Medical Centre

The news that two UK recipients of the Covid-19 Pfizer-BioNTech mRNA vaccine suffered allergic reactions illustrates the need for accurate recording of any adverse events following administration of Covid-19 vaccines. As these vaccines are new, we don’t yet have long-term data on their safety and efficacy. This data is essential to help build public confidence in these vaccines and ensure take-up of the vaccines is high; not just in the UK but globally as well. The data will also help identify how frequently vaccination is needed to ensure vaccine recipients retain their immunity to Covid-19.

The UK is well-placed to collect this data. We have a National Health Service that has developed computerised medical records for use in general practices on a population of around 67 million people. These electronic medical records provide longitudinal data on people’s health and medical experiences. They can now also be linked to other data; such as hospital admissions records and mortality records, as well as to the results of Covid-19 tests, increasing their value for monitoring the safety and efficacy of the new Covid-19 vaccines.

The comprehensive nature of these medical records and the large population they cover mean that they can be used to look at safety and efficacy of Covid-19 vaccines in specific populations. This could be, for example, by age, sex, medical history or ethnic group. It would also be possible to look at more serious health outcomes and death rates by linkage to other data sets. Hence, planning how we would use these data is essential and needs to start now.

The use of these data will be facilitated by the recently developed clinical codes for Covid-19 vaccines for recording information in electronic medical records. These codes include, for example, codes for whether people attended or did not attend for their vaccination appointment; whether they declined to be vaccinated; and whether they had a clinical contra-indication to being vaccinated. Other codes allow recording of the specific vaccine that was administered, which will be essential for comparing the long-term safety and efficacy of different Covid-19 vaccines.

The data from electronic medical records can be supplemented by the reporting of any suspected adverse events by health professionals to the MHRA via the Yellow Card Scheme. Vaccine recipients should also be encouraged to report any reactions directly to the MHRA a well as to their doctor. This allows the MHRA to build up information on the safety profile of the new Covid-19 vaccines and advise patients and the public of any potential problems.

Read Measuring the long-term safety and efficacy of Covid-19 vaccines in full

The results of the AstraZeneca adenoviral ChAdOx1 nCoV-190 vaccine trial published in the Lancet today are encouraging, even if the overall efficacy of 70% is lower than the 90-95% being reported for mRNA vaccines from Pfizer-BioNTech and Moderna; and from the Russian Sputnik adenoviral vector vaccine.

The AstraZeneca vaccine is cheaper than the mRNA vaccines and can be stored in a conventional vaccine fridge. Hence, it is an easier vaccine to use in primary care and community settings, including in low and middle income countries. The most commonly reported adverse reactions were fatigue, headache, feverishness, and myalgia. More serious adverse events were rare; none of which were thought to be due to either of the vaccines used in the study.

Based on these results, once the vaccine is approved by the MHRA, I would like to see it rapidly adopted by the NHS. The vaccine is highly suited for use in UK primary care as it can be stored in general practices and given to patients either opportunistically or in dedicated vaccination clinics. It can also be more easily used in care homes and for housebound patients than the mRNA vaccines.

There is ongoing research looking at vaccine combinations and if this research shows positive results, people may benefit from a second vaccine, such as an mRNA vaccine, after receiving an adenoviral vaccine. One caveat for all the Covid-19 vaccines is that we don’t yet know how long the immunity they generate will last. We also don’t yet know if they stop people being infectious.

Read The AstraZeneca adenoviral Covid-19 vaccine: What potential role does it have? in full

Covid-19 vaccinations will kick off within days but it seems some people need a sharp dose of facts first. In an article published in the Daily Mirror, Matt Roper and I debunk some of the common myths and misconceptions about vaccines.

Scepticism about vaccines has been growing throughout the pandemic and a recent survey found that one in five British adults may refuse to take a coronavirus jab – even though it is probably our only hope of a return to normality.

1. MYTH: A vaccine produced so quickly can’t be safe

Most vaccines take years to develop, test and approve for public use but, says Dr Majeed, a global effort has meant scientists have been able to work at record speed.

He says: “Covid-19 vaccines have to go through the same process of approval as other vaccines. Funding was made available immediately and studies set up rapidly.

“There have been a lot of technological developments that allow vaccines to be developed much more quickly.”

2. MYTH: I might be allergic but won’t know until I get it

Azeem Majeed is professor of primary care and public health at Imperial College London

“Allergies to vaccines are very rare,” says Dr Majeed. “They are given safely to millions of people every year.”

The odds you’ll have a severe reaction to a vaccine is about one in 760,000.

Being struck by lightning next year is higher at one in 700,000.

Most reactions are because of some other component of the vaccine, such as egg protein, if the person is severely allergic.

3, MYTH: There haven’t been enough tests for people with underlying conditions

Dr Majeed says: “There are many vaccine trials taking place and they are being tested in people with different characteristics, such as age, sex, ethnicity and medical history.

“Results show they are safe in all groups they have been tested in.”

4. MYTH: Vaccines can overload your immune system

In 2018 the myth was debunked by American researchers who examined the medical records of more than 900 infants from six hospitals.

 They found no link between vaccines given before the age of two and other infections in the following years.

 “Vaccines do not overload your immune system,” says Dr Majeed. “On the contrary, they generate an immune response that helps reduce the risk of infection, complications and death.”

5. MYTH: The vaccine could actually give me coronavirus

Some vaccines contain the germs that cause the disease they are immunising against but they have been killed or weakened to the point they don’t make you sick.

In the case of a coronavirus vaccine, “none that are in development contain a live coronavirus,” assures Dr Majeed, “and they therefore can’t give you a coronavirus infection”.

6. MYTH: If everyone around me is immune, I don’t need a vaccine

“It’s essential to achieve a high vaccine coverage so we create herd immunity,” says Dr Majeed. “If people refuse to be immunised, we will continue to get outbreaks of Covid-19.

“If you decline to be immunised, you may get infected and also infect the people you come into contact with.”

7. MYTH: It’s better to be immunised by catching Covid

Dr Majeed says: “Vaccines have been shown to be very safe, whereas illnesses such as measles and Covid-19 can lead to serious long-term medical complications.

 “Vaccines have saved many lives and prevented people from being left disabled.”

8. MYTH: Vaccinated children experience more allergic, autoimmune and respiratory diseases

This is another unfounded claim that has led some parents to delay or withhold vaccinations, says Dr Majeed.

 Studies examining many vaccines have failed to find a link with allergies or autoimmune disease.

 “Vaccines protect against many diseases and substantially reduce the risk of illness and death in children,” he says.

9. MYTH: Some of those taking part in trials died

Stories that Dr Elisa Granato, one of the first participants in the human trials of the Oxford vaccine, died shortly after being injected, were shared millions of times.

 The news was false and she gave a BBC interview saying she was feeling “absolutely fine”.

 “Only one death has been reported among people taking part in trials,” says Dr Majeed.

 João Pedro Feitosa, a doctor in Brazil, was given the placebo rather than the vaccine and died of Covid-related complications.

10. MYTH: The swine flu vaccine left people with side effects, so why would this one be safe?

A mass vaccination programme against swine flu in the US in 1976 led to increased chances of people developing Guillain-Barre syndrome, a rare neurological disorder.

 Dr Majeed says: “Covid-19 vaccines have been carefully tested in a large number of volunteers and found to be very safe.

 “Once they are more widely used, there will be monitoring of people who have received the vaccines to identify any future problems.”

11. MYTH: Vaccines cause autism

 The idea that vaccines cause autism has long been disproved but the claims have recently been doing the rounds again.

 Last year a massive study from Denmark found no association between being vaccinated against measles, mumps and rubella, and developing autism.

 It is the latest of at least 12 other studies that have tried and failed to find a link.

 Dr Majeed says: “No evidence has ever been found that vaccines cause autism in children.”

12. MYTH: The Spanish Flu vaccine led to 50 million deaths

During the 1918 pandemic it was the fact there was no vaccine that caused it to infect a third of the world’s population.

 In the 1930s scientists found it was caused by a virus, with the first vaccine developed a decade later.

Read Covid-19 vaccination – separating fact from fiction in full

The global Covid-19 pandemic has led to over 50,000 deaths in the United Kingdom, disrupted health services for many other conditions, and has had enormous economic impacts that have led to massive increases in unemployment and government debt.[1,2,3] With the United Kingdom’s failure to implement an effective test, trace and isolate programme as we have seen in countries such as South Korea and New Zealand, a vaccination programme offers us the best way to finally bring this pandemic under control[4]. It is therefore essential that the Covid-19 vaccination programme is implemented well and that we do not repeat the many mistakes we have seen in the government’s response to Covid-19, such as in the Test and Trace programme.[5]

Primary care should be at the heart of the delivery of the UK’s vaccine programme. With around 7,000 general practices in England, for example, they are easy for patients to access and their staff are generally well-trusted by the public.  Unfortunately, a decade of under-investment in primary care has led to a shortage of general practitioners, very overstretched primary care teams, and reduced the ability of primary care to respond to new challenges.[6] These problems cannot be addressed quickly but the government can take some immediate actions to reduce pressures on primary care. This could include, for example, cutting the administrative burden on general practices by suspending appraisals, revalidation and CQC inspections for the foreseeable future.

To ensure smooth implementation of the vaccine programme, funding is required to pay for new vaccination centres, provide current general practice clinics with the facilities they need such as equipment for transporting and storing vaccines, and meeting the costs of administering a complex vaccination regime to patients who are housebound or living in care homes. Other required measures include funding to rapidly recruit additional staff such as general practitioners, nurses, healthcare assistants to administer vaccines; and staff to provide administrative and management support. It is also essential that primary care services for the management of acute and long-term problems, and preventive programmes such as children’s immunisations, continue to operate normally. This means that additional capacity rapidly needs to be created in primary care so that the vaccination programme does displace or delay other essential clinical work, particularly as Covid-19 vaccines are likely to take longer to administer than the other vaccines currently offered by the NHS, resulting in considerable extra work for primary care teams.

Moving on to the logistics of vaccine delivery, there are currently two types vaccines that are close to approval in the UK. Adenoviral vector vaccines such as ChAdOx1 nCoV-19 are logistically easier to deliver as they can be stored long-term in standard vaccines fridges and so could be administered by primary care teams working in the patient’s usual general practice.[7] In Contrast, mRNA vaccines have to be stored at very low temperatures (minus 70 degrees Celsius for the Pfizer / BioNTech mRNA vaccine) and have to be used within a short period of time after defrosting.[8] Hence, mRNA vaccines are more suitable for large vaccination centres with a high throughput of patients rather than the typical general practice. In the longer term, as more data on safety and efficacy becomes available, it would be appropriate to focus on a smaller number of vaccines, rather than continue with the government’s current approach of having many different vaccine options. As well as simplifying the vaccination programme, this would also cut its costs and reduce the likelihood or patients missing out on their second dose of vaccine because of its unavailability or receiving the wrong vaccine at their second appointment.

Looking forwards, we do not yet know how long the immunity and protection from infection generated by vaccination will last.[9] People may therefore require booster doses of vaccine at regular intervals and the NHS should also plan for this. This requires good call-recall systems, something which general practices can provide because of their computerised medical records and experience of delivering other vaccine programmes. We also need observational studies to assess how frequently “vaccine failures” occur (i.e. how many people contract Covid-19 despite being immunised and what their characteristics are), as well as data on adverse events and safety. The UK, with its system of computerised primary care records, is well placed to generate this data, particularly if linkages can be made to other data such as hospital episode statistics and mortality records. To do this, the problems that afflicted the Test and Trace programme in its early days, such as the failure to record test results in primary care records, must be avoided.[10] This is could be successfully achieved by integrating vaccination recording at the time of vaccination administration in the patient’s primary care record and not creating a separate information technology infrastructure as was done with Test and Trace.[11]

We need to ensure the NHS, and in particular primary care, is well-prepared for the programme and that unrealistic expectations of the timescale are not created amongst the public. The Covid-19 vaccination programme is too important to the health, wellbeing and economic security of the UK to delay its implementation or to get wrong.[12] The government has invested considerable funding into other areas of the Covid-19 response, including funding the private sector to deliver services such as Track and Trace. The funding that has been allocated to the NHS for the vaccination programme is currently small in comparison. Whatever investment is needed for the successful and timely delivery of the vaccination programme should be promptly provided by the government so the programme can begin at scale, rapidly vaccinate the at-risk population of the UK, and finally allow life in the UK to start to return to normal.

This article is based on an editorial published in the British Medical Journal

DOI: https://doi.org/10.1136/bmj.m4654

References

1. 50,000 COVID-19 deaths and rising. How Britain failed to stop the second wave. https://uk.reuters.com/article/health-coronavirus-britain-newwave/special-report-50000-covid-19-deaths-and-rising-how-britain-failed-to-stop-the-second-wave-idUSL8N2I94SG

2. Maringe C, Spicer J, Morris M, Purushotham A, Nolte E, Sullivan R, Rachet B, Aggarwal A. The impact of the COVID-19 pandemic on cancer deaths due to delays in diagnosis in England, UK: a national, population-based, modelling study. The Lancet Oncology. 2020 Aug 1;21(8):1023-34.

3. Office for Budget Responsibility. Economic and fiscal outlook – November 2020. https://obr.uk/efo/economic-and-fiscal-outlook-november-2020/

4. Majeed A, Seo Y, Heo K, Lee D. Can the UK emulate the South Korean approach to covid-19? BMJ 2020; 369 :m2084.

5. Scally G, Jacobson B, Abbasi K. The UK’s public health response to covid-19 BMJ 2020; 369 :m1932

6. Majeed A. Shortage of general practitioners in the NHS BMJ 2017; 358 :j3191

7. Ramasamy MN, Minassian AM, Ewer KJ, Flaxman AL, Folegatti PM, Owens DR, Voysey M, Aley PK, Angus B, Babbage G, Belij-Rammerstorfer S et al. Safety and immunogenicity of ChAdOx1 nCoV-19 vaccine administered in a prime-boost regimen in young and old adults (COV002): a single-blind, randomised, controlled, phase 2/3 trial. The Lancet. 2020 Nov 19.

8. Bower E. Which COVID-19 vaccines are lined up for roll-out on the NHS? https://www.gponline.com/covid-19-vaccines-lined-roll-out-nhs/article/1700217

9. Centers for Disease Control and Prevention. Frequently Asked Questions about COVID-19 Vaccination. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/faq.html

10. Carrell S, Garside J. Coronavirus testing hit by struggle to match results with NHS records  https://www.theguardian.com/world/2020/may/28/coronavirus-testing-hit-struggle-match-results-with-nhs-records.

11. Lind S. GPs may need to record Covid vaccinations on separate IT system, says NHS England. https://www.pulsetoday.co.uk/news/technology/gps-may-need-to-record-covid-vaccinations-on-separate-it-system-says-nhs-england/

12. Iacobucci G. Covid vaccine: GPs need more clarity on logistics and planning, say leaders BMJ 2020; 371 :m4555.

Read Vaccinating the UK against Covid-19 in full