A centralized testing approach, developed by the Coalition for Epidemic Preparedness Innovations (CEPI) and used by more than 30 COVID-19 vaccine developers, will be expanded to create a standardized evaluation model for other epidemic and pandemic disease...
The US Food and Drug Administration (FDA) has amended the emergency use authorizations (EUA) for Pfizer/BioNTech and Moderna COVID-19 vaccines: authorizing the use of a booster shot for all individuals aged 18+.
Pfizer and BioNTech have completed long-range drone deliveries of their mRNA COVID-19 vaccine: with partner Zipline claiming to be the first to deliver vaccines in this way at a national scale.
Novavax has completed its rolling submission to the World Health Organization for emergency use listing (EUL) of NVX-CoV2373, its COVID-19 vaccine candidate.
CEPI, the Coalition for Epidemic Preparedness Innovations, has announced the first funding awards under a $200m program to advance development of vaccines against SARS-CoV-2 variants and other betacoronaviruses.
A clinical trial is exploring the use of the Oxford/AstraZeneca COVID-19 vaccine as an intranasal vaccine: seeing if the new route of administration could improve protection against infection and transmission.
A lot has changed over the last year since IP waiver proposals were first put forward - notably a massive rise in the production of COVID-19 vaccines. Komal Kalha of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)...
Novartis has signed a new initial agreement with BioNTech for COVID-19 vaccine manufacturing: with its sterile manufacturing facilities in Ljubljana, Slovenia, to fill at least 24 million doses in 2022.
CureVac is withdrawing its first-generation COVID-19 vaccine candidate, CVnCoV, from regulatory review: instead it is re-allocating its efforts to its second-generation vaccine program with GSK. ‘The goal has not changed, but the requirements to effectively...
The European Medicine Agency’s human medicines committee (CHMP) says that booster doses of the Pfizer/BioNTech vaccine may be considered in people aged 18+, although decisions on who is offered a booster will be made at a national level.
CyanVac LLC and its subsidiary, Blue Lake Biotechnology, Inc., have enrolled the first participant in a Phase 1 clinical trial of their intranasal COVID-19 vaccine in Rochester, NY.
The US Food and Drug Administration (FDA) has amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to include a single booster dose in certain populations.
Moderna has submitted data for a conditional marketing approval (CMA) with the European Medicines Agency (EMA) for the evaluation of a booster dose of its COVID-19 vaccine.
The US National Institutes of Health (NIH) has begun a clinical trial to assess the antibody response to a COVID-19 vaccine booster in people with autoimmune disease who did not respond to an original COVID-19 vaccine regimen.
The European Medicines Agency’s human medicines committee (EMA CHMP) has this week approved additional manufacturing capacity for Pfizer/BioNTech and Moderna COVID-19 vaccines.
Pfizer and BioNTech are lining up orders of their COVID-19 vaccine for next year and beyond, predicting total capacity in 2022 to rise to 4 billion doses.
Arcturus Therapeutics and its Vietnam partner Vinbiocare will take ARCT-154, a next-generation Arcturus vaccine targeting SARS-CoV-2 variants of concern, into a Phase 1/2/3 trial. The companies will also establish a vaccine manufacturing centre in Vietnam....
With Scancell taking its DNA-based COVID-19 vaccine tech into clinical trials this year, it is already focusing its attention on the tech’s potential to be used as a needle-free booster shot to address Variants of Concern.
A study of more than a million vaccinated people has found 'similar safety profiles' for the AstraZeneca and Pfizer/BioNTech vaccines: adding the incidence of rare blood clots was far higher among people with COVID-19 than those who had received...
South African biopharmaceutical company The Biovac Institute will manufacture and distribute Pfizer and BioNTech’s COVID-19 vaccine in Africa, with the three companies signing a letter of intent this week.
The US Food and Drug Administration (FDA) has granted priority review designation for Pfizer and BioNTech’s COVID-19 vaccine Biologics License Application (BLA).
Antibody responses against the SARS-CoV-2 spike protein were found in 99% of volunteers after the second dose of ReiThera’s COVID-19 vaccine candidate, according to Phase 2 preliminary data.
Ocugen has chosen Jubilant HollisterStier of Spokane, Washington as its manufacturing partner for COVID-19 vaccine candidate COVAXIN, ready for potential commercial manufacture for the US and Canadian markets.
Co-administration of Novavax’s COVID-19 vaccine candidate and an approved influenza vaccine induced robust immune responses, according to data from a clinical trial. “The findings suggest simultaneous vaccination may be a viable immunization strategy,”...
Ocugen will pursue submission of a biologics license application (BLA) in the US for the COVID-19 vaccine candidate, COVAXIN, rather than a EUA application. The company believes that the differentiated vaccine has the potential to address variants, as...
Moderna has applied to expand use of its COVID-19 vaccine to adolescents in the EU: and also plans to submit an application for emergency use authorization (EUA) for this age group in the US.
COVID-19 vaccination via Vaxxas’ novel high-density microarray patch showed 'significantly enhanced' T-cell and spike-specific antibody responses compared to needle delivery, according to a pre-print preclinical study published this week.
Pfizer has enrolled the first subjects in a study exploring the co-administration of its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate following a booster dose of the Pfizer-BioNTech COVID-19 vaccine.
Vaccine effectiveness against symptomatic disease from the B.1.617.2 (‘India’) variant is similar to that found against the B.1.1.7 ('UK') variant, according to a new study.
The antibody response in people aged 80+ is three and a half times greater when the second dose of the COVID-19 vaccine is administered after 12 weeks, compared to the response when the second dose is given after three weeks, according to a UK study....
Moderna has agreed to provide 15m doses of its updated variant COVID-19 vaccine to Australia, providing a boost to its efforts to generate ongoing revenues from its coronavirus work.
The US Food and Drug Administration (FDA) has expanded the emergency use authorization (EUA) for Pfizer and BioNTech’s COVID-19 vaccine: now including adolescents aged 12-15 years old.
The US says it will support the proposed waiver of IP protections on COVID-19 vaccines: but the country’s industry says this sets a ‘dangerous precedent for future pandemics’.
Moderna has reported the first profitable quarter in the company’s history: after 10 years of research and several billion dollars of investment in its mRNA platform. The next step will be to start a rolling submission for a Biologics License Application...
Pfizer has upped its 2021 sales forecast for its mRNA COVID-19 vaccine to $26bn: as well as reporting strong Q1 results for the business overall this morning.
Moderna has announced a set of additional investments to allow it to increase global supply of its COVID-19 vaccine. ‘We believe there will continue to be significant need for our vaccine into 2022 and 2023’, says the company.
Medicago has started a rolling submission with Health Canada for its plant-derived adjuvanted COVID-19 vaccine candidate: championing a unique and versatile platform that can also be scaled up easily.
