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BPL-1357 Universal Flu Vaccine

BPL-1357 Universal Flu Vaccine Description

BPL-1357 is a whole virus influenza vaccine candidate made up of four strains of non-infectious, chemically inactivated, low-pathogenicity avian flu virus. The vaccine candidate was developed by researchers at the National Institute of Allergy and Infectious Diseases (NIAID), a component of the U.S. National Institutes of Health (NIH). The intranasal formulation of BPL-1357 is currently in Phase Ib and II/III trials, designed to block virus transmission, and is also on track for U.S. FDA review by 2029.

BPL-1357 was studied in mice in September 2021, which showed that all mice receiving two doses of the BPL-1357 vaccine, delivered either intramuscularly or intranasally, survived subsequent exposure to lethal doses of each of six different influenza virus strains, including subtypes not included in the vaccine. Similar results were obtained in challenge experiments with ferrets vaccinated with BPL-1357.

“With the BPL-1357 vaccine, especially when given intranasally, we are attempting to induce a comprehensive immune response that closely mimics immunity gained following a natural influenza infection,” stated Matthew J. Memoli, M.D., on June 28, 2022. “This is very different than nearly all other vaccines for influenza or other respiratory viruses, which focus on inducing immunity to a single viral antigen and often do not induce mucosal immunity.”

The NIAID conducts and supports research at the NIH, throughout the USA, and worldwide.

BPL-1357 Vaccine Indication

 This vaccine aims to provide broad-spectrum protection against multiple strains of pandemic-prone viruses. On January 17, 2023, Antiviral Research (Volume 210, 105505) published: The race toward a universal influenza vaccine: Front runners and the future directions. 

BPL-1357 Vaccine News

May 1, 2025 - “Generation Gold Standard is a paradigm shift,” said NIH Director Dr. Jay Bhattacharya. “It extends vaccine protection beyond strain-specific limits and prepares for flu viral threats – not just today’s, but tomorrow’s as well – using traditional vaccine technology brought into the 21st century.”

June 28, 2022 - “Influenza vaccines that can provide long-lasting protection against a wide range of seasonal influenza viruses, as well as those with pandemic potential, would be invaluable public health tools,” said NIAID Director Anthony S. Fauci, M.D. “The scientific community is making progress on this pressing global health priority. The BPL-1357 candidate influenza vaccine being tested in this clinical trial performed very well in pre-clinical studies, and we look forward to learning how it performs in people.”

April 11, 2022 - Researchers at the NIH are investigating a new influenza vaccine that may offer protection against various flu strains. The study aims to gain a deeper understanding of the safety of this flu vaccine.

BPL-1357 Vaccine Clinical Trial

A Phase 1 trial began at the National Institutes of Health Clinical Center in Bethesda, Maryland. The placebo-controlled trial will test the safety of a candidate vaccine, BPL-1357, and its ability to prompt immune responses. The Complete Date is February 2025. Volunteers will be randomized into three groups in a 1:1:1 ratio and receive two doses of either placebo or vaccine, spaced 28 days apart. Group A participants receive BPL-1357 intramuscularly, along with an intranasal saline placebo. Group B will receive doses of the candidate vaccine intranasally, along with an intramuscular placebo. Volunteers in Group C receive a placebo administered intramuscularly and intranasally at both clinic visits. Neither the study clinicians nor the volunteers are aware of the group assignments. Volunteers must not have received any flu vaccination within the past eight weeks.

Additionally, they must agree to forgo seasonal flu vaccination for approximately two months after receiving the second dose of vaccine (or placebo). The study duration for each participant is approximately seven months. In addition to the two clinic visits to receive a vaccine (or placebo), volunteers will be asked to return to the clinic seven times to provide blood and nasal mucosal samples, which the investigators will use to detect and characterize immune responses.

A Phase II clinical trial to evaluate the efficacy and safety of the BPL-1357 vaccine in the setting of a healthy volunteer influenza human challenge study, sponsored and guided by NIAID but performed by UTMB’s research team. The primary hypothesis is that IM (intramuscular) and IN (intranasal) BPL-1357 will be safe and offer protection against mild-moderate influenza disease (MMID) caused by H1N1 influenza challenge compared to placebo. The primary objectives of this study are to measure the efficacy of BPL-1357, administered intramuscularly (IM) or intranasally (IN), in preventing MMID compared to placebo; and to assess the safety of BPL-1357, administered IM or IN in two doses 28 days apart, followed by viral challenge with H1N1. The challenge will be with a human 2015 seasonal-like H1N1 strain against which participants are likely to have partial immunity. The study population includes healthy male and female volunteers, aged 18 to 55 years. The 120 participants are divided into three study arms: placebo, intranasal vaccine, and intramuscular vaccine. 

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BPL-1357
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https://www.clinicaltrials.gov/ct2/results?cond=&term=NCT05027932&cntry=&state=&city=&dist=
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Whole virus vaccine
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Last Reviewed: 
Thursday, May 1, 2025 - 12:35
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Yes
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GEMCOVAC-19 mRNA Vaccine

GEMCOVAC™-19 mRNA Vaccine Description

GEMCOVAC™-19 is an mRNA vaccine developed in India that received Emergency Use Authorization for adults from the office of the Drugs Controller General of India on June 29, 2022.

This mRNA technology provides flexibility to quickly tweak the vaccine for any existing or emerging coronavirus variants, and this technology platform will empower India to be pandemic ready, says the developer GennovamRNA vaccines are highly efficacious because of their inherent capacity of being translated into the protein structure inside the cell cytoplasm. mRNA vaccines are considered safe as mRNA is non-infectious, non-integrating in nature, and degraded by standard cellular mechanisms. 

Gennova Biopharmaceuticals Ltd., a subsidiary of Emcure Pharmaceuticals Ltd., is headquartered in Pune, India, a biotechnology company dedicated to developing, producing, and commercializing biotherapeutics to address life-threatening diseases across various indications.

GEMCOVAC-19 Availability

Local media reported India's National Technical Advisory Group on Immunisation is scheduled to meet on July 20, 2022, to determine GEMCOVAC-19's distribution.

GEMCOVAC-19 Dosage

GEMOVAC-19 is a two-dose vaccine administered intramuscularly 28 days apart. 

GEMCOVAC-19 Side Effects

GEMCOVAC-19 was found to be safe, well-tolerated, and immunogenic in Phase 3 clinical trial.

GEMCOVAC-19 News

June 29, 2022 - Local media reported the company claimed that it aims to produce around 40 – 50 lakhs of doses per month, and this capacity can be quickly doubled.

May 14, 2022 - Local media reported a Gennova Biopharmaceuticals spokesperson told ANI that the company hasn't violated the protocol related to the clinical trial and will be submitting all necessary data for product approval.

GEMCOVAC-19 Clinical Trials

A Prospective, Multicentre, Randomized, Phase II study seamlessly followed by a Phase III study to Evaluate the Safety, Tolerability, and Immunogenicity of the candidate GEMCOVAC-19 (COVID-19 vaccine) in healthy pediatric subjects of 5 to less than 18 years.

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Availability: 
India
Generic: 
mRNA Covid Vaccine
Clinical Trial: 
https://covid19.trackvaccines.org/vaccines/200/#trial-ctri202204041880
Drug Class: 
mRNA Vaccine
Condition: 
Last Reviewed: 
Friday, July 15, 2022 - 01:25
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GEMCOVAC™-19
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Mom taking temperature of little girl
Inducing cellular and antibody arms of the immune system could protect against changing influenza viruses
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New York-based Pfizer Inc. and BioNTech S.E. announced today a new mRNA COVID-19 vaccine supply agreement with the U.S. government. Under this agreement, the U.S. government will receive 105 million vaccine doses (30 µg, ten µg, and three µg), planned for delivery by late summer and continue into the fourth quarter of 2022.

The U.S. government has agreed to pay the companies $3.2 billion upon receiving the first 105 million doses.

This purchase may include adult Omicron-adapted COVID-19 vaccines, subject to the U.S. Food and Drug Administration (FDA) authorization.

Under the new agreement, the U.S. government can purchase up to 195 million additional doses, bringing the total number of potential doses to 300 million.

“This agreement will provide additional doses for U.S. residents and help cope with the next COVID-19 wave. Pending regulatory authorization, it will also include an Omicron-adapted vaccine, which we believe is important to address the rapidly spreading Omicron variant,” commented Sean Marett, Chief Business and Chief Commercial Officer of BioNTech, in a press release issued on June 29, 2022.

“We appreciate the continued partnership of the U.S. government in our shared goal to help end this pandemic.”

The Pfizer-BioNTech COVID-19 Vaccine is based on BioNTech’s proprietary mRNA technology, developed by both BioNTech and Pfizer.

The FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine FDA authorized for Emergency Use Authorization for individuals 12 years of age and older can be used interchangeably by a vaccination provider when prepared according to their respective instructions for use.

However, the formulations of the Pfizer-BioNTech COVID-19 Vaccine authorized for use in individuals six months through 4 years of age, 5 through 11 years of age, and 12 years of age and older are different and should therefore not be used interchangeably, say the companies.

The companies confirmed today some people with weakened immune systems may have reduced immune responses to Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY.

And people should not receive this vaccine if the vaccine recipient had a severe allergic reaction to any of its ingredients or had a severe allergic reaction to a previous dose of Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY.

BioNTech is the Marketing Authorization Holder in the USA.

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Indiana-based Eli Lilly and Company announced today a modified purchase agreement with the U.S. government to supply an additional 150,000 doses of bebtelovimab for approximately $275 million.

The existing U.S. government supply of bebtelovimab monoclonal antibodies (mAbs), including the new purchase, is expected to meet present demand through late August 2022.

Delivery of doses will begin immediately and be complete no later than August 5, 2022.

This additional mAbs purchase is supported in whole or in part with federal funds from the Department of Health and Human Services.

As of June 29, 2022, HHS had distributed about 490,081 Bebtelovimab doses in the USA.

On February 11, 2022, Eli Lilly announced an agreement with the U.S. government to supply up to 600,000 doses of bebtelovimab, with an option of 500,000 additional doses for delivery no later than July 31, 2022. 

To date, over 700,000 patients have been treated with Lilly's mAbs in the U.S., potentially preventing more than 35,000 hospitalizations and at least 14,000 deaths during the worst of the pandemic.

"Lilly and its collaborators have partnered closely with the federal government throughout the pandemic to ensure broad and equitable access to our monoclonal antibodies," said David A. Ricks, Lilly's chair and CEO, in a press release issued on June 29, 2022.

Bebtelovimab is a neutralizing IgG1 mAb directed against the spike protein of SARS-CoV-2.

According to Lilly, Bebtelovimab continues to maintain neutralization activity against the Omicron variants (BA.2.12.1 and BA.4/BA.5) in addition to all known variants of interest and concern.

However, Bebtelovimab has not been approved by the U.S. FDA as of June 29, 2022.

But it has been authorized for emergency use by the FDA under a EUA for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progression to severe COVID-19, including hospitalization or death and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. 

The emergency use of bebtelovimab is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biologicals.

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The U.K. Health Security Agency (UKHSA) recently announced the risk of Middle East Respiratory Syndrome (MERS-CoV) infection to U.K. residents traveling to the Middle East remains 'very low.'

As of June 28, 2022, the National Travel Health Network and Centre and the World Health Organization (WHO) do not advise any travel restrictions to the Kingdom of Saudi Arabia (KSA) concerning MERS-CoV.

MERS-CoV can be spread person-to-person if there is close contact with an infected person, so it is essential to practice good hand and respiratory hygiene, says the UKHSA.

Camels are a source of MERS-CoV infection, so avoiding contact with them is advised.

The WHO reported as of May 12, 2022, the total number of laboratory-confirmed MERS-CoV infection cases reported globally was 2,591, including 894 associated fatalities.

Most of the reported MERS-Cov cases have occurred in countries in the Arabian Peninsula.

Outside this region, there was one large outbreak in the Republic of Korea in May 2015, during which 186 laboratory-confirmed cases and 38 related fatalities were reported.

The UKHSA stated yesterday 'We urge pilgrims returning from Hajj and Umrah to look out for these MERS-CoV symptoms; fever, coughing, shortness of breath, or difficulty breathing. If individuals experience these symptoms within 14 days of leaving the KSA, they should speak with a healthcare provider and mention their travel history.

Dr. Gavin Dabrera, lead for MERS-CoV at UKHSA, said in a media release, "We strongly advise travelers to avoid contact with camels and consumption of camel products in the KSA and to practice good hand hygiene."

As of June 29, 2022, the U.S. FDA had not approved a MERS-CoV prevention vaccine, but several are conducting clinical trials.

Additional Hajj and Umrah vaccine requirements are posted at Vax-Before-Travel.com/Hajj.

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India-based Gennova Biopharmaceuticals Ltd. announced today that its GEMCOVAC™-19 mRNA vaccine received the Emergency Use Authorization from the office of the Drugs Controller General of India.

GEMCOVAC-19 is the first mRNA vaccine developed in India and the only third mRNA vaccine approved for COVID-19 worldwide.

The U.S. FDA has already approved two mRNA vaccines for infants, adolescents, and adults.

GEMCOVAC-19 had reached the primary endpoint of the Phase III clinical trial, and the Central Drugs Standard Control Organisation evaluated the data.

The vaccine was found to be safe, well-tolerated, and immunogenic.

In addition, mRNA vaccines are considered safe as they are deemed non-infectious, non-integrating in nature, and degraded by standard cellular mechanisms. 

Notably, this technology provides flexibility to quickly tweak the vaccine for any existing or emerging virus variants, and this technology platform will empower India to be pandemic ready, says Gennova.

Gennova aims to produce around 40 – 50 lakhs of doses per month, and this capacity can be quickly doubled.

Beyond India, Gennova aims to provide sustainable access to low-and middle-income countries.

Gennova, headquartered in Pune, India, is a biotechnology company dedicated to developing, producing, and commercializing biotherapeutics to address life-threatening diseases across various indications.

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The European Commission (EC) announced today that the Health Emergency Preparedness and Response Authority (HERA) is responding to the expanding monkeypox virus outbreak with an initial delivery of 5,300 IMVANEX® vaccine doses in Spain.

As of June 28, 2022, HERA purchased 109,090 monkeypox vaccine doses.

The EC stated this is the first of a series of vaccine deliveries that will take place in the coming weeks to ensure that all Member States are ready to respond to the monkeypox outbreak, which has exceeded 4,400 cases globally since early May 2022.

As was the case with COVID-19 vaccines, IMVANEX vaccines will be allocated on a pro-rata basis, according to the population of each country. 

EC Commissioner for Health and Food Safety Stella Kyriakides commented in a press release, "As of today, the first deliveries of vaccines in response to the monkeypox outbreak are arriving in the most affected countries."

Portugal, Germany, and Belgium will be the next countries to receive vaccine doses.

"The European Health Union responds in real-time to new health threats and protects its citizens."

"This is the first time that we are, through our HERA, directly buying and donating vaccines to Member States."

It is also the first time the EU budget was used to purchase vaccines donated directly to Member States.

"With HERA up and running, the EU has significantly reinforced its capacity to respond and address new health threats decisively, added Kyriakides.

In its recent risk assessment, the European Centre for Disease Control and Prevention advised affected countries to consider early post-exposure vaccination, using the 3rd generation vaccine produced by Bavarian Nordic, to prevent the contagious monkeypox disease.

In the USA, the Jynneos vaccine distribution is managed by the U.S. CDC.

However, according to New York City and Washington DC reports, consumer demand is overwhelming Jynneos vaccine availability.

Eligible New Yorkers who may have been recently exposed to the monkeypox virus can get the two-dose vaccine at the Chelsea Sexual Health Clinic.

Unfortunately, NYC Health's vaccine supply has been exhausted.

And in Washington, DC, Mayor Bowser and DC Health announced a limited amount of monkeypox vaccination appointments would become available to eligible District residents on June 27, 2022.

But, DC Health's website now says, 'All monkeypox vaccine appointments have been scheduled.'

'Residents should check DC Health's social platforms on Wednesday (6/29) to get an update on additional appointment availability.'

Furthermore, based on the rapid increase in monkeypox cases in the USA, 306 patients in twenty-six states as of today, vaccine demand will continue increasing.

To date, the U.S. government has received requests from 32 states and jurisdictions, deploying over 9,000 doses of vaccine.

The United States announced late on June 28, 2022, that it intends to allocate 296,000 vaccine doses over the coming weeks, 56,000 of which will be allocated immediately.

And in the coming months, a combined 1.6 million additional doses will become available.

Additional monkeypox outbreak news is posted at Vax-Before-Travel.

Note: This information was converted into English and manually curated for mobile readership.

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The U.S. CDC announced today it continues to deploy an aggressive public health response to the monkeypox outbreak in the USA by activating its Emergency Operations Center (EOC).

This action stands up the EOC for monitoring and coordinating the emergency response to monkeypox and mobilizing 300 additional CDC personnel and resources. 

The activation of the EOC will further supplement the ongoing work of the CDC in collaboration with local, national, and international response partners.

As of June 27, 2022, the CDC confirmed about twenty-four states had reported 224 monkeypox patients.

Internationally, about 79 countries have confirmed over 4,400 monkeypox cases.

Last week, CDC began shipping orthopoxvirus tests to five commercial laboratory companies, including the nation’s largest reference laboratories, to increase monkeypox testing capacity and access in every community.

In June 2022, the CDC updated and expanded the monkeypox case definition and continues encouraging health care providers to consider testing for all rashes with clinical suspicion of monkeypox.

Health care providers who see a patient with a rash that resembles monkeypox or might be more characteristic of more common infections (e.g., varicella-zoster, herpes zoster, or syphilis) should carefully evaluate the patient for monkeypox and should consider testing. 

Anyone with risk factors for monkeypox and a new rash should seek care and testing.

Additional monkeypox outbreak breaking news is posted on this weblink.

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Massachusetts-based VBI Vaccines Inc. announced today that new data from a follow-up analysis of a subset of participants from the pivotal Phase 3 study of the Company's 3-antigen prophylactic hepatitis B (HBV) vaccine known in the USA as PreHevbrio™.

Timo Vesikari, M.D., Ph.D., Professor Emeritus and Director of the Nordic Vaccine Research Network in Finland, and principal investigator of the PROTECT and CONSTANT Phase 3 clinical studies, highlighted data from his investigator-initiated analysis that evaluated the duration of immune response approximately 2.5 years after completion of vaccination.

In the follow-up analysis, participants in PROTECT who received VBI's 3-antigen HBV vaccine had 5.5-fold higher mean anti-HBs titers (GMC: 1382.9 mIU/mL vs. 251.4 mIU/mL) and a higher seroprotection rate (SPR: 88.1% vs. 72.4%) compared to those who received Engerix-B, another vaccine.

Additionally, 72.9% of participants who received VBI's 3-antigen HBV vaccine retained anti-HBs titers ≥ 100 mIU/mL compared to 32.6% of those who received Engerix-B.

VBI's hepatitis B vaccine is the only 3-antigen hepatitis B vaccine, comprised of the three surface antigens of the hepatitis B virus – S, pre-S1, and pre-S2.

It is approved for use in the U.S. for adults and in the European Union/European Economic Area, United Kingdom, and Israel.

Hepatitis B is one of the world's most significant infectious disease threats, with more than 290 million people infected globally, says the U.S. CDC.

In addition, an estimated 887,000 people die each year from complications of chronic HBV.

The CDC says most hepatitis viruses can be prevented by vaccination.

However, the five hepatitis viruses – hepatitis A, hepatitis B, hepatitis C, hepatitis D, and hepatitis E – are distinct and can spread differently. 

HBV is transmitted by contact with contaminated blood, blood products, and other body fluids.

Examples of exposures associated with a transmission that travelers may encounter include poor infection control during medical or dental procedures, receipt of blood products, injection drug use, tattooing or acupuncture, and unprotected sex.

HBV infection is the leading cause of liver disease, and with current treatments, it is challenging to cure, with many patients developing liver cancers.

Additional hepatitis vaccine news is posted at PrecisionVaccinations.com/Hepatitis.

Note: VBI's press release was manually curated for mobile readership.

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