Nanolek has problems with the supply of children’s vaccines

The supply of the Pentaxim children’s vaccine to prevent five infections has encountered difficulties. The manufacturer of the drug Nanolek cannot ship the remaining 2.7 million doses under the contract without receiving a drug distribution plan from the Ministry of Health, and the vaccine is already running out in some regions. Experts also see risks of supply disruptions, but the regulator claims that the purchase is on schedule.

Some regions of the Russian Federation are running out of the Pentaxim vaccine for the prevention of diphtheria, whooping cough, hemophilus influenzae, polio and tetanus, a source in the pharmaceutical market told Kommersant. This vaccine, developed by Sanofi, is produced and supplied to the national preventive vaccination calendar (NCPP) “Nanolek”. Local authorities are already asking Nanolek to supply Pentaxim “as soon as possible,” there are more than fifteen such regions, another Kommersant source claims. Kommersant has copies of November appeals from the ministries of health of the Kirov and Tver regions. The administrations of these regions did not answer Kommersant’s questions.

The Federal Center for Planning and Drug Provision of Citizens (FCPiLO) of the Ministry of Health signed a contract for the supply of Pentaxim worth 6.2 billion rubles. in May. The shipment was planned in three stages, two of which were completed. The remaining 2.7 million doses cost 3.1 billion rubles. “Nanolek” was committed to delivery from October 16 to February 1, 2024. But the exact volume should be determined by an additional agreement after the approval of Pentaxim supply volumes for 2024, the contract says. There is no such agreement on the government procurement portal.

The situation is due to the fact that the Ministry of Health has not yet approved the need for vaccines for 2024. In mid-November, “Nanolek” addressed this problem to Deputy Minister Sergei Glagolev and Director of the Federal Center for Pilots and Laws, Elena Maksimkina. As stated in the company’s appeal (Kommersant has a copy), if the Pentaxim distribution plan for the third stage is not provided by November 17, Nanolek “will not be able to guarantee” the supply of vaccines on time in the required volumes.

Nanoleka confirmed to Kommersant that the Ministry of Health should have approved the need for vaccines by November 1, but did not do so. The company has already produced the required volume of Pentaxim and is ready to deliver, but the lack of a distribution plan “has a critical impact on the timing,” they emphasize. Typically, the Ministry of Health approves the need at the end of summer, says a Kommersant source in the market. Nanolek supplies other vaccines under already concluded contracts in full, the company said.

RNC Pharma Development Director Nikolay Bespalov notes that uncertainty with planning increases the risk of supply disruptions. Manufacturers will not produce vaccines without understanding the needs of the state, confirms expert of the All-Russian Union of Patients Aleksey Fedorov. He points out that many vaccines cannot be sold to pharmacies, and private clinics consume small volumes and are inclined towards foreign vaccines.

The Ministry of Health says that Pentaxim stocks in medical organizations are designed for 1.7 months, and in total there are 8.7 months worth of vaccines in circulation. State health authorities in Moscow, Volgograd, Voronezh regions, and the Republic of Crimea stated that there are no problems with the vaccine. In the capital, the reserves will last for 3.5 months; in the Voronezh region they claim that they have received the entire declared volume of Pentaxim. The Ministry of Health added that the region’s need for vaccines for 2024 “has been collected and brought to the attention of the Federal Center for Medical and Regional Prevention for the start of purchases and deliveries, which are proceeding as planned and on schedule.”

Nacimbio (supplies Russian vaccines for the NKPP) confirms that vaccines for 2024 are included in the production plan. They received a preliminary request about the possibility of supply from the Ministry of Health in October.

Polina Gritsenko