By Ilya Zhegulev
KYIV (Reuters) – Ukraine’s plan to launch a Chinese coronavirus vaccine starting next month faces a possible delay due to regulatory delays, according to a letter written by the importer, at an additional risk to the slow vaccination program. from the country .
In the February 3 letter, seen by Reuters, the importer, a partner with vaccine developer Sinovac Biotech, asked Ukrainian authorities for permission to postpone the first shipments of their COVID-19 vaccines to April.
The Ukrainian-based importer, Lekhim, cited delays in obtaining an export license from the Chinese government and the late adoption by the Ukrainian parliament of a special vaccine registration law.
“The consequences of these events were the delay in coordinating the delivery schedule between JSC Lekhim and Sinovac Biotech and the postponement of delivery of the vaccine in Ukraine,” said the letter.
Lekhim, who has an agreement to deliver 1.9 million doses to the Ukrainian government as of March, also wrote that he wanted to change the way the contracted 70% injection effectiveness rate is measured, although he does not link that to his postponement request. .
Lekhim declined immediate comment.
A spokesman for the Ministry of Foreign Affairs of China said in a faxed statement that it was not aware of the events described in a request for comment from Reuters, but added that China and Ukraine had “fruitful cooperation” during the pandemic.
“China has a positive attitude towards international vaccine cooperation and supports relevant companies to cooperate with foreign parties in compliance with laws and regulations,” the statement said on Wednesday.
Sinovac did not immediately respond to a request for comment.
Ukraine’s vaccination program has lagged behind other European countries in the global dose dispute and has not yet started.
CHANGED WORD
The efficacy rates of the Sinovac vaccine varied in tests in several countries. In large-scale studies in Brazil, 50.65% effectiveness was found against COVID-19; in a smaller one in Turkey, it was 91.25%.
The variable data raised questions about whether Ukraine would approve Sinovac. Lekhim’s agreement with the government of Ukraine stipulated that the vaccine must be at least 70% effective against COVID-19.
But the proposed new wording of the agreement would include 70% of patients suffering from mild symptoms, the letter showed. The new formulation would also remove a reference to the efficacy data that needs to be confirmed by the manufacturer.
“Lekhim wrote a letter with a request to postpone delivery schedules,” a source at the Ministry of Health, who declined to be named, but is familiar with the matter, told Reuters.
“They also ask to change the terms of effectiveness,” said the source, adding that “there may be problems” with meeting the effectiveness criteria.
The letter was addressed to Medical Procurement of Ukraine (MPU), the state agency responsible for drug procurement contracts.
“We confirm [it]”The MPU said in response to a Reuters consultation on whether Lekhim had requested to postpone vaccine shipments and to change the terms of effectiveness, saying he referred the matter to the health ministry.
The press office of the Ministry of Health did not immediately respond to a request for comment.
Ukrainian President Volodymyr Zelenskiy publicly supported the use of the Sinovac vaccine on Monday, pointing out that it is being used in Turkey.
(Reporting by Ilya Zhegulev and Natalia Zinets; additional reporting by Pavel Polityuk in Kiev and Roxanne Liu in Beijing; writing by Matthias Williams; editing by Susan Fenton)