In our commitment to prioritising potential treatments for COVID-19, the Medicines and Healthcare products Regulatory Agency (MHRA) approved the COVID-19 Oxford Vaccine Trial request to trial a vaccine to prevent COVID-19 in a little over one working week.
The application was made on 18 March, and on 26 March the MHRA gave the COVID-19 Oxford Vaccine Trial the green light. The procedures for tailored scientific advice and guidance, and a speedy approval process, are part of MHRA’s pledge to prioritise clinical trial applications submitted for COVID-19.
Scientists in Oxford started working on designing a vaccine early in January 2020, and have now identified one to start the first clinical testing phase. If the vaccine is proven to be safe and effective in this and larger trials, it could protect people and help save lives.
The MHRA is dedicated to supporting researchers and all those who are working on a response to COVID-19. We are providing scientific advice and informal guidance for all aspects of product development.
Science Minister, Amanda Solloway, said:
“The government is doing all it can to support the science and research community who are working tirelessly to identify a vaccine to combat coronavirus.
“Accelerating UK vaccine development, including clinical testing, will ensure that any successfully developed vaccine can be made available to people as soon as possible.
Dr June Raine, Chief Executive for the MHRA, said:
“The dedicated scientific advice and rapid approval of this important clinical trial demonstrate our commitment to working together to find a vaccine for this pandemic.
“We support the development and expedite authorisation of clinical trials for COVID-19 treatments, whilst maintaining our high regulatory standards to ensure the safety of people involved in the trials.
“Protecting health and saving lives is at the forefront of our work, and we are committed to enabling the development of safe and effective vaccines and treatments for this virus.‘
MHRA prioritises trial applications for COVID-19
Clinical trials applications can be submitted directly to the MHRA Clinical Trial Helpline by emailing email@example.com, in parallel to the normal Common European Submission Portal (CESP) route, so we can begin work as soon as possible. We then liaise closely with any applicants to ensure it’s managed as efficiently as possible.
More information on clinical trials applications for coronavirus (COVID-19).
We are currently offering an expedited review and approvals process for COVID-19 clinical trials, aiming to complete our review in a week.
We are also able to provide advice on any aspect of a clinical trial. Manufacturers, researchers and other regulators who are working on a response to COVID-19 can email or call our Clinical Trials Unit on firstname.lastname@example.org or 020 3080 6456.
It has been a quiet few days on the ‘advice to the public front’. We have been monitoring the Coronavirus issue and posting applicable (to our residents) information and guidance since 12th March 2020. Since that date we have processed (read) hundreds of pieces of advice and information from HM Government, Public Health England, the NHS and other reputable sources, most of the information we receive is of a technical nature or is targeted at particular ‘settings’, we nonetheless read them all in case there is useful information that we can pass on.
As I said at the head of this post, it has been a quiet few days, but we will continue to monitor the situation and bring you news as soon as it is published.
Please follow the guidelines and stay safe.
The Prime Minister announced today the introduction of effectively total isolation for those most vulnerable, irrespective of age who have serious underlying health issues. The NHS will write to the individuals concerned directly, the criteria will be published shortly and we will publish it as soon as it becomes available. The Secretary of State for the Department of Communities and Local Government announced that there would be a package of support including delivery of medicine and food to those who do not have a network of family and friends to support them.
The Deputy Chief Medical Officer emphasised that for those over 70 but outside ‘most vulnerable; category should stay at home, but in the interests of their mental well-being could go for walks providing that they adhere to the Social Distancing rules – NO CLOSER THEM 2 METRES.
In response to a question the Prime Minister reiterated that he would prefer that the general public to act reasonably and responsibly and make sure that they following strictly the advice given by Government by staying inside, if possible but when outside to ensure they use the SELF-DISTANCING RULES. If sections of the community continue to act irresponsibly, the Prime Minister made it clear that the rules were under constant scrutiny and the Government would use whatever means was necessary to protect the Nation in this emergency.
As soon as more detailed information is available we will publish it here.
In the meantime:
- STAY AT HOME (if you can)
- WHEN OUTSIDE MAKE SURE YOU KEEP AT LEAST 2 METRES FROM ANYONE ELSE.
Guidance on social distancing for everyone in the UK and protecting older people and vulnerable adults
This guidance is for everyone. It advises on social distancing measures we should all be taking to reduce social interaction between people in order to reduce the transmission of coronavirus (COVID-19). It is intended for use in situations where people are living in their own homes, with or without additional support from friends, family and carers. If you live in a residential care setting – guidance is available at residential care setting
We are advising those who are at increased risk of severe illness from coronavirus (COVID-19) to be particularly stringent in following social distancing measures.
This group includes those who are:
- aged 70 or older (regardless of medical conditions)
- under 70 with an underlying health condition listed below (ie anyone instructed to get a flu jab as an adult each year on medical grounds):
- chronic (long-term) respiratory diseases, such as asthma, chronic obstructive pulmonary disease (COPD), emphysema or bronchitis
- chronic heart disease, such as heart failure
- chronic kidney disease
- chronic liver disease, such as hepatitis
- chronic neurological conditions, such as Parkinson’s disease, motor neurone disease, multiple sclerosis (MS), a learning disability or cerebral palsy
- problems with your spleen – for example, sickle cell disease or if you have had your spleen removed
- a weakened immune system as the result of conditions such as HIV and AIDS, or medicines such as steroid tablets or chemotherapy
- being seriously overweight (a BMI of 40 or above)
- those who are pregnant
Note: there are some clinical conditions which put people at even higher risk of severe illness from COVID-19. If you are in this category, next week the NHS in England will directly contact you with advice the more stringent measures you should take in order to keep yourself and others safe. For now, you should rigorously follow the social distancing advice in full, outlined below.
People falling into this group are those who may be at particular risk due to complex health problems such as:
- People who have received an organ transplant and remain on ongoing immunosuppression medication
- People with cancer who are undergoing active chemotherapy or radiotherapy
- People with cancers of the blood or bone marrow such as leukaemia who are at any stage of treatment
- People with severe chest conditions such as cystic fibrosis or severe asthma (requiring hospital admissions or courses of steroid tablets)
- People with severe diseases of body systems, such as severe kidney disease (dialysis)
What is social distancing?
Social distancing measures are steps you can take to reduce the social interaction between people. This will help reduce the transmission of coronavirus (COVID-19).
- Avoid contact with someone who is displaying symptoms of coronavirus (COVID-19). These symptoms include high temperature and/or new and continuous cough;
- Avoid non-essential use of public transport, varying your travel times to avoid rush hour, when possible;
- Work from home, where possible. Your employer should support you to do this. Please refer to employer guidance for more information;
- Avoid large gatherings, and gatherings in smaller public spaces such as pubs, cinemas, restaurants, theatres, bars, clubs
- Avoid gatherings with friends and family. Keep in touch using remote technology such as phone, internet, and social media.
- Use telephone or online services to contact your GP or other essential services.
Everyone should be trying to follow these measures as much as is pragmatic.
For those who are over 70, have an underlying health condition or are pregnant, we strongly advise you to follow the above measures as much as you can, and to significantly limit your face-to-face interaction with friends and family if possible.
This advice is likely to be in place for some weeks.
New and updated industry guidance published on limiting the spread of coronavirus (COVID-19), following last week’s shift to the ‘delay’ phase of the action plan.
People are being urged to stay at home for seven days if they develop a high temperature or new continuous cough as part of an expanded public awareness campaign in the fight against COVID-19, Health Secretary Matt Hancock has announced today (Sunday 15 March).
For the first time, members of the public will see advice in TV adverts featuring Chief Medical Officer Professor Chris Whitty and voiced by actor Mark Strong as part of the government’s drive to ensure everyone knows the best way to limit and delay the spread of the COVID-19.
Building on the current campaign, which reinforces the importance of washing your hands more often, the next phase reflects the government’s shift into the ‘delay’ phase of its action plan to limit the spread of the virus. A key part of this is asking people to self-isolate for seven days if they develop a high temperature or a new continuous cough – however mild.
As well as on TV, people will see and hear the campaign advice in newspapers and magazines, on drive-time radio, online and through social media and on billboards and large digital displays, including at bus stops.
Health Secretary Matt Hancock said:
Coronavirus is the biggest public health crisis we have faced in a generation. It continues to spread both in the UK and around the world and we need to accept that sadly, many more of us will become infected.
The government and the NHS are working 24/7 to fight this virus. We must all work together and play our own part in protecting ourselves and each other, as well as our NHS, from this disease. This expanded campaign will focus on ensuring the public knows exactly what they should be doing to keep themselves and others safe.
Washing hands regularly for 20 seconds or more remains the single most important thing an individual can do, but we now also need to ask anyone with a high temperature or new continuous cough – however mild – to isolate yourself and stay at home for seven days. You should continue to follow our online clinical advice and not go to A&E or your GP if you develop mild symptoms.
Combating this virus will require a national effort – we all have a role to play to slow its spread and protect the elderly and the vulnerable.
Dr Yvonne Doyle, Public Health England’s Medical Director said:
We know that novel coronavirus affects the most vulnerable the most and so it is absolutely vital that we do everything we can to protect them. This new guidance sets out what we can all do to help save the lives of those most at risk.
This week, the UK’s Chief Medical Officers raised the risk to the public from moderate to high. The campaign offers clear, practical advice so the public can play their part in preventing and slowing the spread of the virus.
As per the current advice, the most important thing individuals can do to protect themselves remains washing their hands more often, for at least 20 seconds, with soap and water. Make sure you cough or sneeze into a tissue, put it in a bin and wash your hands.
The next phase of the awareness campaign also reiterates the importance of seeking help online by visiting NHS.uk/coronavirus to check your symptoms and follow the medical advice, rather than visiting your GP. It also urges people with any symptoms to avoid contact with older and more vulnerable people. Where possible, we are urging people to visit the 111 website rather than calling, too, to ensure the phone service is readily available to those who need it.
Last week, the Prime Minister published a ‘battle plan’ for tackling the disease in the UK, which sets out plans for a range of scenarios. This week, the Prime Minister confirmed the UK has moved into the second stage of this plan, the ‘delay’ phase.
NHS, Public Health England and Local Authority Public Health teams up and down the country are working tirelessly to support everyone in need of advice, testing or treatment.
Since January, public health teams and world leading scientists have been working round the clock on the COVID-19 response, and government has been working with partners across the country to provide tailored advice to the public, travellers coming into the country and those most at risk from COVID-19.
THE FOLLOWING INFORMATION HAS BEEN PUBLISHED BY HM GOVERNMENT AND THE NHS.
The Government and NHS are well prepared to deal with this virus.
You can help too.
Germs can live on some surfaces for hours.
To protect yourself and others:
- Always carry tissues with you and use them to catch you cough or sneeze.
- Bin the tissue and to kill the germs wash your hands with soap and water or use sanitiser gel.
- If you have arrived back from China within 14 days follow the specific advice for returning travellers.
This is the best way to slow the spread of almost any germs, including Coronavirus.