Travel Vaccine Breaking News

Massachusetts-based Moderna, Inc. announced a Memorandum of Understanding (MoU) with the government of Canada to build a state-of-the-art messenger RNA (mRNA) vaccine manufacturing facility in Canada.

The goals of this MoU are to build the foundation to support Canada with direct access to rapid pandemic response capabilities and to provide access to Moderna’s vaccines in the development, such as SpikeVax, formerly known as COVID-19 Vaccine Moderna.

The collaboration aims to provide Canadians with access to a domestically manufactured portfolio of mRNA vaccines against respiratory viruses, including COVID-19, seasonal influenza, respiratory syncytial virus, and potential other vaccines, pending licensure.

The new facility is intended to also be activated on an urgent basis to support Canada with direct access to rapid pandemic response capabilities. The MOU includes access to Moderna’s mRNA development engine.

“We are excited to expand our presence and continue our long-term collaboration with Canada,” said Patricia Gauthier, Moderna’s Canadian General Manager. “With our industry-leading mRNA technology platform and rapid drug development capabilities, we look forward to being an active participant in Canada’s robust life sciences ecosystem.”

The MoU was announced on August 10, 2021, by the Hon. François-Philippe Champagne, Minister of Innovation, Science and Industry of Canada, and Stéphane Bancel, Moderna’s Chief Executive Officer in Montreal, Canada.

Three anti-SARS-CoV-2 monoclonal antibody products currently have Emergency Use Authorizations (EUAs) from the Food and Drug Administration (FDA) for the treatment of mild to moderate COVID-19 in nonhospitalized patients with laboratory-confirmed SARS-CoV-2 virus infection who are at high risk for progressing to severe disease and/or hospitalization, reported the U.S. NIH on August 4, 2021.

'The strength of the evidence for using anti-SARS-CoV-2 monoclonal antibodies varies depending on the factors that place patients at high risk for progression to severe COVID-19 and/or hospitalization.'

These products are:

• REGEN-COV2 (Casirivimab plus imdevimab): These are recombinant human monoclonal antibodies that bind to non-overlapping epitopes of the spike protein RBD of SARS-CoV-2. The FDA also updated the EUA for casirivimab plus imdevimab as post-exposure prophylaxis for certain individuals at high risk of acquiring SARS-CoV-2 infection and, if infected, are at high risk of progressing to serious illness. 
• Sotrovimab: This monoclonal antibody was originally identified in 2003 from a SARS-CoV survivor. It targets an epitope in the RBD of the spike protein that is conserved between SARS-CoV and SARS-CoV-2.

However, Bamlanivimab plus etesevimab are neutralizing monoclonal antibodies that bind to different but overlapping epitopes in the spike protein RBD of SARS-CoV-2. The distribution of bamlanivimab plus etesevimab was paused on June 25, 2021, because both the Gamma (P.1) and Beta (B.1.351) variants of concern are currently circulating in the United States have reduced susceptibility to bamlanivimab and etesevimab.

Furthermore, the issuance of a EUA does not constitute final FDA Approval.

Germany-based BioNTech SE announced today for the six months ended June 30, 2021, total revenues were estimated to be €7,356.9 million compared to €69.4 million for the comparative prior-year period.

The revenue expansion was mainly due to rapid increases in the supply of COVID-19 vaccines. 

“We and our partner Pfizer have crossed the one billion mark for COVID-19 vaccine doses shipped worldwide. We are proud to have reached this great milestone after only six months and to have made a difference for people with our proprietary mRNA technology. To address the ongoing pandemic, we are expanding the supply of our COVID-19 vaccine to more than 100 countries and regions worldwide, including enhancing access to low- and middle-income countries,” said Ugur Sahin, M.D., CEO and Co-Founder of BioNTech, in a press statement.

As of July 21, 2021, BioNTech and New York-based Pfizer, Inc. have shipped approximately one billion doses of BNT162b2 (Comirnaty) to more than 100 countries or territories worldwide.

The companies have signed orders of more than 2.2 billion doses for delivery in 2021, as of July 21, 2021.

BioNTech and Pfizer expect BNT162b2 annual manufacturing capacity to reach three billion doses by the end of 2021 and expect to have the capacity to manufacture up to four billion vaccine doses in 2022.

To address SARS-CoV-2 coronavirus variants, BioNTech and Pfizer began a Phase 3 clinical trial in July 2021 to evaluate the safety, tolerability, and efficacy of a 30µg booster dose of BNT162b2 versus placebo in approximately 10,000 participants aged 16 years and older who have previously received two doses of BNT162b2 (Comirnaty) at least six months before randomization.

These phase 3 study participants will be followed for up to twelve months. The trial is being conducted in the United States, Brazil, and South Africa.

Biopharmaceutical New Technologies is a next-generation immunotherapy company pioneering novel therapies for cancer and other serious diseases.  Based in Cambridge, MA, BioNTech US is a fully integrated subsidiary with a strong base in Europe, which focuses on the development of novel neoantigen-specific T-cell therapies and thus ideally complements BioNTech's highly innovative scientific approach and diversified pipeline of pioneering cancer therapies.

The World Health Organization (WHO) issued Influenza Update N° 399 on August 2, 2021, saying, 'Globally, despite continued or even increased testing for influenza in some countries, influenza activity remained at lower levels than expected for this time of the year.'

• In the temperate zones of the southern hemisphere, influenza activity remained at inter-seasonal levels.
• In the temperate zones of the northern hemisphere, influenza activity remained at inter-seasonal levels. 
• In the Caribbean and Central American countries, there were no influenza detections reported. 
• In tropical South America, no influenza detections were reported. 

Furthermore, FluNet reported for the time period from July 5, 2021, to July 18, 2021, laboratories tested more than 134,485 specimens during that time period. Just 720 specimens were positive for influenza viruses, of which 258 (35.8%) were typed as influenza A and 462  (64.2%) as influenza B.

Of the subtyped influenza A viruses, 88 (37.8%) were influenza A(H1N1)pdm09, and 145 (62.2%) were influenza A(H3N2). Of the characterized B viruses, 0 (0%) belonged to the B/Yamagata lineage and 408 (100%) to the B/Victoria lineage.

The WHO says the 'current influenza surveillance data should be interpreted with caution as the ongoing COVID-19 pandemic has influenced to varying extents health-seeking behaviors. The various hygiene and physical distancing measures implemented by Member States to reduce SARS-CoV-2 coronavirus transmission have likely played a role in reducing influenza virus transmission.

This web page has an updated listing of U.S. FDA-approved influenza vaccines for the 2021-2022 flu season.

Today, France-based Valneva SE's published positive topline results from the Phase 3 pivotal clinical trial of its chikungunya vaccine candidate, VLA1553. The trial, involving 4,115 adults across 44 sites in the USA, met its primary endpoint inducing protective Chikungunya neutralizing antibody titers in 98.5% of participants 28 days after receiving a single shot.

The seroprotection rate result of 98.5% exceeded the threshold agreed with the U.S. Food and Drug Administration (FDA). And the single-dose vaccine candidate was found highly immunogenic with a GMT of approximately 3,270, confirming the immunogenicity profile seen in the Phase 1 trial.

Additionally, VLA1553 was also highly immunogenic in elderly study participants.

And VLA1553 was generally well-tolerated among the trial subjects evaluated for safety.

An independent Data Safety Monitoring Board continuously monitored the study and identified no safety concerns. The safety profile is consistent with results from the Phase 1 clinical trial. The majority of solicited adverse events were mild or moderate and resolved within 3 days. However, 1.6% of study participants reported severe solicited adverse events, most commonly fever.

Approximately 50% of study participants experienced solicited systemic adverse events, most commonly headache, fatigue, and myalgia (seen in more than 20% of subjects).

The local tolerability profile showed that approximately 15% of participants experienced solicited local adverse events.

Juan Carlos Jaramillo, M.D, Chief Medical Officer of Valneva, commented in a press release, “These first-ever Phase 3 trial results for a chikungunya vaccine mean that we are a step closer to addressing this major, growing and unmet public health threat."

"We will continue to work with regulators to bring VLA1553 to market as soon as possible.”

The trial will continue towards the final analysis, including the 6-month safety data expected within the next six months. The sponsor of the first chikungunya vaccine approved in the U.S. will be eligible to receive a Priority Review Voucher.

The FDA awarded the VLA1553 program Breakthrough Therapy Designation in July 2021. This new milestone came in addition to the FDA Fast Track designation and the European Medicines Agency’s PRIME designation, which the Company received in December 2018 and in October 2020, respectively.

Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), a Togaviridae virus transmitted by Aedes mosquitoes. The infection leads to symptomatic disease in 72-92% of humans after 4 to 7 days following the mosquito bite. While mortality with CHIKV is low, morbidity is high, says the U.S. CDC. The chikungunya virus has spread to more than 100 countries.

As of July 27, 2021, the CDC reported five chikungunya virus disease cases during 2021.

To make VLA1553 more accessible to Low and Middle-Income Countries, Valneva and Instituto Butantan in Brazil signed an agreement for the development, manufacturing, and marketing of VLA1553. The collaboration falls within the framework of the funding agreement between Valneva and the Coalition for Epidemic Preparedness Innovations signed in July 2019, which provides funding of up to $23.4 million with support from the European Union’s Horizon 2020 program.

Located in Saint Herblain, France, Valneva is a specialty vaccine company focused on developing and commercializing prophylactic vaccines for infectious diseases with significant unmet medical need. 

Pennsylvania-based INOVIO announced today that the company had dosed the first Phase 2 trial subject in its quest to develop the first vaccine against the Middle East Respiratory Syndrome (MERS).

INOVIO designed its DNA vaccine candidate INO-4700 to prevent MERS, a disease in the coronavirus family for which there are no U.S. FDA-Approved vaccines.

The multi-center Phase 2 trial is a randomized, double-blinded, placebo-controlled study designed to evaluate the safety, tolerability, and immunogenicity of INO-4700 administered with INOVIO's smart device, the CELLECTRA® 2000, in approximately 500 healthy adult volunteers.

The study is sponsored by INOVIO and fully funded by the Coalition for Epidemic Preparedness Innovations (CEPI), is being conducted at sites in Jordan and Lebanon where MERS cases have been reported.

This trial builds on the positive results of the Phase 1 trial, published in a peer-reviewed article in The Lancet Infectious Diseases. Study results found high levels of binding antibodies in 92% of evaluated subjects. In addition, significant antigen-specific cytotoxic T-lymphocyte (CTL) responses were also observed.

Importantly, 98% of vaccinated subjects generated an antibody and/or T cell response against the MERS vaccine.

Dr. J. Joseph Kim, President and CEO of INOVIO, said in a press statement, "This advancement not only complements our late-stage efforts with COVID-19, but it also represents an important milestone for INOVIO's infectious disease platform."

"We look forward to continuing our collaboration with CEPI and moving another step closer to providing patients with a safe and effective preventive vaccine against MERS."

INOVIO and CEPI stated they plan to make a stockpile of these vaccines available for emergency use as soon as possible following Phase 2 testing.

Since the MERS virus was first identified in Saudi Arabia in 2012, more than 2,580 cases of MERS-CoV have been detected in 27 countries, reported the ECDC in July 2021.

MERS causes a rapidly progressive respiratory illness that may require intensive care treatment and mechanical ventilation in many patients, says the U.S. CDC. The source of the virus remains unknown, but the pattern of transmission and virological studies point toward dromedary camels in the Middle East as a reservoir from which humans sporadically become infected through zoonotic transmission.

In addition, human-to-human transmission of MERS is amplified among household contacts and in healthcare settings.

INOVIO's pursuit of a MERS vaccine is funded by a previously announced $56 million grant from CEPI. INOVIO is advancing two vaccine candidates through Phase 2 field trials against MERS and Lassa fever, respectively.

INOVIO has 15 DNA medicine clinical programs currently in development, including coronaviruses associated with MERS and COVID-19 diseases being developed under grants from the Coalition for Epidemic Preparedness Innovations and the U.S. Department of Defense.

Note: DNA medicines are composed of optimized DNA plasmids, which are small circles of double-stranded DNA synthesized or reorganized by a computer sequencing technology and designed to produce a specific immune response in the body.

A new study based in Australia published by The Lancet on July 30, 2021, found the gender-neutral national human papillomavirus (HPV) vaccination program led to substantial and ongoing reductions in genital warts among Australian female and heterosexual males, with a marked reduction in young individuals who received the HPV vaccine while attending school.

As of Dec 31, 2018, all Australian-born females younger than 38 years and males younger than 21 years have been eligible to participate in the free quadrivalent or nonavalent HPV vaccine program.

These researchers did a serial cross-sectional analysis of genital wart diagnoses among Australian-born female and heterosexual male individuals attending a national surveillance network of 35 clinics between January 2004 and December 31, 2018. About 121,000 men and 116,000 women were included in the analysis.

They calculated prevalence ratios of genital warts, using log-binomial regression models, for the female-only vaccination period (July 1, 2007, to Feb 28, 2013), gender-neutral vaccination period (March 1, 2013, to Dec 31, 2018), and the whole vaccination period (July 1, 2007, to Dec 31, 2018) compared with the pre-vaccination period (Jan 1, 2004, to June 30, 2007).

Overall, the study observed a 58% reduction in genital wart diagnoses in female individuals and a 45% reduction in genital wart diagnoses in heterosexual male individuals after introducing the HPV vaccination program in 2007.

The largest reduction in genital warts was observed in younger individuals aged 15–20 years.

Furthermore, there was a decreasing magnitude of reduction with increasing age: 80%, 72%, 61%, 41%, and 16% reductions in females aged 15–20 years, 21–25 years, 26–30 years, 31–35 years, and ≥36 years, respectively.

And, 70%, 61%, 49%, 37%, and 29% reductions in males aged 15–20 years, 21–25 years, 26–30 years, 31–35 years, and ≥36 years, respectively.

This study was funded by Seqirus Australia and the Australian Government Department of Health.

Note: an earlier, related study published by The Lancet in May 2021 investigated HPV prevalence in young MSM before and after implementing a school-based quadrivalent HPV (genotypes 6, 11, 16, and 18) vaccination program for boys in Australia in 2013. Interpretation: A reduction in anal, penile, and oral quadrivalent vaccine-targeted genotypes occurred in young MSM following the implementation of a school-based gender-neutral HPV vaccination program.