted quadrivalent influenza vaccines in reducing influenza-related medical encounters in adults 65 years and older with at least one underlying health condition during the U.S. 2017/18 and 2018/19 influenza seasons.
PrecisionVaccinations publishes a listing of flu vaccines for the 2020-2021 influenza season.
Oct 21, 2020 • 10:04 am CDT
20-Valent Pneumococcal Conjugate Vaccine Demonstrated Positive Study Results
New York-based Pfizer Inc. announced the full analysis from one of its Phase 3 studies which evaluated the safety and immunogenicity of its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate in adults 18 years of age or older not previously vaccinated against pneumococcal disease.
This investigational vaccine demonstrated positive safety results and immune responses to 20 S. pneumoniae serotypes in adults and infants.
Oct 21, 2020 • 7:38 am CDT
Protective Antibodies Do Persist
The Director of the US National Institutes of Health (NIH) stated in his blog posting on October 20, 2020: 'The good news is that the longer-lasting IgG antibodies persisted in these same patients for up to four months, which is as long as the researchers were able to look.'
'Levels of those IgG antibodies also served as an indicator for the presence of protective antibodies capable of neutralizing SARS-CoV-2 in the lab. Even better, that ability didn’t decline in the 75 days after the onset of symptoms.'
'While longer-term study is needed, these findings lend support to the evidence that protective antibody responses against the novel virus do persist,' concluded Francis S. Collins, M.D., Ph.D., the 16th director of the NIH.
Oct 21, 2020 • 7:27 am CDT
Will COVID-19 Vaccine Efficacy Vary by BMI?
According to a study published by the journal Nature on October 20, 2020, clinical researchers are unsure whether or not obesity will affect COVID-19 vaccine efficacy.
'People who are obese might have higher levels of immune-regulating proteins, including cytokines. The immune responses unleashed by cytokines can damage healthy tissue in some cases of severe COVID-19,' stated Milena Sokolowska, who studies at the University of Zurich in Switzerland.
'Obesity is also linked to less-diverse populations of microbes in the gut, nose, and lung, with altered compositions and metabolic functions compared with those in lean individuals. Gut microbes can influence the immune responses to pathogens — and to vaccines,' says Sokolowska. 'I will not be surprised if antibody levels are lower and don’t last as long in people who are obese or overweight.'
These researchers have urged pharmaceutical companies to stratify their COVID-19 vaccine study data by BMI.
Oct 20, 2020 • 8:39 pm CDT
192 Pediatric Fatalities Related to Influenza Viruses Last Season
Three influenza-associated pediatric deaths were reported to the US Centers for Disease Control and Prevention during week #41. All three deaths occurred during the 2019-2020 influenza season bringing the total number of deaths occurring during the last flu season to 192, as of data reported by October 16, 2020.
Oct 20, 2020 • 5:45 am CDT
U.S. FDA Begins COVID-19 Vaccine Approval Debate on October 22, 2020
If you’ve been following the U.S. FDA’s Vaccine and Related Biological Products Advisory Committee (VRBPAC) recently, you are aware they will be helping the agency decide whether to approve experimental COVID-19 vaccines for use.
On Thursday, October 22, 2020, the VRBPAC committee will meet at 10:00 am EST to discuss the development of COVID-19 vaccines and the FDA expects tens of thousands of people to attend virtually.