COVID-19 vaccination guidance for people with MS

The Australian and New Zealand Association of Neurologists (ANZAN) in collaboration with MS Australia have developed the following COVID-19 vaccination guidance addressing many common questions about the vaccination process and living with MS through the vaccination roll-out across the country.

Additionally, the Multiple Sclerosis International Federation (MSIF) has released an update to their vaccination guidance to reflect the most current global advice, which you can access here. It should be noted however, that some of this advice does not yet apply to Australia (such as for vaccination in those children under 18 years of age). As the COVID-19 pandemic evolves, internationally we are continuing to gather the evidence to help guide important decisions around the timing of the COVID-19 vaccinations and starting disease modifying therapies (DMTs) and other medications. However, your MS healthcare team and neurologist remain your primary advisors for your individual situation regarding your DMT, medications and vaccination timing. 

Last updated: 4/1/2022
Last reviewed: 10/1/2022

COVID-19 vaccination guidance

The current number one health priority around the world is rapid and efficient roll out of an effective vaccine to contain the COVID-19 pandemic. More than 182 million people have been infected and over four million have died worldwide. Numerous factors known to increase the risk of complications and death from COVID-19 have been clearly defined (age over 60, obesity, diabetes, heart disease, lung disease, high blood pressure, pregnancy and Black, Hispanic and Aboriginal ethnicity). A number of priority groups have been identified based on this evidence for the roll out of vaccination programs, but this will also be influenced by service delivery factors (e.g. healthcare workers).

Evidence shows that a person with multiple sclerosis (MS) is no more likely to develop COVID-19 or its complications, including if on treatment (with the possible exception of those on ocrelizumab who may be at very slightly increased risk). Those with secondary progressive MS and higher levels of disability may be at increased risk of complications from COVID-19.

Those with secondary progressive MS and/or higher levels of disability, heart or lung disease, or advanced age may be at increased risk of complications from COVID-19. 

COVID-19 vaccinations in Australia

The mortality from COVID-19 in Australia is approximately 2% of cases, which is slightly less than the international average mortality . This means that on average, 2 out of every 100 people who contract COVID-19 do not survive and many more require treatment in intensive care or have long-term consequences. Many vaccines have now been formally tested in phase 3 clinical trials in adults. They have been approved in some parts of the world and have proven to be highly effective and very safe. The current recommendation is that all adults (12 years and over) should be vaccinated against COVID-19. From January 2022, the vaccination rollout for children aged 5 to 11 years will commence in Australia (read more).

 

Several vaccines have been proposed for distribution to Australians. Adding to the two vaccines that have already been granted provisional registration by the Therapeutic Goods Administration (TGA) in Australia, Pfizer/BioNTech (“Comirnaty”) vaccine and the AstraZeneca/Oxford (“Vaxzevria”) vaccine, a third vaccination, the Moderna (“Moderna mRNA”) vaccine, has recently also been granted provisional registration in Australia. All three of these vaccines require a course of two doses. Comirnaty and Moderna mRNA are approved for people 12 years and older, and Vaxzevria for people 18 years and older. In December 2021, a new formulation of Cominarty has also been provisionally approved to be used in children aged 5-11 years, using a lower dose of vaccine (read more). However, this is a rapidly changing scenario at present, and the Australian Government is striving to work out the safest and best way forward in this vaccine rollout. Recently, a fourth vaccine from Jannsen-Cilag has also been granted provisional approval by the TGA but is not yet available for the general public. A fifth vaccine, Novavax, is currently under evaluation by the TGA. Below we will consider the issues relevant to these vaccines.

(Pfizer/BioNTech – “Comirnaty” and Moderna – “Moderna mRNA”)

These vaccines use mRNA and our cells own protein manufacturing mechanism to produce the “spike” protein of the SARS-CoV-2 virus that causes COVID-19. This in turn triggers an immunological reaction against the spike protein thereby conferring immunity. This is a new mechanism for vaccination. These vaccines have proven to be 95% effective in large phase III, placebo-controlled, clinical trials. Serious adverse events were seen no more frequently in those receiving the vaccine versus those who received placebo (sham injections). The only side effects that were seen in slightly higher numbers in those receiving the vaccine were local injection site reactions, chills/fever, headache and fatigue/tiredness. These were mostly mild or moderate in severity. These vaccines do not contain eggs, preservatives or latex. From the way that these vaccines work it is not anticipated that there would be any additional risk of adverse outcomes and side effects in a person with MS, including those on treatment. It is considered that for a person with MS the risks of contracting COVID-19 far outweigh any potential risk from the vaccine. These vaccines have been authorised for use in US, EU, UK, Canada and many other countries. The Pfizer/BioNTech vaccine has been approved for use in Australia by the therapeutic goods administration (TGA) and will be the first COVID-19 vaccine to be rolled out in February 2021. The Moderna vaccine may become available in Australia later.

(AstraZeneca – “Vaxzevria” [Oxford], Jannsen-Cilag vaccine – “COVID-19 Vaccine Jannsen”)

These vaccines use a copy of the DNA for the spike protein that has been inserted into an adenovirus (common cold virus) vector that has been modified in such a way that it is unable to replicate itself but can still deliver DNA to our cells. The DNA is used by our cells to make the spike protein and produce an immune response and immunity to the virus that causes COVID-19. This is a commonly used mechanism for many existing vaccines. The AstraZeneca vaccine was 60-% effective in a large phase III, placebo-controlled, clinical trial. The most common side effects included headache, tiredness and muscle aches. Less is known about the efficacy of the Sputnik V vaccine but reports of this being 50-90% have been published. From the way that these vaccines work it is not perceived that they would be associated with any additional risks or issues for a people with MS, including those on treatment. These vaccines have been authorised for use in UK, Russia, India and several other countries. The AstraZeneca vaccine commenced roll out in Australia in March 2021.

(Novavax – “NVX‐CoV2373”)

These vaccines use the spike protein or a part of the protein together with an “adjuvant” that stimulates the body’s immune system. Data for the Novavax vaccine have been released indicating an efficacy of 89.3%. No safety data are available yet for the phase 3 studies but there were no significant concerns in the phase 2 study including in Australian patients. The Novavax vaccine is expected to be made available in Australia in early 2022.

Frequently asked questions regarding the vaccines

Concerns have been raised over the AstraZeneca vaccine and a potential link to blood clots. This is a complex and dynamic situation. Here in Australia, the Government announced that the AstraZeneca vaccine is no longer ‘preferred’ for Australians under the age of 60, unless you live in a delta variant outbreak zone. The revised advice in late July from the Australian Technical Advisory Group on Immunisations (ATAGI) states “ All individuals aged 18 years and above in Greater Sydney, including adults under 60 years of age, should strongly consider getting vaccinated with any available vaccine including Vaxzevria (also known as AstraZeneca COVID-19 Vaccine . This is on the basis of the increasing risk of COVID-19 and ongoing constraints of Comirnaty (Pfizer) supplies. In addition, people in areas where outbreaks are occurring can receive the second dose of the AstraZeneca vaccine 4 to 8 weeks after the first dose, rather than the usual 12 weeks, to bring forward optimal protection.” You can review the ATAGI statements relating to COVID-19 vaccination advice here.

Previously, a link was established between extremely rare cases of blood clots in AstraZeneca recipients, particularly in Europe. However, the risk of developing blood clots remains very low. Those under 50 who have already received their first AstraZeneca vaccine should not be alarmed, and the advice is to go ahead with the second vaccination. And those above 60 should continue as planned. The vaccine is likely to still be available to those under 60 in consultation with your doctor. It is important to note that all of the COVID-19 vaccines available in Australia have gone through rigorous clinical trials. once they have completed those trials there is ongoing medical surveillance all around the world designed to pick up signals that suggest possible adverse events. Surveillance is very thorough and can detect rare health events; in this case blood clotting or thrombosis. It can be difficult to distinguish whether these events are coincidence or side-effects of vaccination, the decision made about this vaccine is to err on the side of caution. It is important to note that blood clots are common in the general population, with 30,000 Australians developing blood clots each year. The latest information on the risk of blood clots can be found on the Australian Government website here

It is currently recommended that everyone over the age of 16 years should be vaccinated against COVID-19. There is no evidence that people with MS are at a greater risk of adverse events following COVID-19 vaccination. Studies in the US, EU and Australia are continually monitoring people with MS.. However, there is no theoretical reason why any of the currently available vaccines should pose any particular risk to a person with MS. The risks of COVID-19 are very real, are higher in a person with MS who has higher levels of disability, and far outweigh any conceivable risks from the vaccines. As a person with MS, you should be vaccinated. 

There is currently no evidence to suggest that this might be the case. All of the COVID-19 vaccines can produce side effects that include fever and fatigue. Fever can on rare occasions cause a re-emergence of previous MS symptoms (a so-called “pseudo-relapse”), but it is widely thought that this only lasts as long as the fever is present (usually less than 24 hours with these vaccines) and does not imply any new inflammation or damage to the nervous system. Similarly, fatigue due to vaccination can be similar to and might compound MS-related fatigue, but this should only be temporary.. 

This is currently being researched in the US, EU and Australia to look at this. None of the currently available vaccines are “live-attenuated virus” vaccines and do not pose any risk of causing the disease which they are aiming to prevent. They are therefore considered to be safe in people who are immunosuppressed. 

Studies looking at this question for the COVID-19 vaccination are currently being undertaken, including a study right here in Australia. Hopefully, these studies will provide information on the effectiveness of the vaccine in people on various therapies, but the results are unlikely to be available for some time. We know from studies with other vaccines that immunosuppressive treatments can reduce the effectiveness of vaccination to a variable degree, but it remains very worthwhile being vaccinated if you are on immunosuppressive therapy.

The practicalities are that you should receive your vaccine whenever it is offered to you. The timing of this will be decided by local government health officials based upon your age, risk profile and other factors (e.g. work in healthcare/travel industry). For those on intermittent immunosuppressive therapies (e.g. ocrelizumab, alemtuzumab, cladribine) it would be sensible to ensure that your vaccinations are completed several weeks prior to your treatment and avoid being vaccinated for several months afterwards. This is in order to maximise the effectiveness of the vaccine and avoid any overlap of side-effects which might cause confusion, rather than because of any safety concerns. For natalizumab avoiding vaccination during the week of your infusion would be wise simply to avoid confusion over any side effects. For all other treatments timing of your vaccination should be determined by availability of the vaccine. If you are considering delaying your vaccination or your MS treatment, please discuss this with your neurologist first. 

It is not recommended that you suspend your MS therapy around the time of your vaccination unless on the advice of your neurologist. The risks to your long-term health of developing a re-occurrence of your MS on stopping therapy are far greater than any potential risks from vaccination. For those on intermittent therapies or who are just about to start a new therapy there may be some scope to better coordinate the timing of your therapy with any planned vaccination, but this should only be done in consultation with your neurologist to ensure that the risks of any delay with your therapy will be minimal or can be reduced in some way.

The clinical trials and approval processes used in each country or region to assess the safety of medications and vaccines have been identical to normal processes, they have simply been undertaken more rapidly than usual because of the urgency of the situation. The process of approval by the TGA, who approve medications and vaccines in Australia, has been completed for the Pfizer/BioNTech vaccine and is currently under way for the AstraZeneca vaccine. The TGA are following their usual procedure and will only approve a vaccine for COVID-19 once they are satisfied that it is safe. Whilst some of the technology being used in the vaccines is new, this technology has been in development over many years and the process of testing the vaccines in pre-clinical studies and then clinical trials has been just the same as in the past. The clinical trials for these vaccines have involved 10’s of thousands of participants. In addition, by the time these vaccines are being administered in Australia, many millions of people will have been vaccinated worldwide and if there were any rare safety concerns these would likely have come to light before they are used in Australia. 

The clinical trials and approval processes used in each country or region to assess the safety of medications and vaccines have been identical to normal processes, they have simply been undertaken more rapidly than usual because of the urgency of the situation. The process of approval by the TGA, who approve medications and vaccines in Australia, has been completed for the Pfizer/BioNTech vaccine and is currently under way for the AstraZeneca vaccine. The TGA are following their usual procedure and will only approve a vaccine for COVID-19 once they are satisfied that it is safe. Whilst some of the technology being used in the vaccines is new, this technology has been in development over many years and the process of testing the vaccines in pre-clinical studies and then clinical trials has been just the same as in the past. The clinical trials for these vaccines have involved 10’s of thousands of participants. In addition, by the time these vaccines are being administered in Australia, many millions of people will have been vaccinated worldwide and if there were any rare safety concerns these would likely have come to light before they are used in Australia. 

Whilst there are some small differences in the efficacy and side effect profiles for each of the vaccines, all of the COVID-19 vaccines that are currently available are very effective and very safe. All the vaccines have shown that they effectively remove the risk of dying from COVID-19. You should therefore have the vaccine that is offered to you. This is likely to be determined by prioritisation and local availability. 

It is true that there were 2 cases of transverse myelitis (demyelination of the spinal cord) out of 5,807 people who received the AstraZeneca vaccine, one of whom it was discovered had MS which had previously been unrecognised. These cases occurred at 10 and 14 days after the administration of either the first or second dose of vaccine. There was one case of transverse myelitis out of 5,829 people in the control group (who received the MenACWY meningococcal vaccine) at 68 days. All these cases were determined to be unrelated to the administration of either vaccine by an expert review panel. The difference in numbers between the two groups was not statistically significant (p=0.997). It is always difficult with relatively rare events of this nature in such studies. By way of comparison the data for “non-COVID related deaths” in this same study showed the reverse pattern; there was 1 death in the COVID-19 vaccinated group and 3 in the control group. It is always sad to think of this, but in such a large study over a period of time, some people will die from random causes. At the moment, there is nothing to suggest that the AstraZeneca vaccine is associated with an increased risk of transverse myelitis. In the past there have been concerns about MS relapses being triggered by vaccination. This, in part, stems from what was probably a real association between certain early vaccines (e.g. an early Rabies vaccine which is no-longer used) and a rare form of demyelination known as acute disseminated encephalomyelitis (ADEM). However, all recent large-scale studies of vaccination programs and the risk of demyelination (MS) have shown no association. The TGA approved the AstraZeneca vaccine for use in Australia after they determined that it was safe, following the review of all the relevant information.

Most countries in the world have mechanisms in place to monitor the safety of medicines and vaccines after they have been approved for use in the community. This is often the only way that rare side effects can be detected. Regulatory bodies will often be asked to investigate unusual occurrences such as a cluster of deaths or other unusual medical outcomes that could potentially be related to a particular product. This is precisely what is happening in Norway. Often these investigations will show that the suspected association is in fact just a random cluster of an unusual outcome. However, if it is demonstrated that there is a link or that a particular group of people is at risk of a particular adverse outcome, then appropriate recommendations and amendments to vaccination procedures will be made. The TGA requested more information from Pfizer regarding these cases and after carefully reviewing the detailed information have concluded that the vaccine is safe and have approved it for use in Australia.

You should advise the person administering the COVID-19 vaccine if you have ever had an allergic reaction to either an earlier dose of the COVID-19 vaccine or any other vaccination. Some vaccines do contain other components to which some people can react. Some of the COVID-19 vaccines have specifically avoided having any of the common precipitants for these types of reaction. The person administering the vaccine will be able to advise on whether or not it will be safe to proceed with the particular vaccine being offered.

The sooner that as many people as possible get vaccinated against COVID-19 the safer we will all be. Relying on everyone else to be vaccinated to prevent you individually being exposed is unlikely to be an effective strategy. Leading Australian experts have stated that it is quite likely that COVID-19 infections may become a recurring phenomenon around the world and that outbreaks may occur from time to time. Whilst being vaccinated does not eliminate the risk of contracting COVID-19 at an individual level, it does very significantly reduce the risk and effectively removes the risk of getting severe disease and dying as a result of the infection. From a personal protection point of view, it is very important to be vaccinated. It is also likely that future travel, including international travel will be dependent on being able to prove that you have been vaccinated against COVID-19.

For more information on COVID-19 and MS, please click here.

Signatories: Professor Michael Barnett (NSW), Dr Heidi Beadnall (NSW), Dr Mike Boggild (Qld.), Dr Karyn Boundy (SA), Professor Simon Broadley (Qld.), Professor Helmut Butzkueven (Vic.), Dr Katherine Buzzard (Vic.), Professor Bill Carrol (WA), Dr Laura Clarke (Qld.), Dr Nicholas Crump (Vic.), Dr Jane Frith (NSW), Dr Natasha Gerbis (NSW), Dr Mahtab Ghadiri (NSW), Dr Lauren Giles (Tas.), Dr Kerryn Green (Qld.), Dr Lesley-Ann Hall (SA), Dr Todd Hardy (NSW), Professor Simon Hawke (NSW), Professor Suzanne Hodgkinson (Vic.), Professor Tomas Kalincik (Vic.), Professor Allan Kermode (WA), Professor Trevor Kilpatrick (Vic.), Dr Rajat Lahoria (ACT), Professor Jeannette Lechner-Scott (NSW), Dr Mark Marriott (Vic.), Professor Pamela McCombe (Qld.), Dr Mastura Monif (Vic.), Dr Jennifer Pereira (NZ), Professor John Pollard (NSW), Dr Sudarshini Ramanathan (NSW), Dr Stephen Reddel (NSW), Dr Izanne Roos (Vic.),Dr Cameron Shaw (Vic.), Dr Marion Simpson (Vic.), Dr Olga Skibina (Vic.), Associate Professor Mark Slee (SA), Dr Judith Spies (NSW), Professor Bruce Taylor (Tas.), Associate Professor Anneke van der Walt (Vic.), Professor  Steve Vucic (NSW), Associate Professor Ernie Willoughby (NZ.)

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COVID-19 vaccination guidance for people with MS