Booster vaccination and booster vaccination.
According to the German Federal Ministry of Health, a booster vaccination is a "renewed administration" of an mRNA vaccine approved in Europe. In this context, a booster vaccination is an administration of the vaccine to recovered individuals. The Austrian Ministry of Social Affairs does not use either term - instead, the term "further dose" is used here. Since a renewed dose (i.e. after the first complete vaccination or basic immunisation) can be either the second or third dose, depending on the vaccine manufacturer, the following article speaks of a "booster vaccination".
Primarily, the ministries thereby want to increase the vaccination protection of certain groups of people in whom the immune response is reduced after a Corona vaccination.
Aim of the booster vaccination:
The German Ministry of Health refers to scientific studies and the recommendations of the Permanent Vaccination Commission (short: STIKO) and also the Conference of Ministers of Health (Kurtz: GMK). The STIKO advises a booster vaccination with the article published in October 2021, as the CoV-19 vaccination protection of the first vaccination series can weaken over time - especially with regard to the prevention of asymptomatic infections and mild courses of disease in groups of people with a weakened immune system. A booster vaccination could significantly increase vaccination efficacy again in these cases. In addition, it was also found that persons in high-risk groups (i.e. low responders) produce fewer antibodies after the first vaccination series than the general average rate. The Austrian Federal Ministry of Social Affairs, Health, Care and Consumer Protection makes recommendations based on current approvals for booster vaccination by manufacturers. This concerns the third dose of Comirnaty for persons 18 years and older, 6 months after the 2nd dose (after vaccination series with the vaccine Comirnaty).
As it stands today, the CoV-19 vaccines Janssen, Spikevax and Vaxzevria are licensed only for the first vaccination series, i.e. 1 and 2 doses respectively. A further administration of a vaccine is therefore considered a so-called off-label use. Currently, the European Commission is reviewing Moderna's vaccine Spikevax for a booster dose.
Booster dose for Moderna
According to the FDA (i.e. Food and Drug Administration) of the USA, the Moderna booster vaccine applied for approval cannot meet all the criteria for an additional vaccination.
The FDA scientists explain that although the Moderna booster vaccine shows an increase in antibodies, it is not significant because the antibody count is already high after the first two Moderna vaccinations. As a reminder, Moderna's basic immunization vaccine contains 100 micrograms of messenger RNA (mRNA) per dose (0.5 ml). In comparison, a basic immunization dose (0.3 ml) from Pfizer/BioNTech has 30 micrograms of mRNA each. According to Prof. John Moore, professor of immunology at Weill Cornell Medical College in New York, there is no specification regarding the antibody boost that would be required. Pfizer trial data from Israel currently provide the only real population data.
Moderna's vaccine shows about 93% efficacy in the neutralization test at four to six months after the second dose, while the Pfizer/BioNTech vaccine's efficacy is about 84% at six months.
Unlike the FDA, the EMA recommends booster vaccination with Moderna's CoV-19 vaccine (i.e., Spikevax) starting at age 18, for adults, six months after the second dose. Pfizer/BioNTech's booster vaccine was also recommended on October 4, 2021. Furthermore, the EMA recommends a third vaccination for immunocompromised individuals four weeks after the second vaccination and full dose (for both mRNA vaccines licensed in Europe). It should be noted that the third vaccination for immunocompromised persons is to be distinguished from a booster vaccination after basic immunization due to decreasing efficacy.
According to the directions for use of manufacturers licensed in Europe, only the Comirnaty vaccine (Pfizer/BioNTech Manufacturing GmbH) mentions receiving a third dose of the vaccine. It is noted that people with weakened immune systems will still not be able to provide complete immunity to the SARS-CoV virus with the third vaccination.
The plan is to boost with Moderna with half a dose, or 50 micrograms of messenger RNA (mRNA).
It should be noted that the EMA can only make recommendations for approvals - the approval itself is decided by the European Commission. In principle, booster vaccines do not need to be individually licensed unless the manufacturer markets the vaccine with a change (e.g. Explicitly designated as a booster vaccine).
According to the EMA, there is currently no "direct evidence" that the ability to produce antibodies protects the individual from the SARS-CoV-2 virus. However, it is expected that the booster dose would increase protection for some patients.
Below is information on the recommendations for booster vaccination for Austria and Germany. The information has been taken from the Ministry of Health of the respective countries and is for informational purposes only - the recommendations do not replace professional medical or pharmaceutical advice. They are not intended for self-medication. For more information on vaccines, ask your doctor or pharmacist and read the instructions for use.
The following COVID-19 vaccines are licensed in Austria:
mRNA from completed 12 years of age:
- Comirnatyby BioNTech/Pfizer
- Spikevaxfrom Moderna
Vector vaccines from completed 18 years of age:
- Vaxzevriafrom AstraZeneca
- COVID-19 Vaccine Janssen from Janssen
Note: The booster recommendation of the Federal Ministry of Social Affairs, Health, Care and Consumer Protection is based, according to their information, on currently limited data and is supported by the current delta mutation of the SARS-CoV virus and current data from Israel.
In Austria, only a third dose of Comirnaty (BioNTech/Pfizer) is licensed for persons 18 years of age and older starting 6 months after the second dose, following a primary vaccination series with the BioNTech/Pfizer vaccine. Since the remaining COVID-19 vaccines are not (yet) licensed for booster vaccination, administration is an off-label use (including for comirnaty under 18 years of age).
The Department recommends booster vaccination for the following groups of persons based on the current delta mutation situation:
1. persons with COVID-19 vaccine Janssen: if vaccinated once, another off-label dose after at least 28 days, preferably with an mRNA vaccine, but again with Janssen is also possible.
2. recommendation of a booster vaccination after a minimum of 9 and a maximum of 12 months after basic immunisation for the following risk groups:
- Residents of old people's homes, nursing homes and retirement homes.
- Persons aged 65 and over
- Persons who have received 2 doses of Vaxzevria from AstraZeneca
- Individuals 12 and older with preexisting conditions and risksfor a severe course of COVID-19:
− Trisomie 21
− Personen mit Demenz, intellektuellen oder körperlichen Behinderungen in und außerhalb von Betreuungseinrichtungen, Personen mit körperlichen Behinderungen mit erhöhtem Risiko für einen schweren COVID-19-Verlauf
− Funktionelle oder strukturelle Lungenerkrankungen, die eine dauerhafte tägliche medikamentöse Therapie benötigen.
− Funktionelle oder strukturelle Herzerkrankungen, die eine dauerhafte tägliche medikamentöse Therapie benötigen (z.B.: Koronare-Herzerkrankung).
− Immundefizienz oder Erkrankung, die mit einer dauerhaften und relevanten Immunsuppression behandelt werden muss wie z.B. mit Cyclosporin, Tacrolimus, Mycophenolat, Azathioprin, Methotrexat, Tyrosinkinaseinhibitoren, laufender Biologikatherapie (bei nicht onkologischer Diagnose) oder Knochenmarkstransplantation innerhalb der letzten 2 Jahre
− Organtransplantation innerhalb des letzten Jahres oder geplante Organtransplantation (auf Warteliste gelistet) oder bei Graft vs. Host Disease
− Chronische Nierenerkrankungen mit Einschränkung der Nierenfunktion
− Chronische Lebererkrankungen mit Einschränkung der Leberfunktion
− Diabetes mellitus
− Zerebrovaskuläre Erkrankungen/Apoplex und andere chronische neurologische Erkrankungen
− Chronische entzündliche Darmerkrankungen, Autoimmunerkrankungen und rheumatische Erkrankungen
− Psychiatrische Erkrankungen (z.B. bipolare Störung, Schizophrenie und schwere Depression)
− Sonstige Erkrankungen mit funktionellen oder körperlichen Einschränkungen, die einen ebenso schweren Krankheitsverlauf von COVID-19 wie bei den hier gelisteten Krankheitsbildern annehmen lassen
3. people who can receive a booster dose from 6 months and should be offered one from 9 to 12 months.
- Staff in homes for the elderly, nursing homes and residential homes for the elderly
- Personnel in the health care sector
- Staff in mobile nursing, care, nursing and 24-hour care as well as caring relatives
- Personnel in educational institutions (child care, school, university, etc.)
4. all other persons should be offered a booster vaccination after 9 to 12 months from the age of 16.
5. recovered persons should be considered as fully vaccinated persons. For recovered persons with two doses, no further vaccination is required in this context, according to the Ministry.
6. convalescents with one dose of Janssen: after 6 to 9 months, they should be given another dose of an mRNA vaccine in preference. However, Janssen is also possible.
7. symptomatic SARS-CoV-2 infection: at present the Ministry does not recommend any further vaccination here.
Here, the Ministry of Health prefers the use of Comirnaty for all points, irrespective of homology or heterology (i.e. cross-vaccination) of the basic immunization, as there is already a European Commission approval here for persons 18 years and older and after at least 6 months.
In the case of off-label use, the ministry says it should be explicitly stated that this is the case and that there is no approval for a further dose, the data is still limited and "little is known about the nature and frequency of side effects".
Where to sign up?
In Austria, registration for a booster vaccination is currently only possible with an appointment, at the places where you also applied for a basic immunisation with an appointment. For this, you can use the booster calculator to calculate the minimum interval and subsequently book an appointment in the permissible period.
Can one decide which third vaccination one would like?
Currently, the booster vaccination in Austria is carried out exclusively with the mRNA vaccines from BioNTech/Pfizer and Moderna, which are approved in Europe.
In Österreich wird die Impfung mit Moderna für alle Personen empfohlen. Dabei wird nicht unterschieden, mit welchem Hersteller die erste Impfserie durchgeführt wurde.
When can I have a booster?
The following time periods refer to from the time of complete basic immunization.
- 1x dose Janssen: at least after 28 days
- Risk groups: at least after 9 and maximum after 12 months (recommended)
- personnel in the health sector, in educational institutions and in old people's/nursing/senior citizens' homes: after 6 months
- remaining persons from 16 years: after 9 to 12 months
- convalescents with one dose: like fully vaccinated persons
- convalescents+ 1x dose of Janssen: after 6 to 9 months
- convalescents+ 2x doses: no further vaccination necessary
- Infected: no further vaccination
The Impfservice Wien offers a booster calculator for this purpose, with which you can quickly calculate when you can get another dose.
According to a resolution of the Conference of Health Ministers (GMK), a booster vaccination is recommended for the following groups of people:
- Residents of old people's homes, nursing homes and homes for the elderly.
- Persons in need of care in their own homes
- Persons with immunosuppression
- People from the age of 80
- People aged 60 and over after individual consideration and medical advice
- Health care workers in medical facilities or nursing homes
- Close household contacts of persons with severe immunodeficiency
- Persons who have been vaccinated with the Janssen vaccine
- People who have received their full series of vaccinations with AstraZeneca's vaccine.
- Individuals who have received a vaccine dose of vector vaccine following coronavirus infection.
According to the STIKO (i.e. Standing Committee on Vaccination), a booster vaccination is recommended for individuals 70 years of age and older.
Where can I register?
Patients in need of care and patients with immunosuppressions and immunodeficiencies can be vaccinated directly by the attending physician or by (mobile) vaccination teams in the respective facilities in which they reside. This also applies to the respective nursing staff.
Persons with basic vaccination can receive the booster vaccination in vaccination centres, doctors' surgeries or through company doctors. The respective federal state decides on the start of the booster vaccinations and their organisation.
Can one decide which third vaccination one would like?
Regardless of the homogeneity or heterogeneity of the first vaccination series, the German Ministry of Health recommends one of the two mRNA vaccines (BioNTech or Moderna) for the booster vaccination. If possible, the vaccine used for the basic immunisation should be preferred. The organisation and implementation of the booster vaccination is the responsibility of the respective federal states.
Are the vaccines of the booster vaccination (mRNA vaccines) adapted to the new virus mutations?
According to the Ministry, booster vaccines are currently in use with the already available mRNA vaccines from Moderna and BioNTech/Pfizer. No manufacturer adjustments have been recorded.
Recommendations of the STIKO for booster vaccination
The Standing Commission on Vaccination (STIKO for short) has reviewed the data on the safety, immunogenicity and efficacy of booster vaccination with mRNA vaccine and recommends it for the following individuals:
- Persons 70 years of age and older
- Residents or persons cared for in nursing facilities (also under 70 years of age)
- Nursing staff and others working in facilities caring for the elderly or those at increased risk for severe COVID-19 events
- Personnel in medical facilities with direct patient contact
- Persons with severe immunodeficiency
- Persons who have been vaccinated with the Janssen vaccine
Regardless of the vaccine used for basic immunization, BioNTech/Pfizer or Moderna mRNA vaccine should be used for booster immunization. If fully immunized with an mRNA vaccine, the same vaccine is recommended for the booster.
The time interval between the first vaccination series and the booster vaccination is identical at the STIKO to that of the German Ministry of Health.
Are possible vaccination damages also legally covered for the booster vaccination?
Throughout Germany, according to the Ministry of Health, there is a right to compensation for any damage to health in connection with approved vaccinations (based on the Coronavirus Vaccination Ordinance since 27.12.2020) regardless of the public recommendations of the state authorities.
Since even a follow-up vaccination or booster vaccination does not take place outside of the approval, but is a medical therapy decision, there is a claim for compensation for these.
How long do persons who have had a basic vaccination but do not receive a booster vaccination retain the status "vaccinated"?
The German Ministry of Health is not yet able to provide any information on this, as it is currently still being examined which vaccination intervals should be adhered to in order to maintain a significant effect against COVID-19.
When can I get a booster?
In principle, booster vaccinations in Germany are carried out at the earliest 6 months after the first vaccination series. An exception is the group of people who received the basic immunization with Janssen and people with severe immune deficiencies. These can receive a further dose as early as four weeks after the first vaccination series.
Persons who had an infection with the SARS-CoV-2 virus before or after vaccination are not recommended to receive a booster vaccination at present.
Does the offer of booster vaccination also apply to heterologously vaccinated individuals (vaccinated with AstraZeneca in combination with mRNA vaccine)?
The recommendation does not apply to these individuals, as they already benefit from the increased efficacy provided by cross-vaccination. Persons who have received a vaccination series with pure vector vaccines (i.e. 1x dose Janssen or 2x dose AstraZeneca) and recovered persons who have received basic vaccination with a vector vaccine booster are affected by this recommendation. The exact time intervals for booster vaccination for cross-vaccination for non-risk groups are currently still under review.
With which time interval should booster vaccinations be carried out for homologous vaccination series (one-time vaccination with Janssen or two-time vaccination with AstraZeneca)?
For these individuals, the recommendation is to receive a booster vaccination 6 months after basic immunization with an mRNA vaccine. For individuals with one dose of Janssen, they can get their booster vaccination after 28 days.
Possible vaccine reactions and controversies
We remind you to be fully informed about the very common, common, occasional, rare and (due to insufficient available data) unknown side effects on the package insert of each vaccine by the attending physician in advance (regardless of vaccine dose).
According to the instructions for use, only the vaccine Comirnaty (Pfizer/ BioNTech Manufacturing GmbH) mentions that a third dose of the vaccination is to be obtained. It is noted, according to the directions for use, that people with weakened immune systems still cannot provide complete immunity to the CoV virus with the third vaccination.
A particularly frequently discussed "flashpoint" among the possible side effects is the possibility of myocarditis and pericarditis or myopericarditis. However, the available reports, studies, and opinions from PhDs and ministries are inconclusive or register wide disparities. The reason for this is the current lack of qualitative studies on the third dose - the Israel studies on Comirnaty are currently the only "real world" analyses.
While the Paul-Ehrlich-Institute reported in the safety report on Covid-19 vaccines on May 7, that in Germany "No risk signal" with regard to myocarditis can be detected, the Ministry of Social Affairs in Austria provides the information that myocarditis is present in very rare cases, increased after the 2nd dose in young men. Since the reactions to a 3rd dose are still unknown with Spikevax and Johnson&Johnson, an open vaccination education on COVID-19 vaccination is significant despite the repeatedly proven very good safety profiles of the mRNA vaccines Comirnaty and Spikevax.
Globally, different governments, institutions, researchers and organizations express different views on booster vaccination. While the U.S. government is in favor of booster vaccination, researchers in the medical journal The Lancet discuss possible risks of rushing to start nationwide booster vaccinations. The WHO is also calling on rich countries to wait until the end of 2021 for boosters and instead achieve a 40% global vaccination rate first.
A detailed consultation with your attending physician in the respective country is recommended in any case, in order to be able to decide optimally whether, when and with what a booster vaccination should be carried out.