3rd Primary Dose COVID-19 Vaccination Guidance for People with MS

November 1, 2021 | Advocacy, Covid-19, Treatments

On the 19^th of October 2021, the Ministry of Health, announced 3^rd primary dose vaccinations for those who are severely immunocompromised. This announcement was based on recommendations by the COVID-19 Vaccine Technical Advisory Group (CV TAG) who continuously review evidence and provides advice to the Programme.

Multiple Sclerosis NZ has prepared this information with advice from our specialist advisors to assist people with MS to understand the recommendations and their eligibility. If you are unsure of any of this information, your suitability, eligibility or how to optimally time a 3^rd primary dose vaccination, we recommend you seek advice from your Neurology Team or GP.

This information can be downloaded as a PDF here: COVID 3rd Primary Dose Guidance for People with MS – 28 October 2021

Rationale for 3^rd primary doses for those who are immunocompromised

The CV TAG provided recommendations on the use of an additional 3^rd primary dose of the Pfizer/BioNTech vaccine for those who are severely immunocompromised. From their review of the evidence it was concluded that “it is evident that some severely immunocompromised people do not mount a sufficient immune response to provide adequate protection against COVID-19. Severely immunocompromised consumers are also at higher risk of severe outcomes from COVID-19 compared to non-immunocompromised consumers. This group also tends to have a prolonged infection and viral shedding period, are at higher risk of developing a new variant, and are more likely to transmit the virus to any contacts compared to non-immunocompromised consumers.”

As a result of this analysis, the CV TAG have recommended a 3^rd full dose of the Pfizer vaccine for those that are severely immunocompromised, to offer extra protection. The evidence suggests a 3^rd primary dose may increase antibody titres (levels/response) in immunocompromised consumers who developed low or no antibody titres (levels/response) to the standard two-dose regimen.

Additionally, the evidence from overseas indicates this would be well tolerated, and adverse reactions reported following a 3^rd primary dose are similar to those after a second dose for example, fatigue and pain at injection site. Most side effects were reported as mild to moderate.

Is a 3^rd primary dose the same as a booster?

No. A 3^rd primary dose is not the same as a booster being considered for the general population. It is the same amount of vaccine as your first and second doses.

Will a 3^rd primary dose guarantee an optimal immune response?

People who are severely immunocompromised may continue to have a suboptimal immune response to vaccination and should continue to follow other public health measures, such as physical distancing, wearing a face covering, practicing hand hygiene, and isolation or quarantine as advised by public health authorities.

Timing of the 3^rd primary dose

The 3^rd primary dose is recommended to be given 2-6 months after the second dose of the Pfizer vaccine, if there no medical reasons not to.

The CV TAG Statement gives specific advice regarding various groups of medications which may result in a reduced response to the first two COVID-19 vaccine doses. Some of these medications are used to treat people with MS, including pulsed corticosteroid therapy (such as methylprednisolone), and some, but not all disease modifying therapies (DMTs) which deplete certain immune cells.

There are also specific recommendations for people who have undergone haemopoietic stem cell transplants (HSCT) recently as discussed below.

All individuals should refer to the full documentation provided by the Ministry of Health in consultation with their medical team to manage the best plan forward. This information can be found here:

Ministry of Health third primary dose website information: COVID-19 vaccine: Severely immunocompromised people | Ministry of Health NZ

Third dose policy statement: covid-19-vaccine-third-dose-policy-statement-21oct2021.pdf (health.govt.nz)

Antibody Testing

Antibody testing assesses the level of antibodies to a virus your body has been able to produce following vaccination. The CV TAG Statement also advises that antibody testing is not recommended to assess for immunity to COVID-19 following vaccination after a second or 3rd primary dose.

Is a 3^rd primary dose recommended for those diagnosed with MS but not on any treatment?

No. A diagnosis of MS does not mean you are immunocompromised. There are currently no recommendations nor evidence to suggest a 3^rd primary dose would benefit people living with MS outside of the immunocompromised groups. A 3^rd primary dose is not currently recommended by the COVID-19 Vaccine Technical Advisory Group (CV TAG).

The current recommendations for patients with MS are:

If you are on either Fingolimod (Gilenya) or Ocrelizumab (Ocrevus) or have been treated with Alemtuzumab a 3^rd primary dose is recommended (see below) and you should make contact with your GP or neurology team.  Patients on Ocrelizumab should discuss the timing of the vaccination with their neurology team to optimise the response to the 3^rd primary dose.

If you have been treated for a relapse with high dose steroids (methylprednisolone) for 10 days or longer in the last month or been on 10mg or more of steroids (such as prednisone) for more than 4 weeks in the last 3 months you should contact your GP regarding your eligibility for a 3^rd primary dose.

Similarly, if you have had aHSCT treatment within the last 24 months see the recommendations below you should discuss with your GP or haematology team whether you are eligible for a 3^rd primary dose.

Specific advice regarding commonly used treatments for MS:

Below is a list of medications and the current opinion regarding a 3^rd primary dose. If you are in any doubt about if and when you should have a 3^rd dose of COVID-19 vaccination you should discuss this with your treating team. 

The guidelines include those who may have stopped a 3^rd primary dose recommended treatment within the last 6 months.

We are aware that some DHBs are preparing to contact those on their records who would benefit from a 3^rd primary dose.

** Patients on Ocrelizumab should discuss the timing of their vaccination with the neurology team to insure optimal effect.

*** Treatment with high-dose Methylprednisolone for greater than 10 days in the last month or prednisone 10mg for more than 4 weeks in the last 3 months or prednisone greater than 7.5mg in combination with other therapies such as methotrexate azathioprine or 6-mercaptopurine which are not routinely used in people with MS. If you are unsure, please contact your GP or Specialist for advice.

Access to the 3^rd Primary Dose for people with severe immunocompromise

There are Four key components to Access a 3^rd Primary dose:

1. Eligibility
   • Either the practice contacts the person to let them know they are eligible for a 3^rd primary dose. If the person is interested, they are invited to make an appointment with their GP/Specialist for a consultation.
   • Or a person is aware of a 3^rd primary dose for severely immunocompromised people and contacts their GP or Specialist to understand if they are eligible.
2. Consumer Consent
   • The Medical Practitioner, gathers written consent using the 3^rd primary dose consent form provided by the Ministry of Health, prior to providing the person with a prescription. The medical practitioner documents the consent in their patient medical record. The consultation will be at no cost to the person.

• Script & Consent Form
  • The medical practitioner provides the person with the prescription and the co-signed consent form.
• Confirm Consent & Administer Vaccine
  • If the facility where the person gave their consent and received prescription is a Covid-19 vaccination site, usual vaccination processes should be followed to administer the vaccine.
  • If the consumer is to be vaccinated at a different time or place, the prescription and consent form must be taken or sent the vaccination site. The consent form must be confirmed and signed by the onsite Clinical Lead prior to vaccination. Clinical Leads should refer to section 18.2 of the Operating Guidelines on written consent forms.

Recommendation

If you are unsure of any of this information, your eligibility or how timings of a 3rd primary dose vaccination, we recommend you seek advice from your Neurology Team or GP.