Oxford/AstraZeneca vaccine rollout plan changed following approval

Millions of people across the UK at risk from Covid will be offered a single first dose of the Oxford/AstraZeneca vaccine, with a booster jab within three months, in a bid to return the country to some normality by the spring, the prime minister has said.

Helen Pidd www.theguardian.com

Rollout of the Oxford vaccine will begin on 4 January following its approval for emergency use by the Medicines and Healthcare products Regulatory Authority (MHRA). The government hopes the vaccine, of which it has ordered 100m doses, will transform prospects in the UK and check the spread of the rampaging coronavirus variant which has caused cases to surge. Pharmacies as well as GPs will be able to give the jabs to those at risk.

But the MHRA and the government’s advisory Joint Committee on Vaccinations and Immunisation delivered a surprise by announcing approval of a regime that was not trialled. Both the Oxford vaccine and the Pfizer/BioNTech jab which is already in use will be given to people as one shot, followed by another up to 12 weeks later, in order to extend some protection to as many people as possible as quickly as possible.

Boris Johnson said at a Downing Street press conference that the benefits from the vaccine would kick in within 21 days. “What that means is we can vaccinate and protect many more people in the coming weeks,” he said.

He hoped that by spring of 2021, many coronavirus restrictions would be able to be lifted. “If we’re right and the vaccination programme does have the positive effects that we think it can have, and I stress these are ifs, then clearly a lot of the non-pharmaceutical interventions … will recede into the past,” he said. “We’ll be able to do things very differently.”

The prime minister added that the public may need to carry on with “basic disciplines” such as washing hands and wearing masks “for a while after”.

The approval of the vaccine by the MHRA after weeks of examining trial data was greeted with excitement and relief by experts. The Pfizer/BioNTech vaccine already in use needs to be stored in the long-term at -70C and is hard to deploy. The Oxford vaccine, however, can be kept in a normal fridge at 2-8C and is easily transported from UK factories, meaning it will not have to be kept in central hospital and community hubs, enabling a swift rollout to GP practices and care homes.

Amid the widespread praise for Oxford University and AstraZeneca in gaining UK approval for a vaccine that is vital to the global prospects of ending the pandemic because of its low cost and normal refrigeration, some experts were anxious at the proposed mode of use. They said it was pragmatic to try to ensure as many people as possible had a first shot, giving them some protection, but that there were unanswered questions. These include the evidence for extending the time between injections to 12 weeks, which could lead to some people not returning for the second dose.

Pfizer/BioNTech said that their vaccine was not designed to be used in two shots 12 weeks apart. In a statement, the firms said there was no evidence the first shot continued to work beyond three weeks.

“Data from the phase 3 study demonstrated that, although partial protection from the vaccine appears to begin as early as 12 days after the first dose, two doses of the vaccine are required to provide the maximum protection against the disease, a vaccine efficacy of 95%. There are no data to demonstrate that protection after the first dose is sustained after 21 days,” they said.

The decision to approve the Oxford/AstraZeneca vaccine followed “rigorous clinical trials and a thorough analysis of the data by experts at the MHRA, which has concluded that the vaccine has met its strict standards of safety, quality and effectiveness”, the DHSC said.

AstraZeneca said its vaccine would be made available to some of the poorest regions of the world at a low cost and was not being manufactured for profit.

Talking to BBC Radio 4’s Today programme, its chief executive, Pascal Soriot, said the company could provide the UK with as many as 2m doses a week and would start shipping the first doses “today or tomorrow”.

He said: “Vaccination will start next week and we will get to 1m a week, and beyond that a week, very rapidly. The good news with this is we are going to be able to inject a lot of people with one dose very quickly, provide them with a reasonably good dose of protection until they get their second dose two to three months later. That will enable us to protect many more people because we can wait two to three months for the second dose.”

Matt Hancock, the UK health secretary, said every adult in the UK could eventually be offered vaccination.

Speaking to BBC Breakfast, he said: “Because we’ve got enough of this vaccine on order to vaccinate the whole population – we’ve got 100m doses on order – add that to the 30m doses of Pfizer and that’s enough for two doses for the entire population.

“So I can now say with confidence that we can vaccinate everyone, except of course for children because this vaccine has not been trialled on children, and anyway children are much, much less likely to have symptoms from the disease.”

Appraisal of the Oxford vaccine has taken longer than it did for the Pfizer/BioNTech product, which the UK was the first country to approve on 2 December. The dossier of testing and trial results for the Oxford vaccine was more complicated.

Pfizer/BioNTech, whose vaccine is based on novel mRNA technology, had clear results, with 95% efficacy from a single international trial involving 43,000 people. Oxford/AstraZeneca had 62% efficacy in their largest trial, of 11,636 people, but 90% efficacy in a small additional sub-group in the UK numbering 2,741 who were given half a dose of the vaccine followed by a whole dose four weeks later.

The MHRA in effect dismissed the finding from the trials that there was 90% efficacy in that subset, which was made up of fewer than 3,000 people in the UK, who were mostly under the age of 55, so was not typical of the population’s most vulnerable. However, the MHRA said it was not the age of the participants that caused the high efficacy rate. Instead, it suggested it may have been because there was a longer gap between the administration of the first and second doses of vaccine. More details of their assessment was to come, the authority said.

Overall, the MHRA said, the efficacy of the vaccine reached about 70% between three weeks and 12 weeks, when given as a single standard dose. The second dose, not later than 12 weeks afterwards, was necessary because the effect may not last without the booster shot, it said.

The MHRA acknowledged there was limited data on the effects of the vaccine in elderly people. Ongoing trials in the UK and US will supply more evidence, but it said it was satisfied the vaccine was safe and effective in the older population.

The researchers have pointed out that none of the volunteers in the trials who had the vaccine became seriously ill or were admitted to hospital.

Prof Andrew Pollard, the director of the Oxford Vaccine Group and the chief investigator of the Oxford trial, said: “The regulator’s assessment that this is a safe and effective vaccine is a landmark moment, and an endorsement of the huge effort from a devoted international team of researchers and our dedicated trial participants.

“Though this is just the beginning, we will start to get ahead of the pandemic, protect health and economies when the vulnerable are vaccinated everywhere, as many as possible as soon possible.”

The Labour leader, Keir Starmer, tweeted: “We now need a national effort to get vaccinations delivered across the country.”

Jonathan Ashworth, the shadow health secretary, welcomed the news, tweeting: “Now let’s go hell for leather to get jabs rolled out. We’ve seen how more virus circulating means opportunities for variants to emerge. This is now a race against time. We need vaccination ramped up especially for NHS staff urgently.”

Johnson said the UK had already vaccinated more than 800,000 people with the Pfizer/BioNTech jab.

Tesco, Pizza Hut and Superdrug in minimum wage fail

Tesco, Pizza Hut and Superdrug are among more than a hundred firms “named and shamed” by the government for not paying workers the minimum wage.

BBC News www.bbc.co.uk

Almost 140 companies investigated between 2016 and 2018 failed to pay £6.7m to more than 95,000 workers.

The minimum wage ranges from £4.15 an hour for apprentices, to £8.72 an hour for over-25s.

Tesco, Pizza Hut and Superdrug said the underpayments were historic errors and staff had been swiftly reimbursed.

Ministers said the offending firms – which included hotels, restaurants, car washes and shops – short changed tens of thousands of workers, in what they described as a “completely unacceptable breach of employment law”.

Cases included employers taking deductions from wages for uniforms, training or parking fees or failing to raise employees’ pay after a birthday which should have moved them into a higher minimum wage bracket.

‘Wake-up call’

It is the first time the government has named firms for failing to pay the national minimum wage since 2018, following reforms to the process to make sure only the worst offenders are revealed.

The Business Minister Paul Scully said he was especially disappointed to see big household names on the list but he said it should be a “wake-up call” to bosses.

“It is never acceptable for any employer to short-change their workers, but it is especially disappointing to see huge household names who absolutely should know better on this list,” he added.

Presentational grey line

What is the minimum wage?

The UK national minimum wage sets out the least a worker can be paid per hour by law.

As of April 2020, it stood at £8.72 an hour for people aged 25 and older – the government refers to this main rate as the National Living Wage.

There are four minimum wages below this amount for younger workers and apprentices:

  • The National Minimum Wage for 21 to 24-year-olds – £8.20
  • For 18 to 20-year-olds – £6.45
  • For under-18s – £4.55
  • For apprentices – £4.15
Presentational grey line

TUC general secretary Frances O’Grady said may firms which failed to pay their workers the minimum wage still wouldn’t be named.

“The government raised the threshold for naming employers compared with the old scheme, meaning fewer bad bosses are exposed.”

Tesco said a technical issue in 2017 meant some workers’ pay “inadvertently” fell below the minimum wage and it had reported the issue itself to HMRC.

“In most cases the reimbursement was £10 or less,” the supermarket said.

Pizza Hut and Superdrug both said the error was related to a previous uniform policy, which required staff to wear a particular colour trousers and shoes.

“It is important to stress that there was never any intent to underpay our employees,” said Pizza Hut. Superdrug said it had changed its policy to make sure the issue did not happen again.

Uni students advised to take two Covid tests when they return

All University of Exeter students will be recommended to take a coronavirus test as soon as possible when they return to campus in the New Year – with advice saying they should complete two before beginning in-person teaching.

Daniel Clark www.devonlive.com 

The university will be offering free tests to all students, including postgraduate researchers, between January 4 and February 5 using their existing test centres on the Streatham and Penryn campuses.

All students are being recommended to book tests for when they arrive in their term-time accommodation and before starting any in-person teaching, or using study or social spaces on our campuses, and should isolate until they receive a result. Students should plan to take two Covid-19 tests before beginning in-person teaching.

Mike Shore-Nye, Registrar and Secretary, said: “It is essential that you allow enough time to take your test and you should book your test to be taken as soon as possible after you arrive at your accommodation. If your preferred slot is not available choose one as close as possible to your arrival time and try to keep away from other people.

“Only by testing can we identify those who are positive and support them to isolate, and this is how we can keep each other safe, avoid further outbreaks and find ways to return to a more normal University life. If you have tested positive for Covid-19 in the last 90 days, there is no need for you to take another test.

“Students should plan to take two Covid-19 tests before beginning in-person teaching.”

Speaking at a Team Devon Local Outbreak Engagement Board meeting in December, Sean Fielding, Director of Innovation, Impact and Business, had added: “We will do 50,000 tests over the first month of the new year. We don’t want people coming into the city and creating an infection risk.

“The return of students will be staggered and there will be a testing schedule as and when they arrive. Every student will be asked to do two tests.”

Examinations for some students begin on January 4, with all exams online, and teaching begins for all students on January 11, but for many students this will initially be online-only

Those degree programmes with placement or practical elements which cannot be delivered online will resume in-person teaching first, with most resuming from the week beginning January 11.

New postgraduate taught students will also begin their in-person teaching from the week beginning January 11, while other final year undergraduate students and returning postgraduate taught students will resume in-person teaching in the week beginning January 25

All other Undergraduate students will resume in-person teaching in the week beginning February 1, while postgraduate research students can resume their research from January 4.

Government guidance adds: “The return of students should be staggered over five weeks – this is to minimise transmission risks from the mass movement of students, with practical and placement students returning first.

“All students should be offered testing on return to university and students who returned home over the winter break should not be encouraged to return to their term-time accommodation until their face-to-face teaching is scheduled to resume

“To minimise the risk to themselves and others on their return to university, before travelling, students should act responsibly, follow local restriction tier guidance on social contact and use local community testing programme and take a test before travelling if they have spent the winter break in a local restriction tier 3 (very high) or tier 4 (stay at home) area where this fits with locally-targeted programmes led by the Director of Public Health.”

Tier 3 was ‘inevitable’ for Devon say MPs and health chiefs

And:

Cllr Paul Arnott, Leader of East Devon District Council, said: “The threat from the new and more transmittable strain of the virus is extremely serious and the people of East Devon must do all they can to protect the health of both themselves and others.

“I wish everyone a happy new year and urge you to celebrate safely from your own home and respect at all times the increased safety obligations of Tier 3.”

Daniel Clark www.devonlive.com 

Devon’s move into Tier 3 restrictions has left MPs disappointed, but they felt it was inevitable.

The government has reviewed the tier restrictions, and Devon is to move up to Tier 3 from Thursday, December 31.

The rules means that you must not meet socially indoors with anybody who you do not live with, or you are not in a support bubble with and you must not meet socially outdoors (in a private garden or at most outdoor public venues) with anybody who you do not live with, or you are not in a support bubble with*.

Hospitality settings, such as bars, pubs, cafes, restaurants and social clubs must close except for takeaway, delivery and click and collect services. Food or drink bought via these must not be consumed on the premises including beer gardens.

Hotels, B&Bs, campsites, holiday lets and guest houses, must close, except for those travelling for work, while most tourist venues and entertainment must close, but some outdoor venues are permitted to remain open.

Steve Brown, Director of Public Health Devon (Designate) said: “Cases in Devon, while we have been in Tier 2, have been rising in all age groups, as per the national trend. Without further intervention with tighter restrictions, we are likely to have seen cases continuing to rise and therefore I feel this announcement was inevitable.

“The decision has been made to place us into Tier 3 and what is important now is we do everything we can to adhere to these tighter restrictions to help bring down cases in Devon

“We will have heard the welcome news today that a second vaccine has been approved for use from early January, but we cannot sit back and relax on the strength of that. Please keep up the effort, and remember the key messages, to social distance, wear your face coverings when in a public space where social distancing is not possible, and wash your hands properly and regularly.”

Anne Marie Morris, MP for Newton Abbot, said: “It is unsurprising that Devon has been placed in Tier 3, given the rising rates across the county & country. January is traditionally the busiest month of the year for the NHS and I would urge people to continue following the rules, in order to reduce the spread of this terrible disease and protect the most vulnerable in society. Alongside colleagues, I continue to call on the Government to publish data on the impact this pandemic is having on non-Covid health conditions.”

Ben Bradshaw MP for Exeter said: “This is clearly disappointing, as our figures are still among the lowest in the country, but I suppose the dire and deteriorating situation elsewhere & the huge pressure on the NHS made it inevitable. We are now paying the price of locking down too late in October, coming out of that lockdown too early & the chaos & confusion over Christmas. I fear we could see another national lockdown before the benefits of the vaccination programme begun to be felt.”

Simon Jupp, MP for East Devon, said; “Devon will move into Tier 3 tomorrow. Case numbers continue to rise across the county and our NHS remains under strain. There is hope and optimism following independent approval of the Oxford-AstraZeneca vaccine which will be rolled-out from next week. This is very welcome news, but we can’t let our guard down.”

Kevin Foster, MP for Torbay, said: “Whilst infection rates in our bay are still relatively low, they are steadily rising, and we cannot ignore the situation in the rest of Devon and the UK as a whole, especially relating to the new strain.

“I appreciate the hard work many in our tourism and hospitality industry have put in over the last month to keep our community safe whilst they were still trading, yet if South Devon were an island of Tier 2, with surrounding areas in Tier 3 and nearby Somerset in Tier 4, it is sadly all too predictable we could see activities and people gyrate towards our bay, potentially bringing the virus with them.

“It is therefore right we move into Tier 3, along with the rest of Devon and Cornwall, at this stage. Yet with the vaccination programme now set to step up massively, we can look forward to the Summer Season with confidence.”

Clodagh Murphy, Chairman of Exeter Chamber, said: “Exeter Chamber understands the need to take tough measures against this rapidly spreading new strain of Coronavirus to protect the NHS and our communities, but this must not be at the expense of further damage to our economy.

“With hospitality businesses already reporting an 80 per cent reduction in takings over the Christmas / New Year period, and now facing closure once again, we urgently call for emergency measures to support those businesses that are most affected by these new restrictions. These include, but not limited to, the hospitality, leisure and tourism sectors which are vital to both Devon and the wider Westcountry’s economic success.

“We want thank all of our local businesses and hospitality for all their hard work over the last nine months as we have tackled the changing landscape of this pandemic. These businesses are the lifeblood of the Devon economy and they have been tremendous.

“The rollout of the vaccine programme, and the approval of the Oxford/AstraZeneca vaccine, gives us all hope of a return to something approaching normality later in 2021. However, in the meantime, we must not allow businesses to fail due to lack of Government support in these final months, so that they are able to come back in the spring/summer and continue to help the region’s economy prosper and grow.”

Anthony Mangnall, MP for Totnes, said: “I have been a firm believer that an end to lockdown is very necessary but we also have to take into account that the numbers are increasing in the South West, along with the rest of the country. I do support the Government in the action today, but important that we have a second vaccine coming online and that will be a lot quicker to rollout.

“We are nearing the light at the end of the tunnel and hoping we can get it to those in most need of it. I understand the frustration – we are at the last moment and the light is almost darkest before the dawn – and we are like a marathon runner on the last mile and we have to focus on the rollout of the vaccine and getting life back to normal, but we have to do it without jeopardising the NHS and the capacity that goes with it.”

But the Oxford-AstraZeneca vaccine has been approved for use in the UK, with the first doses due to be given on Monday.

On the approval of the Oxford vaccine, Ms Morris said: “It is fantastic news that the Oxford/AstraZeneca vaccine has been approved for use by the MHRA. This is a game changer and will enable the NHS to significantly increase vaccination capacity, especially in harder to reach places such as rural care homes. The sooner we can roll out the vaccine, the sooner we can begin to head back to ‘normality’.”

Kevin Foster, MP for Torbay, said: “This is a triumph for British Science and a leap forward in our fight against Covid-19 both in the UK and globally, given it can be distributed via existing vaccination routes due to it being able to be stored in a fridge. I know plans for using it are already well advanced in our bay, including ensuring it reaches the most vulnerable living in care homes.”

“Whilst there will still be some difficult days ahead, the Oxford Vaccine holds out the hope of a more normal summer season for our bay and its tourism industry, but for now we cannot let our guard down.”

Sir Gary Streeter, MP for South West Devon said: “”The approval of the Oxford vaccine is wonderful news. I hope we can vaccinate around two million per week starting almost immediately and also people in care homes.”

MP for Exeter, Ben Bradshaw, said: “It’s great news that the Oxford vaccine has been approved, as this is the one that most of us will get, as it is easier to deploy. The Goverment must now ensure that the NHS has the resources and staff to administer the vaccines round the clock so we can get on top of this pandemic as soon as possible.

“I also agree with those who argue that administering one dose to as many people as possible as quickly as possible would be better than two doses to fewer people, as all the vaccines provide a very good level of protection at one dose and doing that is likely to get us out of this crisis sooner.”

Cllr Paul Arnott, Leader of East Devon District Council, said: “The threat from the new and more transmittable strain of the virus is extremely serious and the people of East Devon must do all they can to protect the health of both themselves and others.

“I wish everyone a happy new year and urge you to celebrate safely from your own home and respect at all times the increased safety obligations of Tier 3.”

Plans to flood River Otter estuary set to be agreed

A previous post from Owl headed:  “Otter restoration project: stop the swamp, or future proof against climate change?” exposed some of the emotion swirling around this project. There have been over 500 comments from members of the public.

So it is interesting to see how the case, which will be determined by EDDC’s planning committee next Wednesday, is summarised by DevonLive’s democratic reporter.

The Exmouth Journal publishes today rather than on its usual Wednesday but does not cover the story.

Daniel Clark www.devonlive.com 

Multi-million pound plans to restore the Otter Estuary to its natural and historic flood plains to avoid a catastrophic failure of sea defences are set to be given the go-ahead next week.

East Devon District Council’s planning committee are being recommended to approve the Lower Otter Restoration Project, which will create 55 hectares of mudflats, saltmarsh and other valuable estuarine habitats.

The project, led by landowner Clinton Devon Estates and the Environment Agency, would see the Big and Little Marsh floodplains around Budleigh Salterton restored, with breaches created in the Little Bank, the Big Bank and the River Otter Embankment to allow water to flow through.

The Lower Otter valley is the subject of plans from the Environment Agency

The Lower Otter valley is the subject of plans from the Environment Agency

The funding will support the Lower Otter Restoration Project’s aims of climate change adaptation by working with natural processes to provide benefits for people and wildlife.

It follows the significant risk that a major flood or extreme tidal event could lead to catastrophic failure of embankments, with unpredictable environmental and social impacts, with recent years having seen part of the South West Coast Path that runs along the embankments closed to the public for significant periods due to erosion caused by such events.

As part of the plans to restore the historic floodplain of the River Otter, breaches in existing embankments would be created to allow water from both the River Otter and the Estuary to inundate the site, creating intertidal saltmarsh and mudflats.

In addition, South Farm Road will be realigned and raised at a point just to the south of the existing road, and a small car park created at its western end and a new road bridge will be required, and a new footbridge to the South. Existing footpaths will be realigned and the landfill site capped and planted with grassland and woodland.

The spit to the South will be allowed to evolve naturally, necessitating the removal of the southern part of the loop path known as Donkeys Turn.

The cricket club will be moved from its current location to land off of East Budleigh Road, permission for which has already been granted under a separate planning application. Floods have left part of their current Ottermouth home under water on three occasions in the last 10 years, with a plan to relocate to Janie’s Field on the outskirts of the town having been agreed.

Recommending approval, the report of planning officers says: “This is a significant application within the Lower Otter Valley which will result in a change to the existing landscape, which has been managed over the past two centuries. The proposal would clearly significantly change the area, particularly by way of breaches to the embankments which would irreversibly change the habitat and visual appearance of the estuary.

“The ambition to return the river to a more natural watercourse will result in the inundation of water to the project area and will result in large areas of new habitat creation. In addition, significant rerouting of the existing South Farm Road is required, and there will be a requirement for additional car parking and a new footbridge to provide adequate facilities for those accessing the area by car, on foot or by bike.

Option 3 – Big and Little Marsh Floodplain Restoration (estimated cost £8-9m) for the Lower Otter Restoration project

Option 3 – Big and Little Marsh Floodplain Restoration (estimated cost £8-9m) for the Lower Otter Restoration project

“The scheme is widely supported by a number of significant conservation bodies which have an interest in the site, this is a result of a number of years of consultation on the project including working groups.

“The Flood Risk Assessment and modelling have fully considered the impact of the scheme on nearby residents and businesses, and have concluded that the risk is minimal.

“Concerns have been raised regarding the positioning and size of the proposed car park which will be addressed by a planning condition, which will also include the requirement for a footpath from the proposed car park and impacts on trees, local landscape, the setting of heritage assets, use of the estuary and contamination have also been addressed.

“It is considered that the proposal is acceptable subject to appropriately worded conditions relating to archaeology, materials of the footbridge, access details and public rights of way, contamination, a construction management plan, groundwater levels, adequate car parking, the provision of a footpath, arboricultural and tree protection details.”

The Environment Agency has submitted plans to East Devon District Council on behalf of LORP as the £15 million project enters its final phase and if approved, work will start in 2021 and be completed by spring 2023.

The River Otter

The River Otter

The Lower Otter project is largely funded by the European Interreg programme through an initiative called Promoting Adaptation to Changing Coasts (PACCo). It is partnered with a similar project in the Saâne Valley in Normandy, France.

Both schemes aim to demonstrate that early adaptation to climate change brings greater benefits than a delayed response or inaction. If successful, the adaptation model for these two projects will be rolled out to other locations in the UK and France.

East Devon District Council’s planning committee meets on Wednesday, January 6, to determine the fate of the application.