Diabetes & COVID-19 Vaccination and treatments

With adults’ vaccine coverage reaching 81.7% in the EU and 58.5% in the WHO Europe region on November 30, 2021, the vaccination rates are beginning to stagnate, reflecting, to a great extent, a high proportion of vaccine-hesitancy. Most countries in Europe are now experiencing yet another COVID-19 wave, due to the higher transmissibility of new variants, the decreasing effectiveness of the COVID-19 vaccines over time, and high transmission rates among unvaccinated people. IDF Europe would like to provide some facts and dispel some myths about vaccination for people living with diabetes (PwD) and encourage them to get their vaccination and booster shots.

Which vaccines are on the market?

For EU countries

The BioNTech-Pfizer vaccine

• Approved by the European Medicines Agency (EMA) for adults on December 21, 2020, with approval for children between 5-11 years old, on November 25, 2021.
• This is the most widely used COVID-19 vaccine in the EU. After the initial contract purchasing 200 million doses on behalf of EU member states with an option to purchase 100 million additional doses, the EU Commission signed a third contract on May 20, 2021, for an additional 1.8 billion doses for EU Member States (MS) between the end of 2021 and 2023 – 900 million doses of the current vaccine and of vaccines adapted to variants, with an option to purchase another 900 million doses.
• Read the safety update here.

The Moderna vaccine

• Approved by EMA on January 6, 2021.
• On 17 February 2021, the European Commission approved a new contract with Moderna, in addition to its previous purchase of 160 million doses. This new contract provided for an additional purchase of 300 million doses (150 million in 2021 and an option to purchase an additional 150 million in 2022).
• On 22 June 2021, the Commission approved an amendment to the second contract for the activation of the 150 million optional additional doses in 2022.
• Read the safety update here.

The AstraZeneca vaccine

• Approved by EMA on January 29, 2021.
• The EU ordered a total of 300 million doses from AstraZeneca for its MS and for the COVAX programme on August 27, 2020.
• Read the safety update here.

COVID-19 Vaccine Janssen

• Approved by EMA on March 11, 2021.
• The EU commission has ordered 200 million doses of the single-shot Janssen vaccine for the second quarter of 2021 with the possibility to purchase an additional 200 million doses.
• Read the safety update here.

The Novavax Vaccine

• Approved by EMA on December 20, 2021.
• The EU commission has ordered 100 million doses for the first quarter of 2022 with the possibility to purchase an additional 100 million doses in 2022 and 2023.
• Read the safety update here

More on the EU vaccine purchasing strategy can be found here.

Under review:

Four additional vaccines, Vidpretyn developed by Sanofi Pasteur, Sputnik V developed by Russia’s Gamaleya National Centre of Epidemiology and Microbiology, Vero Cell COVID-19 developed by Sinovac Life Sciences and VLA2001 developed by Valneva are under review by the EMA until sufficient evidence is provided for a conditional marketing authorisation application.

For Non-EU countries

Countries that are not part of the EU may have access to additional vaccines other than the ones mentioned above. Check out the COVID-19 Vaccine tracker from the WHO to see the eight vaccines approved for use by the organisation. We recommend you consult the website of your national health ministry to read about the vaccines that are available to you.

How are COVID-19 vaccines approved in the EU?

The safety, efficacy, and quality of COVID vaccines are assessed by the EMA. The vaccine developer applies for conditional marketing authorisation (CMA) by submitting all the results of its testing to the EMA. Experts at the EMA then evaluates the data and develop a scientific opinion. The European Commission then reviews this opinion and decide whether or not to grant CMA to the vaccine developer. If CMA is granted, roll out of the vaccine in Member States can occur. The EMA also continues to monitor the vaccines once they are approved to protect patients. Click here for more information on this process.

Facts about the Pfizer Vaccine

How does it work?

• Scientists take parts of the virus’s genetic code (RNA)
• The vaccine enters the body’s cells and tells the cells to produce the coronavirus genetic marker (spike protein)
• This prompts the body’s immune system to produce antibodies that lock on to the coronavirus spike protein
• This marks it for destruction by white blood cells (T cells)
• If the person who has been vaccinated encounters the coronavirus in the future, the antibodies and T cells are triggered to fight the virus

How was the vaccine trialled?

• 44,000 participants
• 6 countries: USA, Germany, Brazil, Argentina, South Africa, Turkey
• Different ages, gender, race, ethnicity
• Showed same/higher levels of antibodies than those recovering from COVID infection
• 95% efficacy
• Length of protection is unknown (may need a booster or annual vaccines)

Is it safe?

• No safety concerns reported in the trial
• Any common serious side effects would have become apparent in a large number of trial participants
• Local side effects at the site of injection
• Pain - mild and self-resolved
• Systemic side effects (whole-body) include headache, chills, muscle ache, tiredness, fever, joint pains
• All are common side effects in other vaccines e.g., flu

Other facts

• There is no whole or live virus in the vaccine so it cannot cause disease
• There are no animal products in this vaccine
• Safe in breastfeeding women
• Generally, not for use in pregnancy
• People who know they are allergic to any of the components of the vaccine should not get it

Facts about the Moderna Vaccine

How does it work?

• The vaccine contains a molecule (mRNA) that has instructions to make spike protein
• When the vaccine enters the body, it tells the cells to make spike protein which is the same protein on the surface of SARS-CoV-2
• This will trigger the immune system to produce antibodies and send T cells to attack it
• If the person who has been vaccinated encounters the coronavirus in the future, the antibodies and T cells will be triggered to fight the virus

How was the vaccine trialled?

• 30,000 participants
• Different genders, races, ethnicities
• 94.1% efficacy
• Length of protection is unknown

Is it safe?

• Most side effects are mild and disappear within a few days
• Common side effects include pain and swelling at the site of injection, tiredness, chills, fever, swollen/tender lymph nodes under the arm, headache, muscle and joint pain, nausea, vomiting

Other facts

• The vaccine does not contain the virus itself and cannot cause COVID-19
• Not yet recommended for use in children
• If you are pregnant/breastfeeding consult with a healthcare professional before getting the vaccine
• People who know they are allergic to any of the components of the vaccine should not get it

Facts about the AstraZeneca Vaccine

How does it work?

• The vaccine is made up of another virus (adenovirus)
• The adenovirus has been modified to contain the gene for making the SARS-CoV-2 spike protein
• Once the vaccine enters the body, the cells will use the gene to make the spike protein
• The immune system will recognise the spike protein as foreign and produce antibodies and activate T-cells to attack it
• Then, if the person comes into contact with SARS-CoV-2 in the future the immune system will be prepared to fight it 

How was the vaccine trialled?

• 24,000 participants
• 3 countries: the UK, Brazil, and South Africa
• Clinical trials included people of different ethnicities and genders
• 60% efficacy
• Length of protection unknown

Is it safe?

• The most common side effects are mild and get better within a few days
• Common side effects are pain and tenderness at the injection site, headache, tiredness, muscle pain, general feeling of being unwell, chills, fever, joint pain and nausea

Other facts

• The adenovirus in the vaccine cannot reproduce and does not cause disease
• Not currently recommended for use in children
• If you are pregnant/breastfeeding consult with a healthcare professional before getting the vaccine
• People who know they are allergic to any of the components of the vaccine should not get it

Facts about the Janssen Vaccine

How does it work?

• The vaccine is made up of another virus (adenovirus)
• The adenovirus has been modified to contain the gene for making the SARS-CoV-2 spike protein
• Once the vaccine enters the body, the cells will use the gene to make the spike protein
• The immune system will recognise the spike protein as foreign and produce antibodies and activate T-cells to attack it

• Then, if the person comes into contact with SARS-CoV-2 in the future the immune system will be prepared to fight it

How was the vaccine trialled?

• 44,000 participants
• United States, South Africa and Latin American countries
• The clinical trials included people of different ethnicities and genders
• 67% efficacy
• Protection starts around 14 days after vaccination but it is not currently known how long protection continues

Is it safe?

• The most common side effects are usually mild or moderate and get better within 1 or 2 days after vaccination
• The most common side effects are pain at the injection site, headache, tiredness, muscle pain and nausea. They affected more than 1 in 10 people

Other facts

• COVID-19 Vaccine Janssen does not contain SARS-CoV-2 itself and cannot cause COVID-19
• COVID-19 Vaccine Janssen is not currently recommended for use in children
• If you are pregnant/breastfeeding consult with a healthcare professional before getting the vaccine
• People who know they are allergic to any of the components of the vaccine should not get it

Facts about the Novavax Vaccine

How does it work?

• The Novavax vaccine is made using the SARS COV-2 spike protein produced in the laboratory
• Once the vaccine enters the body, the cells will use the gene to make the spike protein
• The immune system will recognise the spike protein as foreign and produce antibodies and activate T-cells to attack it
• Then, if the person comes into contact with SARS-CoV-2 in the future the immune system will be prepared to fight it

How was the vaccine trialled?

• 45,000 participants
• Mexico, United States and the United Kingdom
• 90% efficacy
• Protection is optimal 7 days after the second dose

Is it safe?

• The most common side effects with Nuvaxovid in the trials were usually mild or moderate and got better within a few days after vaccination
• These included headache, nausea (feeling sick) or vomiting, muscle and joint pain, tenderness and pain at the injection site, tiredness and feeling unwell
• These affected more than 1 in 10 people

Click here to read more information about the Pfizer/BioNTech vaccine provided by the EMA

Click here to read information about the Moderna vaccine provided by the EMA

Click here to read information about the AstraZeneca vaccine provided by the EMA

Click here to read information about the Janssen vaccine provided by the EMA

Booster shots and co-vaccination with the flu

There is now growing concern about the decreasing effectiveness of the vaccines over time. To answer these concerns, the European Centre for Disease Prevention and Control (ECDC) and EMA have all set recommendations on the safety and effectiveness of COVID booster shots. PwD are considered to be at high risk which gives them the opportunity to obtain the booster shot as a matter of priority in most countries.

In the EU, the EMA published its findings on COVID-19 booster shots and gave regulators its approval in October 2021. Countries such as Germany, Greece, Italy, France, Portugal and several others have already started the administration of extra doses to the “at risk” population.

As most European countries face another wave of the pandemic, booster shots are increasingly becoming a tool to reduce the spread of the virus in the population. France, for example, has recently announced the necessity of having a booster shot to maintain a valid COVID-19 sanitary pass.

The flu and COVID-19 are closely interlinked. As most of the western hemisphere-imposed lockdowns, social distancing and strict restrictions on travelling, an unprecedented decrease in the number of influenza cases was observed in 2020. As most countries in Europe started relaxing their COVID-19 related measures, a rise in cases is expected during the winter of 2021. PwD are disproportionately affected by the flu – three to six times more likely to be hospitalised with influenza than the general population. The flu vaccine can decrease diabetes-related hospital admissions for influenza by as much as 79% over the course of a year.

An increasing number of studies on the simultaneous administration of the COVID-19 vaccine with the flu shot has been reported although no formal recommendation has been given by the EMA.

In the EU, countries such as Italy, the UK, Belgium, and Portugal have given the green light for simultaneous administration but with caution advised for the youth.

We encourage everyone to get the booster shot vaccination when they are offered it.

-Vaccine efficacy lowers with time, most studies show the need for a booster shot 5-7 months after the last vaccine. The EMA recommends that booster doses may be considered at least 6 months after the second dose for people aged 18 years and older.

- A study suggests that elevated HbA1c seemed to lower vaccine efficacy which suggests that booster vaccines are needed to optimally prevent the risk of hospitalization and death of COVID-19 in people living with diabetes.

Covid bivalent vaccine

In anticipation of a potential new wave of COVID-19 infection this autumn and winter, the ECDC and EMA published their recommendation for a second booster shot in July 2022. This is providing a green light for a second booster shot for people aged between 60 and 79 years old and for people with medical conditions putting them at high risk of severe disease such as diabetes.

In the UK, regulators have approved Moderna´s bivalent COVID-19 vaccine “Spikevax” targeting both the original strain and the first version of omicron BA.1 for the second booster shot. The EMA has started a rolling review of both the bivalent Spikevax vaccine and the variant-adapted COVID-19 vaccine from BioNTech-Pfizer “Comirnaty”.

Evidence is still being collected on the effectiveness and safety of these vaccines in large clinical trials. Preliminary data shows that these adapted mRNA vaccines can increase and extend protection against severe cases of COVID-19 compared to the traditional vaccine on the original strain when used as a booster.

The EMA expects the bivalent COVID vaccines to be approved by September, and for them to be used in the autumn booster vaccination campaign where most cases in the region is now linked to the BA.5 variant. Although the vaccine is based on the first strain of omicron BA.1, data shows a higher protection to other omicron variants compared to the vaccine targeting the original COVID strain.

Approved medicines for COVID-19 in hospital settings

In addition to vaccines as the main way out of this COVID-19 pandemic, there are several medicines and treatments that are starting to be approved worldwide. This provides great hope for the treatment of people developing severe forms of the disease as it sharply decreases their risk of death and hospitalisation/time spent hospitalised.

Regkirona

• Approved by EMA on November 11, 2021.
• Regkirona is a medicine developed by Celltrion and used for treating COVID-19 in adults who do not require supplemental oxygen and who are at increased risk of their disease becoming severe. This medicine contains the active substance regdanvimab.
• Regkirona is given as a single infusion (drip) into a vein within seven days of the start of COVID-19 symptoms; the dose depends on the patient’s body weight.
• The active substance in Regkirona, regdanvimab, is a monoclonal antibody with activity against SARS-CoV-2. A monoclonal antibody is a type of protein that has been designed to attach to a specific structure (called an antigen). Regdanvimab has been designed to attach to the spike protein of SARS-CoV-2. When regdanvimab attaches to the spike protein, the virus is unable to enter the body’s cells.

Ronapreve

• Approved by EMA on November 11, 2021.
• Ronapreve is a medicine developed by Roche and Regeneron used for treating COVID-19 in adults and adolescents (from 12 years of age and weighing at least 40 kilograms) who do not require supplemental oxygen and who are at increased risk of their disease becoming severe.
• The medicine can also be used to prevent COVID-19 in people aged 12 years and older weighing at least 40 kilograms. Ronapreve contains two active substances, casirivimab and imdevimab.
• Ronapreve is given as a single treatment by infusion (drip) into a vein or by injection under the skin.
• When used for prevention after contact with a person with COVID-19, Ronapreve should be given as soon as possible after contact occurred. Ronapreve may also be given to prevent COVID-19 when no contact has occurred.

• This medicine is made of casirivimab and imdevimab, two monoclonal antibodies. A monoclonal antibody is a type of protein that has been designed to recognise and attach to a specific structure (called an antigen). Casirivimab and imdevimab have been designed to attach to the spike protein of SARS-CoV-2 (the virus causing COVID-19) at two different sites. When the active substances attach to the spike protein, the virus is unable to enter the body’s cells.

Veklury

• Approved by EMA on July, 7, 2020
• Veklury is an antiviral medicine developed by Gilead to treat COVID-19. It is used in adults and adolescents (from 12 years of age and weighing at least 40 kilograms) with pneumonia requiring supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at the start of treatment).
• Veklury is given via infusion (drip) into a vein. The total duration of treatment should be at least five days and no more than 10 days.
• The active substance in Veklury, remdesivir, is a viral RNA polymerase inhibitor. It interferes with the production of viral RNA (genetic material), preventing the virus from multiplying inside cells. This can help the body to overcome the virus infection and may help patients get better faster.

Xevudy

• Approved by EMA on December 17, 2022
• The active substance of Xevudy, sotrovimab, is a monoclonal antibody, a type of protein that has been designed to recognise and attach to a specific structure (called an antigen). Sotrovimab has been designed to attach to the spike protein of SARS-CoV-2 (the virus that causes COVID-19). When sotrovimab attaches to the spike protein, the virus is unable to enter the body’s cells.
• Xevudy is given as a single treatment by infusion (drip) into a vein. The medicine can only be obtained with a prescription and should be given in healthcare facilities where patients can be adequately monitored during infusion and for one hour afterwards so that they can be managed in case they develop severe allergic reactions, including anaphylaxis.

RoActemra

• Approved by EMA on January 15, 2009
• RoActemra is a medicine used to treat adults with severe rheumatoid arthritis, adults with moderate to severe active rheumatoid arthritis, children from 1 year of age with active systemic juvenile idiopathic arthritis and is also used in adults with COVID-19 who are receiving treatment with corticosteroid medicines by mouth or injection and require extra oxygen or mechanical ventilation (breathing assisted by a machine).
• The active substance in RoActemra, tocilizumab, is a monoclonal antibody, a type of protein that has been designed to recognise and attach to a specific target (called an antigen) in the body to reduce inflammation.
• RoActemra can only be obtained with a prescription and treatment should be started by a doctor who has experience in the diagnosis and treatment of the relevant condition. RoActemra is available as a solution to be injected under the skin and as a concentrate for making a solution for infusion (drip) into a vein.

Paxlovid

• Approved by EMA on January 28, 2022
• Paxlovid is an antiviral medicine that reduces the ability of SARS-CoV-2 (the virus that causes COVID-19) to multiply in the body. The active substance PF-07321332 blocks the activity of an enzyme needed by the virus to multiply. Paxlovid also contains a low dose of the medicine ritonavir, which slows the breakdown of PF-07321332, enabling it to remain longer in the body at levels that affect the multiplication of the virus.
• Paxlovid can only be obtained with a prescription. The recommended dose is two tablets, each containing 150 mg PF-07321332, plus one tablet containing 100 mg ritonavir, to be taken together by mouth twice a day for 5 days. Paxlovid should be given as soon as possible after a diagnosis of COVID-19 has been made and within 5 days of the start of symptoms.

Kineret

• Approved by EMA on March 03, 2002
• Kineret is a medicine that is used to treat signs and symptoms of rheumatoid arthritis, cryopyrin-associated periodic syndromes, familial Mediterranean fever, Still’s disease and COVID-19 in adults with pneumonia requiring supplemental oxygen (low or high flow oxygen) and who are at risk of developing severe respiratory failure.
• The active substance in Kineret, anakinra, is an immunosuppressive medicine (a medicine that reduces the activity of the immune system). It is a copy of a natural human protein called ‘human interleukin 1 receptor antagonist’ that blocks the receptors for a chemical messenger in the body called interleukin 1.
• Kineret can only be obtained with a prescription and treatment should be started and supervised by a doctor. Kineret is available as a solution for injection under the skin. For COVID-19, the dose is 100 mg once a day for 10 days.

Evusheld

• Approved by EMA on March 25, 2022.
• Evusheld is a medicine used to prevent COVID-19 in adults and adolescents from 12 years of age. Evusheld contains two active substances, tixagevimab and cilgavimab.
• It is given as two injections of 150 mg tixagevimab and 150 mg cilgavimab at different sites and can only be obtained via prescription and monitoring.
• Tixagevimab and cilgavimab are two monoclonal antibodies. They have been designed to attach to the spike protein of SARS-CoV-2.

FAQs

Will taking the vaccine affect my diabetes?

As with any vaccine you may have received in the past, the coronavirus vaccine may cause your blood glucose levels to rise for a couple of days. You should not be alarmed by this and can refer to the sick day rules to manage these. Be prepared and ensure that there are people around you who know how to support you if this happens. After the vaccination, drink plenty of water and keep a close eye on your blood glucose levels and you should be good to go.

Will children with diabetes be offered the vaccine?

Currently, none of the vaccines available are recommended for children as more data still has to be collected on the effects of the vaccine on children. This includes children living with diabetes.

Is the vaccine recommended for pregnant/breastfeeding women who have diabetes?

There is currently no evidence to suggest that the coronavirus vaccine poses any additional risks to people with diabetes. However, if you are pregnant or breastfeeding, we recommend that you consult with a healthcare professional first about the best course of action for you.

Countries that are not part of the EU may have access to additional vaccines other than the ones mentioned above. Check out the COVID-19 Vaccine tracker from the WHO to see the eight vaccines approved for use by the organisation. We recommend you consult the website of your national health ministry to read about the vaccines that are available to you.

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