Top 3 Covid vaccine questions – Myocarditis, likelihood of new COVID vaccines, and Omicron variant information

Good morning. My name is Dr Lucas De Toca, and today as always, we will be answering some of the most commonly asked questions on our social media channels. We are on the land of the Ngunnawal people, and I also acknowledge the traditional owners of the lands you may be watching from. Today and for the next few times, I will be joined by Ramas, who will be doing the Auslan interpreting, replacing Linda.

My shout out today goes to the staff behind the Federal Health Departments’ website, the state and territory websites, the website of the public health units. Keeping the most accurate and up-to-date information on those websites is a monumental piece of work but it’s really important that across all of those websites people can go to get the most relevant, most accurate and the latest information on COVID-19 and the vaccination program. We have relied more than ever over the last two years in public health websites to make sure we are aware of the latest case numbers, the latest information on vaccines and the latest information on restrictions. So, please keep checking official Health Department websites for the latest information. Social media is great, we are using it right now, but it often leads to the spread of misinformation as we have seen in many, many cases including completely fabricated reports about what was going on in the Northern Territory. So, go to the official websites from the health departments if you want accurate, scientific information. Try not to get the latest information on COVID from your brother-in-law at the Christmas table. Shout out to all the people who are keeping those websites up to date with the latest information.

Today we are going to talk about myocarditis and its connection as a side effect to some of the vaccines we have in Australia. We are going to talk about Novavax, and potentially other vaccines that we may get in Australia in the future. We’re also going to talk about Omicron and whether certain groups are more susceptible to this new strain. First of all, on myocarditis. When we talk about myocarditis, we talk about a condition in which the muscle cells in your heart, your heart is a muscle. So, the cells that power the muscle of the heart have inflammation. Anything it is in medical jargon means inflammation. So myocardial, the heart of the muscle and itis inflammation of the heart muscle. Many things can cause myocarditis, viruses cause myocarditis. In fact, myocarditis is not uncommon in people who get COVID. At least 11 people out of 100,000 people get myocarditis from COVID. There is also pericarditis, which is the inflammation of the lining that surrounds the heart, and this is also associated with COVID. It happens that in rare occasions, about 2.7 out of 100,000 cases people have had episodes of myocarditis and pericarditis associated with mRNA vaccines, both the Pfizer or Comirnaty vaccine and the Moderna or Spikevax vaccine. These cases are rare, they are more common in younger males. To date, every case in Australia has resolved favourably and we have not had any deaths associated with either the Pfizer or the Moderna vaccines. As I said, these cases are rare, but they do happen. So, when you get your vaccine, you will get information from your doctor on what to look out for on the rare occasion that you have myocarditis. It is a general rule if you experience chest pain and is new and it’s not something you have had before check with a health professional, whether you have had a COVID vaccine or not. Myocarditis happens in the population spontaneously for a range of reasons. People may be predisposed, people may get a viral infection, but we have seen a slightly higher background rate in people who have had the Pfizer and or Moderna vaccines. More commonly after the second dose, a few days after you get the vaccine. It’s a really rare occurrence and it is still incredibly overwhelmed by the benefits you get from vaccination, to the point that the Cardiac Society of Australia and New Zealand has joined ATAGI, the Australian Technical Advisory Group on Immunisation. Reaffirming the importance of these vaccinations and how it overwhelmingly is more beneficial than the small risk of myocarditis. Which can be quite challenging as an experience for someone suffering it, but it does resolve and for all the cases we have had in Australia, it has resolved. It’s important that we use the vaccine to protect ourselves from COVID. Overall, much lower risk of myocarditis than if you had COVID itself plus all the other multitude of benefits that you get because myocarditis is not the only thing you can get from COVID. It protects you from severe disease, hospitalisation, and death, and it protects those around you. Especially if you get your booster which you are eligible for if you are 18 years and over and have had your second dose six months or more ago. In certain circumstances, if you are in an outbreak context or you are going to travel you might even bring it forward to 5 months. Talk to your health professional to discuss your options. If you are not sure when you had your second dose, you can check your certificate which has the date of your latest dose and you can also check it online in your immunisation history statement or on the Medicare Express app that you have on your phone if you have downloaded it which more and more people are downloading now. There is almost no medical intervention that doesn’t have adverse events. The MRNA vaccines, Pfizer and Moderna have this associated rare risk of myocarditis. It tends to be resolved and people recover completely, and it has not led to any deaths in Australia. Internationally, the rates are comparable in terms of the severity that we see. Overall, the benefit of vaccination incredibly exceeds the risks and that is why the Therapeutic Goods Administration, our regulator, has approved it.

Which takes us to the second question which is, when are we going to get Novavax, what is the deal with Novavax, and are we going to get other vaccines in Australia? In Australia the approval for vaccines as for any other drug is undertaken by the Therapeutic Goods Administration, the TGA. The TGA assesses any new candidate that has applied for approval based on its effectiveness, its safety and its quality. Products need to be consistent and have highest quality and make sure they have quality controls in place, so that each different batch is equivalent. So, when there is approval for a product there is assurance that is consistent for the production. Products need to be effective, they need to provide a benefit and one that also stacks up with their claims. The products also need to be safe. The safety of that product needs to be so that if there is any issue or side effects, which as I said most drugs do have. Its exceeded by the benefits that it confers through its effectiveness. Australia is party to the Coalition for Epidemic Preparedness Innovations, which is a global partnership that essentially funnels funds and connects and collaborates vaccine research to accelerate vaccine development. That has been supercharged in the context of the COVID-19 vaccine and that is why there has been so much money, collaboration, international arrangements and large trials that have meant that vaccines have been able to be developed much quicker. Than in other cases which is a great thing but without cutting corners on safety or analysis. CEPI, the Coalition of Epidemic Preparedness and Innovation Is looking at nine different vaccine candidates and Australia has agreement to purchase several of those. At the moment the Novavax candidate is being considered by the TGA. They have applied for approval and the TGA is going through all the data of their submission and anything from other international regulators that TGA frequently discusses things with, to assess whether it is appropriate, safe, effective and of high quality to be used in Australia. If the TGA provides approval, Australia has an advanced purchase agreement with Novavax. So we will have the vaccine available in the country if approved by the TGA to be used, and ATAGI, the Advisory Group on Immunisation will provide a recommendation to the government on how the vaccine could be integrated into our available vaccines portfolio. We understand there is a number of people, not big, because the majority of the country is vaccinated now which is fantastic. But there is a number of people may be waiting for Novavax because of a perception that a protein subunit technology is more traditional in a way than the novel mRNA or adenovirus technologies of the other vaccines we have here. It is important to know that there is decades of research behind MRNA vaccines they are not something that came out of thin air in the last couple of years. The important message is that we still don’t know if Novavax will get approved by regulators, including the TGA, and when the supply of Novavax will make it into the country. So, the best vaccine you can get is the one that is available right now. No vaccine gets approved in Australia that does not pass a rigorous assessment of safety, quality and effectiveness so I would strongly recommend not waiting for Novavax, and to get a vaccine that is available right now. So, you are protected as we have multiple outbreaks of Delta and increasing presence of Omicron in the country. Ultimately if TGA approves and the vaccine is produced at a large-scale internationally, we should have Novavax available in Australia next year to just add another tool to our toolbox of vaccines available here.

Final question, are there certain groups of people more likely to get Omicron? The answer like with many Omicron questions is we don’t yet know. The next couple of weeks are going to be crucial in terms of the incredible data collection happening all around the world where there is Omicron, to understand how the virus behaves and where the impacts are in terms of transmissibility, vaccine and previous immunity effectiveness and in severity. There are still a lot of unknowns. Unfortunately, it takes a little while to collect the data to be able to conclusively say whether this is more transmissible, or this is less severe, or this is more or less resistant to vaccine. So, the answer is we don’t know, but we can make some educated guesses based on what we know. It is still a SARS-CoV-2 variant, the virus that causes COVID-19. With some degree of safety, we can assume the risk factors that predisposes you from severe disease from COVID-19 will also be at play in the Omicron variant as they were in the Delta variant. People with underlying comorbidities, chronic conditions, people who are obese are also at higher risk of severe disease from COVID-19, and of course older age is a very big marker of risk for disease from COVID-19. We would expect it would not be that dissimilar with Omicron. We have some very, very early signs that the identified cases of Omicron that we have, especially in southern Africa where more cases have been characterised, but also the cases we are seeing in Australia and other parts of the world are generally mild or asymptomatic. Which is good but it’s still very early to conclusively say Omicron causes a milder disease. Because a lot of people in our country and other countries in Europe for instance are vaccinated, what we are seeing is a lot of Omicron in vaccinated people. Not because vaccinated people are more susceptible to this but because if most are vaccinated it is just a matter of numbers. That we will see cases in vaccinated people, in Australia we have seen a bit of a mix. It could be that the fact that people are vaccinated people is already playing in reducing severity. It may be that the virus is not less severe it’s just vaccinated people have a much lower risk of non-severe disease. We still don’t know but we’re really hoping that his variant is less severe. It’s not unheard of for viruses to drift towards higher transmissibility and lower severity but we cannot conclusively say that and we should make sure we are putting all the measures that we can to delay the growth of Omicron until we know more. That’s what the governments are doing with their suppression strategy of making some changes of the border parameters to reintroduce 72 hours of quarantine in NSW, Victoria and the ACT, and slightly delaying the reintroduction of other visas and international students until we know more. There is no reason to panic. We have got all the systems in place. We have incredible intelligence across the world working collaboratively to work out new problems, but it is just too early to tell what the impact of Omicron will be until we know more. Stay tuned, we will be posting all the updates on the Australian Government Department of Health’s website.

So, if you want to hear the latest, tune into our channels. Thank you for watching and stay COVIDSafe.