Coronavirus Vaccines and LAM: UPDATED ADVICE

23rd January 2021

 Summary

  • COVID-19 can cause severe illness including loss of life and long-term complications.
  • All available vaccines give high levels of protection against severe Corona virus infection.
  • The COVID-19 vaccines appear both safe and effective for the majority of people.
  • It is recommended that women with LAM, including those taking rapamycin, should take whichever licensed Corona virus vaccine is offered to them.

In response to the COVID-19 pandemic, vaccines against SARS-CoV-2 corona virus have been developed rapidly.  Over 280 vaccines are in development and currently three have been approved for use in the UK and are being distributed. These are:

  • The Pfizer/BioNTech vaccine
  • The Moderna vaccine
  • The Oxford / Astra Zeneca vaccine

 How do the vaccines work?

The Pfizer/BioNTech and Moderna vaccines are RNA vaccines that cause the body to produce a small piece of SARS-CoV-2 protein (called an antigen), which your immune system recognises as foreign. Your immune system generates antibodies and T-cells against the SARS-CoV-2 antigen which can protect against the real Corona virus if you are exposed to it.

The Oxford/Astra Zeneca vaccine uses a weakened adenovirus to induce the production of the SARS-CoV-2 antigen. The adenovirus has been modified so that it cannot reproduce in humans to cause disease.

None of the vaccines:

  • Can cause COVID or other disease
  • Can become incorporated in your DNA
  • Contain animal products
  • Contain significant amounts of alcohol

The vaccines are suitable for:

  • Patients with LAM
  • Patients taking rapamycin
  • All ethnic and faith groups

How are the vaccines given?

All the vaccines require two doses to give the best protection.  Having two doses increases both your level of protection and the duration of protection.  Both doses should be the same vaccine type.

After having the first dose of any of the vaccines, it takes around 2 weeks to generate immunity.  In the vaccine trials, most of the cases of COVID occurring in the vaccinated subjects were in the first 10 days after the first vaccine, before immunity had built up.

The vaccine studies used a vaccination schedule with the two doses 3 – 4 weeks apart. The UK government have decided to schedule the two vaccine doses up to 12 weeks apart. This is a public health measure to increase the number of people with some immunity to Corona virus and will have a greater impact in reducing mortality, severe disease and hospitalisation than fully vaccinating a smaller number of people.  It does mean it will take longer for individuals to get the full benefit of the vaccine.

How effective are the vaccines?

Both the Pfizer/BioNTech and Moderna vaccines have a greater than 90% efficacy in providing protection against COVID-19.  The Oxford/Astra Zeneca vaccine has an efficacy of between 65 – 90% depending on the dose used.  The vaccines are effective at protecting severe disease and hospitalisation. The benefit of vaccination is similar across age, gender, and ethnicity and in people with obesity, diabetes, hypertension and lung disease.

 Can I have the vaccination if I am taking rapamycin (sirolimus) or everolimus for LAM?

Although the safety and efficacy of the COVID-19 vaccination has not been specifically studied in patients taking the mTOR inhibitors rapamycin or everolimus it is unlikely the side effects of vaccination will be different if you are using an mTOR inhibitor.  It is not yet known if mTOR inhibitors will reduce the immunity produced by the vaccination.  Overall, it is likely that patients on mTOR inhibitors will derive some immunity from COVID-19 as a result of being vaccinated.  Therefore it is recommended that women with LAM using the mTOR inhibitors rapamycin or everolimus should have the COVID-19 vaccination (in addition to the influenza and pneumococcal vaccinations) and should continue to take their rapamycin or everolimus as usual.

What are the side effects?

  • Injection site soreness, pain and swelling occur in >85% of people vaccinated.
  • Fatigue and headache occur in over half of the subjects.
  • Chills and joint pains occur in about one-third.
  • Fever occurs in around 15%.

Side effects are usually worse after the second rather than the first dose and worse in people under 55.  The majority of side effects are mild to moderate and resolve over 1-2 days.

Allergies

A very small number of individuals have experienced anaphylaxis when vaccinated with the Pfizer BioNTech vaccine.  Following close surveillance of the initial roll out the MHRA has advised that individuals 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 British Society for Allergy and Clinical Immunology has advised that:

  • Individuals with a history of immediate onset-anaphylaxis to multiple classes of drugs or an unexplained anaphylaxis should not be vaccinated with the Pfizer BioNTech vaccine. The AstraZeneca vaccine can be used as an alternative (if not otherwise contraindicated)
  • Individuals with a localised urticarial (itchy) skin reaction (without systemic symptoms) to the first dose of a COVID-19 vaccine should receive the second dose of vaccine with prolonged observation (30 minutes) in a setting with full resuscitation facilities (e.g. a hospital)
  • Individuals with non-allergic reactions (vasovagal episodes, non-urticarial skin reaction or non-specific symptoms) to the first dose of a COVID-19 vaccine can receive the second dose of vaccine in any vaccination setting

Special situations

Post organ transplant

Transplant recipients were excluded from recent SARS-CoV-2 vaccine trials. However, there is a lot of experience with ‘flu vaccine in transplant recipients and from this it is predicted that vaccines provide potential benefit and little risk to stable transplant recipients. It is recommended that organ transplant recipients discuss their vaccination with their transplant unit.

Use of immunosuppressive treatment (this does NOT include rapamycin/sirolimus prescribed for women with LAM).  

Vaccination is safe and recommended for individuals who are immunosuppressed, although they may not make a full immune response to vaccination. It is suggested that if people are due to receive planned immunosuppressive therapy, vaccination should be considered before starting therapy (ideally at least two weeks before), when their immune system is better able to make a response.  As there are no studies of the Corona virus vaccine response in immunosuppressed individuals, patients should liaise with their medical team.

Pregnancy

There is no known risk associated with giving inactivated, recombinant viral or bacterial vaccines during pregnancy.  They cannot cause infection in either the mother or the baby.  However, although the available data do not indicate any harm to pregnancy, there is not enough evidence to recommend routine use of COVID-19 vaccines during pregnancy. Women should be offered the vaccine as soon as possible after pregnancy.  Current recommendations are that vaccination in pregnancy should be considered, however, where the risk of exposure to SARS-CoV2 infection is high and cannot be avoided, or where the woman has underlying conditions that put them at very high risk of serious complications of COVID-19.  In these circumstances, clinicians should discuss the risks and benefits of vaccination with the woman, who should be told about the absence of safety data for the vaccine in pregnancy.

Breastfeeding

There is no known risk associated with giving non-live vaccines whilst breastfeeding. Breastfeeding women may be offered vaccination with the Pfizer-BioNTech or AstraZeneca COVID-19 vaccines. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for immunisation against COVID-19 and the woman should be informed about the absence of safety data for the vaccine in breastfeeding women.

When can I expect to receive a vaccination?

The vaccination is being distributed to the patients at the greatest risk of severe disease and death, which is determined mostly by increasing age.  Frontline healthcare staff are also being prioritised.  Most women with LAM will be in the clinically extremely vulnerable category (priority group 4 in the table below) and should be called for their vaccinations fairly early compared with the general population.

Priority group 1  Residents in a care home and Staff working in care homes for older adults

Priority group 2  All those 80 years of age and over Frontline Health and social care workers

Priority group 3  All those 75 years of age and over

Priority group 4  All those 70 years of age and over plus clinically extremely vulnerable individuals (not including pregnant women and those under 16 years of age)

Priority group 5  All those 65 years of age and over

Priority group 6  Adults aged 16 to 65 years in an at-risk group

Priority group 7  All those 60 years of age and over

Priority group 8  All those 55 years of age and over

Priority group 9  All those 50 years of age and over

 

Should I still socially distance, wear a mask and take hygiene measures after having the vaccine?

Yes.  Current guidelines are focused upon public health to reduce the spread of the virus in the community and limit severe infections.  Even if you have had the vaccine and are protected you may still be able to spread the virus to others if you are exposed, even if you do not become unwell yourself.  To protect yourself you should remember that full immunity does not occur until 2 weeks after your second dose and is not 100%.  As more people become vaccinated and the prevalence of the virus reduces in the community and we have further data on the effectiveness of the virus and if it reduces transmission, the shielding and other requirements will be able to be relaxed.

Further information

This is a guideline and not intended as individual medical advice.  As the pandemic is still evolving these recommendations will change and people should follow all current recommendations.

Detailed advice on CORONA virus vaccines and their use can be found here.

CORONA virus guidelines can be found here.

 

Professor Simon Johnson

Professor of Respiratory Medicine

UK LAM Centre

Nottingham

January 2021