A study published in Frontiers in Oncology has found that mRNA-based Covid-19 vaccines are safe for high-risk patients.
The first of its kind comprehensive trial had 566 patients with solid or hermatological malignancies, neurological and rheumatological diseases between March and September last year.
Unlike previous clinical trials which were conducted on healthy volunteers, the VAX4FRAIL study had high-risk patients who were given two doses of either the Pfizer-Biontech or the Moderna mRNA vaccines and had to report any adverse events in a questionnaire with questions that focused on the first week after each dose of the vaccine.
According to the website of the National Library of Medicine, “Messenger RNA is a type of RNA that is necessary for protein production. In cells, mRNA uses the information in genes to create a blueprint for making proteins. Once cells finish making a protein, they quickly break down the mRNA. mRNA from vaccines does not enter the nucleus and does not alter DNA.”
It was found that both vaccines were safe even for the immunocompromised and the most common side-effects at the injection site were pain, swelling and a rash. Tiredness, headache, chills and muscle pain were the most common general side-effects that were reported, including in studies that were done on individuals with a healthy immune system.
In a press release, the authors of the study said that the results would help to calm fears among the immunocompromised patients who are at high risk of severe Covid-19 complications, but were also worried about side-effects of the vaccine.
Lead author of the study from the San Raffaele Scientific Institute in Italy, Dr Maria Teresa Lupo-Stanghellini, said, “Our main recommendation based on the results of this study is that vaccination for Covid-19 is strongly recommended and the safety profile is reassuring.”
In the spirit of offering prevention and care for patients, Lupo-Stanghellini added that the ongoing safety monitoring of the Covid-19 vaccine continues.
Encouraging results
Professor Hannelie Meyer, head at the Sekako Makgatho Health Sciences University’s South African Vaccination and Immunisation Centre, said that the results of this study were very encouraging for high-risk individuals, as it has shown that the mRNA Covid-19 vaccines are safe to use in this specific population.
“Most clinical trials evaluating the safety and efficacy of vaccines, including those for the Covid-19 vaccines, exclude high-risk individuals, which is why there were no safety data available for this group when the vaccines were rolled-out for use by the general public.”
Professor Hannelie Meyer
Meyer added that evidence has shown that immunocompromised individuals such as those included in this study, are at an increased risk of complications such as severe pneumonia, hospitalisation, admission to an intensive care unit, invasive mechanical ventilation and death from Covid-19, should they get infected with the SARS-CoV-2 virus.
She added that vaccination of immunocompromised individuals is therefore important to prevent these risks especially since they did not disturb the patients’ normal treatment plan.
Curb misinformation about vaccines
As misinformation about vaccine safety spread, Meyer said that the study would contribute to the overall pool of safety data on the vaccines.
According to Meyer, the most important message that should go out now is about the personal and the public health benefits and advantages of vaccination, including booster doses.
“These kinds of messages will empower others to become vaccine advocates, and play an active role in preventing and addressing misinformation, by further spreading these messages within their own social media networks,” she said.
Public trust in the government remained a challenge to getting more people vaccinated despite efforts by the department of health to provide excellent and quality information and Meyer believes that the country had gotten past the point of waiting for the public to trust the government again.
Adding that the science-believing pro-vaccination public must take action.
“It is way past the time for civil society at large to stand up for public health in South Africa, and stop blaming the government for everything. Perhaps we can start a # movement based on John F Kennedy’s words “Ask not what your country can do for you – ask what you can do for your country,” Meyer added.
Department of health spokesperson Foster Mohale said that the department had a number of monitoring tools in place including a social listening tool which helped the department to pick up misinformation and fake news and rebut them immediately.
The department also conducts constant media briefings and ensures rapid response on misinformation and fake news.
Mohale added that, “We have a crisis communication strategy that we have been using since the outbreak of the pandemic, although we continue to modify its implementation plan because issues change from time to time in order to be relevant with what is happening on the ground. There is no need to change strategy, but tactics and messages, and this is exactly what we are doing.”
The department had also taken the strategy of taking vaccines to the people instead of waiting for them to come to vaccination sites to ensure that the vaccines do not expire.
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