The trial showed that the vaccine was safe and did not cause unwanted side effects in a group of patients with various cancers, neurological and rheumatic diseases associated with immunosuppression.
The results should reassure patients who are hesitant about the vaccine that the vaccine is safe, even for those who are immunocompromised.
To date, many of us have received Covid-19 vaccines, including those based on new mRNA technology, and this has allowed society to reopen in many countries. The vaccine-mediated protection, coupled with an increase in the milder Omicron variant, means that the number of Covid-19 patients with severe disease has decreased significantly over the past year. However, it is not smooth sailing for everyone.
Initial clinical trials for these vaccines were conducted in healthy volunteers. Although this is standard practice, it means that high-risk immunocompromised patients, such as those receiving immunosuppressive drugs for neurological conditions, should not receive treatment. put to the test.
Start before 22 for immunocompromised patients
This lack of trial data may cause these patients to understandably hesitate about the safety and effectiveness of the vaccine. However, in a grim irony, they are also at increased risk for serious complications of Covid-19, suggesting that they would greatly benefit from vaccine-mediated protection. In an effort to shed more light on the safety of an mRNA-based Covid-19 vaccine, a team of researchers in Italy conducted a study to evaluate the safety of the Covid-19 vaccine in high-risk patients.
The researchers enrolled 566 high-risk patients in the trial and administered two doses of the Pfizer-BioNTech vaccine or Moderna mRNA as usual. The patients reported any adverse events in a questionnaire, and the questionnaires focused on the first week after each dose.
The most commonly reported side effects at the injection site included pain, swelling, and rash, while the most common side effects included fatigue, headache, chills, and muscle aches. Such side effects are also commonly reported by people with fully functioning immune systems who have received the vaccine. The study also found no evidence that the patient’s underlying disease was affected and that vaccination did not affect the patient’s ability to receive standard treatment for their conditions.
There is no higher incidence of adverse events in high-risk patients
Notably, we found that the occurrence of adverse events in these high-risk patients was comparable to the occurrence of adverse events reported in vaccine trials conducted. on the general population”. Professor Nicola Silvestris of Bari Aldo Moro University, Italy, senior author, explains.
“Our patients did not show a higher incidence of serious adverse events and we did not see an increased risk of discontinuation of the treatment program due to vaccination. Therefore, Covid-19 vaccination is confirmed as safe, even in this high-risk group.
The results should help allay the fears of immunocompromised patients, who are at high risk for serious Covid-19 complications, but also worried about vaccine side effects.
“Our main recommendation based on the results of this study is that vaccination for Covid-19 is strongly recommended and the safety record gives us peace of mind.” Maria Teresa Lupo-Stanghellini of the Institute of Sciences San Raffaele, Italy, lead author of the study said.
“The ongoing safety monitoring of our Covid-19 vaccine continues in the spirit of providing the best prevention and care for our patients.”