Reports of about 30 deaths among elderly nursing home residents who received the Pfizer vaccine have made international headlines.
With Australia’s Medical Goods Administration (TGA) expected to approve the vaccine imminently and approve a roll out starting next month, the development could be a cause for concern around the safety of the vaccine.
But there are some reasons why this should not happen.
What we know
We have not reported this issue in any other countries that are doing the Pfizer vaccine.
Norway has reported that around 45,000 people across the country have been vaccinated against COVID-19 so far. Her vaccine program has mostly focused on nursing home residents.
In other countries, in the first instance there may be a greater focus on frontline health-care workers. So if there is a connection between deaths in the elderly and this vaccine, it may not be clear yet.
It also depends on monitoring. Norway may have a particularly rapid monitoring and reporting system, which allows everyone to be vaccinated and quickly report any adverse outcomes.
We would soon expect surveillance reporting from other countries with an active vaccination program, increasing critical data to create a more accurate picture of vaccine safety in different populations.
The Norway report will also sensitize other countries to closely monitor those receiving the vaccine, especially in nursing homes that are older and weaker. We can see reports on this coming from other countries in the coming weeks.
But we also cannot. We have limited information about these cases in Norway. Those who were reported dead were elderly and very weak. Many older people had many significant underlying health conditions, and may be nearing the end of their lives, independent of the vaccine.
Although they are under investigation, it is important to note that the deaths have not been conclusively linked to complications with the vaccine. Meanwhile, Australian experts have called for calm.
Vaccines and elderly
In the recent history of vaccines, we have not seen any trends regarding deaths in elderly people after vaccination. For example, there is no evidence that the annual influenza vaccine is associated with deaths in older people – or in people of any age.
However, it is important to note that in comparing flu shot or any other vaccine and COFID-19 with the Pfizer vaccine, we are comparing apples and oranges.
The Pfizer vaccine is based on mRNA technology, which is completely new in human vaccines. This technique introduces part of the genetic material of the SARS-CoV-2 virus as a messenger RNA (mRNA). It instructs your cells to form part of the virus that stimulates an immune response that prevents infection and prevents disease.
All vaccines are designed to produce an immune response – even if in different ways – if our body is to prepare to fight the virus when it encounters it.
The body becomes inflamed by creating an immune response. Some people will have no side effects from the vaccine, but inflammation may manifest differently in different people and between different vaccines. This can mean a reaction at the site of injection, or fatigue, or feeling unwell.
Deaths in Norway were reportedly linked to fever, nausea and diarrhea, which would be tolerable for most people, at the severe end of the spectrum of side effects of the vaccine.
We are now beginning to understand what different people will respond to MRNA. It is possible that this vaccine will have a more severe effect in older, vulnerable people where the initial inflammatory response may be overwhelming.
But it is still too early to draw any conclusions.
Side effects show that a vaccine is causing an immune response
Vaccines need to evoke an immune response to work, and side effects are a byproduct of our body’s immune response.
While the deaths are tragic, they should not cause alarm. This actually tells us that the vaccine is stimulating an immune response. For most people that response will be completely tolerable and lead to the development of immune memory that protects you from severe COVID-19.
The major challenge for any vaccine is producing enough for an immune response so that you are protected from the disease in question, but not so much that you experience extreme effects. Where this line is present in sand varies among individuals, but those receiving the oldest and deadliest vaccine are at greatest risk of serious, potentially life-threatening reactions.
So for those who may be susceptible, we can be a bit more cautious. In approving the Pfizer vaccine, the TGA may consider advising against this particular vaccine for those who are very elderly and frail, especially those who have other conditions and are potentially nearing the end of their lives.
Ideally, this group should consider a case-by-case basis for this group, carefully weighing the risks and benefits in each situation, based on the best available data.
Nathan Bartlett, Associate Professor, School of Biomedical Sciences and Pharmacy, University of Newcastle.
This article is republished from Conversation under a Creative Commons license. Read the original article.