Commirnaty and Spikevax vaccines can be administered as a second booster dose
According to the point I.
In the interest of protecting public health in the context of the ongoing global pandemic of the covid-19 disease caused by the spread of the SARS-CoV-2 virus, to ensure the vaccination of the population of the Czech Republic, the Ministry, under § 8 par. 6 of the Medicines Act
the use of registered medicinal products
COMIRNATY 30MCG/DÁV INJ CNC DIS 195X0,45ML, SRCS code: 0250256, registration number: EU/1/20/1528/001, marketing authorisation holder: BioNTech Manufacturing GmbH, Mainz, Germany,
COMIRNATY 30MCG/DÁV INJ DIS 10X2.25ML, GLUTE code: 0255257, Marketing Authorisation Number: EU/1/20/1528/002, Marketing Authorisation Holder: BioNTech Manufacturing GmbH, Mainz, Germany,
COMIRNATY 30MCG/DÁV INJ DIS 195X2.25ML, SPC code: 0255258, Marketing Authorisation Number: EU/1/20/1528/003, Marketing Authorisation Holder: BioNTech Manufacturing GmbH, Mainz, Germany, (together also referred to as 'the medicinal product COMIRNATY'), and
SPIKEVAX 0.2MG/ML INJ DIS 10X5ML, IMPKl code: 0250303, Marketing Authorisation Number: EU/1/20/1507/001, Marketing Authorisation Holder: MODERNA BIOTECH SPAIN, S.L., Madrid, Spain (hereinafter also referred to as 'the medicinal product SPIKEVAX'),
(hereinafter collectively referred to as 'the subject medicinal products)
in a manner not following the Marketing Authorisation Decision, consisting of administering a second booster dose of the subject medicinal products to persons for whom the primary vaccination schedule has been completed according to the Summary of Product Characteristics:
(a) a medicinal product containing covid-19 vaccine for which a marketing authorisation has been granted under Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency,
(b) a medicinal product corresponding to a medicinal product referred to in point (a); or
(c) a medicinal product the manufacture of which is following a patent of a medicinal product referred to above approved by the World Health Organisation for emergency use,
and in which the first booster dose has been administered.
The dosage for the administration of the second booster dose of COMIRNATA is determined as follows:
one dose (0,3 ml) contains 30 micrograms of covid-19 vaccine mRNA (encapsulated in lipid nanoparticles).
The dosage for the administration of the second booster dose of SPIKEVAX is determined as follows:
one dose (0.25 ml) contains 50 micrograms of mediator (messenger) RNA (mRNA) (encapsulated in SM-102 lipid nanoparticles).
A second booster dose of the subject medicinal products may be administered no earlier than four months after the administration of the first booster dose in subjects who have reached 18 years of age.
A second booster dose of the subject medicinal products should not be administered to persons who are hypersensitive to the medicinal substance or to any of the excipients of the vaccine and to persons who have developed myocarditis or pericarditis as a known but very rare side effect of mRNA vaccines.
The full wording of the measure (only in Czech).