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One vaccine batch being manufactured for J&J by Emergent Biosolutions failed quality checks, reportedly ruining material sufficient for up to 15 million doses.
The French pharma has agreed to "fill and finish" up to 200 million vials of Moderna's shot at its New Jersey plant, the third such manufacturing deal it struck with other vaccine developers.
The French drugmaker, having hit delays with its own coronavirus shot, agreed to manufacture over 100 million doses of Pfizer and BioNTech's vaccine for supply in Europe.
OBSERVATION: Biologics can take a long time to develop but COVID vaccines have been in development for almost 50 years and novel approaches were used to develop these vaccines. Vaccines typically take 10 to 15 years to develop, test and release to the public. The coronavirus vaccines, however, took less than a year.
The expanded licence will include the development of vaccines and therapeutic proteins beyond Covid-19 for human and animal health markets in Africa. During the Covid-19 pandemic, vaccination rates of many countries in Africa were significantly trailing the rest of the world.
GenScript ProBio has announced a strategic collaboration with RVAC Medicines to manufacture GMP-grade plasmid DNA (pDNA) for the latter’s RVM-V001, an mRNA Covid-19 vaccine candidate. Under the agreement, GenScript ProBio will offer GMP plasmid manufacturing service for the RVM-V001 programme.
Moncef Slaoui, a leader of Operation Warp Speed, said he expects 100 million Americans to be vaccinated by the end of February — an ambitious target even as Moderna and Pfizer ramp up manufacturing.
Samsung Biologics and GreenLight Biosciences have completed the initial commercial-scale engineering run for their messenger ribonucleic acid (mRNA) Covid-19 vaccine under their manufacturing collaboration. This will enable GreenLight to commercially deliver the mRNA vaccine.
SUMMARY: Pfizer and Moderna will sell $28 billion of Covid-19 vaccines this year. Pharma companies will make an estimated $40 billion on the global COVID-19 vaccine market this year, which will be split between Johnson & Johnson, AstraZeneca, Novavax, and others. Can the FDA really control the quality of vaccine orders this big?
Novavax has obtained emergency use authorization (EUA) for its Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), from the Taiwan Food and Drug Administration for use in people of the age 18 years and above. The protein-based vaccine is engineered from the genetic sequence of the SARS-CoV-2 virus’ initial strain.
The National Medical Products Administration of China (NMPA) has approved CanSino Biologics ’ (CanSinoBIO) recombinant Covid-19 vaccine (Adenovirus Type 5 Vector) for inhalation, Convidecia Air, as a booster. This vaccine leverages the same adenovirus vector technological platform as Convidecia, the intramuscular version.
Oragenics has secured funding from the Canadian bioresearch consortium CQDM to develop a variant-agnostic protein antigen for use in its Covid-19 intranasal vaccine. In March 2023, Oragenics and Inspirevax entered an exclusive global licence deal to develop the former’s lead intranasal Covid-19 vaccine candidate, NT-CoV2-1.
On August 8, Pfizer and Valneva announced the initiation of a Phase III study with their Lyme disease vaccine , bringing the prospect of an injection to prevent the condition disease one step closer to reality. This means that the vaccine works against multiple serotypes of the disease, she explains. A one-size-fits-all approach.
5-adapted bivalent Covid-19 vaccine for usage in children aged six months to four years. The vaccine is indicated for use as a third 3µg dose in the three-dose initial regimen for children of this age group. Earlier this month, the companies sought FDA EUA for the Omicron-adapted vaccine for use in children aged below five years.
GreenLight Biosciences has entered a partnership with the US National Institutes of Health (NIH) for the development of Covid-19 vaccines, which offer broader protection against new variants and with durable effects. They intend to develop vaccines that provide lasting immune responses compared to existing vaccines.
Croda Pharma has entered a strategic collaboration deal with Botanical Solution Inc (BSI) to expedite the production of sustainable pharmaceutical-grade vaccine adjuvant QS-21. The plentiful supply of QS-21 enables the production of next-generation adjuvant systems for new vaccine development.”
Nantes, France, Naobios, a CDMO (Contract Development and Manufacturing Organization) providing bioprocess development and GMP production of clinical batches of viral vaccines BSL2/BSL3, oncolytic viruses and viral vectors, today announces the next phase in its partnership with FluGen, Inc., The company’s.
The COVID-19 pandemic highlighted a need for local production of vaccines. Now, German pharma company BioNTech has said it will start manufacturingvaccines in Africa.
Last year was a positive year for biopharmaceutical companies, particularly those with Covid-19 vaccines. As a result of huge global sales of mRNA Covid-19 vaccines, the split in profits between Pfizer and BioNTech’s Comirnaty contributed towards revenues of $81.3bn and $22.4bn last year, respectively. YoY revenue growth.
India’s Central Drugs Standard Control Organisation (CDSCO) has granted approval for Bharat Biotech’s BBV154 vaccine for treating Covid-19. BBV154 is claimed to be the first intra-nasal vaccine for Covid-19 in the world.
The Serum Institute, one of the world's largest vaccine producers, licensed Novavax's experimental shot, while Wockhardt signed on with the U.K. to help make AstraZeneca's candidate.
US company Catalent is acquiring the UKâs VaccineManufacturing and Innovation Centre in Harwell: a facility which had been planned to support COVID-19 and wider vaccine production and which is still under construction.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional authorisation for Moderna ’s Covid-19 booster vaccine, mRNA-1273.214 (Spikevax Bivalent Original/Omicron), for use in adults aged 18 years and above. It comprises mRNA-1273 (Spikevax) and a vaccine candidate that acts on the SARS-CoV-2 virus’ BA.1
Moderna and the Australian Government have announced an agreement in principle to build a mRNA vaccinemanufacturing facility in Victoria, Australia: providing up to 100 million doses a year.
Moderna has signed a Memorandum of Understanding with the government of Canada to build a mRNA vaccinemanufacturing facility in the country: which could serve as a model for similar partnerships around the world.
To help boost production of its COVID-19 vaccine, Moderna has enlisted the services of Samsung Biologics , a contract development and manufacturing organization (CDMO) based in South Korea. The vaccine doses are intended for countries outside the US, with manufacturing planned to commence in the third quarter of 2021.
Australiaâs Therapeutic Goods Administration (TGA) has approved manufacture of the AstraZeneca COVID-19 vaccine by CSL â Seqirus: reducing the country's dependence on limited supply from abroad and allowing a wider vaccination campaign to begin.
Manufacturing capacity is often decried as a major bottleneck in administering COVID-19 vaccines to a global population of 7.8 For mRNA vaccines, the bottleneck is the availability of raw materials, not bioreactors.
The Australian biotech GPN Vaccines has expanded a partnership with compatriot contract development and manufacturing organization (CDMO) BioCina to scale up the manufacture of its lead candidate vaccine against pneumococcal diseases such as pneumonia, meningitis and febrile bacteraemia.
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