Vaccine Breaking News

Vaccine breaking news brought to you by Precision Vaccinations.

Jan 17, 2021 • 12:15 pm CST

The Acting US Department of Defense Secretary Christopher Miller stated on January 15, 2021: 'On behalf of Operation Warp Speed, I am proud to report that today, 816,900 additional vaccines were distributed to the American people. Today’s great work brings the total number of COVID-19 vaccine doses distributed to 30,303,375.'

Separately, the U.S. CDC reported 12,279,180 first-vaccine doses had been administered in the USA as of January 15, 2021. The number of people receiving 2 vaccine doses has reached 1,610,524.

From a productivity and efficiency perspective, the state of Texas leads the USA with 2,105,600 vaccines distributed and 1,160,242 administered. Furthermore, Texas has confirmed over 16 million COVID-19 related diagnostic tests.

Jan 17, 2021 • 12:01 pm CST

The US Department of Defense, in coordination with the Department of Health and Human Services, announced they had awarded a $69.3 million contract to CONTINUUS Pharmaceuticals Inc. on January 15, 2021.

The contract is to develop a domestic production capability for critical active pharmaceutical ingredients (APIs) and final dosage form medicines using their proprietary integrated continuous manufacturing (ICM) technology. ICM enables rapid, on-demand production of medicines from API to final dosage form without interruption in a fully-automated, small-footprint facility. 

Massachusetts-based CONTINUUS leverages, a novel continuous manufacturing platform, was initially developed through an $85 million joint research project between Novartis and MIT. This new investment will enable CONTINUUS to commercialize its small-footprint, end-to-end pharmaceutical manufacturing technology. 

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Jan 16, 2021 • 2:30 pm CST

As of January 15, 2021, the U.S. CDC reported (88) cases of the UK's B.1.1.7 variant in the USA. The CDC says, 'Scientists are working on learning more about how easily they might spread, whether they could cause more severe illness and whether currently authorized vaccines will protect people against them. At this time, there is no evidence that these variants cause more severe illness or increased risk of death.'

A recent non-peer-reviewed study reported the 'UK variant of SARS-CoV-2' is thought to be more infectious than previously circulating coronavirus strains due to several changes, including the N501Y mutation.

These researchers stated on January 12, 2021, they found cryo-EM structures of SARS-CoV-2 spike protein ectodomains with and without the N501Y mutation in complex with the VH fragment of the potent neutralizing antibody, VH -Fc ab8.

The mutation results in localized structural perturbations near Y501. Still, VH -Fc ab8 retains the ability to bind and neutralize pseudotyped viruses expressing the N501Y mutant with efficiencies comparable to unmutated viruses.

'These study results show that despite the higher affinity of ACE2 for the N501Y mutant, SARS-CoV-2 can still be neutralized efficiently by an antibody that binds epitopes in the receptor-binding domain of the SARS-CoV-2 spike protein.'

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Jan 16, 2021 • 9:03 am CST

The U.S. Food and Drug Administration (FDA) announced it had authorized 317 coronavirus diagnostic tests, including 236 molecular tests, 68 antibody tests, and 13 antigen tests as of January 15, 2021.

Furthermore, 32 molecular authorizations can be used with home-collected samples. There is one molecular prescription at-home test, one antigen prescription at-home test, and one over-the-counter at-home antigen test.

Previously, the FDA issued on January 8th, an alert to clinical laboratory staff and providers that the FDA monitors the potential impact of viral mutations, including an emerging variant from the United Kingdom known as the B.1.1.7 variant authorized SARS-CoV-2 molecular tests. That false-negative results can occur with any molecular test for detecting SARS-CoV-2 if a mutation occurs in the part of the virus’s genome assessed by that test. 

Furthermore, the FDA recently published 'A Closer Look at COVID-19 Diagnostic Testing' to provide those who might purchase COVID-19 tests, more technical information and resources. The COVID-19 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, the betacoronavirus that causes COVID-19.

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Jan 15, 2021 • 2:07 pm CST

Long Island-based Codagenix Inc. and the Serum Institute of India Pvt. Ltd. recently announced that the first patient had been dosed in the Phase 1 clinical trial of COVI-VAC, a single-dose, intranasal, live attenuated vaccine against SARS-CoV-2, the virus that causes COVID-19. Codagenix expects to report initial data from the study by mid-2021.

The study will also evaluate the vaccine candidate's ability to provoke an immune response by measuring neutralizing antibodies, mucosal immunity in the airway, and cellular immunity. Live-attenuated vaccines generally elicit a robust immune response and are associated with long-lasting cellular immunity.

COVI-VAC was developed with Codagenix's Synthetic Attenuated Virus Engineering platform, which uses synthetic biology to re-code viruses' genes into safe and stable vaccines. This vaccine is designed to produce immunity against all SARS-CoV-2 proteins, not just the spike surface protein.

Pending results of the Phase 1 trial, the companies expect to begin advanced clinical testing in mid-2021.

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Jan 15, 2021 • 10:26 am CST

The US Influenza Hospitalization Surveillance Network (FluSurv-NET) reported on January 15, 2021, a total of 129 laboratory-confirmed influenza-associated hospitalizations occurring between October 1, 2020, and January 9, 2021. FluSurv-NET stated this 'number is lower than average for this point in the season and comparable to counts seen at this point during the 2011-12 season.'

Additionally, the U.S. CDC's week #1 report for the 2021 influenza season commented, 'Flu activity is unusually low at this time but may increase in the coming months.'

The CDC found during week #1, which ended on January 9, 2021, '1.7% of patient visits reported through ILINet were due to Influenza-like-Illness. This percentage is below the national baseline of 2.6%.'

Moreover, only (1) influenza-associated pediatric death has been reported to the CDC during the 2020-2021 season. This data compares with the 2019-202 flu season, when (195) flu-associated pediatric deaths were confirmed.

Since each flu season is unpredictable, the CDC says, 'If you haven’t gotten your flu vaccine yet, get vaccinated now. An annual flu vaccine is the best way to protect against flu and its potentially serious complications.'

 

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Jan 15, 2021 • 9:57 am CST

The JAMA Network published an article by Jennifer Abbasi on January 12, 2021, stating an experimental flu vaccine regimen induced lasting antibodies against a range of influenza strains, according to the final results of a phase 1 trial, published by Nature Medicine.

In the study, 65 healthy volunteers had sustained antibody titers higher than that associated with natural immunity against the H1N1 virus in a previous study, suggesting a strong and durable response. In laboratory tests, the antibodies broadly protected against different group 1 influenza A strains and, when transferred to mice, kept them from losing weight after a viral challenge.

Writing in Nature Medicine, the authors noted 'that research is underway to develop broad vaccines against group 2 influenza A, as well as influenza B, viruses. If successful, a trivalent regimen that combines these candidates ideally would protect against all flu strains—a truly universal flu vaccine.'

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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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