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Covid-19 booster vaccine : MHRA approves second bivalent - 0 views

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    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."
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Moderna bivalent vaccine:Concerns over needles and syringes - 0 views

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    The Pharmacists' Defence Association (PDA) has urged pharmacists working in Covid-19 vaccination role to report any concerns about the needles and syringes supplied with the Moderna Spikevax Bivalent vaccine. The association has heard reports of bending when vaccinators pierce the top of the vial containing the Covid-19 vaccine doses, needles falling out during manipulation and appearing to be bent even before removal from the packaging. PDA has advised its members who are working in a Covid-19 vaccination role "to report any concerns via the Yellow Card medical device reporting system, and to keep up to date with NHS clinical updates for ongoing information and guidance." Current advice from the NHS includes sharing of video and poster resources (available on FutureNHS) which have been produced by the supplier to support the introduction of the new administration needles and syringes for Spikevax Bivalent. This is following a switch from BD Flu+ 23G x 25mm 1ml syringe combined needle and syringe (CNS) to the Owen Mumford Unifine Safety Retractable Needle 25G x 25mm & 1ml Syringe.
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Britain:1st country to approve Covid-19 vaccine - 0 views

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    Britain has become the first country to approve a Codiv-19 vaccine that targets both the original and Omicron variant of the virus. Medicines regulator MHRA approved the so-called bivalent vaccine made by US drug company Moderna as a booster for adults. The agency's decision was based on clinical trial data that showed the booster triggered "a strong immune response" against both Omicron (BA.1) and the original 2020 virus, it said. The MHRA also cited an exploratory analysis in which the shot was also found to generate a good immune response against the currently dominant Omicron offshoots BA.4 and BA.5. "The first generation of Covid-19 vaccines being used in the UK continue to provide important protection against the disease and save lives," MHRA chief executive June Raine said in a statement. "What this bivalent vaccine gives us is a sharpened tool in our armoury to help protect us against this disease as the virus continues to evolve."
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Omicron booster:UK autumn Covid vaccination campaign - 0 views

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    Britain's Covid booster campaign is set to kick off this September, after the country became the first in the world to approve an Omicron-adapted shot. Around 26 million people in Britain are estimated to be eligible for an autumn Covid-19 booster, having had at least two Covid vaccine doses already, a UK Health Security Agency (UKHSA) spokesperson said. The preference is to deploy what is known as a "bivalent vaccine" that targets both the original virus and the Omicron variant through the autumn campaign, but that will depend on the health regulator (MHRA) approving such shots and the state of vaccine supplies. The UK's Joint Committee on Vaccination and Immunisation (JCVI) has advised boosters should be given to over-50s, individuals in clinical risk groups, frontline workers and care-home staff ahead of the winter, when respiratory viruses are typically at their peak. On Monday (August 15), the MHRA gave Moderna's bivalent shot conditional approval. The endorsement of the vaccine is based on data that showed it produced a marginally better immune response against some Omicron variants, versus the original novel coronavirus - although whether that translates into stronger protection against serious disease is unclear.
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