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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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Valneva : UK approves easy-to-store Covid shot - 0 views

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    Britain has approved a new coronavirus vaccine by the Austrian-French drugmaker Valneva. "An approval has been granted after the Valneva Covid-19 vaccine was found to meet the required safety, quality and effectiveness standards," the Medicines and Healthcare products Regulatory Agency said in a statement on Thursday (April 14), adding: "It is also the first, whole-virus inactivated Covid-19 vaccine to gain regulatory approval in the UK." In vaccines such as Valneva's VLA2001, the virus is grown in a lab and then made completely inactive so that it cannot infect cells or replicate in the body but can still trigger an immune response. It is seen by some as having the potential to win over people wary of some which use new mRNA technology. Valneva CEO Thomas Lingelbach said that "this authorisation could pave the way for the availability of an alternative vaccine solution for the UK population."
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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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UK Approves Novavax Covid Jab As Fifth In Country - 0 views

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    Britain has approved Novavax's Covid-19 vaccine for use in those 18 years of age and older, the country's medicines regulator said on Thursday (February 3), bringing a fifth coronavirus shot to its roster amidst the rapid spread of the Omicron variant. The vaccine, Nuvaxovid, was approved as a first and second dose as it met the required safety, quality and effectiveness standards, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) said in a statement. The British approval for Nuvaxovid comes days after the drugmaker filed for US authorisation of the vaccine following months of struggles with development and manufacturing problems, and follows a German backing earlier in the day. "We are continuing our vital safety work in monitoring the use of all Covid-19 vaccines, to ensure that their benefits in protecting people against Covid-19 disease continue to outweigh any risks," MHRA chief executive June Raine said.
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AstraZeneca: 1st Anniversary Of Oxford Vaccine UK - 0 views

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    Health services in the UK today (January 4) marked the first anniversary of the deployment of the Oxford University/AstraZeneca vaccine in fight against Covid-19. Exactly a year ago, the UK became the first country in the world to administer the vaccine by jabbing Brian Pinker, 82 at Oxford University Hospital. So far, around 50 million AstraZeneca vaccines have been administered to people in the UK. Commenting on the landmark day, vaccines minister Maggie Throup said: "The Oxford-AstraZeneca vaccine is a UK success story and demonstrates what can be achieved when researchers, scientists and the government work together. "The at-cost vaccine has given billions of people around the world a way to fight back against this virus." Further, she urged people to get vaccinated to protect themselves and their families this winter.
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Novavax full approval of Covid vaccine later this year - 0 views

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    American biotechnology company Novavax said on Monday (February 28) it would pursue full approval of its Covid-19 vaccine in the second half of this year and forecast total revenue of between $4 billion and $5 billion for 2022. "We expect to gain additional authorizations where we have already filed, including in the US. We will pursue full approval of our vaccine including filing our BLA (biologics license application), in the second half of 2022," CEO Stanley Erck said during a post-earnings call. Novavax late last month filed for emergency use authorization of the shot in U.S. adults, a much-awaited step following months of struggles with development and manufacturing problems. Novavax said it has completed delivery of around nine million vaccine doses to Indonesia, 6 million to Australia and two million to South Korea and expects to supply 69 million doses to Europe in the first half of this year.
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Pfizer BioNTech Covid-19 Vaccine For Under 12s Approved - 0 views

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    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.
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Indian Pharma Companies To Supply Oral Covid Drugs Globally - 0 views

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    Indian pharmaceutical companies are gearing up to become global suppliers of repurposed Covid-19 drugs. With the launch of new innovative Covid-19 oral drugs, Indian companies are again expected to grab opportunities in the global supply of oral Covid-19 drugs, according to data and analytics company GlobalData. As several countries witness increasing cases of Covid-19 despite vaccination, they have started booking supply orders for innovative Covid-19 treatments like antibody cocktails, monoclonal antibodies and the latest addition such Merck's the oral Covid-19 drug 'molnupiravir'. Prashant Khadayate, pharma analyst at GlobalData, comments: "Oral treatment for Covid-19 would be the most convenient option for the patients ranging from mild to moderate Covid-19 and would not require a hospital setting. Currently, a majority of the Covid-19 treatments require a hospital setting." According to GlobalData's Pharma Intelligence Center, the UK is the first country to approve molnupiravir which is in pre-registration stage in the US, EU and Japan.
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70% Community Pharmacies Waiting For Govt Nod Start Booster - 0 views

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    70 per cent of community pharmacies still waiting for government nod to start Covid booster jabdesc-Nearly 70 per cent of community pharmacies in England that offered to participate in the Covid-19 booster programme are still waiting for approval or have been refused, ministers admitted on Monday (December 13). The Liberal Democrats' health spokesperson, Daisy Cooper, exposed the low approval rate and long delays through a written parliamentary question to the health secretary as to "how many community pharmacies were providing Covid-19 vaccinations as of 3 December 2021."In response vaccines minister Maggie Throup said: "As of the end of September 2021, 4,733 contractors submitted 5,376 expressions of interest to take part in the booster vaccination programme, with 1,454 accepted."She added: "As of 3 December 2021, 1,336 community pharmacy vaccination sites were actively providing the service." Some applications were decided by NHS England rather than the Department of Health and Social Care (DHSC).
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Viral Doshi :British Citizen Award for Healthcare Services - 0 views

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    A community pharmacist, Viral Doshi was honoured with the British Citizen Award (BCA) on Thursday (26 January) at the Palace of Westminster for transforming his community centre into vaccination hub during Covid-19 pandemic. Viral was presented with his Medal of Honour by Liam Sargeant, Senior Company Communications Manager, from supporters P&G and TV presenter and Patron of the BCA, Nick Knowles, who hosted the event. At the height of the pandemic, Viral obtained approval to transform his community centre into a vaccination hub. Located in the heart of a multi-ethnic population, with social deprivation, surrounded by wards experiencing high rates of Covid-19. His determination to increase uptake and reduce vaccination hesitancy, led to 80,000 vaccinations being administered, the overall highest vaccination uptake in North West London. Viral is a passionate advocate for the role that GP practices and community pharmacies can play in supporting the health agenda. His objective, to provide better choice and access for the community have been fully met and appreciated by patients. His initiatives led to a dramatic increase in the clinical skills, knowledge and services offered by local community pharmacies around a variety of health topics. This enabled pharmacies to adopt a holistic health approach to working with their communities.
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AstraZeneca:New COVID antibody protects against known virus - 0 views

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    British drugmaker AstraZeneca says it's confident that its new version of COVID-19 antibody treatment could protect immunocompromised patients against all known virus variants. Laboratory studies show the antibody, called AZD3152, neutralises all known variants of COVID-19 and AstraZeneca has support from regulators to make the treatment available by the end of this year, the company's vaccines head Iskra Reic said on Tuesday (April 18). AstraZeneca plans, pending more positive data and regulatory approval, to make the antibody available by the end of 2023. These types of therapies are most needed for people with compromised immune systems, either because of underlying conditions or because they are undergoing immune suppressing treatments. They account for nearly 2% of the global population. AstraZeneca's AZD3152, it new COVID-19 antibody, was acquired through a $157 million deal last year with British biotech start-up RQ Bio. The British drugmaker will likely make future investments like its current partnerships with RQ Bio but did not have any deals to announce, said Reic, a long-time AstraZeneca executive who has led the company's vaccines and immune therapies unit since it was formed in late 2021, during the pandemic.
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UK To Roll Out Covid-19 Antiviral Drug Trial This Month - 0 views

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    Britain will start to roll out Merck's molnupiravir Covid-19 antiviral pill through a drug trial later this month, Susan Hopkins, chief medical adviser at the UK Health Security Agency said on Sunday (November 7). Last week Britain became the first country in the world to approve the potentially game-changing Covid-19 antiviral pill, jointly developed by US-based Merck & Co Inc and Ridgeback Biotherapeutics. The government said in October it had secured 480,000 courses of the Merck drug, as well as 250,000 courses of an antiviral pill developed by Pfizer Inc. Asked about the molnupiravir approval, Hopkins told BBC television: "That is great news and it will start to be rolled out through a drug trial in the end of this month/the beginning of December." Hopkins said all the trials so far had been done with the unvaccinated, so this would help understand how it will work in the wider vaccinated population.
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Pfizer to pay Biohaven $11.6 bln to tap migraine market - 0 views

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    Pfizer said on Tuesday it will pay $11.6 billion to buy Biohaven Pharmaceuticals, making a big bet on its ability to boost sales of the top-selling pill in a new class of migraine drugs. The boards of both companies have approved the deal, they said. Biohaven shares jumped 70 per cent to $141.31, while Pfizer was up slightly at $48.83. Pfizer is flush with cash from a once-in-a-lifetime surge in revenue from Covid-19 vaccines and therapeutics and has said it is looking to buy companies or drugs that could add at least $25 billion in annual sales by the end of the decade. "The CGRP oral medications, though still somewhat newer entrants in a deeply entrenched space, continue to make steady inroads in disrupting the broader migraine market in the U.S.," said BioHaven chief executive Vlad Coric. Biohaven forecast Nurtec sales of $825 million to $900 million in 2022. Pfizer said it expects the pills to eventually overtake the shots.
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