29 January 2021, Friday, 14:00 95

Rada Allows Registration Of Vaccines Against Coronavirus Under Obligations For Emergency Medical Use

Редактор: Daria Zubkova

The Verkhovna Rada has allowed the registration of vaccines against coronavirus under obligations for emergency medical use, which will allow the use of vaccines against coronavirus manufactured by Pfizer\BioNTech, Sinovac Biotech, Moderna, Sinopharm, AstraZeneca.

A total of 280 MPs voted for the adoption of the corresponding bill No. 4613, with the minimum required 226, Ukrainian News Agency reports.

According to the bill, it is proposed to allow the state registration of vaccines for the purpose of emergency medical use, subject to certain obligations, if the applicant can prove that he does not have the ability to provide complete data on the effectiveness and safety of the drug under normal conditions of use for objective reasons.

In particular, urgent registration will be possible if there is evidence of successful preclinical trials, individual phases of clinical trials, and if the results obtained combine scientifically sound evidence, including data from adequate and well-controlled trials, which suggest that the drug may be effective for prevention of coronavirus infection.

It is also proposed to allow the registration of drugs if: the clinical trials were carried out with the permission and/or under the supervision of the relevant competent authorities of the United States of America, the United Kingdom, the Swiss Confederation, Japan, Australia, Canada, China, India or the European Union.

Separately it is noted that the drug should not be developed in a state recognized in the prescribed manner as the aggressor state.

The known and potential benefits of a drug, when used to prevent coronavirus infection, must outweigh the known and potential risks of using the drug.

The term of emergency use is proposed to be limited, until the full completion of clinical trials.

In this case, the registration certificate is issued for one year with the possibility of extension for another one year.

The drugs themselves can only be used with a prescription and under strict medical supervision.

Earlier, the Chairperson of the Verkhovna Rada Committee on National Health, Medical Assistance and Health Insurance Mykhailo Radutskyi (Servant of the People faction), who is one of the authors of the bill, on his Facebook page emphasized that the document would allow the use of vaccines against coronavirus produced by companies Pfizer\BioNTech, Sinovac Biotech, Moderna, Sinopharm, AstraZeneca.

As Ukrainian News Agency earlier reported, the Ministry of Health expects confirmation from the COVAX global initiative that it will receive another 8 million doses of coronavirus vaccine on January 29.

Больше новостей о: Verkhovna Rada vaccine Coronavirus COVID-19 coronavirus vaccine Pfizer Sinovac Biotech AstraZeneca emergency medical use BioNTech Moderna Sinopharm