COVID vaccine for a rare disease? It is the best guide

Disseminating the limited data from the Pfizer / BioNTech and Moderna COVID-19 vaccine trials, clinicians say the benefits of the product outweigh the risks for people with pulmonary embolism and rare diseases. other.

“The reality is that people with rare diseases will never have enough to have the tests out of the gate,” said Tom Maddox, MD, MSc, of BJC HealthCare and Washington University School of Medicine in St. Louis. Louis.

Without hard data, he said, clinicians and researchers can only post why COVID vaccines would work differently in people with pulmonary embolism. “What do we understand about how the disease works? How the disease works? How the vaccine works? Is there anything that the vaccine could do to make the disease worse? worse? Any side effects? “

“The way mRNA vaccines work, the way lung hypertension works, nothing happens to us as a problem,” Maddox said in an interview. “I see no reason to believe [vaccination] it would be dangerous for people with lung cancer, with no reason to believe that it would be less effective. “

In general, the main safety events associated with the COVID vaccine are flu – like symptoms; severe allergic reactions were seen but rarely.

Accordingly, both Pfizer / BioNTech and Moderna vaccines contain known allergies to vaccine components as contraindications – not lung hypertension, according to Justin Ortiz, MD, MS, of the University of Maryland School of Medicine in Baltimore and chairman of the vaccines and immunization work of a group of the American Thoracic Society.

In fact, the CDC includes people with pulmonary edema in a stage 1c vaccine priority because of lung hypertension – including a number of diseases that together affect around 1% of the world’s population – recognized as one of the heart conditions that puts people on the rise. risk of serious illness from SARS-CoV-2 infection.

In 2020, U.S. center managers reported hospitalization and mortality rates of 30% and 12%, respectively, among 50 COVID-19 patients with one of two types of lung hip hypertension, namely arterial hip hypertension lungs (PAH; WHO group 1) and thromboembolic lungs. hip endurance (WHO group 4).

In comparison, the COVID case mortality rate is just 1.7% in the general U.S. population, according to mortality data from Johns Hopkins.

“We fully believe that PAH patients are a high-risk group” and “we recommend vaccination for our patients,” Peter Leary, MD, PhD, of the University of Washington Medical Center, said in a post -d gu MedPage today.

Nevertheless, mRNA vaccine data specific to the lung-mass population are scarce, if any.

For example, the Pfizer / BioNTech vaccine showed 95% efficacy in preventing COVID-19. A phase III trial enrolled more than 2,900 people with chronic lung disease in the 43,548-person study, according to co-author Stephen Thomas, MD, of SUNY Upstate Medical University in Syracuse.

However, no participant had a lung involvement, a Pfizer representative confirmed.

Approximately 5% of participants in the 30,000-person Moderna trial, which reported 94.1% vaccine efficacy, had severe heart disease. Moderna did not clarify how many, if any, patients with pulmonary embolism participated in that trial, although perhaps not more than a little of that 5%.

“In general, it makes sense for patients with pulmonary embolism to be vaccinated, but they should definitely talk to their doctors,” Maddox warned.

“Patients on blood thinning medications or medications that affect their immune system are encouraged to talk to their healthcare providers before receiving the vaccine; however, in my opinion, in the main In some cases the benefits of a vaccine outweigh the risks, “said Ortiz.

Last updated January 21, 2021