COVID-19 Vaccines Q&A and Communications Toolkit

Following the news about the Pfizer / BioNTech vaccine receiving authorisation from the independent Medicines and Healthcare products Regulatory Agency (MHRA), Public Health England have updated their Q&A and COVID-19 vaccines communications toolkit.

Please click here for the link to the COVID-19 communications toolkit that includes new creative content assets for you to use.

The new assets in the toolkit include:

• MHRA Pfizer COVID19 vaccine approval – a suite of videos from Dr June Raine, MHRA.
• Speed of vaccine development – clip from “This Morning” Prof Jonathan Van-Tam, Deputy Chief Medical officer.
• Vaccines meeting safety standards – video from Dr June Raine, MHRA

PHE will be regularly adding to the toolkit over the coming weeks with short clips from the announcements along with graphics, visuals and further videos. You can also access PHE’s campaign resource centre where more helpful vaccine related resources will be made available as and when they are ready.

Q&A

The Q&A from Public Health England is as follows:

Deployment and Timing

When will the first patient be vaccinated?

• An enormous amount of work has taken place to ensure we have the logistical expertise, transport and workforce to rollout a vaccine, at the speed at which it can be manufactured.
• We will be ready to start vaccination in December.

How many doses of the Pfizer COVID-19 vaccine will need to be administered?

• The vaccine is given in two doses – three weeks apart – and data from clinical trials showed the vaccine is 94 percent 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.

How quickly is the Pfizer vaccine effective after doses.

• Full protection should begin 7-10 days after the second injection.

Where/how are vaccines going to be administered?

• Vaccination to at-risk groups till take place at the most appropriate settings to encourage uptake. This includes administering vaccination to at risk individuals in their usual place of residence. The three models of delivery are:
• Hospital Hubs – NHS providers vaccinating staff onsite.
• Local Vaccination Services – Community and primary care-led service based on local and logistical considerations but is likely to include GP practices, local authority sourced buildings or other local facilities, and potentially roving teams if vaccines are transportable in this way.
• Vaccination Centres – Large scale centres such as sports and conference venues set up for high volumes of people.

Who is going to be administering these vaccines?

• Recruitment of workforce has focused on those who already have experience in handling vaccinations but may currently work outside of NHS settings, for example, independent nurses or allied health care professionals.

Will vaccinations be available across the UK?

• Vaccination will be managed by the health services in each nation: NHS England and NHS Improvement, NHS Wales, NHS Scotland, and Health and Social Care Northern Ireland. The UK government is working closely with the Devolved Administrations to ensure an aligned approach to COVID-19 vaccine deployment across the UK.
• The vaccine will be available for free across the UK. We have procured vaccines on behalf of all parts of the country. And the Government is working with the devolved administrations to ensure it is deployed fairly across the UK.

Now that we have a vaccine, can we end restrictions and lockdowns?

• An effective vaccine will be the best way to protect the most vulnerable from coronavirus and the biggest breakthrough since the pandemic began. A huge step forward in our fight against coronavirus, potentially saving tens of thousands of lives.
• Once vaccinations begin, we will closely monitor the impact on individuals, on NHS pressures and on the spread of the virus.
• As large numbers of people from at risk groups are given an effective vaccine, we will be able to gather the evidence to prove the impact on infection rates, hospitalisation and reduced deaths; if successful this should in time lead to a substantial reassessment of current restrictions
• The full impact on infection rates will not become clear until a large number of people have been vaccinated with two doses, but as larger numbers do get vaccinated, we will hopefully move further along the path back to a more normal way of life.

When will you publish vaccine ingredients?

• The MHRA will publish information on the ingredients in a summary of product characteristics (SpC) or equivalent. See here for more details.

Can the government be sure that safety won’t be compromised due to the speed of a COVID-19 vaccine?

• 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. No stages in the vaccine development process are bypassed.
• All vaccines are tested through three phases of clinical trials to ensure they meet the gold standard. Phase 1 trials are with a small group of people to make sure there are no safety concerns and determines the appropriate dosage for the best immune response. Phase 2 trials are conducted on a larger group of people to check the vaccine works consistently and that the immune response is sufficient. Phase 3 trials test the vaccines on thousands of people for scientists to assess if the vaccine is producing immunity that will prevent disease.
• Usually, these phases are run in sequence, but in an effort to find a safe and effective COVID-19 vaccine as quickly as possible, once safety has been ascertained through Phase 1, Phases 2 and 3 are being run in parallel.
• The data from each phase then goes to the regulator in a “rolling” review rather than once the trials have completed, which means the regulator can start looking at the results earlier than normal.
• Companies have made decisions to begin large scale production of vaccines which are still in trials. This means that if the vaccines are not shown to be safe and effective and are not approved for use the companies will have to destroy what they have manufactured. If, however the vaccines are successful, that means the vaccines are ready to be distributed.

How can people be confident there won’t be long term side effects?

• Every single vaccine authorised for use in the UK has been authorised by the MHRA and the three components of authorisation are a safety assessment, an effectiveness assessment and a manufacturing quality assessment.

How was the COVID-19 vaccine developed so fast?

• Vaccine technology and the technological approaches to making vaccines are getting better and better and we couldn’t have done it in this timeframe if we went back to the 2009 pandemic and we had a new virus about which we knew very little. We’re in a different place today because of the technology.
• It was very clear that it was a global public health emergency from the word go and governments were prepared to put in lots of funding to manufacturers, without any guarantee of success, but hoping that they would find a solution
• Manufacturers knew this had to be a straight run through, they didn’t have time for investment decisions and pausing or thinking about a commercial market at the end of it. It had to happen with real urgency.
• But the vaccine trials have been just the same as normal vaccine trials. Phase one, phase two and phase three. Where time has been saved is by recruiting participants in advance, so at the moment the study protocol is in place, the Ethics Committee is in place, so are the vaccine trial participants – which speeds up the process. And that happened at phase one, phase two and phase three and therefore things ran very fast.

How can a vaccine be developed in nine months?

• These vaccines have been through phase 1, phase 2 and phase 3 clinical trials just like ordinary vaccines. The Pfizer vaccine clinical trial size was around 45,000 people. These are very, very big studies.
• Time has been gained is instead of getting an investment decision then going to ethics committee then starting to recruit volunteers, all of the recruiting volunteers was done in advance so that the people were completely ready to go and the ethics committees moved very fast to approve the trials.
• Organisations like the National Institute for Health Research made this their top priority and plans were made for the next phase by the companies without having to wait for things like investor decisions.
• But the numbers of people in the trials were the same as you would expect for any other vaccine, and on top of that the safety assessments and the assessments of effectiveness at the end are the same – it’s the same regulators doing the same job.
• Companies have made decisions to begin large scale production of vaccines which are still in trials. This means that if the vaccines are not shown to be safe and effective and are not authorised for use the companies will have to destroy what they have manufactured. If, however the vaccines are successful, that means the vaccines are ready to be distributed.

Regulation and Authorisation

How are vaccines regulated and authorised for use?

• The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK’s independent regulator. Their role is to ensure medicines, devices and vaccines work effectively and are safe for use.
• Each COVID-19 vaccine candidate is assessed on a case by case basis and will only be authorised once it has met robust standards of effectiveness, safety and quality.
• Teams of scientists and clinicians carefully, methodically, scientifically rigorously review all data on safety, effectiveness and quality as soon as they become available, and have done so throughout all tests and trials
• The data looked at includes all the results from laboratory studies, clinical trials, manufacturing and quality controls and testing the product. The public on that basis should be very confident that all tests are done to the very highest standards, and only then will a COVID-19 vaccine be made available

Prioritisation

The full prioritisation list can be found here and is as follows (in order of priority):

• Residents in a care home for older adults and their carers
• All those 80 years of age and over and frontline health and social care workers
• All those 75 years of age and over
• All those 70 years of age and over and clinically extremely vulnerable individuals
• All those 65 years of age and over. All individuals aged 16 years to 64 years with underlying health conditions which put them at higher risk of serious disease and
• mortality
• All those 60 years of age and over
• All those 55 years of age and over
• All those 50 years of age and over

Why aren’t BAME groups being prioritised?

• There is clear evidence that certain Black, Asian and minority ethnic (BAME) groups have higher rates of infection, and higher rates of serious disease and mortality. The reasons are multiple and complex.
• There is no strong evidence that ethnicity by itself (or genetics) is the sole explanation for observed differences in rates of severe illness and deaths. What is clear is that certain health conditions are associated with increased risk of serious disease, and these health conditions are often overrepresented in certain Black, Asian and minority ethnic groups.
• Prioritisation of people with underlying health conditions will also provide for greater vaccination of BAME communities who are disproportionately affected by such health conditions.
• Tailored local implementation to promote good vaccine coverage in Black, Asian and minority ethnic groups will be the most important factor within a vaccine programme in reducing health inequalities in these groups.

Why aren’t you vaccinating economically active people? Surely that would be a good approach to get the economy back up and running again?

• The full impact of vaccination on infection and transmission of the virus will not become clear until a large number of people have been vaccinated.
• The Joint Committee on Vaccination and Immunisation (JCVI) are the independent experts who advise Government on which vaccine/s the United Kingdom should use and provide advice on prioritisation at a population level.
• The Committee have advised that the first priorities for any COVID-19 vaccination programme should be the prevention COVID-19 mortality and protection of health and social care staff and systems. Secondary priorities could include vaccination of those at increased risk of hospitalisation and at increased risk of exposure, and to maintain resilience in essential public services.
• Given the current epidemiological situation in the UK, all evidence indicates that the best option for preventing morbidity and mortality in the initial phase of the programme is to directly protect persons most at risk of morbidity and mortality.

What about people who are immunocompromised who can’t benefit from a vaccine?

• The Government is exploring all avenues available to us, to ensure that a treatment for COVID-19 is found.
• Treatments containing COVID-19 neutralising antibodies have been secured from AstraZenaca to support immunocompromised people who will not be able to benefit from a COVID-19 vaccine.
• The antibody treatment currently being developed by AstraZeneca is a combination of two monoclonal antibodies and has the potential to be given as a preventative option for people exposed to the virus, and to treat and prevent disease progression in patients already infected by the virus if successful.

Why do the JCVI’s recommendations focus on reducing people’s individual risk and not stopping transmission?

• The most important thing is that we protect those who are most at risk of dying. At the start of any vaccination programme, we won’t know the impact of the vaccine on transmission and so we will vaccinate those who are at highest risk of serious illness and death. This includes older people and care home residents.
• As vaccination programmes roll out globally, our understanding of the safety and effectiveness of each vaccine will increase, and these data will be used to develop advice on the next phase of the programme.

Why is vaccination not recommended for children?

• Almost all children with COVID-19 have no symptoms or mild disease and the vaccines not yet been tested in younger children. The Committee advises 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.

Is the vaccine safe for people with pre-existing conditions?

• The trials have involved people with chronic underlying conditions deliberately, and they have involved people from very broad age ranges and quite a lot of people in the elderly bracket. The JCVI have looked at this, there’s no indication that there should be any difficulty in giving it to people with chronic underlying conditions.
• The JCVI has picked out, not just by age, but people 18 to 65 with at-risk conditions. And, and the reason for that is that they are at extremely high risk from coronavirus compared with the general population.

Why is vaccination not recommended for pregnant women?

• These vaccines have not yet been tested in pregnant women and so we are taking a highly precautionary approach. Women should not be vaccinated if they may be pregnant or are planning a pregnancy within three months of the first dose.
• Data are anticipated which will inform discussions on vaccination in pregnancy. JCVI will review these as soon as they become available.

What about if a woman becomes pregnant between her first and second dose – what happens then?

• Although the available data do not indicate any safety concern or harm to pregnancy, there is insufficient evidence to recommend routine use of COVID-19 vaccines during pregnancy. Vaccination should be postponed until completion of pregnancy. If a woman finds out she is pregnant after she has started a course of vaccine, she should complete her pregnancy before finishing the recommended schedule.

What vaccines will we have?

• The UK has secured access to seven different possible vaccines, across four different vaccine types, reflecting the government’s strategy to ensure the UK has a supply of vaccines should they prove safe and effective in clinical trials. These are at separate stages of development.
• We have secured early access to over 357 million vaccines doses through agreements with several separate vaccine developers at various stages of trials, including:
• 100 million doses of University of Oxford/AstraZeneca vaccine – phase 3 clinical trials

• 40 million doses of BioNTech/Pfizer vaccine
• 7 million doses of Moderna vaccine
• 60 million doses of Novavax vaccine
• 60 million doses of Valneva vaccine
• 60 million doses of GSK/Sanofi Pasteur vaccine
• 30 million doses of Janssen vaccine

We have invested over £230m into manufacturing any successful vaccine and an enormous amount of planning and preparation has taken place across Government to be able to quickly roll out the vaccine, including ensuring we have adequate provision, transport, PPE and logistical expertise to do so. We are also working at pace to prepare for the delivery of any potential COVID-19 vaccination programme as quickly as possible.

Vigilance, surveillance and adverse incidents

• Each COVID-19 vaccine candidate is assessed on a case by case basis and will only be approved by the independent regulator, the MHRA, once it has met robust standards of effectiveness, safety and quality. Right through the tests and the trials, teams of scientists and clinicians carefully, methodically, scientifically rigorously review all data on safety, effectiveness and quality as soon as they become available.
• Like all medicines, vaccines can cause side effects. Most of these are mild and short-term, and not everyone gets them.
• The independent expert working group have supported MHRA proposals for a proactive safety monitoring strategy. This comprises the Yellow Card scheme and a special active monitoring programme which we are inviting people to join.
• Approved COVID-19 vaccines will be monitored continuously after roll out by the MHRA and PHE to ensure that the benefit of the vaccines continues to outweigh any risk.
• You can report suspected side effects to COVID-19 vaccines through the Coronavirus Yellow Card reporting portal https://coronavirus-yellowcard.mhra.gov.uk/
• The MHRA will work in collaboration with partners in the health system to rapidly assess all available safety data in real time and communicate any emerging issues, as necessary.

If there are any significant medical incidents, could rollout could be halted?

• Each COVID-19 vaccine candidate is assessed on a case by case basis and will only be approved once it has met robust standards of effectiveness, safety and quality. Right through the tests and the trials, teams of scientists and clinicians carefully, methodically, scientifically rigorously review all data on safety, effectiveness and quality as soon as they become available.
• Once a vaccine has been rolled out, PHE will continue to closely monitor safety data. In the rare instance of a medical incident, DHSC will review the available data.
• The government are clear that all vaccines being rolled out must continue to meet high standards of safety and efficacy

Vaccine trials importance

• The encouraging news about vaccines is thanks to clinical study participants volunteering to take part and shows the importance of this vaccine research.
• Clinical trials into the vaccines against COVID-19 continue at pace, and it is essential that these do so. We will need data about a number of vaccines and their safety and effectiveness, in order to protect the population. No one vaccine is likely to be suitable for everyone, the first vaccine may not be the most effective and easiest to use, and we must make sure that the other studies continue to allow us to have a selection of vaccines to protect the whole population. We are likely to need several vaccines to provide enough doses for everyone at risk, as early as possible.

How many people have taken part in clinical trials and what about ages, ethnic backgrounds and medical conditions?

• All of the vaccines will be tested on between 15,000 to 50,000 people across the world. They are tested on both men and women, on people from different ethnic backgrounds, and of all ages between 18-84.
• The studies have also looked as to whether the vaccines work on people with certain medical conditions and in older people, as their immune responses can work less effectively and therefore give them less protection through vaccines. As a result of this testing on a representative sample of the population, we can be confident that an approved vaccine will be effective for the wider population in the UK.
• There will be further studies to look at how best to use the different vaccines, for example, which vaccine is most effective in which individuals and what sized dose is most effective A number of vaccines remain in development, and these may offer benefits over the first approved vaccine/s.
• All this ongoing research will be vitally important to ensure we get the best protection from the vaccine. Research and vaccine development will not end with the first approved vaccine – there will be a process of continuous improvement.

Will people on vaccine trials be able to have a COVID-19 vaccine when it is available?

• Once a vaccine is available, we will have a process in place so people on vaccine studies are not disadvantaged. People taking part in the vaccine research will still be able to have an approved vaccine when this is available. Taking part in a study is the best way to help effective vaccines to be identified and made available to everyone earlier and may even give you early access to a vaccine later found to be effective.

Communications & Campaigns

Are you launching a campaign with celebrities to promote vaccinations?

• An effective vaccine will be the best way to protect the most vulnerable from coronavirus and the biggest breakthrough since the pandemic began, potentially saving thousands of lives.
• We will provide advice and information at every possible opportunity to support those who have been prioritised to receive a vaccine and anyone who has questions about the vaccination process.

What is the government doing about the spread of disinformation?

• Letting vaccine disinformation spread unchecked could cost lives. We take this issue extremely seriously and have secured a major commitment from Facebook, Twitter and Google to tackle it by not profiting from such material, and by responding to flagged content more swiftly.

PHE continue to work closely with social media firms to promote authoritative sources of information so people have access to vaccine facts not fiction.