Group items tagged

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a second "bivalent" vaccine as a Covid-19 booster. The updated booster vaccine made by Pfizer/BioNTech, targeting two coronavirus variants, has been approved for use in individuals aged 12 years and above. In each dose of the booster vaccine, 'Comirnaty bivalent Original/Omicron', half of the vaccine (15 micrograms) targets the original virus strain and the other half (15 micrograms) targets Omicron (BA.1). Dr June Raine, MHRA chief executive said: "I am pleased to announce that we now have a second approved vaccine for the UK Autumn booster programme. The clinical trial of the Pfizer/BioNTech bivalent vaccine showed a strong immune response against the Omicron BA.1 variant as well as the original strain. Bivalent vaccines are helping us to meet the challenge of an ever-evolving virus, to help protect people against Covid-19 variants. We have in place a comprehensive safety surveillance strategy for all UK-approved Covid-19 vaccines, and this will include the updated booster we approved today."

Clinical trials for BioNTech's cancer vaccines should start this year in Britain, marking an important step towards their possible sale on the open market, the German company's top executive Ugur Sahin told magazine Der Spiegel. BioNTech, known for its COVID vaccine with U.S. partner Pfizer, is currently deciding which types of cancer it wants to test its personalized cancer immunotherapies on and the locations where it will conduct the trials, Sahin said. The company wants these therapies, which are based on messenger RNA (mRNA) technology similar to the one that underpins its COVID-19 vaccine, to soon become a regular treatment for cancer patients. "We believe that this should be possible for large amounts of patients before 2030," Sahin said.

The Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday authorised a Covid-19 vaccine for infants as young as six months, opening the door for vaccinating the country's youngest children once the UK's Joint Committee on Vaccination and Immunisation (JCVI) agrees. The regulator authorised the vaccine - made by Pfizer and BioNTech - for children aged six months to four years old, after it was deemed safe and effective based on an ongoing clinical trial involving 4,526 participants. Whether the vaccine is eventually deployed in this age group depends on a recommendation from the JCVI, which advises UK health departments on which shots should be used as part of the national vaccination programme. The vaccine is tailored for use in this age group - it is a lower dose version than the one used in children aged five to 11 years. It is given as three injections in the upper arm, with the first two doses given three weeks apart, followed by a third dose administered at least two months after the second dose.

UK regulator has approved a new age-appropriate formulation of the Pfizer BioNTech Covid-19 vaccine for use in children aged 5 to 11 years old. The new paediatric formulation of Covid vaccine meets the required safety, quality and effectiveness standards, the Medicines and Healthcare products Regulatory Agency (MHRA) announced on Wednesday (December 22). Dr June Raine, MHRA chief executive said that parents and carers can be reassured that this approval has been given after robust review of safety data. These data showed a favourable safety profile for use in 5-11-year olds compared with that seen in other age groups, the regulator said. Raine said: "We have carefully considered all the available data and reached the decision that there is robust evidence to support a positive benefit risk for children in this age group.

German biotechnology company BioNTech has signed a deal with the Department of Health and Social Care to enrol up to 10,000 patients in clinical trials by the end of 2030 for personalised cancer therapies, the German drug maker said. The multi-year collaboration is focused on cancer immunotherapies based on mRNA or other drug classes, infectious disease vaccines, and investments into expanding the company's footprint in the UK, BioNTech said in a statement on Thursday (January 5). Under the agreement, the parties plan to utilise UK's clinical trial network, genomics and health data assets, aiming to enrol the first cancer patient in the second half of 2023, the company said.

Thousands of cancer patients in England are set to gain fast-tracked access to personalised cancer vaccine trials through a new National Health Service(NHS) initiative, the Cancer Vaccine Launch Pad. This groundbreaking service aims to find new life-saving treatments by matching eligible patients with clinical trials across the country. The first patient to receive a personalised vaccine for bowel cancer is Elliot Phebve, a 55-year-old lecturer, treated at University Hospitals Birmingham NHS Foundation Trust. Phebve, diagnosed through a routine health check, underwent surgery and chemotherapy before joining the trial. Sponsored by German biotech company BioNTech SE, the colorectal cancer vaccine trial is one of several taking place across NHS trusts.