SAM Vice Minister Ž.Simonaitytė: We will explain if we can independently confirm the vaccine and use it without waiting for the EC’s decision



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“We will have a separate conclusion on whether we can separately approve such a vaccine and use it as a member without waiting for a decision from the European Commission. Because here it is probably necessary to assess not only Lithuanian legislation, but also EU legislation on whether we may or may not, but also our obligations not to compete with other EU countries. So our separate confirmation and separate permission to say that we take a vaccine at risk and use it ourselves will not be treated as our competition with other Member States and which ones these are the possible consequences for all the other vaccine chains already approved, ”said the vice minister at the committee meeting.

Photo by Lukas Balandis / 15min / Živilė Simonaitytė

Photo by Lukas Balandis / 15min / Živilė Simonaitytė

Gytis Andrulionis, head of the State Drug Control Service (IARC), who participated in the meeting, told MPs that it is not only the prices of vaccines that are being hidden. The most confidential, he said, are the delivery times of the vaccine.

“Price is not the competing item, because the price differs 11 times, competing in terms of delivery and other details. As a result, deadlines are sensitive and confidential, ”he said.

According to G. Anddrulionis, the contracts foresee quarterly delivery times to the European Union and not to each country individually. Then the vaccine is distributed pro rata beginning.

According to him, the EC plans to buy very large quantities of the vaccine in excess of what countries need.

“Definitely make sure of 2 billion doses of vaccine, certainly more than the EU needs,” he stressed.

The SFVS chief said that Lithuania can expect to acquire 12 million. the number of vaccines.

Talk about higher volumes from Pfizer and BioNTech

According to the director of SFVS, the EU plans to acquire 300 million. Pfizer and BioNTech are the only vaccines currently registered in the EU. At the moment, according to him, he is considering ordering a larger quantity.

“The process of additional, in fact, even the number of the initial acquisition, has started. This week, Lithuania presents its position on the desire to buy additional vaccines from Pfizer and BioNTech,” said the head of the service.

According to him, there is the possibility for each country to exchange quotas.

“We, like Lithuania, can increase and decrease that amount, if we stay from other countries, we can redeem that balance,” he said.

According to G. Anddrulionis, from now on all manufacturers, with whom additional contracts on vaccines will be concluded, will have to find additional funding for vaccine research and development.

“The companies are asking for it, the EC has promised it. That is to say, there is no European money left, the Member States, if they also involve the producer, provide support ”, he said.

Photo by Sigismund Gedvila / 15min / Gytis Andrulionis

Photo by Sigismund Gedvila / 15min / Gytis Andrulionis

According to G. Anddrulionis, this was also the case for the Pfizer and BioNTech vaccines: the EU funded the development of this vaccine.

“The philosophy itself was that the EC pays each vaccine manufacturer, but the amounts vary widely, but in principle several hundred million euros, and that is the only reason the company centrally agrees to sell to the EU and supply to EU members at the same time in larger quantities than in other regions of the world. ” He said.

G. Anddrulionis went on to say that, in other words, the EC purchased that priority supply compared to other states and other regions.

NSGK member and former Prime Minister Saulius Skvernelis asked Deputy Health Minister Ž.Sonaonaitytė if it was not true that the EU funded the development of the Pfizer and BioNTech vaccines, but now non-EU countries receive more.

“From the SAM point of view, it is difficult to comment on why the producer chooses the states, it is possible to discuss the bargaining power, the prices paid, but there are foreign policy issues here that I would not like to comment on,” he replied.

Fear of ‘vaccine nationalism’

At the meeting, G. Anddrulionis explained why a plan was born to acquire the vaccine at the EU level so that countries do not compete with each other.

According to him, already at the beginning of the pandemic it was clear that each state is fighting for itself; for example, it was forbidden to sell certain drugs and the like. Therefore, it was feared that such “drug nationalism” would not emerge in the case of vaccines. That is why it was decided to acquire the EU jointly.

He highlighted that there are currently 63 clinical trials of candidate vaccines in the world, 172 in the preclinical phase.

“The EC is asking member states to diversify purchases not only between manufacturers but also between platforms,” ​​he said. G. Anddrulionis explained that the different platforms mean that some vaccines could protect against virus mutations, others could not.

“A rare manufacturer develops one vaccine at a time, usually several,” he said.

He stressed that vaccines are very different from each other.

There are different views on the speed of the EMA

Ž.Simonaitytė agreed with S.Skvernelis that the speed of the European Medicines Agency (EMA) is not satisfactory; when it planned to approve a new vaccine on Monday, the agency did not.

However, G. Anddrulionis noted at the meeting that it typically takes a year for the agency to register a new preparation, while the approved Pfizer and BioNTech vaccines were shipped to the EMA in early December. According to him, EMA is working at unprecedented speeds.

Health Minister Arūnas Dulkys announced on Tuesday that vaccine shipments will arrive in Lithuania regularly each week in the coming months, and presented which groups will be vaccinated and when. All Lithuanian doctors are expected to be vaccinated in January.



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