18 Mar 2022 09:49

Gamaleya Center files with Russian Health Ministry documents for registration of Sputnik V nasal vaccine

MOSCOW. March 18 (Interfax) - The Russian Health Ministry's Gamaleya Center has applied to the Health Ministry for registration of the intranasal form of the Sputnik V vaccine, and relevant information has appeared in the state register of medicines. The fact of the application has been confirmed by the center's Director Alexander Gintsburg.

"We have sent a package of documents to the Health Ministry that are needed for considering the issuance to us of registration of the nasal form of the Sputnik V vaccine," Gintsburg told Interfax.

No serious side effects were found in volunteers after vaccination during clinical trials, the scientist said.

"No, there have not been any serious side effects, except for those recorded before. It seems to me that even fever was recorded in a smaller percentage of volunteers than when the injected form of the vaccine was used," Gintsburg said.

The center hopes the documents will be considered within a short period of time and registration will be issued in the near future.

If registration is issued, the number of vaccines to be produced will be determined by the government, the scientist said.

"As we are not a commercial entity, we need a government resolution before we start working. [It depends on] how many they request. If they request a million doses, then that number of vaccines can be made in collaboration with the well-known Geranium plant over a three-week period; one month maximum," he said, responding to a question as to how quickly and in what volumes production can be launched.

The vaccine in spray form can be used for additional protection along with the main vaccination, Gintsburg said.

"I believe it needs to be used as an addition [to the injected form]. And in the process of use, if the pandemic continues, and, unfortunately, it looks like it will, then we will see, maybe recommendations to use it as an independent means [of vaccination] will be given over time. But now it will be an additional booster, which reinforces, accordingly, the classical vaccination scheme, creating an additional barrier at the level of the mucus membranes in the nasopharynx, which is the gate to infection," he said.

The nasal form will be needed for [higher] risk groups in particular, he said.