U.S. health officials announced Thursday that they will conduct clinical trials to test different dosing strategies for the Jynneos monkeypox vaccine amid controversy over its effectiveness.
The study will involve 200 adults aged 18 to 50 across the country and will be supported by the National Institute of Allergy and Infectious Diseases (NIAID).
The Jynneos vaccine, made by Denmark-based Bavaria Nordic, is approved in the United States for the prevention of smallpox and monkeypox in people 18 years of age and older.
However, while men who have sex with men, who are the highest risk group, are encouraged to get vaccinated, there is no certainty about the effectiveness of this vaccine.
The new assay is not designed to produce an estimate of efficacy, but to measure the immune response of different dosage levels and administration methods.
“NIAID’s Jynneos vaccine trial will provide important insights into the immunogenicity, safety and tolerability of alternative dosing approaches that will expand the current vaccine supply,” NIAID Director Anthony Fauci said in a statement. said.
The vaccine is based on an attenuated virus that has been modified so that it cannot replicate and is given in two doses 28 days apart.
The first group of volunteers will be vaccinated subcutaneously, and the second group will receive injections intradermally, that is, between the layers of the skin.
This last strategy aims to increase the availability of vaccines as it uses one-fifth of the standard dose.
A third group will also receive intradermal injections, but at half the dosage level of the second group.
The scientists will evaluate the peak immune responses and compare side effects between members of the different groups.
President Joe Biden’s administration is betting heavily on the Jynneos vaccine to curb the spread of monkeypox, which has infected more than 20,000 people in the United States since May.
The current global epidemic mainly affects gay and bisexual men.
Historically, the virus spreads through injuries, direct contact with bodily fluids and respiratory droplets, and sometimes through indirect contamination through surfaces such as shared bedding.
But there is preliminary evidence that sexual transmission may play a role in this epidemic.
The virus causes painful lesions on the skin and has flu-like symptoms.
Most people recover fully, but the disease can cause serious complications such as bacterial infections, brain swelling, and death.
source: Noticias
