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Berlin – The German federal states still have 60,840 Mpox vaccine doses in stock. It is currently unclear whether any of these will be distributed to African countries with current Mpox outbreaks. This was revealed by a query from the German Medical Journal at the 16 health ministries of the federal states.

Only two states are pushing for donations or discussions about them with the federal government. Several health authorities currently classify the stocks of the Jynneos drug as not marketable in their country. In principle, a number of federal states referred to the responsibility and decision-making authority of the federal government, which procured the vaccines.

The reason for the assessment by some federal states that Jynneos is not marketable: In the European Union (EU), the vaccine Imvanex from the same manufacturer is now approved against Mpox and is regularly available (Modified Vaccinia Ankara, Bavarian-Nordic, MVA-BN).

“The stocks of the Jynneos vaccine cannot currently be used up because the Imvanex vaccine is available,” said the Saxon State Ministry for Social Affairs and Social Cohesion, for example. Against this background, the exemption regulation under which Jynneos was procured is no longer “relevant,” said the Thuringian Ministry of Health. According to information from the federal states, the Jynneos stocks will last until the end of May 2025.

Minimal differences between vaccines

Imvanex was initially approved in the EU against smallpox and received additional approval against Mpox in summer 2022. “Since the vaccine was not available, the Jynneos vaccine was used exclusively for vaccination against Mpox until summer 2023,” writes the Robert Koch Institute (RKI) on its website.

At that time, the Federal Ministry of Health (BMG) procured the Jynneos vaccine, which had already been approved against Mpox in the USA, in order to contain the infection, but which has not yet been approved in the EU. The basis for this was Section 79 Paragraph 4a of the German Medicines Act (AMG), a spokesman said.

According to the RKI, the two vaccines are identical “except for minor differences in the manufacturing process and quality specifications.” Therefore, vaccination series started with Jynneos can also be continued with Imvanex.

Only a few signal willingness to donate

When asked about a possible donation or sale of vaccine doses to affected African countries, the vast majority of federal states responded by referring to the federal government, which would have to decide on this. Berlin, among others, reported that it was not known whether the federal government was planning to donate or pass on the vaccine doses.

Schleswig-Holstein and Lower Saxony, however, responded differently. “The federal government, as the owner of the doses, is currently examining whether to distribute the vaccine,” said the Lower Saxony Ministry of Health. “Lower Saxony welcomes this review and expressly advocates making the maximum number of vaccines available in an unbureaucratic and free manner.”

Lower Saxony’s Health Minister Andreas Philippi (SPD) had already spoken out in favor of rapid and extensive deliveries of vaccines about a week ago and exchanged views with Federal Health Minister Karl Lauterbach (SPD), a spokesman said.

The Ministry of Health of Schleswig-Holstein stated: “An exchange with the federal government is taking place on this matter.” The federal government was recently contacted about this issue.

The BMG had German Medical Journal A few days ago, the Ministry of Health announced on the question of possible vaccine donations that it was examining whether and what kind of help could be provided. However, so far there has been no concrete request for help from the recipient countries. “Neither the countries, nor the target group to be vaccinated, nor a vaccination schedule or the logistical questions (types of containers, needles, etc.) have been clarified so far.”

The Hamburg Social Welfare Authority named further possible hurdles: the vaccine must be transported at minus 20 degrees, which creates logistical challenges, especially with small quantities. Whether the vaccine can be used in Africa must also be examined against the background of approval issues.

The BMG’s central stock of Jynneos amounts to about 117,000 doses, which was handed over to the Federal Ministry of Defense in the first half of 2024, it said.

The World Health Organization (WHO), among others, called for vaccine donations for the affected regions last week when it declared a health emergency of international concern.

It will probably take several months for new Mpox vaccine doses to be produced once there is concrete demand from a country, wrote Sania Nishtar of the vaccine alliance Gavi in ​​a commentary in Lancet (DOI: 10.1016/S0140-6736(24)01706-9). In the meantime, vaccine donations from high-income countries’ stockpiles are the approach with the greatest immediate impact.

Keep Jynneos just in case

Other federal states have declared that they want to keep the Jynneos vaccine doses that are still in storage. “There are currently no plans to distribute them to other countries, as it is a relatively small amount of vaccine that is to be kept in the state,” said Saxony-Anhalt’s Ministry of Health.

Brandenburg announced: “The state’s vaccine stocks will continue to be maintained in order to respond to possible local outbreaks as part of post-exposure prophylaxis.”

In some cases, Jynneos is still considered to be currently usable. Since the vaccine’s manufacturing process differs only slightly from Imvanex, it is “marketable in Germany and thus also in Rhineland-Palatinate with a view to its proper approval in the USA and Canada,” said the local health ministry. Mecklenburg-Western Pomerania also considers the use of Jynneos to be “permissible and effective.”

In Hamburg, Jynneos continued to be administered, a spokeswoman said. This was due to a still outstanding reimbursement agreement between health insurance companies and the Association of Statutory Health Insurance Physicians and slightly higher delivery costs, which may have to be paid by patients. The social welfare office therefore did not yet consider uncomplicated care for vulnerable groups to have been fulfilled.

Berlin, which currently classifies Jynneos as not marketable, explained that the vaccine would be “held in stock until further notice” in order to ensure that patients can continue to receive care in the event of a possible shortage. “This would first have to be determined by the BMG.”

The BMG explained the different views of the states: If there are still Jynneos vaccine doses in stocks, the states could still put them on the market “taking into account the expiration date and storage conditions” if this is necessary to ensure the supply to the population.

The decision as to whether this requirement is still met after Imvanex enters the market is up to the state authorities and depends, for example, on the respective regional infection situation and the vaccine doses available on the market. Not all federal states provided information on this question.

Demand for Mpox vaccinations varied regionally from 2022

The RKI’s Mpox vaccination monitoring of the outbreak from 2022 had shown that this vaccination offer was used to varying degrees depending on the federal state. In the period from June 2022 to January 2024, a large proportion of the reported Mpox vaccinations were administered in Berlin, ahead of the most populous federal state of North Rhine-Westphalia and Hamburg.

While Berlin reported more than 33,000 such vaccinations, in some federal states there were fewer than 300 over the entire period, such as in Mecklenburg-Western Pomerania, Saarland and Saxony-Anhalt. Bavaria did not report any figures, according to the report.

The extent of current Jynneos stocks in the countries is very uneven: North Rhine-Westphalia (more than 15,000 doses) and Bavaria (more than 12,000) are among the Medical Journal-Evaluation of the states with the largest reserves, other states such as Brandenburg and Bremen say they only have a few hundred doses left.

No further vaccine procurement for the time being

In view of the developments in the outbreak regions, no further Mpox vaccines have yet been procured at either federal or state level. “The federal government has not currently ordered any additional vaccine doses,” a BMG spokesman said.

Several of the federal states emphasized the availability of Imvanex and referred to the current risk assessment of the RKI. “The available vaccines are currently sufficient in this context,” said Mecklenburg-Western Pomerania, for example. Baden-Württemberg also emphasized that there were no indications of supply bottlenecks in Germany with regard to Imvanex.

Only the Lower Saxony Ministry of Health stated that the situation should not be taken lightly. “The Central African countries that are severely affected by Mpox urgently need support to contain Mpox and prevent further spread. The federal government should therefore consider further procurement with the aim of quickly delivering the vaccines to the affected regions.”

In response to a request, the European Commission said that a contract for the delivery of up to two million doses of Imvanex, valid until November 2024, exists with the manufacturer Bavarian Nordic. The existing framework agreement also allows donations from member states to countries outside the EU.

At the same time, so-called rescEU stocks of Imvanex would also be kept, which could be used as a last resort if capacities in member states were exhausted.

A spokesman for the EU Commission also referred to the agreement reached in mid-August between the Commission, the vaccine manufacturer and the African Centers for Disease Prevention and Control that around 215,000 doses would be donated to African countries in need. © ggr/aerzteblatt.de