One of the biggest concerns associated with the COVID-19 vaccines has been their effect on rare disease patients. There has been minimal research into this topic, leading many to be wary of the vaccine. Now, medical experts have come together to announce that the vaccines are safe for rare disease patients. This news was released at a webinar that was hosted by the National Organization for Rare Disorders (NORD) and attended by the CDC and FDA. Other rare disease organizations sponsored the event, such as the ALS Association, the Muscular Dystrophy Association, and the Cystic Fibrosis Foundation.
The Vaccines and Rare Diseases
Rare disease patients are worried about the coronavirus, as many are immunocompromised or at a high risk of a severe case. This led to mental health issues, canceled doctor appointments, and overall negative effects. While the development of the two vaccines, created by Modera and Pfizer, helps to soothe some of their fears about the virus, it also brings new worries.
Because of the severity of the pandemic, the vaccines were sped through the clinical trial process and granted emergency use authorization. This means that there is less evidence. While this has been a concern for many, FDA officials assured webinar viewers that there is “clear and compelling evidence” of the safety and effectiveness of the vaccines.
Another concern was the lack of rare disease patients in the clinical trials. Once again, the FDA assured viewers that the evidence shows that the vaccine is safe for those with rare conditions, even ones that compromise the immune system.
The next common question was in regards to gene therapy. Patients wondered if they would develop antibodies to the vector used to carry the vaccine, making them unable to utilize gene therapies. The experts assured viewers that the vectors used to carry the vaccine are very different than those used in gene therapies, meaning that people can utilize both.
While they acknowledge that further research is needed to understand the effectiveness of the vaccine on rare disease patients, they suggest that for some, “the benefits outweigh the risks.” It is better for these patients to get vaccinated than to risk contracting COVID-19.
In terms of which vaccine is better, the advice was to get whichever you can access first. They are the same form of vaccine, mRNA, making them similar. They even demonstrate similar efficacy, sitting at about 94-95%.
Another issue that the experts could not answer directly was the rollout of vaccines. They noted that it varies from state to state, and it is important to keep track of your state’s rules.
You can read more about the webinar here.
