Archiv: Medicines and Healthcare Products Regulatory Agency (UK)


27.01.2021 - 02:34 [ theDispatch.com/ ]

Is the U.S. Holdup of the Oxford/AstraZeneca Vaccine Justified?

The Oxford/AstraZeneca vaccine has advantages that make it an attractive possibility. It can be stored at normal refrigeration temperatures, and its price is low relative to its competitors. Public health experts have long targeted it as ideal for use in lower and moderate-income countries because of these features.

The problem is that its U.S. Phase III trial was delayed because of an adverse event investigation in the fall, and the data from the international trials used by the U.K. government are difficult to interpret due to unplanned modifications to dosing levels.

02.01.2021 - 08:32 [ .business-live.co.uk ]

Wrexham factory to produce millions of doses of the Oxford/AstraZeneca vaccine

(30.12.2020)

The Wrexham plant is able to produce around 300 million doses of the vaccine each year, and has been producing 150,000 phials a day for months in readiness to roll out the vaccine across the UK.

The CP Pharmaceuticals lab will carry out the „fill and finish“ stage of the manufacturing process. This involves dispensing the vaccine into vials ready for it to be sent out across the country.

The 18-month agreement with parent company Wockhardt was announced back in August.

30.12.2020 - 10:09 [ UK Department of Health and Social Care / UK Medicines and Healthcare Products Regulatory Agency ]

Oxford University/AstraZeneca vaccine authorised by UK medicines regulator

The Government has today accepted the recommendation from the Medicines and Healthcare products Regulatory Agency (MHRA) to authorise Oxford University/AstraZeneca’s Covid-19 vaccine for use.

30.12.2020 - 10:05 [ BBC ]

Covid-19: Oxford-AstraZeneca coronavirus vaccine approved for use in UK

The Oxford-AstraZeneca vaccine has been approved for use in the UK, with the first doses due to be given on Monday amid rising coronavirus cases.

30.12.2020 - 03:58 [ mark cording / Twitter ]

What’s the update on the Oxford vaccine Mr Hancock

30.12.2020 - 03:50 [ Matt Hancock, secretary of State for Health & Social Care / Twitter ]

Fantastic to see Margaret Keenan receive her second dose of the @Pfizer /@BioNTech_Group #coronavirus vaccine

30.12.2020 - 03:38 [ BBC ]

Covid: Millions more braced for tougher rules in England

Government sources have indicated an announcement later will see more areas move into tier four – „stay at home“.

Health Secretary Matt Hancock is due to detail the changes – which could be introduced within days – in the House of Commons after 14:30 GMT.

30.12.2020 - 03:35 [ noone@nowhere / Twitter ]

Still no Oxford vaccine emergency approval. Unbelievable.

(23.12.2020)

28.12.2020 - 17:26 [ gab.ai/murali / Twitter ]

How many willing to bet that this case is part of pharma wars to sabotage Oxford vaccine?

(28.11.2020)

28.12.2020 - 17:25 [ Telegraph.co.uk ]

Coronavirus latest news: One million vaccinations a week will not bring pandemic under control, warns Sage expert

Sir Jeremy Farrar, the director of the Wellcome Trust who advises Number 10’s advisory panel Scientific Advisory Group for Emergencies (Sage) said: „We’re not going to be free of this pandemic by February, this is now a human endemic infection.

28.12.2020 - 17:24 [ .oxfordmail.co.uk ]

No herd immunity through vaccine programme before summer, Sage scientist warns

Calum Semple, professor of outbreak medicine at the University of Liverpool and a member of the Scientific Advisory Group for Emergencies (Sage), described the Oxford/AstraZeneca vaccine as a “game changer” if it is approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the coming days.

But he told BBC Breakfast…

28.12.2020 - 09:24 [ Telegraph.co.uk ]

Oxford coronavirus vaccine: 10,000 medics and volunteers recruited to administer jab

The Oxford/AstraZeneca jab could be approved early next week by the independent Medicines and Healthcare products Regulatory Agency (MHRA), after the final cut of data was submitted by the Government last Monday.

28.12.2020 - 05:18 [ noone@nowhere / Twitter ]

Still no Oxford vaccine emergency approval. Unbelievable.

(23.12.2020)

27.12.2020 - 11:09 [ DailyMail.co.uk ]

Britain could be free of Covid restrictions by February after ministers pinpointed the 15million people to vaccinate to end the cycle of lockdowns, with Oxford’s jab due to be approved Monday and rolled out within a week

Government sources say that between 12 million and 15 million people have been identified as likely to require hospital treatment if they contract coronavirus, or be at risk of dying from it. Once this group has received the vaccine – which some officials hope could be achieved by the end of February – then the NHS would no longer be at risk of being overwhelmed if the virus spread through the greater population. That would remove the main argument for shutting the economy at a stroke.

A source said: ‚The path to liberation is finally becoming clear.‘

27.12.2020 - 11:02 [ theSun.co.uk ]

‚THE BEST OF BRITISH‘: Oxford Covid vaccine expected to be approved MONDAY as huge efforts ‘pay off’

„We have seen the best of British at every stage, from our world-leading scientists working around the clock to carry out vital research, to builders and engineers constructing new facilities.

“Manufacturers are boosting their capabilities and hundreds of thousands of people in every corner of the UK are taking part in clinical trials ­­— developing, finding and preparing for a vaccine has involved us all.

“It has and continues to be a truly UK-wide effort and one which showcases what a fantastic nation we are.”

27.12.2020 - 05:22 [ gab.ai/murali / Twitter ]

How many willing to bet that this case is part of pharma wars to sabotage Oxford vaccine?

(28.11.2020)

27.12.2020 - 05:20 [ Sean / Twitter ]

Can I ask why the Oxford vaccine approval is taking so long? It only took 23 days for Pfizers, we are nearly at day 30 and still no sign of approval!

(21.12.2020)

27.12.2020 - 05:05 [ Telegraph.co.uk ]

Millions to receive Oxford coronavirus vaccine from Jan 4

The Government is aiming for two million people to receive their first dose of either the Oxford vaccine or the Pfizer jab within a fortnight as part of a major ramping up of the inoculation programme.

23.12.2020 - 11:32 [ BBC ]

Oxford vaccine: How did they make it so quickly?

(23.11.2020)

Scientists took a common cold virus that infected chimpanzees and engineered it to become the building block of a vaccine against almost anything.

Before Covid, 330 people had been given ChAdOx1 based-vaccines for diseases ranging from flu to Zika virus, and prostate cancer to the tropical disease chikungunya.

The virus from chimps is genetically modified so it cannot cause an infection in people. It can then be modified again to contain the genetic blueprints for whatever you want to train the immune system to attack.

23.12.2020 - 11:18 [ inews.co.uk ]

Boris Johnson’s future as Prime Minister rests on the Oxford vaccine being approved

The hope in Downing Street is that the Oxford vaccine will get the green light by the end of the year. This would allow the Prime Minister to start laying out plans for restrictions to be lifted.

21.12.2020 - 22:37 [ DailyMail.co.uk ]

UK has vaccinated 500,000 people against Covid since December 8, Boris Johnson says as regulators face growing pressure to approve Oxford’s jab in desperate race to speed up the roll-out

The MHRA drugs regulator has been doing its final review of the vaccine for three weeks now, since November 27, with a decision expected by next Tuesday.

(…)

However, they made a decision about Pfizer and BioNTech’s jab within 10 days of being instructed to do so by the Department of Health.

20.12.2020 - 10:10 [ theGuardian.com ]

Oxford vaccine still under review, says UK medicine agency

But Whitehall sources said that while they hoped the vaccine would be available that week, it was by no means certain, and the authorisation could be delayed until the beginning of January.

The delay has caused frustration in Whitehall and the NHS, with the vaccine taking much longer to meet approval than the Pfizer vaccine, which was rolled out in the UK last week.

20.12.2020 - 10:00 [ theHill.com ]

FDA investigating allergic reactions to Pfizer vaccine reported in multiple states

“We are working hand in hand with the Centers for Disease Control and Prevention (CDC), and we’ve actually been working closely with our United Kingdom colleagues, who of course reported the allergic reaction. I think we’ll be looking at all the data we can from each of these reactions to sort out exactly what happened, and we’ll also be looking to try to understand which component of the vaccine might be helping to produce them,” Marks said.

09.12.2020 - 18:30 [ Tagesschau.de ]

Biontech-Pfizer-Impfstoff: Britische Behörde warnt Allergiker

Laut dem von Pfizer veröffentlichten Studienprotokoll wurden in der zulassungsrelevanten Untersuchung aber keine Teilnehmer aufgenommen, die eine Vorgeschichte schwerer Nebenwirkungen im Zusammenhang mit einem Impfstoff und/oder schwerer allergischer Reaktionen auf einen Inhaltsstoff der Studie haben.

Das MHRA hatte als weltweit erste Regulierungsbehörde dem Impfstoff vor einer Woche eine Notfallgenehmigung erteilt. Sie will die Fälle nun untersuchen.

09.12.2020 - 18:18 [ Standard.co.uk ]

Warning after two NHS workers have allergic reaction to Pfizer/BioNTech Covid vaccine

They developed symptoms of “anaphylactoid reaction” shortly after receiving the vaccine, but both recovered after the appropriate treatment.

After the incident, the Medicines and Healthcare products Regulatory Agency (MHRA) told NHS trusts that anyone who has a history of “significant” allergic reactions – including to medicines, food or vaccines – should not currently receive the vaccine.

08.12.2020 - 18:11 [ DailyMail.co.uk ]

Oxford confirms its Covid vaccine is 70% effective and safe – but scientists warn regulators face ‚dilemma‘ in approving jab to be given as 1.5 doses (which they accidentally found is 90% protective)

The MHRA has been considering whether to approve the vaccine since November 27 and is expected to reach a decision before the end of the year.

02.12.2020 - 15:13 [ apnrews.com ]

UK authorizes Pfizer coronavirus vaccine for emergency use

The Medicines and Healthcare Products Regulatory Agency, which licenses drugs in the U.K., recommended the vaccine could be used after it reviewed the results of clinical trials that showed the vaccine was 95% effective overall — and that it also offered significant protection for older people, among those most at risk of dying from the disease.