Pfizer / Biontech and Moderna are trying to get their corona vaccine approved for use in the EU as a matter of urgency, after previously reporting promising test results.
Pfizer / Biontech announced on Tuesday that they have applied for approval, reports Reuters. Moderna announced that they had submitted the necessary information for an approval on Monday.
No other vaccine has gone so far as to apply for a conditional authorization for the European market. Now the two vaccine candidates will go through the EU system. If they are approved, it means that they can also be used in Norway.
Steinar Madsen, medical director at the Norwegian Medicines Agency, says that the European Medicines Agency will process the Pfizer / Biontech vaccine on 29 December. On 12 January, the Moderna vaccine will be discussed.
– If there is a positive statement from the scientific committee, the European Commission will approve the vaccines. Then they are automatically approved in Norway, and can be used, says Madsen.
It was first signaled by the EU that the first approval could come in January / February, but recently the president of the commission, Ursula von Leyen , said that two of the vaccines could be approved in December.
The road to approval
Vaccines we will use here in Norway will first be approved by the EU. An EU approval will mean that the vaccine is automatically approved for Norway as well.
It is the European Commission that makes the final decision. Before that, the vaccine must be evaluated in the European Medicines Agency (EMA). Those who actually give advice are the Committee for Medicinal Products for Human Use (CHMP) in the EMA.
In order to be approved, the CHMP must review the data from the vaccine manufacturer. This is a lot of work. There are different data from the three phases of the vaccine development and everything that happened in the process before the vaccine was given to the first person. There is also supplementary documentation of how the vaccine is produced.
After the EU has approved a vaccine, it is up to the Norwegian government whether the vaccine will be used in Norway.
Source: nrk.no
