Corbevax (BECOV2D) / Biological E Ltd, Dynavax - LARVOL DELTA

Immunogenicity and safety of Biological E's CORBEVAX™ vaccine as a heterologous booster dose in adult volunteers previously vaccinated with two doses of either COVISHIELD™ or COVAXIN: A prospective double-blind randomized phase III clinical study. (PubMed, IJID Reg) - "One serious adverse event occurred and was deemed unrelated to the booster. In conclusion, heterologous boosting with CORBEVAX™ substantially enhanced humoral and cellular immunity against SARS-CoV-2 VoCs while being well tolerated."

Clinical • Journal • P3 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG

Acute longitudinal extensive transverse myelitis following the second dose of an inactivated COVID-19 vaccine: A case report of the youngest patient with post-Sinovac™ tetraplegia and poor prognosis. (PubMed, Turk J Phys Med Rehabil) - "Spine magnetic resonance imaging showed LETM from C3 to T3 spinal cord segments. The outcome of this Sinovac™-induced LETM patient, who was inadequately treated with corticosteroids in the acute phase, showed a poor prognosis despite months of neurorehabilitation."

Journal • CNS Disorders • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • Urology

Safety and immunogenicity of booster doses of an XBB.1.5 RBD subunit COVID-19 vaccine among individuals aged 5-80 years in India: a phase 3, single-blind, randomised controlled trial. (PubMed, Lancet Reg Health Southeast Asia) - "Real-world studies may provide additional evidence about the effectiveness of this new updated vaccine. Biological E Limited, India."

Journal • P3 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Cross-Sectional Study on Side Effects of "Corbevax" Covid-19 Vaccine among 12- to 14-Year Age Group in a Tertiary Care Hospital in Meerut, Uttar Pradesh. (PubMed, Indian J Community Med) - "Initially, Covaxin and Covishield were used...Of all the participants, 41.48% had developed side-effects with pain at site of injection being the most commonly reported symptom (64.29%), and about half among those affected had resolved spontaneously. The vaccine causes only mild symptoms and is safe for use in children."

Adverse events • Journal • Observational data • Infectious Disease • Novel Coronavirus Disease • Pain • Respiratory Diseases

Response to: Comment on: Retinal venous occlusion in a child following Corbevax COVID-19 vaccination. (PubMed, Indian J Ophthalmol) - No abstract available

Journal • Infectious Disease • Novel Coronavirus Disease • Retinal Vein Occlusion

Healthcare provider perspectives on COVID-19 vaccination for children in India. (PubMed, BMJ Paediatr Open) - "Most respondents were in support of the COVID-19 paediatric vaccination, although just over half did not feel adequately informed. Concerns about vaccine hesitancy among caregivers were the leading reported barrier. Targeted interventions are needed to provide adequate knowledge support to healthcare providers and evidence-based public health messaging to reduce vaccine hesitancy among caregivers."

Journal • Infectious Disease • Novel Coronavirus Disease • Pediatrics

A Recombinant Protein XBB.1.5 RBD/Alum/CpG Vaccine Elicits High Neutralizing Antibody Titers against Omicron Subvariants of SARS-CoV-2. (PubMed, Vaccines (Basel)) - "(1) Background: We previously reported the development of a recombinant protein SARS-CoV-2 vaccine, consisting of the receptor-binding domain (RBD) of the SARS-CoV-2 spike protein, adjuvanted with aluminum hydroxide (alum) and CpG oligonucleotides...(4) Whereas we observed modest cross-neutralization against Omicron subvariants with the sera from mice vaccinated with the WT RBD/CpG/Alum vaccine or with the BA.4/5-based vaccine, the sera raised against the XBB.1.5 RBD showed robust cross-neutralization. These findings underscore the imminent opportunity for an updated vaccine formulation utilizing the XBB.1.5 RBD antigen."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Comment on: Retinal venous occlusion in a child following Corbevax COVID-19 vaccination. (PubMed, Indian J Ophthalmol) - No abstract available

Journal • Infectious Disease • Novel Coronavirus Disease • Retinal Vein Occlusion

From concept to delivery: a yeast-expressed recombinant protein-based COVID-19 vaccine technology suitable for global access. (PubMed, Expert Rev Vaccines) - "Clinical Development and Delivery: The approach used by LMIC developers to establish the industrial process, clinical development, and deployment is described. Highlighted is an alternative model for developing new vaccines for emerging infectious diseases of pandemic importance starting with an academic institution directly transferring their technology to LMIC vaccine producers without the involvement of multinational pharma companies."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

"How does Corbevax compare?" (@Ackpht)

Immunogenicity and safety of Biological E's CORBEVAX™ vaccine compared to COVISHIELD™ (ChAdOx1 nCoV-19) vaccine studied in a phase-3, single blind, multicentre, randomized clinical trial. (PubMed, Hum Vaccin Immunother) - "Both COVISHIELD™ and CORBEVAX™ vaccines showed comparable seroconversion post-vaccination against anti-RBD-IgG response. The subjects in CORBEVAX™ cohort also exhibited higher interferon-gamma secreting PBMC's post-stimulation with SARS-COV-2 RBD-peptides than subjects in COVISHIELD™ cohort."

Clinical • Journal • P3 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG

Covid-19 vaccination program for children: An electronic assessment of symptoms. (PubMed, Curr Drug Saf) - "After analysis, 70.98% of respondents who took the first dose of the medication experienced side effects, while 50.62% of respondents who took the second dose of the medication stated the same. The major side effects reported were injection site pain, fever, tiredness, body ache, headache, etc. After conducting a poll on children (aged 12-18) who had received the COVID-19 vaccination, we concluded that immunizations rarely cause moderate side effects that are manageable."

Journal • Infectious Disease • Novel Coronavirus Disease • Pain

"I assume Corbevax is being updated for currently circulating variants…are you following the annual update model or something more VoC-centric?" (@1cooldudeski)

"🟣 @mebottazzi (1966): microbióloga hondureña nacida en Italia y ponente en #Balmis2022. Junto a @PeterHotez ha desarrollado la #vacuna Corbevax contra la #Covid19, libre de patentes y a bajo coste. #DiaDeLaMujer #8M2023 #8Marzo" (@InstitutoBalmis)

Infectious Disease • Novel Coronavirus Disease

"BCM pioneers to speak on development of Corbevax | KWKT - FOX 44 https://t.co/EnrN7uWmlI" (@PeterHotez)

"ICMR backs Corbevax, nasal vac for booster | Mint https://t.co/GPysWlHANK" (@PeterHotez)

"Can you say Corbevax? If not, the doctor @PeterHotez is in & he can tell you aaaaallll about it." (@gozer_the)

Heterologous Booster Dose with CORBEVAX following Primary Vaccination with COVISHIELD Enhances Protection against SARS-CoV-2. (PubMed, Vaccines (Basel)) - "RBD-specific B memory and antibody-secreting (non-memory) B lymphocytes were enhanced with both boosters; however, the duration of response was longer with the heterologous booster compared to the homologous, indicating greater protection with the heterologous booster. The rate of infection 14 days after administration of the heterologous booster was comparatively lower than that of the homologous booster, with the symptoms being much less or asymptomatic."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

"More on Corbevax and our @BCM_TropMed @TexasChildrens @biological_e US-India partnership @SandhuTaranjitS @cgihou https://t.co/T9cSJRzmrU" (@PeterHotez)

Licensing / partnership

LericiPea Award "Ligurian in the World" 2022 to Maria Elena Bottazzi [Google translation] (YouTube) - "...having decided, together with my colleague Peter Hotez and his team, to make the anti COVID 19 vaccine, called Corbevax, accessible to all, without patenting it."

Video • Novel Coronavirus Disease

"India-US relations two-way street and very symbiotic: Ambassador Taranjit Sandhu - Many thanks Ambassador @SandhuTaranjitS⁩ for highlighting Corbevax and our unique US-India partnership ⁦@cgihou⁩ https://t.co/ptFsReng8z" (@PeterHotez)

Licensing / partnership

Proven Way to Beat Monster COVID Variants Won’t Work in U.S. (Daily Beast) - "Singapore beat its XBB wave the simplest way possible. The tiny Asian city-state, population 5.5 million, has 'among the best-vaccinated and boosted population globally,' Peter Hotez...told The Daily Beast. Ninety-two percent of the population is fully vaccinated with one of four approved vaccines: the two messenger-RNA jabs from Pfizer and Moderna as well as separate protein-based and inactivated-virus vaccines from Novavax and Sinovac, respectively....The main worry, when BQ.1 and XBB first appeared, was a 'recoupling' of cases and deaths. It didn't happen in Singapore. And it hasn't happened in India, either. But India's experience 'is less clear-cut,' Hotez said."

Audio • Novel Coronavirus Disease

Corbevax Vaccine Shot Registration Online for 5 to 12 Years Old Approved - "The COVID vaccination for children in the age category of 12 to 14 years will begin from tomorrow as the government has granted the Corbevax vaccine to be managed to the 12 to 14 years age category which is making by Biologicals E. Ltd....Dr. Peter Hotez...had too soon told the Indian Express, 'We know all the technologies needed to make a reconnect protein (vaccine) for coronaviruses with a high degree of efficiency & integrity were.'"

Media quote • Novel Coronavirus Disease

Seeking Vaccine Equity (Synapse) - "...formed a product development partnership with her colleague...Dr. Peter Hotez, to develop technologies for neglected tropical diseases often afflicting the Global South....The result? An open-source, low-cost COVID-19 vaccine Corbevax in collaboration with Developing Countries Vaccine Manufacturers Network....Gandhi then touched on current COVID-19 vaccines. The reason was hybrid immunity - a combination of having had the vaccine and infection. 'There were high rates of hospitalizations in the Omicron surge among the unvaccinated in the United States if you were still unvaccinated with that degree of transmissibility,' she said."

Media quote • Novel Coronavirus Disease

Safety, tolerability and immunogenicity of Biological E's CORBEVAX™ vaccine in children and adolescents: A prospective, randomised, double-blind, placebo controlled, phase-2/3 study. (PubMed, Vaccine) - "The safety profile of CORBEVAX™ vaccine in <18 to ≥5 years' children and adolescents was found to be safe and tolerable. Significant increase in anti-RBD-IgG and nAb-titers and IFN-gamma immune-responses were observed post-vaccination in both pediatric age sub-groups. The nAb titers observed in both the pediatric age cohorts were non-inferior to the adult cohort (BECT069 study) in terms of ratio of the GMT's of both the cohorts. This study shows that CORBEVAX™ vaccine is highly immunogenic and can be safely administered to pediatric population as young as 5 years old. The study was prospectively registered with clinical trial registry of India- CTRI/2021/10/037066."

Journal • P2/3 data • Infectious Disease • Novel Coronavirus Disease • Pediatrics • Respiratory Diseases • IFNG • IL4