On social media, a document about an exemption from the Medical Products Agency has been circulated and in some circles it has aroused suspicion about Pfizer and Biontech's vaccine against covid-19.

The exemption from the Medical Products Agency means that Pfizer / Biontech does not send a package leaflet in the package to the vaccine.

- According to the exemption, the package leaflet will instead be available electronically on, among other things, the Medical Products Agency's website.

You will also be able to get it physically from your healthcare provider or sent home from the company or us.

The exemption decision only applies to the packaging, not the vaccine itself.

Everything with the vaccine is exactly as it should be, says Ingela Ottoson, group manager at the unit for Product Information and responsible for dispensers at the Medical Products Agency.

Faster access to vaccines

Why are you giving this exemption?

- The exemption has been granted to ensure the availability of the vaccine to the public.

This vaccine must be stored very cold, minus 70 degrees, throughout the process.

This means that it is difficult to get the package leaflet and it could also affect the durability if the package is opened.

It would also take much longer to translate the package leaflet into the different languages ​​of all countries, and in this way Swedish patients will have access to the vaccine faster.

"No risk to the patient"

The dispensation also means that the packaging lacks a 2D code, with information on, among other things, batch and expiration dates.

Due to the requirement that the vaccine be stored in 70 minus, it has been difficult to attach the code to the packaging.

But the information, which would be in the 2D code, is in close proximity to the packaging.

All EU countries have given the same exemption to Pfizer and Biontech, according to Ingela Ottoson.

- The packaging will be in English, this is what healthcare is used to, and each region has designed information in Swedish for healthcare staff on how the vaccine should be diluted and given to patients.

We would not have approved this if we considered that this posed a risk to patients.

"Does not even affect rights"

A statement has circulated on social media that patients who receive the Pfizer / Biontech vaccine due to the exemption are not entitled to report or receive compensation for side effects.

- No, it is absolutely not.

The fact that the package leaflet is not in the box does not even affect rights, compensation or insurance.

Here you will find the package leaflet for the Pfizer / Biontech vaccine.