The Johnson & Johnson anti-Covid vaccine is “safe”: “Having acknowledged the pronouncement of the EMA and the opinion of the AIFA CTS, we read in a press release signed by Locatelli (Superior Health Council), Magrini (Aifa) and Rezza (Ministry of Health) – which reaffirms the extreme rarity of thrombosis events associated with thrombocytopenia described following vaccination against COVID-19 with the Janssen – Johnson & Johnson vaccine, and considering that this vaccine has proved to be certainly effective in reducing the risk of serious illness, hospitalization and death related to COVID-19, the same conditions of use of the Vaxzevria vaccine are recommended ”. “Therefore, the Janssen vaccine, the use of which is approved from 18 years of age, should preferentially be administered to people over the age of 60, or to those who, having a high risk of serious and fatal disease, need to be protected as a priority “.
It is a monovalent vaccine composed of a recombinant vector based on human adenovirus type 26 that is incompetent for replication, encoding the complete sequence of the SARS-CoV-2 spike glycoprotein (S) in a stabilized conformation.
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 contribute to protect against COVID-19.
What Janssen COVID-19 Vaccine is and what it is used for
The Janssen COVID-19 Vaccine is a vaccine used for the prevention of COVID-19, a disease caused by the SARS-CoV-2 virus. Janssen COVID-19 Vaccine is given to adults aged 18 years and over. The vaccine causes the immune system (the body’s natural defenses) to produce antibodies and blood cells that are active against the virus, thus providing protection against COVID-19. None of the components of this vaccine can cause COVID-19.
What you need to know before receiving the Janssen COVID-19 vaccine
COVID-19 Janssen Vaccine must not be given if you are allergic to the active substance or any of the other ingredients of this medicine (listed below).
Warnings and Precautions
Talk to your doctor or health care provider at the vaccination center before receiving the vaccine if:
• * had a severe allergic reaction after injecting any other vaccine;
• * passed out after any needle injection;
• * have a severe infection with a high fever (over 38 ° C). However, you can have the vaccination if you have
mild fever or mild upper respiratory infection such as a cold;
• * you have problems with bleeding or bruising spontaneously or if you are taking a medicine
anticoagulant (to prevent blood clots);
• * your immune system is not working as it should (immunodeficiency) or you are taking
medicines that weaken the immune system (such as high-dose corticosteroids,
immunosuppressants or anticancer medicines).
Blood clots in association with low platelet levels have been observed very rarely following administration of the COVID-19 Janssen vaccine. This condition included severe cases with blood clots even in unusual sites (e.g. brain, intestines, liver, spleen), in some cases with the presence of bleeding. Cases occurred in the three weeks following vaccination and mainly in women under 60 years of age. This condition also resulted in death.
Seek immediate medical attention if, after a few days of vaccination, severe or persistent headaches or blurred vision occur, or if unexpected bruises appear on the skin somewhere other than the vaccination site, as well as shortness of breath, chest pain, leg swelling or persistent abdominal pain. In these cases, inform your doctor that you have received the Janssen COVID-19 Vaccine in the previous days.
EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), at its meeting on April 20, 2021, concluded that the benefits of the COVID-19 Janssen vaccine in combating the still widespread threat of COVID-19 (which in turn causes clotting problems and can be fatal) continue to outweigh the risk of side effects.
Other medicines and COVID-19 Janssen vaccine
Tell your doctor or vaccination center healthcare professional if you are using, have recently used or might use any other medicines, or if you have recently been given any other vaccines. Version 02. of 21/04/2021
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before receiving this vaccine. Experience with the use of Janssen COVID-19 vaccine in pregnant women is limited. Animal studies with COVID-19 Janssen vaccine do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal / fetal development, parturition or postnatal development. Administration of COVID-19 Janssen vaccine during pregnancy should only be considered when the potential benefits outweigh the potential risks to the mother and fetus.
Duration of protection and limitations of vaccine efficacy
The duration of the protection offered by the vaccine is unknown; clinical trials are still underway to establish it. Protection begins approximately 14 days after vaccination. As with all vaccines, vaccination with COVID-19 Janssen Vaccine may not protect all vaccinated individuals. It is therefore essential to continue to strictly follow public health recommendations (mask, spacing and frequent hand washing).
How the COVID-19 Janssen Vaccine is given
Janssen COVID-19 vaccine is given as a single dose (no booster required) as an injection into the upper arm intramuscularly.
Possible side effects
As with all vaccines, side effects can occur with COVID-19 Janssen vaccine, although not everybody gets them. Get urgent medical attention if you experience symptoms of a severe allergic reaction; these reactions can include a combination of any of the following symptoms:
• * feeling faint or lightheaded
• * changes in heartbeat
• * shortness of breath
• * wheezing
• * swelling of the lips, face or throat
• * hives or rash
• * nausea o vomito
• * stomach ache.
The following side effects can occur with the COVID-19 Janssen vaccine:
Very common side effects (may affect more than 1 in 10 people):
• * headache
• * nausea
• * muscle aches
• * pain where the injection is given
• * feeling of extreme tiredness
Common side effects (may affect up to 1 in 10 people):
• * redness where the injection is given
• * swelling where the injection is given
• * chills
• * articolar pains
• * temperature
• * cough
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Uncommon side effects (may affect up to 1 in 100 people):
• * rash
• * muscle weakness
• * pain in the arms or legs
• * feeling of weakness
• * feeling of general malaise
• * aged
• * sore throat
• * back pain
• * tremor
• * excessive sweating
Rare side effects (may affect up to 1 in 1,000 people)
• * allergic reaction
• * urticaria
Very rare side effects (may affect up to 1 in 10,000 people)
• blood clots often in unusual sites (eg brain, intestines, liver, spleen) associated with low blood platelet levels.
Undesirable effects with frequency not known (frequency cannot be estimated from the available data):
• * severe allergic reaction
If you get any side effects, even if not listed above, talk to your doctor or
contact the vaccination center.
What Janssen COVID-19 Vaccine contains
The active ingredient is a human adenovirus (type 26 adenovirus) unable to replicate which codes for the
glicoproteina spike del SARS-CoV-2.
This product contains genetically modified organisms (GMOs).
The other ingredients are: 2-hydroxypropyl-β-cyclodextrin (HBCD), citric acid monohydrate, ethanol, hydrochloric acid, polysorbate 80, sodium chloride, sodium hydroxide, trisodium citrate dihydrate, water for injections.
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