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Brochure and summary of the characteristics of the product against the Janssen K-19 Vaccine published by the Ministry of Health.
This is the second adenovirus vaccine approved by the European Medicines Agency after AstraZeneca, but the first to be administered in a single dose. With it, there are four vaccines approved by the EMA, points out dnes.bg.
It is not yet clear when the first deliveries will begin, but it is expected to happen in April. It is indicated for active immunization to prevent coronavirus in people over 18 years of age.
Vaccination should be postponed in people with severe acute febrile illness or acute infection. However, vaccination should not be delayed in the presence of a mild infection and / or mild fever.
The package leaflet also states that, as with other intramuscular injections, the vaccine should be used with caution in people receiving anticoagulant therapy or those with thrombocytopenia or a blood clotting disorder (eg, hemophilia), because they may bleed after of intramuscular administration.
The duration of protection provided by the vaccine is unknown, as it is being established in ongoing clinical trials.
Protection begins approximately 14 days after vaccination. As with all vaccines, vaccination with the K-19 Janssen vaccine may not provide protection to all vaccine recipients.
The safety of the K-19 Janssen vaccine was evaluated in an ongoing phase 3 study (COV3001). A total of 21,895 adults 18 years and older received K-19 Jaccine Janssen. The median age of the participants was 52 years (range 18-100 years).
A safety analysis was performed after reaching the median follow-up 2 months after vaccination. A longer safety follow-up> 2 months was available for 11,948 adults who received the K-19 Janssen vaccine.
The most frequently reported local side effect is pain at the injection site (48.6%). The most frequent systemic adverse reactions were headache (38.9%), fatigue (38.2%), myalgia (33.2%), and nausea (14.2%). Most side effects occur within 1-2 days after vaccination and are mild to moderate in severity and short-lived (1-2 days).
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