The University of Oxford in partnership with AstraZeneca began vaccinations yesterday for a new phase in human trials to test a COVID-19 vaccine ‘AZD2816’ in volunteers against the Beta [South African] variant.
A judgement has been issued in the legal dispute between the European Commission and AstraZeneca over a shortfall of delivery of the company’s COVID-19 vaccine doses to the EU-27.
Moderna has initiated the rolling submission process with the US Food and Drug Administration (FDA) for a Biologics License Application (BLA) to distribute and market its mRNA COVID-19 vaccine in the US for use in individuals aged 18 and older.
Canadian biotechnology company, Medicago, announced positive interim Phase 2 results this week for its plant-derived COVID-19 vaccine, which has been tested in combination with GSK’s pandemic adjuvant.
RoslinCT is set to collaborate with the Scottish Universities Life Sciences Alliance (SULSA) and additional academic institutions to deliver high impact advanced therapy and vaccine manufacturing GMP training.
Synthetic biologists based at Northwestern University in the US have discovered a new way to increase production yields of protein-based vaccines five-fold, significantly broadening access to potentially lifesaving medicines.
Emergent BioSolutions, a contract development and manufacturing organization (CDMO), has agreed with the US FDA not to manufacture any new COVID-19 vaccine materials at its Bayview facility in Baltimore, Maryland, while the regulator investigates the...
Emergent BioSolutions Inc yesterday reported that is on target in terms of all its commitments for COVID-19 vaccine production; it also reaffirmed its financial guidance, after a production issue at its Baltimore plant last week saw a massive batch of...
The EU Commission has adapted its export authorization mechanism for COVID-19 vaccines, shoring up its ability to prevent shipments going to countries with advanced immunization rates and good access to vaccines.
The RDIF, Russia’s sovereign wealth fund, and India based, Virchow Biotech Private Limited, have today announced a partnership to produce and supply a minimum of 200 million doses of the Russia developed Sputnik V vaccine against COVID-19.
The European Medicine Agency (EMA) says its safety committee has ruled that COVID-19 Vaccine AstraZeneca is safe and effective, and the benefits of its use outweigh any possible risks.
US biotech, Moderna, reports today that the first participants have been dosed in its Phase 2/3 clinical trial investigating the efficacy of its COVID-19 vaccine in children ages 6 months to less than 12 years.
Denmark has halted its vaccination campaign with COVID-19 Vaccine AstraZeneca, as a precautionary measure while a full probe is ongoing into reports of blood clots in people who received the vaccine, including one case in that country, where a person...
Valneva and Pfizer have initiated a Phase 2 study for their Lyme disease vaccine candidate: which is the only active Lyme disease vaccine in clinical development today.
Researchers from Cleveland Clinic's Global Center for Pathogen Research & Human Health, who have developed the nanotechnology based vaccine, say it has shown strong efficacy in preclinical disease models.
Convergence towards common global standards for clinical trial application (CTA) rules, along with unilateral and mutual recognition of CTA approvals are some suggestions made by industry insiders in a new paper to enable robust and timely development...
The pharma giant had announced last week that it could deliver only 25% of the doses originally promised to the EU-27 for Q1 2021 due to production issues at one of its European factories. But it has now agreed to send 9m additional doses and will start...
The European Medicines Agency (EMA) today advised that AstraZeneca’s COVID-19 vaccine can be given conditional marketing authorization (CMA) in the EU to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older.
The EU Commission has published a redacted version of the contract it signed with AstraZeneca on COVID-19 vaccine delivery in August last year, in a bid to show that the pharma giant is backtracking on its commitments.
The Commission has today put in place a measure that requires companies it has secured COVID-19 vaccine deals with to notify the authorities in member states about any intention to export vaccines produced in the EU.
Belgian health authorities announced today that they visited Novasep’s plant in that country to determine if expected delays in the deliveries of AstraZeneca’s COVID-19 vaccine to the EU are related to production issues at that site.
French company, Sanofi, says it will support the manufacturing and supply of BioNTech’s COVID-19 vaccine, which is being co-developed with Pfizer, in a pledge to increase vaccine accessibility.
EU health commissioner, Stella Kyriakides, last night again expressed dissatisfaction with the responses the EU executive has received from AstraZeneca over the company's announcement there would be significant shortfalls in the supply of its COVID-19...
Merck is shutting down the programs linked to its two COVID-19 vaccine candidates following early trial data indicating that they failed to generate immune responses comparable to a natural infection or existing vaccines.
GSK has sold its GCLP-certified clinical bioanalytical laboratory located in Marburg, Germany to Canadian clinical research organization (CRO), Nexelis.
Moderna announced today that it is expanding its pipeline of innovative vaccines with three new development programs based on the 'clinical success' of its infectious disease vaccine portfolio to date.
The EU Commission has obtained 300 million more doses of the Pfizer-BioNTech COVID-19 vaccine, doubling the amount currently available to EU-27 countries.
The EU Commission has granted a conditional marketing authorization for the COVID-19 vaccine developed by US biotech, Moderna, the second COVID-19 vaccine authorized in the EU.
AstraZeneca officially announced today the Serum Institute of India had obtained emergency use authorization in India for its COVID-19 vaccine. It also confirmed the vaccine has been granted emergency use authorization in Argentina, Dominican Republic,...
The US Food and Drug Administration (FDA) has authorized emergency use of Moderna’s vaccine against COVID-19, mRNA-1273, in individuals who are 18 years of age or older.
The US Food and Drug Administration (FDA), in a review of Moderna’s COVID-19 vaccine candidate, found no safety concerns that would preclude the granting of emergency use authorization (EUA) for the vaccine in the US during the pandemic.
As the US FDA advisory committee meets to discuss the merits and risks of Pfizer/BioNTech’s application for emergency use of their COVID-19 vaccine candidate, we talk to two US legal experts to get their perspective on vaccine distribution stateside....
The US Food and Drug Administration (FDA) said there are ‘no specific safety concerns that would preclude issuance of an EUA’ for the investigational COVID-19 vaccine (BNT162b2) from US pharma giant, Pfizer, and its German partner BioNTech.
The Medicines & Healthcare Products Regulatory Agency (MHRA) in the UK has granted a temporary authorization for emergency use for Pfizer and BioNTech's mRNA vaccine (BNT162b2), against COVID-19.
Up to 10% of vaccines can be reportedly lost in transit due to breakage or fluctuations in sub-zero temperatures required for preservation, but a manufacturer of data-driven temperature-controlled smart containers says it can cut that rate to just 0.1%.
Sanofi’s MenQuadfi becomes the first quadrivalent meningococcal conjugate vaccine available in Europe in a fully liquid presentation, avoiding the need for vaccine reconstitution.
AstraZeneca says interim analysis of clinical trials in the UK and Brazil of its candidate COVID-19 vaccine being developed in partnership with the University of Oxford - AZD1222 - showed the vaccine was highly effective in preventing COVID-19, the primary...
How prepared is the existing global cold chain, and especially refrigerated transport, to cope with the full temperature ranges required for the multiple COVID-19 vaccine candidates? A cold chain expert responds.
As vaccine development for COVID-19 continues to be successful in terms of clinical data, the next step in getting the vaccines to people is storage and distribution.
COVID-19 is like a big oak tree casting shade on all other biopharma industry developments. Vaccine-related articles dominate the most popular story rankings. With Pfizer and BioNTech now out in front in the coronavirus vaccine race, we track the related...
