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+.
A probe has identified 'human error’ at the Spanish contract development and manufacturing organization, Rovi, as the reason for the presence of metal contaminants in Moderna COVID-19 vaccine doses, leading to Japanese authorities withdrawing 1.6...
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.
Moderna is investing in a 462,000 square foot building in Cambridge, Massachusetts, to create a purpose-built space for scientific research and development labs.
Japan’s health ministry is to secure 150 million doses of Novavax’ vaccine candidate that Takeda is producing. The Japanese government's purchasing agreement is subject to regulatory approvals.
Moderna and the nonprofit Institute for Life Changing Medicines (ILCM) are collaborating to develop a new messenger RNA (mRNA) therapeutic (mRNA-3351) for Crigler-Najjar Syndrome Type 1 (CN-1), an ultra-rare disease.
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.
Moderna has initiated its submission to the US Food and Drug Administration (FDA) to support the authorization of a booster dose of its mRNA COVID-19 vaccine at the 50-microgram (mcg) dose level.
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.
Moderna has signed a Memorandum of Understanding with the government of Canada to build a mRNA vaccine manufacturing facility in the country: which could serve as a model for similar partnerships around the world.
The EU Commission has extended vaccination with Moderna’s COVID-19 vaccine to adolescents, following on from the EMA's recommendation in relation to the use of the shot in children aged between 12 and 17.
The safety committee of the European Medicines Agency (EMA) has concluded that myocarditis and pericarditis can occur in very rare cases following vaccination with the COVID-19 vaccines from Pfizer and Moderna.
Moderna says new data indicates its COVID-19 vaccine offers protection against emerging variants, including the seemingly fast spreading Delta variant, first identified in India.
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.
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.
Flagship Pioneering has unveiled Laronde: a platform company developing Endless RNA. Endless RNA is a novel, engineered form of RNA that can be programmed to express therapeutic proteins inside the body: ‘a groundbreaking therapeutic platform capable...
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...
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.
The UK’s Joint Committee on Vaccination and Immunisation (JCVI) says that pregnant women should be offered either the Pfizer/BioNTech or Moderna COVID-19 vaccines.
Moderna will take mRNA flu and HIV vaccines into Phase 1 trials this year, as well as beginning a pivotal Phase 3 study for its cytomegalovirus (CMV) vaccine candidate.
A UK study, which has been trialing the combination of Oxford-AstraZeneca and Pfizer vaccine doses, is now extending the program to include Moderna and Novavax vaccines.
COVID-19 mRNA vaccines are ‘highly effective’ in producing antibodies against SARS-CoV-2 in pregnant and lactating women; and also confer protective immunity to newborns, according to a new study.
The European Medicines Agency (EMA) has approved BioNTech’s Marburg site for COVID-19 vaccine production; which will become one of the largest mRNA vaccine manufacturing sites in Europe and the world. Elsewhere, additional sites are also set to produce...
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.
Baxter BioPharma Solutions will provide fill/finish sterile manufacturing services and supply packaging for approximately 60-90 million doses of Moderna’s COVID-19 vaccine this year.
Moderna has announced new capital investments to increase COVID-19 vaccine manufacturing capacity: targeting global capacity of 1.4 billion doses in 2022.
Moderna’s variant-specific vaccine – designed to tackle the South Africa variant – has been shipped to the US National Institutes of Health (NIH) for a Phase 1 clinical trial.
Johns Hopkins Medicine researchers have studied the reaction of nearly 200 solid organ transplant recipients to their first COVID-19 vaccine shot. The findings, they say, suggest that the Moderna and Pfizer/BioNTech mRNA vaccines can be safely given to...
Advice published by the World Health Organization today says the two doses of the Moderna vaccine should be administered 28 days apart; but this interval can be extended up to 42 days if necessary.
An in vitro study shows Moderna's existing mRNA COVID-19 vaccine provides protection against strains that have emerged from South Africa and the UK. But it does suggest reduced protection against the South Africa strain, and so the company is also...
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.
Moderna has announced it will submit an Emergency Use Authorization request to the US FDA today for its COVID-19 vaccine candidate. It has also released the Phase 3 primary efficacy analysis, showing 94.1% efficacy.
