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$4.8 Million Award Funds Betacoronavirus Vaccine Development

Avacc 101 is Intravacc subunit betacoronavirus vaccine candidate

October 6, 2022

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The U.S. Department of State reissued its Travel Advisory for the country of Mexico today without a ranking. The State Department generally assigns its travel advisories a numeric scale from 1 to 4.

As of October 5, 2022, the State Department indicates several areas of Mexico have an elevated risk of civil unrest.

Mexican state summaries and advisory levels are listed on this weblink.

U.S. government employees may not travel between Mexican cities after dark, may not hail taxis on the street, and must rely on dispatched vehicles, including app-based services and regulated taxi stands.

Also, U.S. government employees may not drive from the U.S.-Mexico border to or from the interior parts of Mexico, except for daytime travel within Baja California and between Nogales and Hermosillo on Mexican Federal Highway 15D, and between Nuevo Laredo and Monterrey on Highway 85D.

However, there are no restrictions on travel for U.S. government employees in Quintana Roo state, which includes the tourist areas in Cancun, Cozumel, Isla Mujeres, Playa del Carmen, Tulum, and the Riviera Maya.

If you decide to travel to Mexico, the state department suggests several actions, including, but not limited to, enrolling in the Smart Traveler Program to receive Alerts and make it easier to be located in an emergency.

Furthermore, the U.S. Mission to Mexico announced on October 4, 2022, Mexican immigration authorities (INM) implemented a pilot project to eliminate the Forma Migratoria Multiple (FMM) in select airports across Mexico.

Under the new pilot program, INM stamps the visitor’s passport with the period of authorized stay instead of issuing a paper FMM.

U.S. citizens are reminded to carefully review and abide by the admission period authorized by immigration authorities upon entry.

In addition, visitors to Mexico must carry their original passport—not a copy—at all times.

Moreover, the CDC’s Order requiring proof of vaccination for non-U.S. citizens and nonimmigrants to travel to the U.S. remains in effect.

For more information, see Requirement for Proof of COVID-19 Vaccination for Air Passengers.

From a health perspective, the U.S. CDC suggests checking your vaccination status and medicines supplies and visiting a travel specialist at least a month before your trip to Mexico.

Additional travel diseases and vaccine information are posted at Vax-Before-Travel.

Vaccine Treats:

Measles

Image:

Image Caption:

U.S. Dept. of State

Live Blog Update Author:

Don Hackett

Location Tags:

Mexico

Vaccine:

Priorix MMR Vaccine

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The recent detection of vaccine-derived poliovirus (VDPV) in London, England, and in New York has highlighted how poliomyelitis has not been overcome and remainsa globall problem, not confined to Afghanistan, Pakistan, and Africa.

To address the risk of circulating VDPVs, a global collaborative effort over the past decade has enabled the development of a novel oral polio vaccine type 2 (nOPV2) that is as immunogenic as the current Sabin IPV strain vaccine while being less likely to revert to neurovirulence than oral polio vaccines, wrote Ananda S Bandyopadhyay, MBBS, and Simona Zipursky, MSc, in The Lancet Infectious Diseases on September 23, 2022.

The successful development of nOPV2—the first vaccine against type 2 poliovirus and the first vaccine ever authorized by the WHO Prequalification team, has led to the deployment of approximately 450 million doses of nOPV2 for outbreak control.

A total of 38 countries have already met the verification requirements to use nOPV2.

Monitoring the use of nOPV2 has confirmed it is more genetically stable and less likely to result in VDPV than the Sabin strain, suggesting that the target of the global eradication of poliomyelitis might be a little more attainable than previously believed.

As of October 5, 2022, the nOPV2 is not authorized by the U.S. FDA.

The Imovax Polio® Ipol® IPV vaccine and combination vaccines have been used in the USA since 2000.

The U.S. CDC confirmed that the U.S. was added to the list of countries for circulating vaccine-derived poliovirus on September 13, 2022.

And on September 26, 2022, the CDC issued an Alert - Level 2, Practice Enhanced Precautions travel advisory stating that anyone unvaccinated, incompletely vaccinated, or with an unknown polio vaccination status should complete the routine polio vaccine series before any international travel.

Additional polio outbreak news is posted at Vax-Before-Travel.com/Polio.

Note: This information was manually translated and curated for international travelers.

Vaccine Treats:

Polio

Alert Message:

nOPV2 vaccine distribution

Image:

Image Caption:

U.S. CDC

Live Blog Update Author:

Don Hackett

Location Tags:

Global

Vaccine:

IPOL Poliovirus Vaccine

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The European Centre for Disease Prevention and Control (ECDC) recently reported that Europe's 2021–2022 highly pathogenic avian influenza (HPAI) epidemic season was the largest ever observed.

As of October 3, 2022, the latest ECDC data shows that 48 million birds were culled in 37 European countries.

This news is vital since HAPI can sporadically infect humans, causing mild to very severe diseases.

"Thankfully, there have been no human infections during the recent outbreaks of avian influenza in the EU/EEA," said Andrea Ammon, ECDC Director, in a related press release.

"However, several groups of people, mainly those working in the animal sector, are at increased risk of exposure to infected animals."

"Vigilance is needed to identify infections with influenza viruses as early as possible and to inform risk assessments and public health action," she added.

Since 2003, more than 860 human infections with HPAI A(H5N1) viruses have been reported to the World Health Organization (WHO).

With about 53% of those HAPI patients resulting in fatalities.

Ancestors of HPAI A(H5N1) viruses first emerged in southern China in 1997.

According to the U.S. CDC, the Asian lineage H5N1 and H7N9 have caused the most human infections.

Internationally, 54 countries reported an H5N1 outbreak in birds in 2021 and 2022.

The Eurasian H5N1 strain first appeared in North America in January 2022 and has affected poultry/birds in 40 states and led to the loss of about 47 million birds as of October 3, 2022.

The CDC says, 'the public health risk associated with these avian influenza detections in birds remains low.'

However, the CDC did confirm one H5 human infection in Montrose County, Colorado, in April 2022.

The CDC says annual flu shots do not protect people from avian influenza (bird flu) pandemic infections.

The U.S. FDA has approved a bird flu pandemic vaccine that would distribute if a person-to-person outbreak occurs.

The FDA has authorized CSL Seqirus' Audenz™ monovalent cell-based vaccine for persons at increased risk of exposure to the influenza A virus H5N1 subtype.

Additional avian influenza vaccine news is posted at PrecisionVaccinations.com/Avian.

Image:

Image Caption:

by Gerhard

Live Blog Update Author:

Karen McClorey Hackett

Location Tags:

Europe

Vaccine:

Audenz Influenza A(H5N1) Vaccine

Bird Flu Epidemic in Europe Extended

Bird flu pandemic vaccines include Audenz

October 5, 2022

Fact checked by Robert Carlson, MD

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The U.S. Food and Drug Administration (FDA) released important information about the risk of COVID-19 due to specific SARS-CoV-2 virus variants not neutralized by Evusheld™ on October 3, 2022.

Evusheld, a Long-Acting antibody combination (tixagevimab co-packaged with cilgavimab), is currently the only pre-exposure prophylaxis (PrEP) option for COVID-19.

The FDA continues to recommend Evusheld as an appropriate option for PrEP to prevent COVID-19, in combination with other preventative measures like getting vaccinated and boosted as recommended, as Evusheld still offers protection against many of the currently circulating variants and may offer protection against future variants.

The FDA says healthcare providers should inform patients of this risk and advise patients who develop signs or symptoms of COVID-19 to test for SARS-CoV-2 infection and promptly seek medical attention, including starting treatment for COVID-19, as appropriate if they test positive.

Detailed neutralization data can be found in the revised authorized Fact Sheet for Healthcare Providers.

The FDA issued an emergency use authorization for Evusheld on December 8, 2021. Since then, about 860,000 Evusheld doses have been distributed in the U.S.

Evusheld has also been authorized in Europe, the U.K., and other countries.

Additional mAbs products targeting COVID-19 are listed at PrecisionVaccinations.com/Antibody.

Vaccine Treats:

COVID-19

Image:

Image Caption:

U.S. FDA

Live Blog Update Author:

Staff Review

Location Tags:

Maryland

Vaccine:

EvuSheld Long-Acting Antibody

VIR-2482 Influenza Monoclonal Antibody

VIR-2482 Monoclonal Antibody 2023

Vir Biotechnology VIR-2482 is an investigational intramuscularly administered influenza A-neutralizing monoclonal antibody (mAb) designed to protect people against seasonal and pandemic influenza. Due to its broad strain coverage of diseases, it has the potential to overcome the limitations of current influenza vaccines and lead to meaningfully higher levels of protection due to its broad strain coverage and because it does not rely on individuals to create their protective antibody response. In vitro, VIR-2482 has been shown to protect all significant strains of influenza A. VIR-2482 incorporates Xencor's Xtend™ Technology and has also been half-life engineered so that a single dose can last the entire flu season.

Under the collaboration agreement signed with GlaxoSmithKline (GSK) in 2021. GSK has an exclusive option to lead the post-Phase 2 development and commercialization of VIR-2482. VIR-2482 is partly funded with federal funds from the Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), under Other Transaction Number: 75A50122C00081. BARDA's initial investment of approximately $55 million will support the Phase 2 PENINSULA trial. In addition, the multi-year contract also allows for a potential total investment of up to $1 billion for the clinical development of additional future pandemic influenza monoclonal antibodies, as well as the possible development of up to 10 emerging infectious disease or Chemical, Biological, Radiological, and Nuclear medical countermeasure candidates.

VIR-2482 has completed a Phase 1 clinical trial. On July 20, 2023, Vir Biotechnology, Inc. announced that the phase 2 PENINSULA trial evaluating VIR-2482 for preventing symptomatic influenza A illness did not meet primary or secondary efficacy endpoints.

Vir Biotechnology is a commercial-stage immunology company in San Francisco, CA, focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases.

VIR-2482 Indication

VIR-2481 is currently being developed to prevent influenza A viruses and pandemic influenza. Seasonal influenza is a highly contagious respiratory disease that can cause severe illness and life-threatening complications. Pandemic influenza is an infectious airborne respiratory disease that is unpredictable in timing and severity and for which humans have little or no immunity.

VIR-2482 News

July 20, 2023 - "Although, these topline data are disappointing, further analysis is necessary to better understand these outcomes, which we plan to present at a major medical congress," said Phil Pang, M.D., Ph.D., Vir's Executive Vice President, Chief Medical Officer and Interim Head of Research.

December 21, 2022 - Vir Biotechnology has enrolled approximately 3,000 participants in their Phase 2 PENINSULA (PrevEntioN of IllNesS DUe to InfLuenza A) trial.

October 18, 2022 - Vir Biotechnology, Inc. announced that the first participant had been dosed in the Phase 2 PENINSULA trial evaluating VIR-2482 for preventing illness due to influenza A.

October 4, 2022 - The U.S. Government's Biomedical Advanced Research and Development Authority announced an initial investment of $55 million for the ongoing and rapid development of VIR-2482. The multi-year contract has the potential for up to $1 billion to aGovernment'sevelopment of a full portfolio of innovative solutions to address influenza and potentially other infectious disease threats.

February 17, 2021 - GlaxoSmithKline plc and Vir Biotechnology, Inc. announced they have signed a binding agreement to expand their existing collaboration to include the research and development of new therapies for influenza and other respiratory viruses.

December 31, 2022 - the U.S. NIH published: VIR-2482: A potent and broadly neutralizing antibody for preventing influenza A illness.

March 25, 2020 - Xencor, Inc. announced it has entered into a technology license agreement with Vir Biotechnology, Inc., in which Vir will have non-exclusive access to Xencor's Xtend™ Fc technology to extend the half-life of novel antibodies that Vir is investigating as potential treatments for patients with COVID-19, the disease caused by the novel coronavirus SARS-CoV-2.

VIR-2482 Clinical Trials

VIR-2482 has been studied in a phase 1 clinical trial. The Phase 2 PENINSULA study was last Updated on December 20, 2022.

0 min read

Manufacturer:

Vir Biotechnology

Reviewer:

Robert Carlson, MD

Vaccine:

VIR-2482 Influenza Monoclonal Antibody

Generic:

VIR-2482

Drug Class:

Monoclonal Antibody

Clinical Trial Phase I:

Study of VIR-2482 in Healthy Volunteers

Clinical Trial Phase II:

Phase 2 Study to Evaluate the Efficacy and Safety of VIR-2482

Condition:

Influenza

Last Reviewed:

Thursday, July 20, 2023 - 09:20

Status:

Candidate

Manufacturer Country ID:

FDA First In Class:

Yes

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California-based Vir Biotechnology, Inc. today announced that the Biomedical Advanced Research and Development Authority (BARDA) awarded Vir a multi-year contract with the potential for up to $1 billion to advance the development of a full portfolio of innovative solutions to address influenza and potentially other infectious disease threats.

As part of BARDA’s ongoing effort to prepare and respond to public health emergencies, the agency will initially invest approximately $55 million for the continuing and rapid development of VIR-2482, an investigational prophylactic monoclonal antibody (mAb) designed to protect against seasonal and pandemic influenza.

In vitro, VIR-2482 has been shown to cover all significant strains of influenza A that have arisen since the 1918 Spanish flu pandemic.

This includes a Phase 2 pre-exposure prophylaxis trial expected to begin in the second half of 2022, with initial data anticipated in mid-2023.

Bolyn Hubby, Ph.D., EVP, and chief corporate affairs officer at Vir Biotechnology, commented in a press release on October 4, 2022, “Today’s announcement represents the culmination of our ongoing dialogue with the U.S. government around our shared interest in protecting society from global infectious disease threats, and we are thrilled to embark on this broad, multi-year collaboration.”

The balance of the award is subject to BARDA exercising up to 12 options in further support of the development of pre-exposure prophylactic mAb, including and beyond VIR-2482 for the prevention of influenza illness or possibly supporting medical countermeasures for other pathogens of pandemic potential.

VIR-2482 has the potential to overcome the limitations of current flu vaccines and lead to meaningfully higher levels of protection due to its broad strain coverage and because it does not rely on an individual to create their protective antibody response.

VIR-2482, which incorporates Xencor’s Xtend™ Technology, also has been half-life engineered, so a single dose has the potential to last the entire influenza season.

Pandemic influenza is a contagious airborne respiratory disease, which is unpredictable in timing and severity and for which humans have little or no immunity.

Four influenza pandemics have occurred over the past century, the most severe being the 1918 “Spanish flu,” which is estimated to have caused up to 50 million deaths worldwide.

Under the collaboration agreement signed with GlaxoSmithKline (GSK) in 2021, GSK has an exclusive option to lead the post-Phase 2 development and commercialization of VIR-2482.

Please visit the latest Zoonotic Influenza News for additional information on Avian, Pandemic, and Swine influenza.

Vaccine Treats:

Pandemic Influenza

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