CHECKLIST: Is the fourth dose of the coronavirus vaccine not approved? It is not true, the ministry responds iRADIO

A video is circulating on the Internet in which a man tries to convince viewers that the fourth dose of the vaccine against the coronavirus, specifically from Pfizer, is not approved due to the lack of the so-called summary of product data on the website of the State Agency for Medicines Control. But how about the server iROZHLAS.cz in the next part of the series Verification! confirmed by the Ministry of Health, the authorization of the application of booster doses is placed above the mentioned summary as part of the measures according to the Medicines Act.



Prague
5:00 a.m September 4, 2022

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The circulated video allegedly proves that the fourth dose of the vaccine is unapproved | Source: Reprofoto iROZHLAS.cz

To the verification mailbox of the project! the request to verify the video questioning the safety of the fourth dose of the coronavirus vaccine landed several times. “My mother-in-law is being lured by dubious videos and articles. What’s the problem if there really is a description for three doses in the description of the Comirnaty vaccine? And who is that person performing there?” read one of them.

In the video, a man identified as Dr. Jiří Urbanek announces that the fourth dose of the covid vaccine is in fact unapproved.

“The fourth dose is an unapproved use of a medicinal product. The only binding document that says how the medicinal product or vaccine should be used is the so-called SPC or summary of contribution data. Now it is clearly written on the website that the Comirnaty vaccine is administered in three doses,” says Urbanek.

Safe vaccines

On the website of the State Drug Control Office, the mentioned summary of data on the contribution really only refers to the first booster dose, the third overall. However, as the iROZHLAS.cz server discovered, the measure regarding the use of vaccines is approved beyond the scope of this document.

The use of the vaccine beyond the scope of the summary results from the decision of the Ministry of Health to allow vaccination with a second booster dose, which is available to the iROZHLAS.cz server. The ministry decided on the temporary permit on July 15.


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In the aforementioned decision, the ministry states that for mRNA-type vaccines (Comirnaty vaccines from Pfizer/BioNTech and Spikevax from Moderna – editor’s note) “there are already publications showing that fourth doses of covid-19 mRNA vaccines are safe and provide substantial increases in antibody concentrations and cellular immunity”.

Ministry spokesman Ondřej Jakob subsequently confirmed this to the editors. “TOIn the fourth dose, a measure was issued under the Medicines Act, which was to temporarily use vaccines beyond the approved SPC,” he wrote in an email.

The iROZHLAS.cz server met with the author via video call and confronted him by verifying the misleading information.

“Perhaps I used the word unapproved awkwardly. Yes, the Ministry allows it, but from the point of view of the SPC, it is a preparation (fourth batch – editor’s note) unapproved, it is still an off-label use of the vaccine,” stated Urbanek.

“What is legal is not always ethical. It seems to me that the ministry withheld important information,” Urbanek pointed out.

Approved procedure

Vaccination against the coronavirus, however, does not affect the principle of so-called off-label use. This was also confirmed by the State Drug Control Office.

In the case of administration of the fourth dose, it is the so-called emergency use (emergency use), which is based on European Directive 2001/83/EC. Specifically, in Article 5, point 2. It says that member states can temporarily authorize the distribution of an unregistered medicinal product in response to the presumed or confirmed spread of pathogenic agents, toxins, chemical substances or nuclear radiation that could cause harm,” she told the iROZHLAS server .cz office spokesperson Klára Brunclíková.

Verification office!

In the series Verification House! the iROZHLAS.cz server has been dedicated to disinformation spread in the public space for a long time. You can find a complete overview of debunked lies here.

While off-label use is defined by the Medicines Act as follows: “The attending physician may, if the medicinal product is not distributed or there is no medicinal product with the necessary therapeutic properties in circulation, use the registered medicinal product in a way that is not in accordance with the summary of product information, if however, such a method is sufficiently justified by scientific knowledge. The provider of health services is authorized for damage to health or the death of a person.”

And what is the difference between these two non-standard procedures? “Off-label is the responsibility of the health service provider, and ’emergency use’ is a decision on authorization for use at the national level, where the state takes responsibility. This is definitely an approved procedure,” Brunclíková clarifies.

“The claim that this is an unapproved procedure is misleading. This is an approved procedure at the national and European level,” the spokesperson points out.

The ministry’s report also lists the most serious risks that have been associated with the use of previous doses, along with warnings for certain people against its use.

HAVE YOU ENCOUNTERED MISINFORMATION?

Dear readers, if you come across information on social networks about which you are not sure of its origin or veracity, send it to the e-mail address [email protected] The iROZHLAS.cz server will try to verify it for you.

“From the point of view of safety, the Institute (for drug control) does not recommend the administration of a second booster dose of mRNA vaccines in persons who have hypersensitivity to the medicinal substance or to any auxiliary substance of the given vaccine and in persons who have manifested myocarditis or pericarditis as a known but very rare adverse the effect of mRNA vaccines,” the decision describes.

The SPC document (the abbreviation comes from the title “summary of product characteristics”), which the mental coach Urbanek mentions, defines the information portal of the Ministry of Health as a comprehensive document that contains all essential information related to the use of the medicinal product, its dosage, indications, interactions, side effects , pharmacodynamic and pharmacokinetic properties as well as information on the proper storage of the drug and the marketing authorization holder.

Veterinarian epidemiologist?

“I’m not saying it’s not fair use. The Ministry thereby relieves health workers and everyone who injects the vaccine and the holder of the registration decision of responsibility,” Urbanek responds to the verification of the false statement.


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But he doesn’t want to delete or edit the video. “I didn’t deliberately insult anyone. That’s your interpretation,” concluded Urbanek.

The rich list of jobs of the trained veterinarian Jiří Urbanek includes, among other things, years of experience in the companies Pfizer and Johnson & Johnson, i.e. the current manufacturers of covid vaccines, mainly in the positions of product manager.

Doctor Urbanek currently runs the company Prepare for Success, in which he offers customers a path to satisfaction and money. “We will teach you the rules, proven and new techniques and tactics to be successful traders. We will give you procedures tested in practice. We change your lives,” the site states.

There is no mention of the covid-19 pandemic in the mental coach projects. He is, however, very active on his Facebook profile – in addition to motivational videos, he frequently shares misleading posts from controversial groups, such as the Healthy Forum movement, which repeatedly called for the cancellation of all anti-epidemic measures during the pandemic.

He also continues to praise the personalities of the Czech disinformation scene, including the microbiologist Sonia Pekova, an unsuccessful candidate for the Chamber of Deputies for the Swiss Democracy movement.

Timon Love

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