Current status on the application: Is a third vaccination necessary?
A single dose of Johnson & Johnson vaccine still reduces the risk of severe covid 19. However, numerous reports of breakthrough infections are increasing.
Thus, the efficacy of a single dose of the Johnson & Johnson vaccine is (significantly) reduced compared to the Omikron variant.
For this reason, the Standing Commission on Vaccination (STIKO) gradually adjusted its recommendations in recent weeks and months: First, it advocated an “optimized basic immunization”. First, it advocated an “optimized basic immunization”, i.e. a second mRNA vaccination from the fourth week after basic immunization.
In a second step, the STIKO now also recommends an additional booster (with an mRNA vaccine) to maintain the best possible protection against the Omikron variant. Those under 30 years of age should receive only the BioNTech preparation as a booster.
What is Johnson & Johnson’s vaccine?
The vaccine Ad26.CoV2.S is a vector vaccine developed by the Belgian pharmaceutical company Janssen Pharmaceutical (in Germany: Janssen-Cilag GmbH) – Janssen is part of the US company Johnson & Johnson.
Following isolated cases of cerebral venous thrombosis in younger people in the U.S. after vaccination, the STIKO has been recommending it primarily for people aged 60 and older since May 10, 2021.
How well does the Johnson & Johnson vaccine work against Covid-19?
According to regulatory documents, Johnson & Johnson’s Ad26.COV2.S vaccine has an averaged efficacy of 66 percent against the original (wild-type) coronavirus.
Regulatory studies: efficacy across all age groups
The majority of the 44,000 study participants in the ENSEMBLE pivotal trial were between the ages of 18 and 59. However, several thousand participants were also older than 60 years. Consequently, the vaccine’s efficacy could be well determined even in this age group, which is particularly prone to severe courses.
The study results indicated that the vaccine is similarly effective across all age groups. That is, it is probably as effective at younger ages as it is in older persons 60 years of age and older.
Efficacy of Johnson & Johnson vaccine against viral variants.
The Johnson & Johnson vaccine also protects against certain coronavirus variants. In general, efficacy data vary considerably (depending on the study considered, however).
- 70 percent compared to the alpha variant
- 52 percent compared to the beta variant
- 37 percent compared to the gamma variant
Compared to the delta variant, the Johnson & Johnson vaccine (as a single dose) shows significantly reduced efficacy against infection. Nevertheless, the vaccine probably continues to prevent severe courses.
In contrast, the loss of efficacy of a single dose compared to the now predominant Omikron variant is severe. A single dose no longer offers sufficient protection against infection with Omikron. According to the manufacturer, a double vaccination (homologous vaccination series) with the J&J vaccine can again raise the protection against severe courses to high levels.
In practice, however, booster vaccination often follows a crossed vaccination schedule: that is, a combination of the J&J vaccine and other coronavirus vaccines is administered with a time delay – mRNA vaccines in particular have proven effective in this context.
Tolerability and side effects of the Johnson & Johnson vaccine.
The Johnson & Johnson vaccine Ad26.COV2.S is rated by experts as safe and well tolerated.
In the registration studies, vaccinated individuals reported typical vaccine side effects such as swelling at the injection site or fever. Only very rarely did physicians observe severe adverse events, such as severe intolerance reactions.
Typical vaccination reactions
About half of all study participants reported typical mild to moderate vaccine reactions. According to the study, side effects of the Johnson & Johnson vaccine include:
- Pain and swelling at the injection site
- Fatigue
- Nausea
- Headache
- Muscle pain
- Feverish reactions
- Chills
These vaccination reactions can also occur after other vaccinations such as those against measles or chickenpox. They are due to the immune system reacting to the vaccine.
Vaccine reactions usually subside within hours or a few days. They affect younger people more often than older vaccinees over the age of 60.
Further information on typical vaccination reactions can be found in detail here.
Vaccination during pregnancy?
There are not yet sufficient data to provide information on safety or efficacy in pregnancy. It is not known whether Johnson & Johnson vaccine Ad26.COV2.S passes into breast milk.
The available pivotal studies included individuals who were at least 18 years of age. Consequently, there are no data yet on efficacy, tolerability or side effects for children and adolescents younger than 18 years.
Vaccination in case of existing allergies?
No recommendations are yet available on whether allergic individuals should be vaccinated with Ad26.COV2.S. However, if you suffer from known allergies, be sure to tell your vaccinator.
As a general rule, general safety precautions apply: Have medical monitoring (e.g., at the vaccination center or doctor’s office) at least 15 minutes after a vaccination for early vaccine reactions. Healthcare professionals can then quickly counteract sudden hypersensitivity reactions (anaphylaxis).
Vaccination in case of illness?
If you are acutely ill, i.e. have a fever of 38.5 degrees Celsius or higher, an agreed vaccination date should be postponed. Vaccination can then take place after recovery. To do this, call your vaccinating doctor in good time to reschedule a scheduled vaccination appointment.
However, a mild cold – or only a slightly elevated temperature – is usually not an obstacle to vaccination.
Vaccination with anticoagulants?
In this case, your doctor administers the vaccine with a particularly thin needle and then presses on the injection site longer to avoid possible bleeding and bruising.
Vaccination in case of immunodeficiency?
There are no firm data on how the Johnson & Johnson vaccine Ad26.COV2.S works in immunocompromised individuals. Presumably, reduced efficacy is to be expected, since the weakened immune system of affected individuals can only respond to vaccination to a limited extent.
However, a special danger for immunocompromised persons is not to be assumed, since it is not a live vaccination.
Dangers of an overdose?
Cases of overdose have not been reported at this time. However, it is clear from the registration studies that even a dose increased by a factor of two was well tolerated by the vaccinees.
However, those individuals who received an increased dose reported increased typical vaccine reactions such as increased pain at the injection site, as well as fatigue, headache or febrile reactions.
Effects on driving ability?
Some of the typical vaccination reactions – such as fatigue or tiredness – could possibly temporarily limit your ability to drive. In such cases, it is advisable to wait until the effects have subsided before getting behind the wheel.
Very rare vaccination complications
As with all vaccines, isolated complications cannot be completely ruled out. Since the introduction of the Johnson & Johnson preparation, blood clotting disorders have occurred in very rare cases.
Signs of such complications include severe (prolonged) headaches, seizures, blurred vision, unexplained bleeding, and unexplained bruising on the skin – especially on parts of the body other than the actual injection site.
Also, (pronounced) shortness of breath, chest pain, leg swelling or persistent abdominal pain may be an indication of possible complications.
Such complications usually occur within a period of up to three weeks after vaccination. In such cases, contact a physician immediately, as blood clotting disorders can be very dangerous if left untreated!
The group of observed blood clotting disorders includes:
Venous thromboembolism: In very rare cases, physicians observed the formation of blood clots following vaccination, resulting in vascular occlusion. Individuals who have a generally increased risk of thrombosis should be sure to communicate this to their vaccinating physician in advance of vaccination.
Thrombosis with thrombocytopenia syndrome: This is a complication associated with the formation of blood clots (thromboses) in combination with a deficiency of blood platelets (thrombocytopenia). In severe cases, the blood clots can occur in unusual parts of the body – for example, in certain areas of the brain (so-called sinus vein thrombosis), but also in the spleen, liver and intestinal veins.
The incidence of such complications – as of the cutoff date of September 20, 2021 – is one person for every approximately 217,000 doses of Johnson & Johnson vaccine administered. In other words, a total of 13 cases have been observed in approximately three million doses of vaccine administered since the vaccination campaign began.
Symptoms can occur within three weeks of vaccination and, contrary to initial assumptions, are independent of gender. The reason for the observed symptoms is seen in a falsely activated coagulation cascade. This is mediated by transient antibodies against the so-called platelet factor 4.
For more information on Guillain-Barré syndrome, click here.
Contraindication in case of previous capillary leak syndrome
According to a July 19, 2021, announcement from the manufacturer Janssen-Cilag, a condition known as capillary leak syndrome (CLS) has been observed, with a frequency of one case per approximately six million doses of vaccine administered.
CLS is one of the rare diseases in which the function of blood and lymph vessels is disturbed.
The blood vessels of affected individuals become permeable, allowing fluid to flow into the tissues. As a result, blood pressure drops rapidly. Progressive swelling of the arms and legs occurs. This altered distribution of fluid in the tissues can lead to shock or even organ failure.
This is a very rare side effect that has now been included in the updated product information. So doctors now clarify in advance whether CLS episodes have already occurred in the past. In such a case, physicians will switch to an alternative coronavirus vaccine.
Use
Physicians administer the Johnson & Johnson vaccine intramuscularly. Usually into the deltoid muscle of the upper arm. A single vaccination is not sufficient for the Johnson & Johnson vaccine, according to current knowledge.
In practice, however, the STIKO in Germany recommends mRNA vaccines as follow-up vaccinations for all persons 18 years and older – both for second and third vaccinations.
Transport and shelf life
Unlike the particularly sensitive mRNA vaccines, Johnson & Johnson’s Ad26.COV2.S is far more stable. It has a shelf life of at least three months at two to eight degrees Celsius. At very lower temperatures – i.e., minus 20 degrees Celsius – it can even be stored for two years, according to the manufacturer.
Accordingly, the vaccine from the manufacturer Johnson & Johnson is – with restrictions – significantly less dependent on a complex cold chain. This facilitates home visits by mobile vaccination teams, for example. The vaccine would therefore also be suitable for use in doctors’ offices.
Despite its greater stability, doctors ideally vaccinate an opened ampoule within two hours. The vaccine itself is supplied in refrigerated ampoules. Each ampoule contains five vaccine doses. Each vaccine dose is equivalent to 0.5 milliliters.
How does the Johnson & Johnson vaccine work?
The Johnson & Johnson vaccine is the second coronavirus vaccine in Western countries to use the so-called vector technique (vector vaccines).
As a result, they produce the viral protein molecule. The immune system reacts to this and thus “trains” for actual contact with the pathogen Sars-CoV-2.
Vector from “cold viruses
Ad26.COV2.S is based on a technology specially developed by Janssen Pharmaceutical. Unlike the vaccines from BioNTech/Pfizer and Moderna, the genetic information of the blueprint for the spike protein is available here in the form of DNA.
In order to transport this genetic information into the human cell, a “transport vehicle” is needed. In technical circles, this is referred to as a vector.
The vector of the Johnson & Johnson vaccine was originally derived from a harmless human cold virus (adenovirus). In order to be able to function as a “transport virus,” the scientists modified it: it is now no longer able to replicate on its own and thus cause disease (non-replicating vector).
Janssen/Johnson & Johnson already had very good experience with this technology. The Ebola vaccine recently approved in Europe, for example – approved by the EMA on July 01, 2020 – is based on the same technology. So there is already a lot of data available on the safety and tolerability of this vaccine technology.
