COVID is left with a nose – Newspaper Kommersant No. 153 (7354) of 08/23/2022

The authorities of the Kursk region announced that they were the first in Russia to launch mass vaccination with a nasal vaccine against coronavirus. According to the regional administration, almost 7,000 people have already been vaccinated in this way. However, as Kommersant found out, this is not about a special vaccine in the form of nasal drops, registered in April 2022, but about the usual Sputnik V. With the help of special nozzles, it is administered internally, that is, through the nose. The Ministry of Health of the Russian Federation explained that this is allowed by the instructions. At the same time, experts interviewed by Kommersant questioned both the legal and medical validity of such use.

In mid-August, the head of the health committee of the Kursk region, Ekaterina Pismenny, said that the region was the first in the Russian Federation to launch “mass nasal vaccination against coronavirus.” Ms. Pismenny clarified that the nasal vaccine has arrived at all medical institutions and is popular: only in one of the large points in Kursk, about 100 people are vaccinated a day, and a total of 6,933 residents of the region have already been vaccinated. According to the head of the Komzdrav, the nasal vaccine is easier to tolerate than the usual one, and no serious side effects have been identified during its use.

Kommersant drew attention to the fact that in the unified state register of Roszdravnadzor, which publishes information about all medicines released in the country, there is no data on the production of a vaccine in the form of drops or spray.

The Ministry of Health of the Russian Federation explained to Kommersant that Sputnik V, intended for intramuscular injections, is injected through the nose. In accordance with the instructions for medical use, the department clarified, the introduction of the Gam-Kovid-Vak vaccine (trade name Sputnik V) is possible both intramuscularly and internally – using a spray nozzle on a vertical type syringe. Vaccination is carried out in two stages with an interval of three weeks. Two disposable spray nozzles are required, which are purchased at the expense of the funds of the constituent entities of Russia. Currently, according to the press service of the Ministry of Health of the Russian Federation, the regions continue to purchase spray nozzles. Note that on Monday afternoon, Kommersant did not find on the website of the State Register of Medicines (GRLS) instructions for Sputnik V, which the medical department refers to. Although this document was previously published there.

The administration of the Kursk region told Kommersant that the region “took the initiative, independently contacted the supplier of nozzles for the nasal vaccine, thus becoming one of the three constituent entities of the Russian Federation among the first to receive a nasal vaccine for mass vaccination of the population.” The region received the first batch of 12 thousand nozzles (atomizers). In the near future, according to the authorities, a second delivery is expected “according to the general distribution from the Ministry of Health of the Russian Federation.”

At the same time, in other subjects interviewed by Kommersant, they did not report their intention to purchase nozzles and introduce Sputnik V internally. Chelyabinsk, Ivanovo, Novosibirsk, Ulyanovsk, Saratov regions, Krasnodar, Perm, Altai Territories, Tatarstan, Dagestan, Buryatia and Bashkiria are waiting for centralized deliveries from the Russian Ministry of Health of the nasal vaccine. The authorities of the Astrakhan and Samara regions specified that deliveries are expected in September this year.

The vaccine “Gam-Kovid-Vak” in the form of nasal drops, according to the GRLS, was registered on April 31, 2022 after two phases of accelerated clinical trials. However, it was never released into civilian circulation.

Nikolai Kryuchkov, an expert in the development and research of medicines, explains this by the lack of nozzles – they are all foreign-made.

Now, according to the expert, the authorities have managed to localize their own production and establish alternative supply channels. Nikolai Kryuchkov draws attention to the fact that, according to the instructions, the nasal vaccine is identical to Sputnik V for intramuscular injection: the release form, dosage, vials, and storage conditions are the same. The only fundamental difference is that this drug can only be produced by the Gamaleya Institute (Sputnik V is produced at seven factories, including Binnopharm and R-Pharm). In addition, the instruction allows release both with a dosing device and without it.

“Therefore, in fact, from a medical point of view, using an internally separate vaccine or regular Sputnik V is the same thing. However, they are legally different drugs. According to regulatory rules, you can’t just take a vaccine for intramuscular injection, open it, remove the protective cap, change it to a nozzle, and get a new drug,” says Mr. Kryuchkov.

Doctor of Biological Sciences, Professor Konstantin Severinov believes that it is impossible to use a vaccine intended for intramuscular injection internally.

“Just like you can’t stab it in the brain, in the heel and other places. Any change in the form of application of the drug will most likely require a dose change. And it needs to be calculated in the course of research,” says Mr. Severinov. He explains that, from the consumer’s point of view, the nasal form is much more convenient. In addition, such a vaccine is likely to have fewer side effects. “The intramuscular administration of the adenovirus vaccine is very rare, but causes a strong reaction in some people. Milder side effects, in particular fever, are quite common. Nasal forms do not lead to this. Perhaps this is due to the fact that in the nasal cavity adenoviruses, similar to those on the basis of which Sputnik is made, are found in natural conditions, ”says Mr. Severinov. However, he continues, there are people who are concerned about the safety of the nasal form, “because from the nose is very close to the brain.” That is why clinical trials are needed to test the safety and efficacy of new forms of the vaccine. Konstantin Severinov emphasizes that although many companies are now developing nasal vaccines, none of them, except for Sputnik V drops, have been certified.

Natalia Kostarnova; Sergei Tolmachev, Voronezh; corset “b”