Month: March 2021

Questions and answers about England’s new Covid-19 rules

Can I have a BBQ on the front of my house with others from my street?

Under the Rule of Six, you can only meet with a group of more than six if they are from your household and one other household (a maximum of two households). For example, if there were four people in your household and four in another household, the eight of you could meet for a BBQ as you are from two households. If your group is from more than two households, then a maximum of six people can meet, so you could not hold a BBQ for your entire street.


Can I use my friend’s toilet?

You are allowed to use your friend’s toilet if this is necessary. You should though avoid interacting or coming into close contact with anyone from your friend’s house while you are indoors as this is where the risk of infection is greatest. You should also wear a face mask or face covering whilst indoors, wash or sanitise your hands when entering the house, and spend the minimum time indoors. After using the toilet, wash your hands thoroughly, ideally using a separate towel or disposable hand towels, and go back outside immediately once you finish.


Can I meet with five mums and their kids in a park?

Large parent and child groups can only take place outdoors if they are for the benefit of children aged under five and organised by a business, charity or public body. If this was an informal meeting, however, you would need to limit the group to a maximum of six people. So, if you had five mums, only one child could join because children count towards the size of the group


If I can meet up with a BBQ, what are the rules around cups, plates, utensils?

There are no specific rules around cups, plates, and utensils but you should practise good infection control measures at a BBQ. You should use separate cups, plates and utensils for each person present and not share them as sharing will increase the risk of infection. You should also avoid sharing food because this has been shown to increase the risk of infection. Hence, shared food such as bowls of nuts or buffet style food is best-avoided as handling food by many people will increase the risk of infection (not just for Covid-19 but also for gastroenteritis).


Can I now chat with other mums in the school playground?

The same rules apply while you are in the playground as in other outdoor settings so you could only chat to a maximum of five other mums. However, schools would not look favourably on large groups of parents mixing in their playgrounds as they know this would increase infection risks and so may discourage such groups meeting on their grounds.


Now I’m allowed to see my mum who lives in another county, can I stay overnight in a hotel so I can spend more time with her?

This is a grey area as overnight stays away from home are only allowed for specific purposes. If this was a social visit, an overnight stay away from home would generally not be allowed. However, the rules also state that you can stay away from home overnight if you are unable to return to your main residence the same day. So, if your mother lived too far away for you to visit and return the same day, an overnight stay may be permissible


Can two households and the people in both their support bubbles meet, even if there will be 15 people?

You can meet in a group of any size from up to two households, including members of any existing support bubble. So, a group of 15 can meet outdoors if they are from a maximum of two households and their respective support bubbles.


Now I’m allowed to go walking outside my local area, am I allowed to camp overnight?

You can go walking outside your local area but an overnight camp would not be allowed as this would be seen as being for a non-essential purpose.


Can 10 people meet up for a game of five-a-side football?

10 people could only meet for an informal game of five-a-side football outdoors if they are from a maximum of two households. If they are from more than two households, they would exceed the maximum number of six people who can get together. You can take part in formally organised outdoor sports with any number of people but this must be organised by a business, charity or public body, and the organiser must take the required infection control precautions,


Are we on track to open shops, theme parks and gyms on April 12? What might set it back?

We are on track to open a wider range of businesses on April 12 because Covid-19 case numbers, hospital admissions and deaths are all currently falling in England. If there was a rapid increase in the number of cases in the next 1-2 weeks, this might lead the government stop this re-opening of businesses but this looks unlikely to be the case.


Could a hairdresser come and cut my hair in my garden?

As your haircut is taking place outdoors and only two people are involved, this is permissible under the rules. Your haircut though can’t take place indoors or at the hairdresser’s premises for now.


Can I conduct my yoga class in my garden or a park?

If this is a formally organised event held by a qualified yoga instructor or by a yoga club, then you can conduct your class outdoors without limits on numbers. You can’t however meet for an informal yoga session with your friends if this breached the rules on the maximum number of people who can get together.


Will more people than just the designated person be able to visit my mum in the garden of her care home?

Care homes can offer visits to other friends or family members if these take place outdoors, such as in the garden of the care home. You need to be mindful though that care home residents have a very high risk of serious illness and death if they contract Covid-19, so good infection control measures must be followed. Ideally, the visitors should also have been vaccinated as should your mum.


Can I go to the beach?

Yes, you can visit a beach but overnight stays away from home would not be allowed for this purpose, so you would need to be able to go to the beach and return home the same day.

Questions and answers about Covid-19 vaccination in children

Why should children have the vaccine?

Children will usually have a mild or asymptomatic illness and are very unlikely to die if they contract Covid-19. But they can sometimes have a prolonged illness that can result in them being absent from school and which can also occasionally lead to serious long-term complications, such as Multisystem Inflammatory Syndrome. Children can also transmit infection to others at higher risk of serious illness and death, such as their parents and grandparents.


Will all under-18s get the jab or specific groups/age groups?

Covid-19 vaccines will only be made available to children once we have good evidence of their safety and efficacy, and they have been licensed for use in children in the UK by the MHRA. It’s likely that any vaccination programme for children will start with those old enough to attend secondary school (above the age of 11 years), with vaccinations for younger children starting later.


Will it be compulsory?

Childhood vaccinations are not compulsory in the UK and are only given with parental consent.


Does it have to be an injection?

All the Covid-19 vaccinations in use in the UK, or which are close to being approved, are given by injection. It will be sometime, perhaps years, before we have vaccines that can be given by other routes, such as the nasal influenza vaccine that is used in children.


Will babies get it when they get their other jabs?

The timing of vaccination will depend on the results of research studies and the conditions put in place by the MHRA and guidance from the JCVI. Hence, we cannot yet say if younger children will be able to get the vaccine at the same time as their other vaccinations. But if this was possible, this would make vaccination more straightforward for children, parents and the NHS.


Will children get it at school or elsewhere?

This has not been decided yet but if vaccines are given to school-age children, this would be easier to carry out in schools as we currently do for the influenza vaccine for children. However, the government may also decide to use the NHS Covid-19 vaccine centres because some vaccines – such as the Pfizer mRNA vaccine – are not very easy to transport.


Are children getting vaccines in other countries? What has happened?

There are trials underway in some countries, such as the USA and UK, to test the safety and efficacy of Covid-19 vaccines in children. Israel has started to use vaccines in 16-17 year olds. Some children aged 16-17 years old in the UK with serious medical problems are also being vaccinated. However, the use of Covid-19 vaccines in children is not yet widespread, even for older children.


Does it mean children who aren’t vaccinated won’t be able to travel abroad?

It’s likely that children will be excluded from the need to provide proof of vaccination to travel overseas as there are not yet any vaccines that are approved for use for them. They may though require a recent negative test for Covid-19 before they can travel. It’s also possible that some countries will change their rules once Covid-19 vaccination becomes common in children.


If every person in Britain is vaccinated, will Covid be eradicated?

Only one disease, smallpox, has been entirely eradicated through vaccination. Some people will refuse to be vaccinated and in those who are vaccinated, the vaccines are not 100% effective in preventing infection, although they are very effective at preventing serious illness and death. Hence, we will still see cases of Covid-19 in the UK but if we have very high vaccine uptake in our population, we are unlikely to see large outbreaks unless a new variant of virus appears that is resistant to current vaccines.

Covid-19 vaccine adverse events: balancing monitoring with confidence in vaccines

As the global covid-19 vaccine rollout continues, uncertainties regarding the association between thromboembolic events and the Oxford-AstraZeneca vaccine have dominated the news during March, leading 18 European countries to suspend its use whilst this association was investigated by the European Medicines Agency. This suspension of the vaccine will have serious implications for vaccine confidence in general and, in particular, for global vaccination programmes. It has already  heightened anxiety levels and affected vaccine uptake especially among vaccine-hesitant groups due to claims about side effects that are not supported by real world data or data from clinical trials.

Of all the covid-19 vaccines currently licensed or in development, the Oxford-AstraZeneca vaccine was considered the vaccination of choice by many countries because of its low cost and ease of storage compared to other vaccines. In the UK, more than 25 million people have had their first dose of covid-19 vaccine, comprising almost half of the adult population, with either the Oxford-AstraZeneca or Pfizer-BioNTech vaccines.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has monitored the safety of both vaccines through the Yellow Card scheme—a mechanism of reporting any possible vaccine side effects known as adverse drug reactions (ADRs). However, these reports do not mean there is causal link between the use of a vaccine and side effects. Data up to 7 March shows an estimated 11.7 million first doses of Oxford-AstraZeneca and 10.9 million doses of Pfizer-BioNTech vaccines were administered in the UK, resulting in 35,325 and 61,304 reports of possible side effects for Pfizer and AstraZeneca vaccines respectively, indicating a very low rate of reported side effects. The overwhelming majority of reports consist of injection-site reactions and symptoms secondary to the normal immune response such as “flu-like” illness, headaches, chills, and fatigue. All these are in line with the findings from clinical trials and from side effects reported with other routinely used vaccines.

Reports of severe allergic reactions to the Pfizer (223 reports) and AstraZeneca (234 reports) vaccines have been very rare. Available MHRA data do not suggest that venous thromboembolism is caused by the AstraZeneca vaccine. To date, there have been five reports of cerebral venous sinus thrombosis to MHRA, a rare type of blood clot in the cerebral veins, with no causal association with the vaccine. The temporal association between vaccination and death in mostly elderly patients with health conditions have also been reported in about 500 cases. However, there is no evidence to support that vaccination caused these deaths.

While the investigations of a potential link between AstraZeneca vaccine and thromboembolic events continue, the MHRA, the World Health Organization (WHO) and the European Medicines Agency (EMA) have ruled out the causal link and stated that the population benefits far outweigh the risks, thereby reaffirming the safety of the vaccine that over 17 million people in the UK and EU have so far received. Around 30 cases of thromboembolic events have been reported amongst five million vaccinated people in EU; this rate remains lower than that observed in the general population.

Receiving a covid-19 vaccine is a landmark and memorable event for people and this coupled with a heightened sense of awareness following vaccination may lead to more cases being picked up. Moreover, there will be more presentations and over-diagnoses of thromboembolic events as expected following a highly publicised safety scare such as this.

While routine monitoring of vaccines to avoid potential harms is necessary, pausing or delaying vaccines must be evidence-based. The speculative commentary, generated by the media, will have serious and unintended consequences including an increase in vaccine hesitancy and even refusal; across Ireland, 30,000 vaccination appointments were cancelled during the week starting 15 March. Safety signals occur often with vaccines, with the majority representing false signals; although well-intentioned, the misapplied precautionary principle will undermine public trust, and heighten covid-19 risk through amplification of misinformation and disinformation campaigns of the “anti-vaxxer” movement. Vaccine-hesitant individuals are concerned about side effects and health-related long-term effects; these reports will make it very challenging to overcome these concerns at a time when covid-19 cases are still increasing across many European countries, requiring optimal uptake of vaccines to limit the impact of the covid-19 pandemic on populations.

The risks and trade-offs of suspending a life-saving vaccine must be carefully weighed especially during a pandemic; covid-19 itself is associated with blood clotting disorders. Historical precedents show that widely publicised safety scares have profound and long-lasting influence on vaccine confidence. [1] In 2017, the announcement that the dengue vaccine, Denvaxia, posed a risk to those who had not previously been exposed to the virus caused a drop in vaccine confidence in the Philippines and Indonesia. The safety controversy around the human papillomavirus vaccine in Japan caused one of the sharpest declines in vaccine uptake (from approximately 74% in those born in 1994-1998 to approximately 0.6% for those born in 2000). [2] The shock of this still reverberating today with Japan ranking among the lowest in vaccine confidence in a worldwide study. [1] A decline in vaccine uptake was also observed in Indonesia following warnings by the country’s faith leaders. [3]

Covid-19 vaccines are the single most effective way to prevent severe illness and death from the disease and accelerate the re-opening of society following non-pharmacological interventions such as lockdowns. Furthermore, vaccines are safe and have contributed to saving millions of lives. We call for monitoring of vaccine safety to occur out of the media limelight as sensationalist and exaggerated reporting will do irreparable damage to vaccine confidence. This includes suggestions by some media outlets that the actions taken by European countries were driven by political reasons. Sensationalist media reporting will lead to increased vaccine hesitancy, further loss of lives and derail efforts to end the current pandemic. Governments responses must be led by independent evidence through established public health and regulatory bodies such as the WHO, EMA and MHRA.

Mohammad S Razai, Academic Clinical Fellow in Primary Care, St George’s University of London. 

Tasnime Osama, Honorary Clinical Research Fellow, Department of Primary Care & Public Health, Imperial College London.

Azeem Majeed, Professor of Primary Care & Public Health, Department of Primary Care & Public Health, Imperial College London. 

This article was first published on BMJ Opinion

Questions and Answers about the AstraZeneca Covid-19 Vaccine

Should I really be worried about blood clots?

The AstraZeneca vaccine has been given to many millions of people across the world (over 10 million in the UK). A few of these people have suffered from blood clots after receiving the vaccine but no causal relationship has been found and the number of people affected is not above what we would expect in the general population in people who did not receive the vaccine.

How safe is the vaccine?

The clinical trials in which the vaccine was tested showed it was very safe, with a very low level of serious side effects and this has been confirmed subsequently in the wider use of the vaccine in the UK and elsewhere. The benefits of the vaccine far outweigh any risks. The clinical events that led to concerns about the vaccine are very rare with only a small number of episodes among the many millions of people who have received the vaccine.

Why are so many countries suspending it?

When a possible side effect is linked to a drug or vaccine, some countries will temporarily suspend use of the product until this has been investigated further. This does not mean that the vaccine is unsafe and we would expect further review of the data to confirm its safety.

Can I reduce the risk of a blood clot by taking an aspirin?

It’s probably not advisable to use aspirin in this way because no link between blood clots and the vaccine has been confirmed and there is a small risk of suffering a serious stomach bleed after taking aspirin.

What are the other possible side effects of the vaccine?

The most common side effects of the vaccine are pain and tenderness at the injection site, headache, tiredness, generalised muscle pain, shivering and a fever. These side effects usually resolve within a few days.

Does your age affect the likelihood of side effects? (For instance, do younger people feel worse because their immune systems are better?)

Side effects can occur at all ages but tend to be less common in older people. This is thought to be because the immune system gradually weakens with age, which also leaves older people more susceptible to infection.

Won’t I still be protected if I refuse the vaccine, because so many other people have had it?

It’s important that as many people as possible receive the vaccine. If a large number of people are not vaccinated, we will continue to see outbreaks of Covid-19, with some people suffering a serious infection that could result in hospital admission or death. The vaccine is not 100% effective and children are not currently being immunised, so there will be many people in the population who can still become infected.

What’s the down side of not having the vaccine?

If you don’t receive the vaccine, you are at much higher risk of contracting a Covid-19 infection. These infections can be serious, leading to long-term complications and death in many people. You may also infect others, including elderly relatives who may be at high-risk of serious illness. Furthermore, the more people who receive the vaccine, the more likely we are to an end to the pandemic and the lockdown measures it has led to.

Assessing risk for healthcare workers during the Covid-19 pandemic

In March 2020, the World Health Organization classified Covid-19 as an international pandemic. Initial guidance from many organisations identified people who might be more vulnerable to covid-19, based on knowledge of those known to be most susceptible to adverse outcomes from the influenza virus. Health conditions divided individuals into those who are “extremely vulnerable,” for whom shielding is required, and those at “increased risk of severe illness.”

In a paper published in the British Medical Journal, we provided guidance for employers on assessing risk for healthcare workers during the Covid-19 pandemic. Risk management should involve training, measuring how well control measures are working, and learning from that experience. A risk management process should also involve consultation with staff. The pandemic has created an opportunity to improve safety in the workplace beyond covid-19, to consider cultural factors, and to ensure that all staff feel included and supported to raise concerns. How such processes have been conducted should also be evaluated to help improve risk management in the current pandemic and in any similar events in future.


COVID-19 vaccine allocation: addressing the United Kingdom’s colour-blind strategy

Our new paper published in the Journal of the Royal Society of Medicine discusses whether the government should take ethnicity into account when establishing priority groups for Covid-19 vaccination as one component of a strategy to target health inequalities.

COVID-19 has disproportionately affected Black, Asian and Minority Ethnic (BAME) groups, resulting in higher rates of infection, hospitalisation and death. The COVID-19 pandemic has also exposed the pre-existing racial and socioeconomic inequalities in the UK. However, the Joint Committee on Vaccination and Immunisation has omitted ethnic minorities from the top priority groups which include older age, frontline health and social care workers, and care home staff and residents. The invisibility of these vulnerable groups from the priority list and the worsening healthcare inequities and inequalities are putting ethnic minorities at a significantly higher risk of COVID-19 illness and death.

The UK’s vaccine allocation strategies have the potential to further exacerbate the pre-existing, persistent but avoidable, racial inequalities that the COVID-19 pandemic and the wider governmental and societal response have harshly exposed and amplified. Dismissing the racial and socioeconomic disadvantages that ethnic groups face may result in a devastating impact lasting far beyond the end of the pandemic.

Controlling further outbreaks and, ultimately, ending the pandemic will require implementation of approaches that target ethnic minorities as well as ensuring that vaccine allocation strategies are effective, fair and justifiable for all.


Media Coverage

Associations between attainment of incentivized primary care indicators and incident sight‐threatening diabetic retinopathy

Our new study published in the journal Diabetes, Obesity and Metabolism shows a lower incidence of sight‐threatening diabetic retinopathy in people with type 2 diabetes who meet QOF targets for HBA1c, blood pressure and lipid control.

We aimed to examine the impact of attainment of primary care diabetes clinical indicators on progression to sight‐threatening diabetic retinopathy (STDR) among those with mild non‐proliferative diabetic retinopathy (NPDR).

We carried out a historical cohort study of 18,978 adults (43.63% female) diagnosed with type 2 diabetes before 1 April 2010 and mild NPDR before 1 April 2011 was conducted. The data were obtained from the UK Clinical Practice Research Datalink during 2010‐2017, provided by 330 primary care practices in England. Exposures included attainment of the Quality and Outcomes Framework HbA1c (≤59 mmol/mol [≤7.5%]), blood pressure (≤140/80 mmHg) and cholesterol (≤5 mmol/L) indicators in the financial year 2010‐2011, as well as the number of National Diabetes Audit processes completed in 2010‐2011. The outcome was time to incident STDR. Nearest neighbour propensity score matching was undertaken, and univariable and multivariable Cox proportional hazards models were then fitted using the matched samples. Concordance statistics were calculated for each model.

A total of 1037 (5.5%) STDR diagnoses were observed over a mean follow‐up of 3.6 (SD 2.0) years. HbA1c, blood pressure and cholesterol indicator attainment were associated with lower rates of STDR (adjusted hazard ratios [95% CI] 0.64 [0.55‐0.74; p < .001], 0.83 [0.72‐0.94; p = .005] and 0.80 [0.66‐0.96; p = .015], respectively).

Our findings provide support for meeting appropriate indicators for the management of type 2 diabetes in primary care to bring a range of benefits, including improved health outcomes—such as a reduction in the risk of STDR—for people with type 2 diabetes.