Vaccine Breaking News

Vaccine breaking news brought to you by Precision Vaccinations.

Jan 15, 2021 • 8:29 am CST

The Rockefeller Foundation announced a new $30 million Advance Market Commitment (AMC) to scale up pandemic testing needs and safely reopen schools, communities, and the economy. The investment serves as a financial guarantee that enables Thermo Fisher Scientific to procure and strategically stock up to $30 million in Covid-19 tests at a time.

The first AMC order of 300,000 COVID-19 tests, costing $9 million, has already been purchased and sold to states through the facility.

"Just like we need breakthroughs in the lab, we need breakthroughs in the marketplace to get tests to the frontlines quicker, cheaper, and more efficiently than ever before," said Dr. Rajiv J. Shah, President of The Rockefeller Foundation, in a press release issued on January 14, 2021. "This innovative collaboration will change business as usual, avoid detrimental competition between states, and help us deploy rapid tests straight to schools, nursing homes, and workplaces to stop outbreaks before they spread."

Jan 15, 2021 • 5:34 am CST

State and local health officials in the USA could accelerate COVID-19 vaccine delivery by working more closely with community pharmacists, announced the National Community Pharmacists Association (NCPA).

“Based on what we’re seeing, the vaccine rollout is going better in states where community pharmacists are key partners in the distribution,” said NCPA President Brian Caswell in a press statement. “West Virginia and Arkansas are good examples, where state and local health departments are working closely with community pharmacists to reach more patients and satisfy the demand."

"Community pharmacies are a force multiplier,” he continued. “They also have a high degree of trust with their patients, and that’s critical for overcoming vaccine hesitancy.”

Caswell noted that there are more than 21,000 community pharmacies in the USA, with 79% located in communities with fewer than 50,000 people, according to NCPA research. Most of these pharmacies are already doing immunizations for other diseases, and the overwhelming majority want to administer the COVID-19 vaccine to their patients, stated the NCPA.

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Jan 15, 2021 • 5:20 am CST

The New England Journal of Medicine published an internal study on January 13, 2021, which found a single vaccine dose of Johnson & Johnson's Janssen COVID-19 vaccine candidate created an immune response that lasted at least 71 days. After a single vaccination, neutralizing antibodies against COVID-19 were observed in more than 90% of volunteers at Day 29 and 100% of the volunteers between the ages of 18 and 55 at Day 57.

'Our interim analysis indicates that vaccine candidate Ad26.COV2.S is safe and immunogenic in both younger and older adults.'

'This finding has supported our decision to proceed with phase 3 trials to evaluate the efficacy of either a single-dose or two-dose regimen of the lower dose (5×1010 viral particles) of Ad26.COV2.S.'

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Jan 14, 2021 • 8:43 am CST

Mayo Clinic researchers published a study in the NEJM on January 13, 2021, regarding the use of convalescent plasma and the risk of death from COVID-19 when hospitalized. These researchers concluded by saying, 'Among patients hospitalized with Covid-19 who were not receiving mechanical ventilation, transfusion of plasma with higher anti–SARS-CoV-2 IgG antibody levels were associated with a lower risk of death than transfusion of plasma with lower antibody levels.'

Of the 3,082 patients included in this analysis, death within 30 days after plasma transfusion occurred in (22.3%) in the high-titer group, (27.4%) in the medium-titer group, and (29.6%) in the low-titer patient group.

The association of anti–SARS-CoV-2 antibody levels with the risk of death from COVID-19 was moderated by mechanical ventilation status. And, these data were consistent with a mortality benefit associated with high-titer plasma administered earlier in the course of the disease.

Although patient age was not the primary focus of these analyses, it was estimated to be the most important variable in predicting the risk of death within 30 days after plasma transfusion.

These findings were an important component of the scientific evidence considered by the U.S. FDA in the decision on August 23, 2020, to issue an emergency-use authorization for convalescent plasma in the treatment of hospitalized adults with COVID-19.

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Jan 14, 2021 • 7:00 am CST

UK-based Synairgen plc announced on January 13, 2021, that the first patient had been dosed in the United Kingdom as part of its global Phase III trial (SG018) evaluating Synairgen’s inhaled formulation of interferon beta-1a (SNG001) for the treatment of hospitalized COVID-19 patients.

Interferon beta ('IFN-beta') is a naturally-occurring protein, which orchestrates the body's antiviral responses. It is used widely in treating multiple sclerosis and is a safe and well-tolerated drug.

There is growing evidence that the lung deficiency in IFN-beta production could explain the enhanced susceptibility in 'at-risk' patient groups to developing severe lower respiratory tract (lung) disease during respiratory viral infections. Furthermore, viruses, including coronaviruses such as SARS-CoV-2, have evolved mechanisms that suppress endogenous IFN-beta production, helping the virus to evade the innate immune system, says the company.

Synairgen’s SG018 trial is a randomized placebo-controlled study conducted in approximately 20 countries, enrolling 610 COVID-19 patients who require supplemental oxygen.

SNG001 had been granted Fast Track status from the U.S. FDA on December 13, 2020.

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Jan 13, 2021 • 8:11 pm CST

The New England Journal of Medicine published an interim analysis of phase 1–2a trial of the Ad26.COV2.S vaccine on January 13, 2021, and reported an acceptable safety and reactogenicity profile and was immunogenic after a single vaccination with either the low or high dose.

This analysis found a single dose of Ad26.COV2.S elicited a strong humoral response in most 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.

Also, during 71 days of follow-up after the first dose, antibody titers further increased and stabilized, suggesting the durability of the Ad26.COV2.S-elicited immune response.

Additionally, the potency of Ad26.COV2.S is supported by the results of a study involving non-human primates, in which a single dose provided complete protection against SARS-CoV-2 virus replication in the lung and near-complete protection in the nose. An efficacious single-dose Covid-19 vaccine has obvious logistic advantages over a two-dose vaccine, especially during a pandemic.

These researchers observed that among participants between the ages of 18 and 55 years, a second vaccine dose at day 57 further increased the antibody titer, a finding that was also in line with our recent observations in nonhuman primates.

Johnson & Johnson's Janssen Vaccines & Prevention B.V. is the sponsor of the experimental COVID-19 vaccine candidate known as 'Janssen COVID-19 Vaccine.'

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Jan 13, 2021 • 1:45 pm CST

The US Centers for Disease Control and Prevention (CDC) reported on January 13, 2021, there have been 10,278,462 first-doses COVID-19 vaccines administered in the USA. And, 1,084,177 of those vaccinations have occurred in Long-Term Care Facilities.

In the USA, there are two experimental COVID-19 vaccines authorized for emergency use. Worldwide, various countries have authorized six other COVID-19 vaccines for use. None of these vaccines have been officially approved.

Furthermore, researchers do not know whether COVID-19 vaccinated people can spread the SARS-CoV-2 betacoronavirus. Although vaccines have been proven to protect recipients from getting ill, research has yet to determine whether they prevent the new virus, or the recent variants, from replicating altogether.

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Jan 13, 2021 • 10:20 am CST

Wisconsin-based Promega announced on January 13, 2021, labs performing the U.S. Centers for Disease Control and Prevention (CDC) Flu SC2 Multiplex Assay, a single test to diagnose infection caused by SARS-CoV-2, influenza A, or influenza B, can now use two Promega instruments and a Promega nucleic acid purification kit in the protocol.

In a letter dated January 8, 2021, the US Food and Drug Administration authorized an amendment to the Emergency Use Authorization for the CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay that adds the Maxwell® RSC 48 and Maxwell® CSC 48 instruments, along with the Maxwell® RSC Viral Total Nucleic Acid Purification Kit, as options for the test procedure.

“Multiplex molecular tests are crucial as the flu season overlaps with the COVID-19 pandemic, and we’re glad that Promega can continue to support laboratories by providing them more options as testing evolves and advances,” stated Heather Tomlinson, Director of Clinical Diagnostics at Promega, in a press statement.

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Jan 13, 2021 • 5:48 am CST

The Director of the US Centers for Disease Control and Prevention (CDC) Robert Redfield M.D. announced on January 12, 2021, the CDC would require all air passengers entering the USA to present a negative COVID-19 test, taken within 72 hours of departure​, beginning January 26, 2021.

Furthermore, this CDC order requires international airlines to 'deny boarding of passengers if they do not provide documentation of a negative test or recovery before entering the USA.'

The CDC has also issued a Level 4 Travel Health Notice for the United Kingdom (UK) to reduce the introduction and spread of new variants of the SARS-CoV-2 coronavirus. The UK's Public Health England confirmed on December 21, 2020; a novel variant had been identified, B.1.1.7, which was spreading within the UK. As of January 11th, the CDC confirmed (72) B.1.1.7 Lineage Cases in the USA.

Separately, the US Department of State issued a Level 3 Travel Advisory for the UK on January 12th.

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Jan 13, 2021 • 5:20 am CST

The European Medicines Agency (EMA) confirmed it had received an application for conditional marketing authorization for an experimental COVID-19 vaccine developed by AstraZeneca and Oxford University on January 12, 2021. The assessment of the vaccine, known as COVID-19 Vaccine AstraZeneca, will proceed under an accelerated timeline, stated the EMA.

If the EMA concludes that the benefits of the vaccine outweigh its risks in protecting against COVID‑19, it will recommend granting conditional marketing authorization. The European Commission will then fast-track its decision-making process to grant conditional marketing authorization for its Member States.

The AstraZeneca COVID-19 (AZD1222) coronavirus vaccine candidate, formerly known as ChAdOx1 nCoV-19, is made from a virus (ChAdOx1), a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees, that has been genetically changed so that it can't grow in humans. Genetic material has been added to the ChAdOx1 construct, which is used to make proteins from the SARS-CoV-2 coronavirus called Spike glycoprotein. 

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Jan 12, 2021 • 12:38 pm CST

California-based Gilead Sciences, Inc. and Vir Biotechnology, Inc. announced that the companies have entered into a clinical collaboration to evaluate novel therapeutic combination strategies to develop a functional cure for chronic hepatitis B virus (HBV), which affects more than 290 million people worldwide. 

The companies stated they plan to initiate a Phase 2 trial evaluating combination therapy for both treatment-experienced and treatment-naïve people living with HBV. The multi-arm trial will evaluate different combinations of selgantolimod, Gilead’s investigational TLR-8 agonist; VIR-2218, Vir’s investigational small interfering ribonucleic acid (siRNA); and a commercially-sourced, marketed PD-1 antagonist.

The safety and efficacy of selgantolimod and VIR-2218 have not been established. They are investigational compounds, not approved by the U.S. FDA or any other regulatory authority.

Phil Pang, M.D., Ph.D., Chief Medical Officer of Vir Biotechnology, stated in a press release, “We believe a functional cure for the majority of patients will require a reduction of the levels of circulating viral proteins together with an immune boost to stimulate the production of new T-cells that can bring the infection under control."

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Jan 12, 2021 • 9:57 am CST

The US Health and Human Services Secretary Alex Azar announced on January 12, 2021, that “the COVID-19 vaccine administration in the states has been too narrowly focused.”

As a result, the administration is now asking states to vaccinate people age 65 and over and those under 65 with underlying health conditions that put them at high risk, Sec. Azar told ABC's “Good Morning America."

“We now believe that our manufacturing is predictable enough that we can ensure second doses are available for people from ongoing production. We’ve already distributed more vaccine than we have health care workers and people in nursing homes,” Azar said. “We’ve got to get to more channels of administration. We’ve got to get it to pharmacies," reported the AP.

Sec. Azar indicated the federal government “will deploy teams to support states making mass vaccination efforts if they wish to do so.”

As of January 11, 2021, the U.S. CDC's dashboard shows over 25 million experimental mRNA vaccine doses have already been distributed.

Jan 12, 2021 • 5:45 am CST

France-based Valneva SE announced on January 12, 2021, it is in advanced discussions with the European Commission for the supply of up to 60 million doses of its COVID-19 vaccine, VLA2001, the only inactivated vaccine candidate in clinical trials against COVID-19 in Europe.

The experimental VLA2001 vaccine consists of inactivated whole virus particles of SARS-CoV-2 with high S-protein density, combined with two adjuvants, alum and CpG 1018. This adjuvant combination has consistently induced higher antibody levels in preclinical experiments than alum-only formulations and has shown a shift of the cellular immune response towards Th1. CpG 1018 is a component of the U.S. FDA-approved HEPLISAV-B® vaccine.

VLA2001 is produced on Valneva’s established Vero-cell platform, leveraging the manufacturing technology for Valneva’s licensed Japanese encephalitis vaccine, IXIARO®. The process, which has already been upscaled to the final industrial scale, includes inactivation with BPL to preserve the native structure of the S-protein. And, VLA2001 is expected to conform with standard cold chain requirements (2 degrees to 8 degrees Celsius), says the company.

Thomas Lingelbach, Valneva's CEO, said in a press statement, “Today’s announcement helps to ensure that millions of Europeans potentially have access to a proven and well-established inactivated vaccine approach, upon approval of the VLA2001 COVID-19 vaccine."

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Jan 12, 2021 • 5:19 am CST

UNICEF announced international health and humanitarian organizations had established a global Ebola vaccine stockpile to ensure timely outbreak response on January 12, 2021. This vaccine stockpile will enable countries to contain future Ebola epidemics by ensuring access to vaccines for populations at risk during outbreaks.

The injectable single-dose Ervebo Ebola vaccine is manufactured by Merck, Sharp & Dohme Corp. and developed with financial support from the US government. The European Medicines Agency licensed the Ervebo vaccine in November 2019. The vaccine is now prequalified by the WHO and licensed by the U.S. FDA and eight African countries.

Prior to licensure, Ervebo was administered to more than 350,000 people under the “compassionate use” protocol.

Dr. Tedros Adhanom Ghebreyesus, WHO Director-General, stated in a press release, “Ebola vaccines have made one of the most feared diseases on earth preventable. This new stockpile is an excellent example of solidarity, science, and cooperation between international organizations and the private sector to save lives.”

The vaccine stockpile is stored in Switzerland and ready to be shipped to countries for emergency response. The decision to allocate the vaccine will be made within 48 hours of receiving a country's request; vaccines will be made available together with ultra-cold chain packaging by the manufacturer for shipment to countries within 48 hours of the decision.

Jan 11, 2021 • 5:11 pm CST

A study published in the International Journal of Infectious Diseases found early administration of Oseltamivir (Tamiflu) has a beneficial impact in reducing 30-day readmissions and mortality in adult influenza patients when compared to a delayed administration after hospital admission or untreated patients and should be considered in all patients who require hospitalisation.

These Australian researchers concluded by saying 'The beneficial effect of Oseltamivir in reducing readmissions could be related to a reduction in the incidence of secondary complications of influenza such as bacterial pneumonia or fewer exacerbations of underlying chronic medical conditions.'

'The findings of this study support the Infectious Diseases Society of America clinical practice guidelines on influenza and the US Centers for Disease Control and Prevention (CDC) antiviral treatment recommendations for influenza (Nov. 30, 2020) that clinicians should start antiviral treatment as soon as possible for hospitalized patients with documented or suspected influenza regardless of illness duration prior to hospitalization.'

The CDC states 'Decisions about starting antiviral treatment for patients with suspected influenza should not wait for laboratory confirmation of influenza virus infection. Empiric antiviral treatment should be started as soon as possible in the priority groups.'

 

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