Vaccine Breaking News

Vaccine breaking news brought to you by Precision Vaccinations.

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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Jan 11, 2021 • 2:03 pm CST

A 2018 study showed that vaccinated patients were 59% less likely to be admitted to an ICU than those who had not been vaccinated among adults hospitalized with influenza. Among adults in the ICU with the seasonal flu, vaccinated patients on average spent 4 fewer days in the hospital than those who were not vaccinated, stated the U.S. CDC on December 16, 2020.

'Getting vaccinated yourself may also protect people around you, including those who are more vulnerable to serious flu illness, like babies and young children, older people, and people with certain chronic health conditions,' says the CDC.

Furthermore, several studies have shown that in addition to protecting pregnant women, a flu vaccine given during pregnancy helps protect the baby from flu for several months after birth, when he or she is not old enough to be vaccinated.

'Getting a flu vaccine is more important than ever during 2020-2021 to protect yourself and the people around you from flu and to help reduce the strain on healthcare systems responding to the COVID-19 pandemic. Most flu vaccines in the USA protect against four different flu viruses (“quadrivalent”); an influenza A (H1N1) virus, an influenza A (H3N2) virus, and two influenza B viruses, says the CDC.

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Jan 11, 2021 • 12:44 pm CST

The US Centers for Disease Control and Prevention (CDC) updated its website on January 11, 2021, indicating 8,987,322 first-doses vaccines administered in the USA. And, 937,028 of those vaccinations have occurred in Long-Term Care Facilities.

The CDC previously stated on January 7, 2021, the Pharmacy Partnership for Long-Term Care (LTC) Program is facilitating on-site vaccination of residents and staff at more than 75,000 enrolled long-term care facilities while reducing the burden on administrators, clinical leadership, and health departments.

The LTC program provides end-to-end management of the COVID-19 vaccination process at no cost to facilities, including cold chain management, on-site vaccinations, and fulfillment of reporting requirements. 

The CDC stated it 'expects the program services to continue on-site at participating LTC facilities for approximately 2-months from the first vaccination date. After the initial phase of vaccinations, facilities may continue working with the federal pharmacy partner they were matched with or shift to another pharmacy provider that is enrolled with the jurisdiction to provide ongoing COVID-19 vaccination.'

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Jan 11, 2021 • 9:47 am CST

The U.S. COVID Data Tracker reported about 259 million RT-PCR diagnostic tests, excluding antibody and antigen tests, have been performed to confirm if a person has a SARS-CoV-2 virus infection, as of January 10, 2021.

The state of California leads the USA with 30,858,194 coronavirus tests performed, followed by New York (23,154,720), Florida (17,916,523), and Texas (15,635,459).

And, as of January 8, 2021, the U.S. FDA had authorized 311 coronavirus diagnostic tests, including 235 molecular tests, 64 antibody tests, and 12 antigen tests.

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Jan 11, 2021 • 8:31 am CST

Massachusetts based Moderna, Inc. announced that it is expanding its mRNA vaccines with three new development programs. This announcement reflects the Company’s commitment to accelerating its infectious disease portfolio based on Moderna’s experience with its COVID-19 vaccine.

These mRNA vaccine candidates are against seasonal influenza, HIV, and the Nipah virus. 

Stéphane Bancel, Moderna’s CEO, stated in a press release issued on January 11, 2021, “Even as we have shown that our mRNA-based vaccine can prevent COVID-19, this has encouraged us to pursue more-ambitious development programs within our prophylactic vaccines modality. Beyond vaccines, we are extending our mRNA development work to a total of 24 programs across five therapeutic areas.”

Moderna also announced an expansion of its respiratory syncytial virus vaccine program into older adults.

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Jan 10, 2021 • 2:42 pm CST

New York-based COVAXX announced on January 8, 2021, it has initiated preclinical work on a second vaccine candidate to address the latest mutations of the SARS-CoV-2 coronavirus responsible for COVID-19, and specifically the South African mutation.

The COVAXX multitope vaccine is being developed using high precision, commercially proven, and scalable synthetic peptide-based vaccine platform, designed to activate both B-cell and T-cell responses.

“We have been studying the new South African mutation and we believe it is a significant threat to public health," said COVAXX's CEO Mei Mei Hu, in a press statement. “As a result, we are not only testing UB-612 against these variants but have also begun early testing and design of a second vaccine candidate that addresses both the UK and the South African variant and the potential to be a single-dose vaccine for primary immunization.”

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Jan 9, 2021 • 3:30 pm CST

A research article published by the American Association for the Advancement of Science on January 6, 2021, stated 'understanding immune memory to the SARS-CoV-2 betacoronavirus is critical for improving diagnostics and vaccines, and for assessing the likely future course of the COVID-19 pandemic.'

These researchers analyzed multiple compartments of circulating immune memory to SARS-CoV-2 in 254 samples from 188 COVID-19 cases, including 43 samples at ≥ 6 months post-infection.

They found IgG to the Spike protein was relatively stable over 6+ months. And spike-specific memory B cells were more abundant at 6 months than at 1-month post symptom onset.

Furthermore, SARS-CoV-2-specific CD4+ T cells and CD8+ T cells declined with a half-life of 3-5 months.

The researchers concluded by saying: 'While immune memory is the source of long-term protective immunity, direct conclusions about protective immunity cannot be made based on quantifying SARS-CoV-2 circulating antibodies, memory B cells, CD8+ T cells, and CD4+ T cells, because mechanisms of protective immunity against SARS-CoV-2 or COVID-19 are not defined in humans. Nevertheless, some reasonable interpretations can be made.'

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Jan 9, 2021 • 12:05 pm CST

Maryland-based Novavax, Inc. announced that it had executed an Advance Purchase Agreement with the Commonwealth of Australia for 51 million doses of NVX-CoV2373, Novavax’ COVID-19 vaccine candidate. This follows an agreement in principle that was announced in November 2020.

“The continued increase in significant COVID-19 transmission in virtually all parts of the world underscores the need for multiple safe, efficacious vaccines in enormous quantities to stop the pandemic,” said Stanley C. Erck, Novavax President, and CEO, in a press statement issued on January 7, 2021.

Novavax stated it is working with Australia’s regulatory agency, the Therapeutics Goods Administration (TGA), to obtain product approvals upon demonstrating efficacy in clinical studies. The company aims to deliver initial doses by mid-2021. As part of the agreement, Australia will have the option to purchase up to an additional 10 million doses.

Novavax is currently conducting late-stage clinical studies to demonstrate the efficacy, safety, and immunogenicity of NVX-CoV2373 for the prevention of COVID-19. This includes two large pivotal Phase 3 clinical trials in the USA / Mexico (PREVENT-19 trial) and in the United Kingdom, as well as a Phase 2b trial in South Africa.

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Jan 8, 2021 • 2:48 pm CST

New York-based Applied DNA Sciences, Inc. announced that the U.S. FDA published a safety communication that identifies the Linea™ COVID-19 Assay Kit as one test-marketed under an Emergency Use Authorization that potentially identifies certain SARS-CoV-2 mutations, including a mutation found in the U.K. variant of SARS-CoV-2 (B.1.1.7).

Identifying certain virus mutations can help identify samples that should be further characterized by genetic sequencing and can potentially assist with the early detection of new SARS-CoV-2 variants in patients, which may reduce the further spread of infection and COVID-19 cases.

Dr. James A. Hayward, president, and CEO, Applied DNA, stated in a press release issued on January 8, 2021, “Using our Assay Kit, we have already identified variants of SARS-CoV-2 via S-gene dropout, sequenced the identified variants with partners and identified common genetic progenitors that are shared by B.1.1.7 and other emerging SARS-CoV-2 variants. Utilizing this knowledge, we have begun to develop new assays to detect specific mutations in SARS-CoV-2 and to adapt our assay to address the evolving SARS-CoV-2 threat.”

The Linea™ COVID-19 Assay Kit is authorized by FDA for the qualitative detection of nucleic acid from SARS-CoV-2 in respiratory specimens, including anterior nasal swabs, self-collected at a healthcare location or collected by a healthcare worker, and nasopharyngeal and oropharyngeal swabs, mid-turbinate nasal swabs, nasopharyngeal washes/aspirates or nasal aspirates, and bronchoalveolar lavage specimens collected by a healthcare worker from individuals who are suspected of COVID-19 by their healthcare provider. 

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