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The FDA granted Novavax’s COVID-19 vaccine Emergency Use Authorization after a lengthy and obstacle-riddled journey. It is authorized as a two-dose primary series for adults 18 years and older.
The FDA plans to review changes to Novavax’s manufacturing process before it authorizes its vaccine.
The FDA has expressed worries over four cases of heart inflammation, or myocarditis, that were observed in pivotal clinical trials of Novavax's COVID-19 vaccine.
Novavax and Serum Institute of India Receive Emergency Use Authorization for Novavax' COVID-19 Vaccine in Thailand
Novavax, Inc. and Serum Institute of India Pvt. Ltd. announced that the Thailand Food and Drug Administration has granted emergency use authorization for Novavax' protein-based vaccine for active immunization to prevent coronavirus disease 2019 caused by the severe acute respiratory syndrome coronavirus 2 in individuals 18 years of age and older.
Two companies in India have halted vaccine manufacturing, which could be a sign that the pandemic may be coming to an end. For that and more COVID-19 news, continue reading.
Novavax and Serum Institute of India Receive Emergency Use Authorization for COVID-19 Vaccine in India
Novavax, Inc. and Serum Institute of India Pvt. Ltd. today announced that the Drugs Controller General of India (DCGI) has granted emergency use authorization (EUA) for Novavax' recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M™ adjuvant.
Novavax and Serum Institute of India Announce World Health Organization Grants Emergency Use Listing for NVX-CoV2373 COVID-19 Vaccine
Novavax, Inc. and Serum Institute of India Pvt. Ltd. (SII), the world's largest vaccine manufacturer by volume, today announced that the World Health Organization (WHO) has granted Emergency Use Listing (EUL) for NVX-CoV2373.
A study out of the University of Oxford found that two shots of the Pfizer-BioNTech vaccine or the AstraZeneca-Oxford vaccine were not as effective at against Omicron as they were against previous variants.
The U.S. Centers for Disease Control and Prevention (CDC) reported that the Omicron variant of COVID-19 had been identified in California.
The Centers for Disease Control and Prevention’s vaccine advisory committee meets today to discuss authorizing the Pfizer-BioNTech vaccine in children aged 5 to 11 years.
Novavax and Serum Institute of India Receive Emergency Use Authorization for COVID-19 Vaccine in Indonesia
Novavax, Inc. and Serum Institute of India Pvt. Ltd. announced that the National Agency of Drug and Food Control of the Republic of Indonesia, or Badan Peng was Obat dan Makanan, has granted emergency use authorization for Novavax' recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M™ adjuvant.
By administering a vaccine directly into the nasal cavity, the mucus membranes of the nose and throat would provide better protection than the intramuscular alone.
The company’s lead candidate, INNA-051, is an innate immune agonist that directly stimulates the host’s natural immune defense system.
The WHO’s Emergency Use Listing (EUL), a prerequisite for COVAX Facility vaccine supply, evaluates the safety, quality, and efficacy of the COVID-19 vaccines. As such, today’s approval allows the vaccine to be used by agencies and NGOs around the world.
Dynavax and Serum Institute of India Announce First Participant Dosed in a Phase 1 Clinical Trial Evaluating an Improved Tdap Vaccine Adjuvanted with CpG 1018
- Tdap vaccine adjuvanted with CpG 1018 is focused on addressing rising incidence of pertussis since the change to acellular vaccines in the 1990s - CpG 1018 adjuvant has the potential to increase durability of the immune responses to pertussis and reduce transmission in previously vaccinated asymptomatic individuals
Serum Institute Of India And Dynavax Announce First Participants Dosed In The Phase 1/2 Clinical Trial For A COVID-19 Vaccine
Further strengthening its fight against COVID-19, Serum Institute of India (SIIPL), the world's largest vaccine manufacturer by volume, has partnered with Dynavax Technologies Corporation (Nasdaq: DVAX) a biopharmaceutical company focused on developing and commercializing novel vaccines, and today joint
ABEC , a leading global provider of integrated solutions and services for biopharmaceutical manufacturing, today announced it is supporting Serum Institute of India Pvt. Ltd. (SIIPL) in Pune, India by delivering six 4,000L CSR bioreactors for the manufacturing of Novavax’ COVID-19 vaccine can
9/30/2020The Serum Institute of India (SII) has agreed to produce and deliver up to an additional 100 million doses of an approved COVID-19 vaccine for citizens of India and neighboring low- and middle-income countries as part of a collaboration with Gavi and the Bill & Melinda Gates Foundation.
Serum Institute of India Initiates Manufacturing of Codagenix's Intranasal Live-Attenuated COVID-19 Vaccine Candidate
- Phase 1 clinical trial of CDX-005 expected to initiate prior to year-end 2020 - Serum Institute to ramp-up manufacturing for large-scale safety and efficacy studies and to meet global vaccine supply requirements [22-September-2020] FARMINGDALE, N.Y. , Sept. 22, 2020 /PRNewswire/ -- Codagenix, Inc., a clinical-stage biotechnology company developing pr
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 16, 2020.