Johnson & Johnson and rare thrombosis, new opinion on the safety of the anti covid vaccine from the EMA, which reiterates that there are no “specific risk factors” but that there is a “possible link” between the product and rare thrombosis. But how is the drug made? What are the side effects, the efficacy data and what does the leaflet say? Here is everything Aifa explains about the fourth vaccine to be recommended in the EU to prevent Covid-19 after the Pfizer, Moderna and AstraZeneca drugs.
What’s this
According to the Aifa website, “COVID-19 Vaccine Janssen is a vaccine used to prevent coronavirus disease 2019 (COVID-19) in people aged 18. The vaccine causes the immune system to produce antibodies. and specialized white blood cells that act against the virus, offering protection against disease. After administration, SARS-CoV-2 S-glycoprotein is transiently expressed, stimulating both neutralizing anti-S antibodies and other specific functional anti-S antibodies , as well as cellular immune responses directed against the S antigen, which may help protect against COVID-19. After administration, SARS-CoV-2 S glycoprotein is transiently expressed, stimulating both neutralizing anti-S antibodies and other functional anti-S specific antibodies, as well as cellular immune responses directed against the S antigen, which may help protect against COVID-19. “
Effectiveness
These are the vaccine efficacy data reported in the Aifa Summary of Product Characteristics: “A phase III, randomized, double-blind, placebo-controlled multicenter study (COV3001), currently underway, has been conducted in the United States , in South Africa and Latin American countries to evaluate the efficacy, safety and immunogenicity of a single dose of COVID-19 Vaccine Janssen for the prevention of COVID-19 in adults aged 18 years and older. The study excluded subjects with abnormal immune system function resulting from a clinical condition, subjects who were being treated with immunosuppressive therapies within 6 months, and pregnant women. Participants with stable HIV infection on treatment were not excluded. Licensed vaccines, excluding live vaccines, could be given more than 14 days before or more than 14 days after vaccination in the study. Licensed live attenuated vaccines could be given more than 28 days before or more than 28 days after vaccination in the study. A total of 44 325 subjects were randomized in parallel in a 1: 1 ratio to receive an intramuscular injection of COVID-19 Vaccine Janssen or placebo. A total of 21 895 adults received COVID-19 Vaccine Janssen, while 21 888 adults received placebo. Participants were followed up for a median of 58 days (range: 1-124 days) after vaccination. The population for the primary efficacy analysis of 39 321 subjects included 38 059 subjects seronegative to SARS-CoV-2 at baseline and 1,262 subjects with unknown serological status. Demographics and baseline characteristics were similar between subjects receiving COVID-19 Vaccine Janssen and those receiving placebo. In the population included in the primary efficacy analysis, among participants who received COVID-19 Vaccine Janssen, the median age was 52.0 years (range: 18-100 years); 79.7% (N = 15 646) of the subjects were aged between 18 and 64 years [il 20,3% (N=3 984) era di età pari o superiore a 65 anni e il 3,8% (N=755) era di età pari o superiore a 75 anni]; 44.3% of the subjects were female; 46.8% came from North America (United States), 40.6% from Latin America and 12.6% from South Africa. A total of 7,830 subjects (39.9%) had at least one pre-existing comorbidity at baseline associated with an increased risk of progression to severe COVID-19 (comorbidities included: obesity defined as BMI ≥30 kg / m2 (27.5% ), hypertension (10.3%), type 2 diabetes (7.2%), stable / well-controlled HIV infection (2.5%), severe heart disease (2.4%) and asthma (1.3% )). Other comorbidities were present in ≤1% of subjects. The cases of COVID-19 have been confirmed by a central laboratory based on a positive result for SARS-CoV-2 virus RNA obtained by polymerase chain reaction (PCR) test. “
Side effects
This is what is illustrated in the summary of the safety features of the vaccine from Aifa: “The safety of COVID-19 Vaccine Janssen has been evaluated in a phase III study currently underway (COV3001). A total of 21,895 adults aged equal or older at age 18 received COVID-19 Vaccine Janssen. The median age of subjects was 52 years (range: 18-100 years). Safety analysis was performed once a median duration of post-follow-up was reached. vaccination of 2 months. A safety follow-up beyond 2 months is available for 11 948 adults who received COVID-19 Vaccine Janssen. In Study COV3001 the most commonly reported local adverse reaction was injection site pain (48 , 6%). The most common systemic adverse reactions were headache (38.9%), fatigue (38.2%), myalgia (33.2%) and nausea (14.2%). body ≥38.0 ° C) was observed in 9% of the participants Most reactions adverse events occurred within 1-2 days of vaccination and were mild to moderate in severity and of short duration (1-2 days). Reactogenicity was generally milder and less frequently reported in the elderly (763 adults aged ≥65 years). Overall, the safety profile was consistent among participants with or without prior evidence of SARS-CoV-2 infection at baseline; a total of 2,151 HIV-positive adults at baseline received COVID-19 Vaccine Janssen (9.8%) “. Here is the link to the pdf of the ‘Summary of product characteristics’ prepared by Aifa, here is the link to the pdf of the package leaflet .
Thrombocytopenia
According to Aifa’s ‘Summary of Product Characteristics’ chapter ‘Special warnings and precautions for use’, the Johnson & Johnson product “is a monovalent vaccine composed of a recombinant vector based on human adenovirus type 26 that is incompetent for replication, coding for the complete SARS-CoV-2 spike glycoprotein (S) sequence in a stabilized conformation. any bleeding disorder (such as haemophilia), as bleeding or bruising may occur in these individuals following intramuscular administration. “