What is the progress of the vaccination programme locally?
As of 9th April, over 60% of adults locally have received at least a first dose.
All eligible care homes have been visited and residents and staff offered the vaccine, and a large proportion of housebound patients have been vaccinated.
All local practice staff and some pharmacy staff have also had their first vaccine.
This is a fantastic achievement and I’m enormously grateful to everyone working so very hard. We will continue to see an increase in vaccinations as more and more of the vaccine is provided to us locally.
Some residents are registered with GP practices in other parts of Leicestershire, Nottingham, Northamptonshire and Lincolnshire and therefore will be invited to vaccination in those areas. I also await an update for Harborough.
Is the AZ vaccine still safe?
Yes. All vaccines and indeed medicines have side effects, and the chances of someone developing a blood clot having had the AstraZeneca jab remains very small: 4 in 1 million.
To set this in context, a study in the British Medical Journal in 2015 found 6 in 10,000 women who are taking the combined birth control pill levonorgestrel will develop a blood clot (this combined pill had the lowest incidence of blood clots that they examined). This is not to diminish the risk, but to set out that what we consider everyday medicines, also carry risks.
JCVI states ‘all those who have received a first dose of the AstraZeneca COVID-19 vaccine should continue to be offered a second dose of AstraZeneca COVID-19 vaccine, irrespective of age.’ Therefore, for recipients in cohorts 1-9 who have received a first dose of AstraZeneca and are due to receive their second dose, should receive their second.
MHRA are clear that the only individuals who should not have a second dose of AstraZeneca are:
- ‘Administration of the COVID-19 Vaccine AstraZeneca in patients with a history of cerebral venous sinus thrombosis, acquired or hereditary thrombophilia, heparin-induced thrombocytopenia or antiphospholipid syndrome should only be considered when the potential benefit outweighs any potential risks. Patients who have experienced major venous and arterial thrombosis occurring with thrombocytopenia following vaccination with any COVID-19 vaccine should not receive a second dose of COVID-19 Vaccine AstraZeneca.’
Please read all the formal guidance here:
I'm concerned about blood clots for under 30s with AZ?
The MHRA has announced that people under the age of 30 in the UK will be offered the Pfizer or new Moderna vaccine going forward rather than the AstraZeneca vaccine. This is about risk vs benefit. A healthy under 30 year old has extremely low risks from COVID-19 so the medical advisors are being cautious.
The guidance remains that anyone who has already received their first AstraZeneca vaccine should receive a second dose of AstraZeneca, regardless of their age, except for the small number of people who experienced blood clots with low platelet counts from their first vaccination.
Please read all the formal guidance here:
I had a AZ vaccine and have a history of blood clots or a similar condition - should I not have a second?
Please speak to your GP. Administration of the COVID-19 Vaccine AstraZeneca in patients with a history of cerebral venous sinus thrombosis, acquired or hereditary thrombophilia, heparin-induced thrombocytopenia or antiphospholipid syndrome should be only be considered when the potential benefit outweighs any potential risks.
Patients who have experienced major venous and arterial thrombosis occurring with thrombocytopenia following vaccination with any COVID-19 vaccine should not receive a second dose of COVID-19 Vaccine AstraZeneca.
Please read all the formal guidance here:
I'm under 30 and my first vaccine was AZ - should my second be?
JCVI states ‘all those who have received a first dose of the AstraZeneca COVID-19 vaccine should continue to be offered a second dose of AstraZeneca COVID-19 vaccine, irrespective of age.’ Therefore, for recipients in cohorts 1-9 who have received a first dose of AstraZeneca and are due to receive their second dose, should receive their second.
The current advice is that you have AZ as your second dose too because the evidence so far shows that any risk of blood clot is far more likely to take place in the short term after your first dose, and not after your second. However Please speak to your GP as there are exceptions, which are:
- Administration of the COVID-19 Vaccine AstraZeneca in patients with a history of cerebral venous sinus thrombosis, acquired or hereditary thrombophilia, heparin-induced thrombocytopenia or antiphospholipid syndrome should be only be considered when the potential benefit outweighs any potential risks. Patients who have experienced major venous and arterial thrombosis occurring with thrombocytopenia following vaccination with any COVID-19 vaccine should not receive a second dose of COVID-19 Vaccine AstraZeneca.
The study on mixing vaccines hasn't concluded as yet so we don't know how safe that is, or how much protection you'll have if vaccines mixed. If you're under 30 and already had the vaccine it's because of how great a risk the virus poses to you. The Govt medical experts have concluded that the risk of COVID-19 to a CV/CEV under 30 far outweighs risk and likelihood of blood clot.
Please read all the formal guidance here:
I'm CEV/CV and over 30 and worried about having AZ vaccine?
JCVI has weighed the relative balance of benefits and risks and advise that the benefits of prompt vaccination with the AstraZeneca COVID-19 vaccine far outweigh the risk of adverse events for individuals 30 years of age and over and those who have underlying health conditions which put them at higher risk of severe COVID-19 disease. Therefore, for recipients in cohorts 1-9 aged 30 years and above who are scheduled to receive a first dose of AstraZeneca, vaccination should continue.
When are our vaccination centres operating?
Our local vaccination centres have received a delivery of almost 1,000 vaccinations each week since they opened. Our vaccination centres then have five days scheduled to deliver the Pfizer vaccinations and ensure there is no wastage before another delivery is made. In addition, where other vaccination hubs have been unable to administer all of their delivery, we have received their un-deployed vaccines for us to administer.
Much of the operation of the centres until now has been getting vaccines out to care homes, as well as to those who are housebound and other vulnerable individuals so therefore these do not take place in the vaccination hub, but the team are still very much operating and working long hours to do so.
Our clinicians and volunteers are doing a phenomenal job, and delivering to the schedule set by the Government. As the AstraZeneca / Oxford vaccine rolls out, we will see an increase in deliveries, but we have received our vaccination deliveries from the Government and they have been administered. Residents are also being vaccinated at the Mass Vaccination Hubs and in our local hospitals.
This is a national programme and we need to vaccinate the entire country to defeat the vaccine. Vaccination centres are receiving as much notice as is possible before their vaccine delivery. We are making great progress locally.
How is the large-scale vaccination programme being delivered for us in Rutland and Melton?
Vaccinations began locally on Saturday, 12 December at Leicester General Hospital. Some residents may be invited to other locations for vaccination depending on where they receive healthcare.
We now have vaccination centres locally in Melton, Oakham and in Billesdon. Vaccinations are also being delivered in Care Homes and in the homes of those who are house-bound.
In addition you may be invited to vaccination at a Mass Vaccination Hub, there is one in Leicester.
Many residents are registered with GP practices in other parts of Leicestershire, as well as in Nottinghamshire, Lincolnshire, Peterborough and Northamptonshire. If you are registered in one of these areas you will be vaccinated at the many hubs in these areas.
I've been invited to a Mass Vaccination Hub - do I have to go to it or can I wait for a local vaccination slot?
To be clear - this is an additional service to give you more choice, flexibility and the opportunity to be vaccinated, quicker.
You can accept the national vaccination offer and travel to a mass vaccination hub, we have one in Leicester and there are others further afield.
OR
You can choose instead to wait for an invitation locally at our hubs in Melton, Oakham, Billesdon, Market Harborough, Charnwood, Leicester hospitals, Stamford, Grantham, Peterborough, or within Northamptonshire or Rushcliffe (depending on which GP you’re registered at) if you don’t wish to travel further for your vaccination.
Is the vaccine free?
The vaccine is free across the UK.
The NHS will never ask you to pay or provide your bank details.
How will I be contacted for my vaccination?
You do not need to take any action, you will be contacted when the NHS is ready and able to vaccinate you. This will be by letter or text message - the first invitations went out on Thursday 10th December.
I understand that there is an anxiety to get the vaccine quickly, so I ask your patience. Please wait to be contacted.
Please be very careful as criminals are sending out these vaccination requests asking for financial and ID information, using the NHS logo and format. They are fake and a scam. The NHS will
NEVER ask for payment - the vaccine is free;
NEVER ask for your bank details;
NEVER arrive unannounced at your home to administer the vaccine;
NEVER ask you to prove your identity by sending copies of personal documents such as your passport.
If you know you have been targeted, please contact the local police at https://www.actionfraud.police.uk/.
What vaccines has the Government secured access to?
The Government’s vaccine taskforce has secured early access to 7 of the most promising vaccine candidates including:
- BioNTech/Pfizer for 40 million doses
- Oxford/AstraZeneca for 100 million doses
- Moderna for 7 million doses
- Novavax for 60 million doses
- Janssen for 30 million doses
- Valneva for 100 million doses
- GlaxoSmithKline and Sanofi Pasteur for 60 million doses
All of these vaccines will be subject to the same intense scrutiny process I laid out above, and only administered if our best scientists are confident they are both safe and effective.
What is the progress with approving all vaccines?
BioNTech/Pfizer, Oxford/AstraZeneca and Moderna vaccines are approved and being given to UK residents and residents of our overseas territories.
The Novavax vaccine, trialled in the UK, has results showing 89 per cent effectiveness in preventing COVID-19. These trials included the new variant of COVID-19, so we know this vaccine is effective against at least some of the new strains in circulation. It is likely the other vaccines already approved are too. The Government is moving swiftly to approve the Novavax vaccine, and if it is approved it will be made right here in the UK, at a facility in Teesside.
Janssen's single dose vaccine has also had positive results.
Can I choose which COVID-19 vaccine I have?
No. The Joint Committee on Vaccination and Immunisation has not advised a preference between the Pfizer-BioNTech or Oxford-AstraZeneca vaccine in any specific population, stating that "both give very high protection against severe disease... and both vaccines have good safety profiles".
You will have to have two doses of the same vaccine and in certain circumstances the NHS may advise you have a certain vaccine.
Please rest assured that both vaccines have been cleared through the MHRA’s stringent and comprehensive approval process and have been found to meet their strict standards of safety, quality and effectiveness.
Is the NHS confident that the Pfizer and Oxford vaccines are safe?
Yes. The NHS will not offer any COVID-19 vaccinations to the public until the independent experts have signed off that it is safe to do so. The MHRA, the official UK regulator, has said that both of these vaccines have good safety profiles and offer a high level of protection, and the NHS has full confidence in their expert judgement and processes.
As with any medicine, vaccines are highly regulated products. There are checks at every stage in the development and manufacturing process, and continued monitoring once they have been authorised and is being used in the wider population. Please see the question below regarding blood clots.
Please find links below to the MHRA’s rationale for approving the vaccines.
Pfizer/BionTech: https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19
Oxford/AstraZeneca: https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca
What about blood clots for under 30s with AZ?
The MHRA has announced that people under the age of 30 in the UK will be offered the Pfizer or new Moderna vaccine going forward rather than the AstraZeneca vaccine.
I know this will worry some of you. All vaccines and indeed medicines have side effects, and the chances of someone developing a blood clot having had the AstraZeneca jab remains very small: 4 in 1 million.
To set this in context, a study in the British Medical Journal in 2015 found 6 in 10,000 women who are taking the combined birth control pill levonorgestrel will develop a blood clot (this combined pill had the lowest incidence of blood clots that they examined). This is not to diminish the risk, but to set out that what we consider everyday medicines, also carry risks.
The guidance remains that anyone who has already received their first AstraZeneca vaccine should receive a second dose of AstraZeneca, regardless of their age, except for the small number of people who experienced blood clots with low platelet counts from their first vaccination.
I had the AstraZeneca vaccine for my first vaccine, and when invited, I will book to have it for my second dose.
More than 37 million jabs overall have already been administered, the vaccination programme is saving lives – so far Public Health England analysis shows at least 6,100 deaths in those aged 70 and older in England have been prevented up to the end of February.
How were the COVID-19 vaccines developed so quickly?
There are a number of enablers that have made this ground-breaking medical advancement possible and why it was possible to develop them relatively quickly compared to other medicines;
The different phases of the clinical trial were delivered to overlap instead of run sequentially which sped up the clinical process;
There was a rolling assessment of data packages as soon as they were available so experts at the MHRA could review as the trial was being delivered, ask questions along the way and request extra information as needed – as opposed to getting all information at the end of a trial;
Clinical trials managed to recruit people very quickly as a global effort meant thousands of people were willing to volunteer.
Were the COVID-19 vaccines tested on high risk groups?
For both vaccines trial participants included a range of those from various ages, immune-compromised and those with underlying health conditions, and both found the efficacy of the vaccine translates through all the subgroups.
Details of trial participants for both vaccines are published online and can be found linked below.
Pfizer/BionTech: https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19
Oxford/AstraZeneca: https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca
Why is vaccination not recommended for children?
Almost all children with COVID-19 have no symptoms or mild disease and the vaccines have not yet been tested in younger children. The advice is that only children at very high risk of catching the virus and serious illness – such as older children with severe neuro-disabilities in residential care – should be offered vaccination. Studies are now taking place with children.
Why are older people being prioritised over younger people who are out of the house working?
The priorities are based on reducing risk of harm. The immune system in older people differs from that of younger people and whilst the younger, working population are just as likely to become infected they are much, much less likely to become severely ill. An older person becoming infected with SARS-CoV-2 is more likely to result in severe COVID-19 disease and require hospitalisation. The biggest risk of dying from COVID-19 comes with age, even more so than underlying conditions such as cardiovascular disease or diabetes, for example, or being male or being in BAME groups. With each 20 year increase in age the risk of dying from COVID-19 increases by approximately 10 times. When a vaccine has been shown to be effective in preventing disease in older people, then they should be the first to receive it as they are most at risk.
Was the Government right to space out first and second vaccinations?
We made a decision to give a large degree of protection to as many people as possible as soon as possible, to save as many lives as possible. The data shows this was the right decision, and that extended intervals between vaccinations gives GREATER protection from COVID-19. The WHO is supporting this.
The full statement on prioritisation and the data that supports this decision can be found here: https://www.gov.uk/government/publications/prioritising-the-first-covid-19-vaccine-dose-jcvi-statement
Dr David Nabarro, the World Health Organisation's special envoy on COVID-19 has said: “Isn't it wonderful that it has turned out, as a result of the UK's bravery frankly, that these extended intervals seems to be associated with greater protection... So, yes, I think the UK's approach so far has been vindicated and yes, it has taught a great lesson for the rest of the world. Thank you, thank you British scientists."
What is the best period of time between vaccinations?
For the Pfizer vaccine, 12 weeks has shown best efficacy of interval.
For the AstraZeneca vaccine, the greater the interval, the more effective it is, so 12+ weeks is mandated.
How long does the vaccine take to become effective?
The immune system can take a number of days or weeks to generate an immune response before protection from the virus begins. While you will need two doses of the vaccine to get the best long-term protection from the virus, you will still have a significant level of protection at 22 days after you received the first dose.
No vaccine is 100% effective, so everyone should continue to take the recommended precautions to avoid infection.
Do I need to get the vaccine if I have contracted COVID-19 and recovered?
Yes. There is a lot of uncertainty about how much immunity a person gains after natural infection. The levels of immunity that we can measure so far show a lot of individual variation – some people have very few antibodies after infection, but these antibodies can be boosted by vaccination. We can’t assume that everyone who has had COVID-19 would have enough immunity to protect them. It is likely that, in a significant proportion of the population, the vaccine will induce more effective and longer lasting immunity than that induced by infection. Hence it is recommended that everyone take the vaccine so that, if your immunity after disease is absent or low, it can be boosted.
Can I catch COVID-19 from the vaccine?
No, you cannot catch COVID-19 from the vaccine. This is because none of the COVID-19 vaccines being administered in the UK contain the live virus that causes infection, meaning the vaccine cannot make you sick with COVID-19.
Instead, the vaccines teach our immune systems how to recognise and fight the virus that causes COVID-19.
Do the COVID-19 vaccines prevent transmission of the virus?
While the Pfizer and Oxford vaccines provide protection from serious disease, there is not yet conclusive evidence on whether they prevent someone from passing the virus on to others.
This means after vaccination it is important you continue to follow the guidance to protect those around you.
How long will my COVID-19 vaccine be effective for?
We expect the vaccines to work for at least a year – if not longer. However, this will be closely monitored.
Is it safe to have the COVID-19 vaccine if I’m pregnant?
It is advised that vaccination in pregnancy should be considered where the risk of exposure to COVID-19 is high and cannot be avoided (such as in front line NHS staff), or where the woman has underlying conditions that put them at very high risk of serious complications of COVID-19.
Will the COVID-19 vaccine affect my or my partner's ability to have children?
After a rigorous study, there is currently no evidence that there is any impact on fertility. While more testing needs to be done to ensure that it is safe for pregnant women, there is no scientific, medical or biological reason why the design of the Pfizer vaccine should affect pregnancy and fertility. The Royal College of Gynaecologists and the Royal College of Midwives have confirmed there is no biologically plausible mechanism by which current vaccines would cause an impact on women’s fertility.
What we do know is that COVID-19 is likely more severe in pregnant women, which is why it is important to take the vaccine if you are a loved one of a pregnant woman to protect yourself and to protect those close to you.
What does a new virus strain mean for a vaccine?
New COVID-19 strains have been found in the United Kingdom, and it's important that you know the facts as they are known about what this means.
Firstly, viruses mutate all the time as they circulate through populations. Sometimes it can even mean a virus becomes less deadly or less virulent.
Please be reassured that it is highly unlikely that this new variant will not respond to one of the vaccines the Government has purchased. Additionally, there is no evidence to suggest that this strain of COVID-19 is more severe, nor is there any evidence that current tests do not work to detect the virus.
Should people with allergies take the vaccine?
Most people with allergies can have the vaccine. For example, some allergies, such as hay fever, are mild and do not pose a risk. The MHRA recommends that people with a history of anaphylaxis to food, an identified drug or vaccine, or an insect sting CAN receive any COVID-19 vaccine, as long as they are not known to be allergic to any component of the vaccine. The vaccine should not be given to people who have a history of immediate-onset anaphylaxis to any of the vaccine’s components. If you carry an EpiPen in case of allergic reaction, you have a history of immediate-onset anaphylaxis and so should discuss this with your doctor, nurse or pharmacist before getting the vaccine. People are asked to remain at the vaccination centre for a short period of time after receiving their vaccination so that the healthcare professionals can check there is no immediate adverse response to the vaccine.
Is the issue of anaphylaxis with the Pfizer vaccine less with the Oxford vaccine if you have had a history of this?
The Pfizer COVID-19 Vaccine contains polyethylene glycol (PEG), which is from a group of known allergens commonly found in medicines and also in household goods and cosmetics. Known allergy to PEG is extremely rare but would contraindicate receipt of this vaccine.
Patients with undiagnosed PEG allergy may have a history of unexplained anaphylaxis or of anaphylaxis to multiple classes of drugs
The Oxford vaccine does not contain PEG, and is a suitable alternative.
Why should a young person take the vaccine when the risk of COVID-19 mortality is so low?
There is a huge variability in the symptoms and severity of COVID-19 disease between different people; from an infection with SARS-CoV-2 that doesn’t have any symptoms (asymptomatic infection) to severe COVID-19 disease resulting in hospitalisation and in some cases death. While younger people are usually at the less severe end of the spectrum this does not mean that the illness is not harmful to their health. In fact, there are many instances of long COVID that have blighted the lives of young people.
In addition, although we don’t yet have a lot of evidence to support this, having the vaccine might stop you being able to be part of the chain of infection that spreads the virus. So, an added benefit might be to help reduce spread of the virus for everybody.
There is COVID-19 at my child’s school. Why aren’t my children being given the vaccine?
Initial vaccine testing was not done on children. Children are at extremely low risk of becoming severely ill with COVID-19 – they are at higher risk of being involved in a serious traffic accident than they are of ending up in hospital with COVID-19. So the benefits of vaccinating children are not yet clear. If the vaccine stops people from passing the infection to others, then vaccinating children in order to stop the spread of the virus will make a lot of sense.
Can the COVID-19 vaccines alter my genetic material?
There is no evidence to suggest that individual genetic material will undergo alteration after receiving the vaccine.
The Oxford vaccine works the same as the flu jabs many of us have each year.
The Pfizer vaccine uses mRNA technology which teaches our cells to make a protein that triggers a protective immune response. The mRNA is broken down soon after it enters the body and never enters the nucleus of the cell, where our DNA is kept.
Am I automatically protected from COVID-19 after my first vaccination dose?
The first dose of the COVID-19 vaccine should give you good protection from coronavirus from 22 days after inoculation. However, you need to have the two doses of the vaccine to give you longer lasting protection. This means you should continue following the hands, face, space advice after your vaccination.
Are there meat derivatives or porcine products in the Pfizer or Oxford Vaccines?
No, there are no meat derivatives or porcine products, including gelatine, in the Pfizer or Oxford vaccines. A detailed review of the vaccines and their ingredients have been provided which you can find linked below by vaccine.
Pfizer/BionTech: https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19
Oxford/AstraZeneca: https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca
Are our vaccine supplies secure? The EU's actions suggest they're not?
The EU has backtracked and now will not override the agreements we have with them as they seek to control vaccine exports.
Constructive conversations with the EU took place yesterday and today, and the Government is reassured the EU will not block suppliers fulfilling contracts for vaccine distribution to the UK. We will continue to support vaccine deliveries to all countries by providing UK expertise to support manufacturers, such as sending experts last month to the Halix plant in the Netherlands, which makes the Oxford-AstraZeneca vaccine, to help with supply problems.
Whilst the EU’s actions over the last 24 hours were poorly done, let’s move forward from this disappointing state of affairs and focus on rolling out our vaccination programme, and working with our neighbours and allies to save lives and end the pandemic.
Why were the EU and other countries behind us on approving the vaccine if it’s safe?
The EU’s Medicines Regulatory Agency previously relied on the UK to take the lead in assessing new medicines and vaccines. It is not that the EU has not approved the vaccine because it is not safe, indeed it is likely that several other regulators in the EU and US will also make decisions before the end of the year. As of December 11, Canada has approved the vaccine and it has passed the FDA's scientific advisory panel, waiting for full approval which is expected.
I recall receiving emails from constituents criticising the UK for leaving the EU vaccine procurement scheme – that we would get less, and later, access to COVID-19 vaccines. The UK government recently changed regulations so that during the transition period (ie before the end of this year) new vaccines could be approved for use in the UK without waiting for EU approval or any delays. It is easier for single countries to be nimble in crises than a multinational government. As it happens, we also have far bigger stocks of vaccine than any other EU country, thanks to the Government’s vaccine taskforce.
Should we be sharing our vaccines with other countries?
Once, and only once, our vaccine supply is assured and we have vaccinated all the priority groups, all over 50s and our vulnerable or priority keyworkers, I believe we should support our Irish kin within the Common Travel Area and our Commonwealth allies with any SURPLUS from our 400m vaccines ordered.
In addition, the UK is the biggest donor in the world to the COVAX global vaccination programme, which will see 1.3 billion doses of COVID-19 vaccines funded by the UK to help 92 developing countries this year.
PFIZER VACCINE
How does the Pfizer vaccine work?
The Pfizer/BioNTech Covid jab is an mRNA vaccine – a cutting-edge technology. The vaccine works by introducing into the body genetic material, called mRNA, that contains the instructions to make the so-called “spike” protein of the coronavirus.
In response to these proteins, the body’s immune pathways are activated – a response that offers protection should we encounter the virus itself.
It requires two vaccinations.
How effective is the Pfizer vaccine?
About 95 per cent. The phase 3 trials of the Pfizer/BioNTech vaccine involved 42,000 people, about half of whom got the experimental vaccine and the rest a placebo. In total, 170 people fell ill with covid-19. Only eight of them were in the vaccine group; 162 had received the placebo. So around 5 per cent of cases were in the vaccine group, which is where the 95 per cent figure comes from. That is a very healthy number: the World Health Organization (WHO) has said it would be happy with 50 per cent. (from the New Scientist)
How do we know the vaccine is safe for use when it has been developed at pace?
There are extensive checks and balances required at every stage of the development of a vaccine and this is no different for a COVID-19 vaccine.
All vaccines are tested through three phases of clinical trials to make sure they meet the gold standard:
Phase 1 – With a small group of people to make sure there are no safety concerns and determine appropriate dosages for the best immune response.
Phase 2 – With a larger group of people to check the vaccine works consistently and that the immune response is sufficient.
Phase 3 – With thousands of people for scientists to assess whether the vaccine is producing immunity that will prevent disease.
Usually these phases are run sequentially, but due to the urgency of the pandemic these stages have been run in parallel.
The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK’s independent regulator and their role is to ensure medicines, devices and vaccines work effectively and are safe for use.
Teams of scientists and clinicians have carefully, methodically, scientifically and rigorously reviewed all data on safety, effectiveness and quality of the Pfizer/ BioNTech vaccine, and have done so throughout all phases of the development and trialling program.
The data from the Pfizer/BioNTech clinical trials showed the vaccine is 94% effective in protecting people over the age of 65 from coronavirus, with trials suggesting it works equally well in people of all ages, races and ethnicities. There were also no serious safety concerns reported in the trials.
The data looked at includes all the results from laboratory studies, clinical trials, manufacturing and quality controls and testing the product. On this basis, we should be very confident that all tests have been done to the very highest of standards.
Whilst it can take 10-15 years to develop a vaccine, scientists have long recognised the threat of a pandemic such as COVID-19 and had already researched how the right vaccine might be created and used. This means scientists were starting from a base of knowing how to make a vaccine that should work, and therefore could begin trials more quickly than usual and have spent the last year focusing all their efforts on doing so.
Is it safe for Pfizer vaccine doses to be delivered up to 3 months apart?
New medical and epidemiological evidence was given to the Government by the Joint Committee on Vaccination and Immunisation (JCVI) which advises the Government on how to roll out the vaccination scheme and agreed to by all four UK Chief Medical Officers.
The urgent priority is to save lives and to get us back to normal. The epidemiological evidence and understanding tells us that we need to increase the number of vulnerable people who have received a first vaccination. The data now shows us a very high efficacy rate from just the first dose, which was not known before, and therefore the committee now advises that the first dose should be given to as many eligible people as possible, and that this is more effective that delivering a second dose in a shorter period, and crucially will save significantly more lives.
By making this change: far, far more lives will be saved, and we remain within the Pfizer-BioNTech guidance which is that the second dose should be given with 3-12 weeks. You can read the guidance here with the references included:
Each first dose protects a life. This is new information and we must act on it as to fail to would be absolutely wrong and cost lives.
This is a change determined by the scientists, Chief Medical Officers, and the regulator.
This decision will save lives by giving thousands more protection, which is far better than giving a very small amount higher protection. In a pandemic we must respond to new information as we receive it, and we must listen to the medical experts and scientists.
This is a matter of life and death, and that is why it is right that now we know how much protection the first vaccine gives you, that we give as many other people the same level of protection. It would be wrong to risk others’ lives when a longer wait between vaccinations will save lives.
Are there any side effects?
Sometimes, but they are mild. In the trial, the vaccine was generally well-tolerated, and an independent data monitoring committee reported no serious safety concerns. The worst side effects were fatigue and headaches after the second dose. About 4 per cent of people reported fatigue and 2 per cent a headache. Other side effects were pain at the injection site and muscle pain. These are “common reactions you would have with vaccination”, says Özlem Türeci at BioNTech. Older adults reported fewer and milder side effects.
Does it stop people from catching and transmitting the virus?
We still don’t know. The trial was designed to test for symptomatic COVID-19 and confirmed infection with the virus. Assessing whether the vaccine prevents transmission – which is probably a prerequisite for attaining vaccine-induced herd immunity – is much harder. But Pfizer says it is carrying out more studies on this important question and will release information soon.
What is the process for the UK to receive the Pfizer/BioNTech vaccine?
Despite the huge complexities of storing the vaccine at -70 degrees, work is ongoing to ensure that the NHS is able to vaccinate as soon as vaccines arrive. The time between approval and deployment of a vaccine is usually about one week, due to travel and extensive safety and quality control requirements. As I said, we expect the very first vaccinations to take place next week.
The steps include:
- Pfizer dispatches the vaccine from Belgium and it will arrive in the UK. This is followed by a post-delivery quality assurance process to ensure the vaccine’s quality and integrity has been maintained,
- Once all checks are complete the vaccine will be made available to order by authorised sites in the NHS,
- Orders will be packed and shipped as appropriate for the required storage temperature of each vaccine. Generally, vaccines will be delivered on a next day delivery schedule except for more remote parts of the UK where delivery may take 48 hours,
- Delivering the Pfizer/BioNTech COVID-19 vaccine is complex as it needs to be stored at very cold temperatures and moved carefully, so at first we will only be able to deliver it from ‘hospital hubs’. Defrosting the vaccine takes a few hours and then additional time is required to prepare the vaccine for administering.
ASTRAZENECA / OXFORD VACCINE
How do viral vector vaccines, such as the AstraZeneca/Oxford vaccine, work?
This type of vaccine uses an unrelated harmless virus (the viral vector) to deliver SARS-CoV-2 genetic material into the body. When administered, our cells use the genetic material to produce a specific viral protein, which is recognised by our immune system and triggers a response. This response builds immune memory, so your body can fight off the virus in the future.
Is it safe for the AstraZeneca vaccine doses to be delivered up to 3 months apart?
Further studies on the AstraZeneca vaccine are extremely promising. The vaccine shows 76 per cent sustained protection in the 3 month interval until the second dose.
As published in the Lancet:
“These analyses show that higher vaccine efficacy is obtained with a longer interval between the first and second dose, and that a single dose of vaccine is highly efficacious in the first 90 days, providing further support for current policy.”
Additionally, it has a 67 per cent reduction on PCR swabs with those who have been administered, meaning in two thirds of those with a first dose, COVID-19 becomes very difficult to pass on.
As of today, the UK has given a first dose of vaccine to over 9.6 million people. We still have a ways to go, but this is a huge step forward, and today's good vaccine trial news is a reminder that we are on the right track. Stay safe, follow the rules and get your vaccines when asked.
Does immunity from the vaccine last longer than immunity after getting COVID-19?
We do not know the answer to this question yet because people have only been followed up for a maximum of 7 months after vaccination so far. We suspect that in some cases (e.g. mild or asymptomatic infection), the immunity elicited by the vaccine would be better than that elicited by the natural infection, but we do not know for sure. But, from the concentrations of antibodies induced by the vaccine, and the rate at which these antibodies decline over time, it is looking very promising that immunity induced by the vaccine will last at least as long as the immunity induced by infection and in all likelihood it will last much longer.
Do I still need to wear a mask or observe social distancing after receiving the vaccine?
Yes. We know the vaccine can protect people from getting sick from the disease COVID-19 that is caused by the viral infection. However, we do not yet know if being vaccinated will stop you from getting the viral infection, so you could be an asymptomatic carrier who could pass the infection onto others who may be vulnerable.
Also, you will not be protected against the disease until at least three weeks after your first dose and you will not be fully protected until three weeks after your second dose.
Does the AstraZeneca/Oxford vaccine being developed so quickly mean that it is less safe than other vaccines?
No, it doesn’t. The reasons that this was developed so quickly do not include cutting corners on safety. There are a few reasons that enabled the speed in 2020:
- Technology. This viral vector vaccine (in common with many of the approaches used for the other vaccine candidates) could be rapidly deployed for development and testing once the SARS-CoV-2 genetic sequence became known, but this was actually done on the back of almost ten years prior research using this method of producing vaccines.
- Scientists. A LOT of scientists contributed to this, working extra long hours to make it work and to assess the results.
- Money. Normally raising money to develop a vaccine takes a long time. At each stage you have to stop and apply for more funding to carry out the next stage. Funding applications take a year or more. In 2020 for SARS-CoV-2, rapid investment of a lot of taxpayers’ money in many countries meant there weren’t the normal financial obstacles.
- Environment. Sometimes you can develop a vaccine but can’t test it until there is an epidemic in progress. There was no problem in this regard.
- Luck. Sometimes the target that is picked for vaccine studies, which is usually something seen on the outside of the virus, is not a good candidate for raising an immune response. The S protein target on SARS-CoV-2 that most vaccine companies picked to work with turns out to be an excellent target for activating the immune response.
- Volunteer test subjects. Last but definitely not least. Tens of thousands of volunteers took part in the safety trials and the randomised control trials so recruiting volunteers was not an issue as it may be under normal circumstances.
- Testing. Normally the various phases of safety testing happen sequentially, often because of financial restraints, in this case safety testing happened concurrently.
Are there any side effects from the vaccine?
Yes, but these are generally mild. As with all vaccines, because you are stimulating the immune system you may experience some mild flu-like symptoms, but these are temporary. The most common reactions are fatigue, headache and pain at the injection site. Some people might also get chills, joint pain or fever.
Will the vaccine be effective against different variants of the SARS-CoV-2 virus?
The human immune system is diverse and dynamic so we think it will, but we don’t yet know this for a fact in all variants. We will need to monitor emerging virus variants and continually check (in the lab) whether serum from vaccinated people can neutralise them. So far there is no evidence that the UK variant can escape from antibodies made in response to the old variant. There is some evidence that another variant might be able to escape, and studies are ongoing to investigate this further. If we find any significant reduction in neutralisation of variant viruses, we may need to subtly tweak the vaccine to induce a broader repertoire of neutralising antibodies.
Who was the AstraZeneca/Oxford COVID-19 vaccine tested on?
In the phase 3 clinical trial, half the volunteers had the COVID-19 vaccine and the rest were given a MenACWY (meningitis) vaccine, or saline solution, as control. Volunteers were from Brazil, and UK, other trials are continuing in South Africa and USA.
In the data published so far, from the UK and Brazil, there were 5,807 COVID-19 vaccine recipients and 5829 in the control group. Of the COVID-19 vaccine recipients, 88% were aged between 18 and 55, 12% were aged over 55. 17% were BAME, 39% were male. People characterised as high risk due to underlying conditions (e.g. cardiovascular disease; diabetes; respiratory disease) or due to high risk occupations were included.
Are there risks that might have been missed in the trials, but will become apparent in the longer term?
All known risks have been checked, but there may be unknown risks. Reactions to vaccines usually happen very soon after vaccination – if you have the vaccine, you are asked to wait at the vaccination centre for a few minutes as a precaution. All the initial phase 1 safety trial volunteers have been followed up for at least 7 months and no major concerns have been raised. Safety monitoring, known as pharmacovigilance, is to be continued for 2 years after the vaccine is released; in the UK, this is carried out by the MHRA.
How are long term side effects tested/monitored?
Safety monitoring is to be continued for 2 years after the vaccine is released. There is a system in place (known as the yellow card system; https://yellowcard.mhra.gov.uk/) to monitor and report adverse events immediately in a process known as pharmacovigilance. In the UK, this is carried out by the MHRA.
