The percentage of respiratory specimens testing positive for the SARS-CoV-2 virus decreased from 5.2% during week #36 to 4.8% during week #37, reported the U.S. CDC on September 18, 2020.
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Coronavirus Positivity Rates Decreased 7%
Very Few Flu Cases Confirmed in the USA
During week #37 of the 2019-2020 flu season, 1.0% of patient visits reported through the U.S. Outpatient Influenza-like Illness Surveillance Network to the U.S. CDC were due to influenza-like illness. This percentage is below the national baseline of 2.4%. Iowa was the only state to report 'high' flu activity levels, as of September 17, 2020.
An updated list of influenza preventive vaccines authorized for the 2020-2021 flu season in the Northern Hemisphere is published by PrecisionVaccinations.
Which COVID-19 Vaccines Are Conducting Phase 3 Studies?
As of September 18, 2020, the latest news, including China and Russia, regarding SARS-CoV-2 virus preventive vaccines is listed on this CoronavirusToday webpage.
Science, Not Politics, Guides the CDC
'The U.S. CDC is not being compromised or politically influenced by the administration,' CDC Director Robert Redfield, MD, asserted during his testimony to the US Senate Appropriations Committee on September 16, 2020. "I want to make it really clear about the respect for the science at CDC and the independent integrity of the CDC's Morbidity and Mortality Weekly Report."
"At no time has scientific integrity of the Report been compromised and I can say under my watch it will not be compromised."
India Purchases 100 Million Doses of Russia's Sputnik V Coronavirus Vaccine
India based Dr. Reddy’s Laboratories Ltd. and the Russian Direct Investment Fund (RDIF) and announced on September 16, 2020, they have agreed to cooperate on phase 3 clinical trials and distribution of the Sputnik V vaccine in India. Upon regulatory approval in India, the RDIF will supply 100 million vaccine doses to Dr. Reddy’s.
G V Prasad, Co-Chairman and Managing Director of Dr. Reddy’s Laboratories, stated in a press release: “The Phase I and II results have shown promise.... Sputnik V vaccine could provide a credible option in our fight against COVID 19 in India.”
Over 100 Million Coronavirus Tests Confirmed
As of September 17, 2020, the U.S. FDA has authorized 248 coronavirus diagnostic tests, which include 198 molecular tests, 46 antibody tests, and 4 antigen tests. And, there have been 100,269,291 tests reported in the USA.
The diagnostic tests most people discuss are RT-PCR, the nasal-swab test that detects viral RNA, and various antibody tests, that detect if you have an immune response due to past exposure to the SARS-CoV-2 virus.
RSV Vaccine Study Doses 1st Person
A privately held Swiss biotechnology company, Virometix, announced on September 17, 2020, the completion of the initial vaccination of the 1st dose cohort in the Phase 1 study of V-306, its candidate vaccine for prophylaxis of RSV (Respiratory Syncytial Virus) infection in neonates. All 20 subjects received the first dose of V-306 or placebo, as planned and early clinical experience is encouraging with no adverse events reported to date.
The Data Safety Monitoring Board will meet on October 2nd, 2020, to review the safety data for the first cohort, and if all goes well, these subjects will receive their 2nd dose of vaccine in November 2020, stated the company's press statement.
COVID-19 Vaccine Candidate Expands 2nd Vaccinations
Massachusetts based Moderna announced on September 17, 2020, the COVID vaccine candidate mRNA-1273 Phase 3 COVE study being conducted with U.S NIH and BARDA has enrolled 25,296 participants. Furthermore, 10,025 participants have received their 2nd vaccination to date.
The study team is testing if the vaccine can help the immune system produce effective antibodies against the SARS-CoV-2 virus so that, in case of infection, the virus does not cause illness. This vaccine candidate cannot cause infection or make someone sick with COVID-19.
COVID-19 Neutralizing Antibody Study Authorized
Sorrento Therapeutics announced on September 16, 2020, that it received a 'study may proceed letter' from the U.S. FDA for its phase 1 clinical trial for COVI-GUARD (STI-1499) in hospitalized COVID-19 patients. Sorrento previously announced, in preclinical studies, STI-1499 demonstrated a 100% in vitro neutralizing effect against SARS-CoV-2, preventing infection of healthy cells in such preclinical in vitro studies.
STI-1499 was further evaluated in preclinical studies using multiple SARS-CoV-2 strains including the highly contagious D614G variant. In these preclinical studies, the antibody has been 100% effective against the highly contagious D614G variant strain at similar doses to those observed in experiments with the USA-WA1/2020 strain.
Australia's Flu Season Had Minimal Impact on Society
According to the Australian Department of Health's latest influenza surveillance report on September 6, 2020, influenza and influenza-like-activity are lower than average across all systems, and given the low numbers of lab-confirmed cases, there has been "minimal impact on society" this flu season. At the national level, notifications of laboratory-confirmed influenza have substantially decreased since mid-March 2020 and remain low.
Cell-Based Quadrivalent Flu Shots Found Very Effective
New Jersey based Seqirus announced on September 16, 2020, the publication of real-world evidence (RWE) on the company's cell-based quadrivalent influenza vaccine (QIVc) in the peer-reviewed medical journal Vaccine. This study's results indicate QIVc was more effective compared with standard, egg-based quadrivalent vaccine in preventing influenza-related hospitalizations/ER visits, all-cause hospitalizations, and hospitalizations/ER visits related to serious respiratory events.
An updated list of U.S. FDA authorized influenza vaccines for the 2020-2021 flu season is published by PrecisionVaccinations.
CDC Publishes COVID-19 Vaccination 'Playbook'
The U.S. CDC published a 'playbook' on September 16, 2020, which says 'immunization with a safe and effective COVID-19 vaccine is a critical component of the United States strategy to reduce COVID-19-related illnesses, hospitalizations, and deaths and to help restore societal functioning. The goal of the U.S. government is to have enough COVID-19 vaccine for all people in the United States who wish to be vaccinated.'
'Early in the COVID-19 Vaccination Program, there may be a limited supply of vaccines, and vaccination efforts may focus on those critical to the response, providing direct care, and maintaining societal function, as well as those at highest risk for developing severe illness from COVID-19.'
Information in this interim playbook will be updated as new information (e.g., recommendations for pregnant women or pediatric populations) becomes available, said the CDC.
Pediatricians Prefer Pro-Vax Patients
A new survey published by the JAMA on September 15, 2020, found 51% of pediatric offices in the USA have policies to dismiss families that refuse childhood vaccines. This data supports the WHO's statement in January 2020, that vaccine hesitancy one of the top 10 threats to global health.
Pfizer Provided Positive COVID-19 Vaccine Update
As part of a virtual Investor Day in New York on September 15, 2020, Pfizer Inc. presented new data on the BNT162b2 vaccine candidate being developed in collaboration with BioNTech SE, such as the following:
- New stability data that supports the storage of vials at refrigerated (2-8 °C) conditions for up to 5 days at the administration point of use locations.
- Phase 1 immunogenicity data for the BNT162b2 candidate at 2-weeks post-second dose (35 days) provide additional data that neutralizing geometric mean titers remain higher than that of a panel of human SARS-CoV-2 convalescent sera.
- Limited blinded tolerability data from the ongoing Phase 3 trial, confirming the mostly mild to moderate tolerability profile as was observed in Phase 1 study.
- Submission of an amended protocol to the U.S. FDA for the Phase 3 pivotal trial to expand recruitment to approximately 44,000 participants that allow for the enrollment of new populations.
- Based on current infection rates, the companies continue to expect that a conclusive readout on efficacy is likely by the end of October 2020.
Combination Treatment Reduces Coronavirus Viral Load by Nearly 100%
Innovation Pharmaceuticals reported on September 15, 2020, receiving additional data from a U.S. Regional Biocontainment Laboratory (RBL) collected during ongoing in vitro testing supporting Brilacidin as a potential treatment for SARS-CoV-2, the novel coronavirus responsible for COVID-19.
In human lung epithelial cell line experiments performed at the RBL, Brilacidin in combination with Remdesivir, compared to Remdesivir-only treated conditions, showed statistically significant and synergistic inhibition of SARS-CoV-2.
Of particular note, overall viral load was reduced by 99.85 percent in one combination experiment, with the remaining coronavirus dropping to nearly undetectable levels.
Brilacidin is one of the few drugs targeting COVID-19 that has been tested in human trials (a total of 8) for other clinical indications, providing an established safety and efficacy database on over 460 subjects, thereby potentially enabling it to rapidly help address the SARS-CoV-2 coronavirus pandemic.
Scientists Debate Russia's Coronavirus Vaccine's Fast-Track Process
An open letter to the study authors who recently published clinical trial results in The Lancet on September 4, 2020, says that 'the paper presents its results only as box plots without providing a detailed breakdown of the data on which they are based.'
“While the research described in this study is potentially significant, the presentation of the data raises several concerns which require access to the original data to fully investigate”, the letter in Nature says. This letter has been signed by 38 scientists, as of September 15, 2020.
In August 2020, Russian authorities approved the Sputnik V vaccine for widespread use, and have said that it could be available to the general public in November 2020. This fast-track approval caused consternation among researchers, who argued that the decision to roll out the vaccine before larger safety and efficacy trials had been completed was rushed.
Shingles Vaccine Candidate Produced 'Robust Antibody Responses'
Curevo Vaccine, a Washington-based biopharmaceutical company announced on September 15, 2020, antibody response data from its completed Phase 1 study investigating the safety, tolerability, and immune system response of the CRV-101 vaccine candidate targeted against the Shingles virus in several formulations.
The administration of Curevo’s adjuvanted sub-unit Shingles investigational vaccine resulted in a robust antibody response against a key component of the shingles virus at 1 month after 2nd vaccination, and at 1-year. The Phase 1 study included 89 subjects, with solicited reactogenicity adverse events consisting of no grade 3 local injection site events and only one grade 3 systemic event (fever) in the highest dose group.
“The frequency of grade 2 individual solicited reactogenicity events, including pain at the injection site, were less than 6.5% overall CRV-101 doses. Currently licensed adjuvanted gE subunit vaccine studies have shown higher reactogenicity in younger populations, so we do not expect to see increased reactogenicity in the target age group of 50 years or older,” said Lisa Shelton, ARNP, Associate Director of Clinical Operations.
Curevo's press release stated it will present results from their Phase I trial at the virtual World Vaccine Congress Washington conference.
Maryland Company's Coronavirus Vaccine Production Capacity Reaches 2 Billion
Maryland-based Novavax, Inc. announced on September 15, 2020, it has increased its manufacturing capacity of the late-stage vaccine candidate NVX-CoV2372 to over 2-billion doses annually, when all planned capacity has been brought online by mid-2021.
“Today’s agreement with Serum Institute ... put in place a global supply chain that includes the recently acquired Praha Vaccines and partnerships with leading biologics manufacturers, enabling (vaccine) production on 3 continents,” said Stanley C. Erck, President and Chief Executive Officer of Novavax, in a press statement.
Pittsburgh Takes the Lead of the NIH's Blood Thinner Studies
The US National Institutes of Health announced on September 10, 2020, it has selected the University of Pittsburgh to lead a trio of Phase 3 clinical trials involving COVID-19 patients. Collectively known as ACTIV-4 Antithrombotics, these late-stage trials will explore the use of blood thinners in saving lives and improving care, particularly among adult COVID-19 patients who are at risk of developing life-threatening blood clots.
Researchers and clinicians have noted that many patients who have died from COVID-19 formed blood clots throughout their bodies, including in their smallest blood vessels. This unusual clotting causes multiple health complications, from lung and other organ damage to heart attacks, pulmonary embolism, and strokes.
Antithrombotics, also known as blood thinners or anticoagulants, keep blood protein and platelets from turning into clumps or sticking to each other. However, doctors have not yet figured out if, and at what point in the course of COVID-19 disease, blood thinners might be effective at treating patients with this new condition.
COVID-19 Preventive Vaccine Update: September 15, 2020
As of September 15, 2020, there are several late-stage vaccine candidates in phase 3 clinical study in the USA and around the world. The SARS-CoV-2 vaccine development landscape includes innovative platforms such as nucleic acid (DNA and RNA), virus-like particle, peptide, viral vector (replicating and non-replicating), recombinant protein, live attenuated virus, and inactivated virus approaches.
An updated listing is found at CoronavirusToday.
AstraZeneca COVID-19 Vaccine Study 'Remains on Hold in the USA'
The clinical trial of AstraZeneca's AZD1222 vaccine candidate in the USA 'will remain on hold until the U.S. Food and Drug Administration and a safety panel investigate the case,' reported CNBC on September 14, 2020. An AstraZeneca spokeswoman declined to comment on when the experimental coronavirus vaccine's U.S. trial would resume.
The company announced on September 12, 2020, that it was restarting the phase 3 study in the UK.
An email sent to CNBC stated that AstraZeneca... "will continue to work with health authorities across the world, including the U.S. FDA, and be guided as to when other clinical trials can resume." The status of the South African and India studies remains unknown, but the clinical trial in Brazil has also restarted.
Oral COVID-19 Vaccine Candidate To Launch Phase 1 Study
Vaxart, Inc. announced on September 14, 2020, its oral COVID-19 vaccine candidate will launch a Phase 1 open-label, dose-ranging study that will be conducted in healthy adults ages 18 to 55 years old. This study’s primary objective is to examine the safety and reactogenicity of 2-doses of the vaccine. Secondary objectives include immunogenicity, duration of an immune response, and occurrence of symptomatic COVID-19.
Some States Significantly Increased HPV Vaccination Rates
A new study published by Pediatrics on September 14, 2020, which included 19.8 million person-years, found the proportion of 15-year-old girls and boys with at least a 1-dose HPV vaccination increased from 38% and 5% in 2011, to 57% and 51% in 2017, respectively.
Furthermore, the proportion with at least a 2-dose HPV vaccination went from 30% and 2% in 2011 to 46% and 39% in 2017, respectively.
By 2017, the 2-dose HPV vaccination coverage significantly varied by state and gender, such as 80% in the District of Columbia, among girls, to 15% in Mississippi among boys. This geo-segmentation was positively correlated with local legislation for HPV vaccine education and pediatrician availability.
China Ramps Up Flu Shots
In China, the rush is on to get a flu shot before a possible winter revival of the coronavirus pandemic, reported the SCMP on September 14, 2020. But compared to other countries, China’s influenza vaccination rate has been historically very low, with only about 2% of China’s vast population having flu shots in recent years.
For people aged 65 and older, who account for most of China's influenza fatalities (88,100) each year, only 7% had flu shots for the 2018-2019 flu season, reported a study published in September 2019. This compares with flu shot rates of 84% in South Korea and 73% in Australia according to data from the WHO.
In the USA, the CDC has authorized various vaccines for the 2020-2021 flu season, which can be found at PrecisionVaccinations.
Janssen Launched Phase 2 COVID-19 Vaccine Studies in Germany. Netherlands, and Spain
Janssen Vaccines & Prevention B.V. will begin Phase 2 trials of its COVID-19 vaccine candidate known as Ad26.COV2-S in Spain, the program's lead investigator Alberto Borobia said to Reuters on September 13, 2020. About 190 people would take part in Spain's trials, which will take place in 3 hospitals and be concluded by September 22, 2020.
The Spanish study is part of Phase II trials of the vaccine that are being carried out in three countries, including the Netherlands and Germany. The phase 2 trials will last 2-months and include 550 participants in total.
The primary purpose of this phase 2 study is to assess humoral immune responses of 3 dose levels of Ad26.COV2.S administered intramuscularly (IM) as a 2-dose schedule (56 days apart); Ad26.COV2.S administered IM as a single vaccination, and to test both compressed and expanded 2-dose schedules of Ad26.COV2.S (28 and 84 days apart).
Pharmaceuticals Help Extend Life Expectancy
Researchers used vital statistics data and cause-deletion analysis to identify the diseases and conditions most responsible for changing life expectancy. Published by Health Affairs on September 8, 2020, twelve conditions were found most responsible for changing life expectancy explained 2.9 years of net improvement (85 percent of the total 3.3 years between 1990 and 2015).
And, 35% of this life expectancy improvement was attributable to pharmaceuticals, which includes innovative vaccines.
Executive Order Lowers Drug & Vaccine Prices in the USA
The president of the United States, Donald J. Trump, signed Executive Order on September 13, 2020, requiring the secretary of the US Department of Health and Human Services to “immediately” test a payment model for Medicare to pay “no more than the most-favored-nation price.' This means the lowest price paid in other 'developed' countries, for specific “high-cost” prescription drugs, vaccines, and other products.
AstraZeneca Re-Launches Phase 3 COVID-19 Vaccine Study
Brazil and Russia to Co-Produce 50 Million Sputnik V Vaccine Doses
The Russian Direct Investment Fund and the Health Secretariat of the Brazilian state of Bahia announced on September 11, 2020, that they signed a cooperation agreement to supply Brazil with up to 50 million doses of the Russian Sputnik V vaccine, a SARS-CoV-2 virus preventive vaccine, beginning in November 2020, subject to Brazilian government regulatory approval.
According to the TASS news agency, the head of the Russian Direct Investment Fund Kirill Dmitriev stated 'Brazil is a strategic partner since it has production facilities that allow the supply of (Sputnik V) throughout South America.'
"By March 2020, 50 million doses, and maybe even 100 million doses, which is enough for half of the population of Brazil," Dmitriev said.
The CDC Reports a Very Quiet Flu Season
On September 11, 2020, the U.S. CDC published the updated '2019-2020 Influenza Season Week #36 reported, with data ending September 5, 2020. Nationwide during week #36, 0.9% 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 2.4%.
Based on the National Center for Health Statistics mortality surveillance data available on September 10, 2020, 5.4% of the deaths occurring during week #36 were due to pneumonia and influenza. And, there were no new influenza-associated pediatric fatalities reported. This data indicates a total of 188 influenza-associated pediatric deaths have occurred during the 2019-2020 season in the USA.
The most common flu shot for the 2020-2021 influenza season in the Northern Hemisphere are quadrivalent vaccines that protect people against 4 viruses; influenza A (H1N1) virus, influenza A (H3N2) virus, and 2 influenza B viruses, said the CDC on August 21, 2020.
Development Update: Coronavirus Vaccines in Phase 3 Studies
The SARS-CoV-2 vaccine development landscape includes nucleic acid (DNA and RNA), virus-like particle, peptide, viral vector (replicating and non-replicating), recombinant protein, live attenuated virus, and inactivated virus approaches. As of September 11, 2020, there are several COVID-19 vaccines in phase 3 studies, which are highlighted at CoronavirusToday.
China's Adenovirus Vaccine is Differs From AstraZeneca's Coronavirus Vaccine
China's media reported on September 10, 2020, CanSino's Chief Scientific Officer Zhu Tao stressed the safety of a recombinant adenovirus vector vaccine the company has developed after a trial on another vaccine using a similar mechanism was recently suspended by AstraZeneca and Oxford University, after a volunteer became ill during the trial.
One difference is that the Ad5-nCoV vaccine uses adenovirus that exists in human bodies, while the AstraZeneca vaccine candidate AZD1222 uses chimpanzee adenovirus. No severe adverse effects from Ad5-nCoV have been discovered so far, Zhu noted at a conference in Shanghai on September 9th.
CDC's Next Vaccine Review Meeting Scheduled for August 22, 2020
The U.S. CDC's Advisory Committee on Immunization Practices (ACIP) holds meetings each year in Atlanta, Georgia, to review scientific data and vote on vaccine recommendations. These ACIP meetings are open to the public and available online via live webcast.
The next ACIP meeting is scheduled for September 22, 2020, will be a virtual meeting and no registration is required to view the webcast. And, the August 2020 ACIP presentation slides are available at this CDC link.
Furthermore, on October 22, 2020, the 161st meeting of the Center for Biologics Evaluation and Research’s, Vaccines and Related Biological Products Advisory Committee will discuss the development, authorization, and/or licensure of vaccines to prevent COVID-19.
“The FDA has scheduled a meeting and is also prepared to rapidly schedule additional meetings of this committee upon submission of any applications as appropriate,” said FDA Commissioner Stephen M. Hahn, M.D. “I want to assure the American people that the process and review for vaccine development will be as open and transparent as possible.”
On September 10, 2020, Dr. Hahn told CNBC that 'any vaccine data released will be discussed publicly by an advisory committee of outside experts and that Peter Marks, who runs the FDA division that oversees vaccine approvals, will ultimately make a recommendation.'
Pharmacists Authorized to Administer Coronavirus Vaccines
The U.S. Department of Health and Human Services (HHS) issued new guidance on September 9, 2020, authorizing state-licensed pharmacists to order and administer, and state-licensed or registered pharmacy interns acting under the supervision of the qualified pharmacist to administer, COVID-19 vaccinations to persons ages 3 or older, subject to certain requirements.
"This action builds upon our Administration's progress toward delivering a safe, effective, and widely available vaccine by 2021," said Assistant Secretary for Health ADM Brett P. Giroir, M.D. "Allowing pharmacists to order and administer COVID-19 vaccines will greatly expand convenient access for the American people."
Previously, the National Community Pharmacists Association announced on September 8th, its CEO B. Douglas Hoey was invited to join Operation Warp Speed, the unprecedented race to develop, approve, produce, and distribute hundreds of millions of doses of vaccines to prevent COVID-19 pneumonia.
“Developing a vaccine in record time is the first hurdle. Then we need a way to distribute hundreds of millions of doses in record time. Community pharmacies are crucial to the administration of the millions of doses that will be needed to overcome the debilitating effect of the virus, and I’m glad to have the opportunity to represent community pharmacy as part of the effort,” said Hoey, in a press statement.
US Government Orders up to $166 Million of Japanese Encephalitis Vaccine
France based Valneva SE announced on September 9, 2020, the signing of a new contract, lasting up to 3-years, with the U.S. Department of Defense (DoD) for the supply of its Japanese encephalitis (JE) vaccine, IXIARO®, which is the only JE vaccine approved by the U.S. FDA.
This new contract has one base year, plus two option years, with a base-year value of $61 million. Deliveries for the base-year will commence in the fourth quarter of 2020. The DoD has the option to purchase a total of $76 million – $105 million worth of IXIARO across the 2 option years.
Franck Grimaud, Chief Business Officer of Valneva commented in a press statement: “The U.S. military has been using IXIARO for the past 10-years and we are excited to continue to help protect military personnel, their families, civilian government service personnel, and government contractors from this potentially deadly disease.”
25% of Mexicio To Receive Russia's Sputnik V Vaccine
The Russian Direct Investment Fund (RDIF) and Landsteiner Scientific announced an agreement on September 9, 2020, for the supply of 32 million doses of the coronavirus preventive Sputnik V vaccine to Mexico, with deliveries expected to start in November 2020, subject to approval by Mexico’s regulators.
Kirill Dmitriev, the CEO of RDIF. said in a press statement: “...a recent survey revealed that 66% of Mexicans express confidence in the Russian vaccine. We have agreed to deliver the large batch of Sputnik V vaccine to Mexico, which will help 25% of the Mexican population to receive access to the safe and effective (SARS-CoV-2) vaccine."
INOVIO Increases Capacity to Produce 100 Million COVID-19 Vaccine Doses
Pennsylvania based INOVIO announced on September 8, 2020, that Thermo Fisher Scientific has signed a letter of intent to manufacture INOVIO's DNA COVID-19 vaccine candidate INO-4800. With its consortium of third-party manufacturers, which includes Richter-Helm BioLogics and Ology Biosciences, INOVIO plans to have 100 million doses of INO-4800 manufactured in 2021, subject to FDA approval of INO-4800 for use as a COVID-19 vaccine.
INO-4800 is INOVIO's DNA vaccine candidate intended to protect against the novel coronavirus SARS-CoV-2, which causes COVID-19 pneumonia. INOVIO has extensive experience working with coronaviruses and was the first company with a Phase 2 vaccine for a related coronavirus that causes Middle East Respiratory Syndrome (MERS-CoV).
Pediatricians Promote Flu Shots For Children
The American Academy of Pediatrics (AAP) updated its policy statement on September 8, 2020: “Recommendations for Prevention and Control of Influenza in Children, 2020–2021."
“As a pediatrician, I am very concerned about the health of children and their families this fall if these two potentially deadly viruses are circulating in the community at the same time,” said Flor Munoz, M.D., FAAP, lead author of the recommendations, developed by the AAP Committee on Infectious Diseases, in a press statement. “Children play a pivotal role in the transmission of influenza to others in their household. They can also get seriously ill from influenza without a vaccination.”
Dr. Munoz added: “Besides getting our vaccine to prevent influenza, we can be vigilant in making sure we and our children continue to maintain COVID-19 precautions, including social distancing, face coverings, and frequent handwashing.”
Influenza vaccine options for the 2020-2021 flu season are list on this page.
These CEO's Pledge Vaccine Safety is Priority #1
Nine CEOs signed an innovative pledge on September 8, 2020, to continue to make the safety and well-being of vaccinated individuals the top priority in the development of the first COVID-19 vaccines. The CEOs represent AstraZeneca, BioNTech SE, GlaxoSmithKline plc, Johnson & Johnson, Merck, Moderna, Inc., Novavax, Inc., Pfizer Inc., and Sanofi.
'We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which COVID-19 vaccines are evaluated and may ultimately be approved.'
Group B Streptococcus Vaccines: One Step Further
The Lancet published a new study on September 3, 2020, reporting on a phase 1/2 clinical trial evaluating a vaccine composed of capsular polysaccharide conjugated to cross-reactive material 197 (CRM197) and directed against 6 capsular polysaccharide serotypes of group B streptococcus (GBS). These serotypes (Ia, Ib, II, III, IV, and V) account for the vast majority of isolates causing invasive GBS disease worldwide.... in neonates, as well as in adults.
These authors report that 3 different doses of this Pfizer hexavalent vaccine candidate formulated with or without aluminum phosphate as its adjuvant were safe and well-tolerated in healthy, non-pregnant, adult volunteers. And, the vaccine elicited a robust immune response for at least 6-months.
Chikungunya Vaccine Candidate Launches Phase 3 Clinical Study
France based Valneva SE announced on September 8, 2020, the initiation of a pivotal Phase 3 clinical trial for its differentiated, single-shot chikungunya vaccine candidate VLA1553, the first chikungunya vaccine to be eligible to receive an FDA Priority Review Voucher. This vaccine candidate is designed for prophylactic, active, single-dose immunization against chikungunya. As a live-attenuated vaccine, VLA1553 is particularly well suited to target long-lasting protection.
The safety profile is anticipated to be similar to licensed vaccines for active immunization in adults and children.
Wolfgang Bender, M.D., Ph.D., Chief Medical Officer of Valneva, commented in a press statement, “Developing a vaccine against chikungunya is critical as the virus represents a major public health threat and there are currently no preventive vaccines or effective treatments available."
Intranasal Pertussis Vaccine Candidate Found Safe and Immunogenic
The Lancet reported the early-stage vaccine candidate BPZE1 was found safe, induced a high colonization rate in an adult population, and was immunogenic at all doses. 'These findings justify further clinical development of the live attenuated, intranasal pertussis vaccine BPZE1, to ultimately be used as a priming vaccine for newborn children, or a booster vaccine for adolescents and adults, or both,' concluded this study.
The BPZE1 strain was developed at the Institute Pasteur de Lille and Inserm by a team of scientists led by Dr. Camille Locht. BPZE1 contains genetic modifications to eliminate, attenuate, or inactivate (3) different B. pertussis toxins. BPZE1 is an investigational vaccine that has not been approved by the U.S. FDA.
2nd West Nile Virus Related Fatality Confirmed in Dallas
Dallas County Health and Human Services (DCHHS) reported on September 6, 2020, the 2nd West Nile virus (WNV) associated death of the 2020 season. Both were diagnosed with West Nile Neuroinvasive Disease (WNND). Additionally, DCHHS reported the 5th human case of WNV infection in Dallas County, Texas, for 2020.
As of August 25, 2020, throughout the USA, 63 cases of WNV in people have been reported to U.S. CDC. Of these, 47 (75%) were classified as neuroinvasive diseases, such as meningitis or encephalitis, and 16 (25%) were classified as a non-neuroinvasive disease.
During 2019, there were 958 cases of WNV in people reported to the CDC, led by the states of California (225) and Arizona (174).
Mexico Launches Coronavirus Vaccine Development Effort
Esther Orozco, the coordinator of the scientific group that represents Mexico at the Coalition for Epidemic Preparedness Innovations, told Reuters on September 6, 2020, 'research based on a virus that transmits the avian Newcastle Disease is the most viable candidate to produce the first vaccine in Mexico. ND is caused by infections with one of the different strains of virulent avian Newcastle disease virus, recently renamed Avian avulavirus.
And, the vaccine is being developed by Laboratorio Avimex with researchers from Mexico’s UNAM, and the Mexican Social Security Institute. Orozco said it is 'ready to start the first phase of testing with humans.'
Which Coronavirus Vaccines Are Conducting Stage 3 Studies?
SARS-CoV-2 Pandemic Significantly Decreased Shingles Vaccinations
Since the declaration of the COVID-19 pandemic in January 2020, ordering rates across adult vaccines decreased an average of 62%, reported IQVIA. This data is most concerning for seniors who incur the most illnesses, hospitalizations, and deaths from vaccine-preventable illnesses that occur among adults.
To counter this trend, GSK launched a media campaign on August 5, 2020, to help increase vaccination among older adults. GSK has launched a website where adults ages 50 and older can learn about the value and importance of vaccines and see a list of vaccines routinely recommended for their age group. The vaccine awareness campaign will run through 2021.
A highlighted shingles vaccine for seniors is Shingrix, since nearly most adults 50+ years of age carry the inactive chickenpox virus that can cause shingles. Through March 2020, about 17 million people had received the Shingrix vaccine, with about 80% of them completing their 2-dose series, reported GSK.
Visit broughtbyvaccines.com for more information.
US Defense Department Launches 5 Vaccine Study Sites
The U.S. DOD announced on September 3, 2020, it has selected (5) locations to participate in the Phase III trial evaluating the SARS-CoV-2 preventive vaccine candidate AZD1222, which is under development by AstraZeneca. This study is looking for people who are at an increased risk of SARS-CoV-2 infection.
These locations are the Naval Medical Center San Diego, Joint Base San Antonio Brooke Army Medical Center, Wilford Hall Ambulatory Surgical Center (San Antonio), Walter Reed National Military Medical Center (Bethesda, MD), and Fort Belvoir Community Hospital (Fort Belvoir, VA).
To volunteer, visit www.CoronavirusPreventionNetwork.org, click on “Volunteer Now” and complete the survey. Once the survey is completed, the local study site coordinators will contact Military Health System beneficiary volunteers in their area who are a good match for this late-stage COVID-19 vaccine study.
Over 44 Million Completed Coronavirus Tests
To date, the U.S. FDA has authorized 242 coronavirus diagnostic tests, which include 194 molecular tests, 44 antibody tests, and 4 antigen tests. And there are 4 tests that differentiate between influenza and COVID-19 infections.
As of September 4, 2020, there have been over 44.2 million commercial tests to confirm if a person has a SARS-CoV-2 infection since March 1, 2020. And new data from the U.S. CDC indicates the percentage of laboratory tests positive for SARS-CoV-2 nationally was (5.4%) last week.
Pneumonia and Influenza Fatalities Continue Decreasing
Based on the National Center for Health Statistics mortality surveillance data available on September 3, 2020, just 5.4% of the fatalities occurring during the week ending August 29, 2020 (week 35) were due to pneumonia and influenza. This percentage is a decrease from the epidemic threshold of 5.5% for week #35.
The good news from this report is there were (0) influenza-associated pediatric fatalities reported to U.S. CDC during week #35. A total of 188 influenza-associated pediatric fatalities have already occurred during the 2019-2020 flu season in the Northern Hemisphere.
The CDC has authorized various influenza vaccines for the fast-approaching 2020-2021 flu season, which can be found at this PrecisionVaccinations webpage.
Hydroxychloroquine Found Not Associated with Lupus Patient's Hospitalized Infections
A study published on August 24, 2020, compared the risk of hospitalized infection (HI) between users and non-users of the antimalarial drug hydroxychloroquine (HCQ) in systemic lupus erythematosus (SLE).
These researchers from Japan found that the use of HCQ, also known by the brand name Plaquenil, is not associated with short-term risk of HI, which refers to both hospitalizations that occur due to infections, as well as infections that occur during hospitalization. The use of HCQ was not approved for lupus treatment in Japan until 2015.
This study has heightened relevance regarding the ongoing debate of treatment options for non-severe COVID-19 disease patients.