KYIV, Feb 9 (Reuters) - Ukraine's plan to roll out a Chinese-made coronavirus vaccine from next month faces possible delay because of regulatory hold-ups, according to a letter written by the importer, in a further risk to the country's slow-moving vaccination programme.
In the Feb. 3 letter, seen by Reuters, the importer, a partner of vaccine developer Sinovac Biotech (SVA.O), asked Ukrainian authorities to be allowed to delay the first shipments of its COVID-19 vaccines to April.
The importer, Ukraine-based Lekhim, cited delays in obtaining an export licence from the Chinese government and the late adoption by Ukraine's parliament of a special vaccine registration law.
"The consequences of these events were the delay in the coordination of the delivery schedule between JSC Lekhim and Sinovac Biotech and the postponement of the delivery of the vaccine in Ukraine," said the letter.
Lekhim, which has a deal to deliver 1.9 million doses to the Ukraine government from March, also wrote that it wanted to change the way the shot's contracted efficacy rate of 70% is measured, though it did not link this to its request for the delay.
Lekhim declined immediate comment. Sinovac and China's foreign ministry did not immediately respond to requests for comment.
Ukraine's vaccination programme has lagged behind other European countries in the global scramble for doses and has yet to start. read more
Sinovac's vaccine efficacy rates have varied in testing across several countries. In larger-scale trials in Brazil, it was found to be 50.65% effective against COVID-19; in a smaller one in Turkey, it was 91.25%.
The variable data has raised questions about whether Ukraine would approve Sinovac. Lekhim's agreement with the Ukraine government stipulated that the vaccine must be at least 70% effective against the COVID-19 disease.
But the proposed new wording of the agreement would include in the 70% those patients who suffered mild symptoms, the letter showed. The new wording would also remove a reference to the efficacy data needing to be confirmed by the manufacturer.
"Lekhim wrote a letter with a request to defer the delivery schedules," a health ministry source, who did not want to be quoted by name but is familiar with the matter, told Reuters.
"They also ask to change the terms of the efficacy," said the source, adding that "there may be problems" with meeting the efficacy criteria.
The letter was addressed to Medical Procurement of Ukraine (MPU), the state agency handling medical procurement contracts.
"We confirm [it]," MPU said in response to a query from Reuters about whether Lekhim had requested delaying the vaccine shipments and changing the efficacy terms, saying they had referred the matter to the health ministry.
The health ministry's press service did not immediately respond to a request for comment.
Ukrainian President Volodymyr Zelenskiy publicly backed the use of the Sinovac vaccine on Monday, pointing to it being used in Turkey. read more
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