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Ukraine passes law expediting COVID-19 vaccine approval, banning Russian vaccines

Ukraine passes law expediting COVID-19 vaccine approval, banning Russian vaccines

1.02.2021 | Alexandra Briscoe | Victoria U. Wellington Faculty of Law, NZ JANUARY 31, 2021 06:56:25 PM | 840

The Ukrainian parliament passed a bill Friday aimed at expediting Ukraine’s approval of COVID-19 vaccines. The bill also prohibits the use of Russian vaccines.

The law establishes a new procedure for approval of medicinal products in “emergency situations.” Under this new framework, the Ministry of Health is able to approve a medication where: 1) there is information on successful preclinical trials and certain phases of clinical trials with scientifically justified evidence; 2) permission to use the medication has been given by a competent authority in the United States, Great Britain, Switzerland, Japan, Australia, Canada, China, India, at least one EU country, or it was prequalified by the WHO; and 3) the benefits of the medication outweigh its potential risks.

However, the law also stipulates that the medication must not have been developed in an “aggressor state,” thereby prohibiting the use of the Russian COVID-19 vaccine, Sputnik V. Ukraine’s refusal to use the Russian vaccine comes in spite of the government’s estimation that it will need to purchase a further 15 million doses of the COVID-19 vaccine, in addition to those it expects to receive under the global COVAX scheme.

Although Ukraine has not yet approved any COVID-19 vaccines, it is hoped that this new law will facilitate the commencement of its inoculation program, which is scheduled to begin in February.

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