Data Of 1st Phase Of Russia's COVID-19 Vaccine Trials Enough For Registration - Researcher

Data of 1st Phase of Russia's COVID-19 Vaccine Trials Enough for Registration - Researcher

Analysis of data obtained in the first phase of the clinical trials of the vaccine against COVID-19 developed by the Sechenov First Moscow State Medical University would be enough for registering the vaccine if it is proven efficient, Elena Smolyarchuk, the head of Sechenov University's Center for Clinical Research on Medications, said on Wednesday

MOSCOW (Pakistan Point News / Sputnik - 15th July, 2020) Analysis of data obtained in the first phase of the clinical trials of the vaccine against COVID-19 developed by the Sechenov First Moscow State Medical University would be enough for registering the vaccine if it is proven efficient, Elena Smolyarchuk, the head of Sechenov University's Center for Clinical Research on Medications, said on Wednesday.

"According to a protocol approved by the Ministry of Health, statistical analysis of data that was obtained in the first phase of clinical trials will be sufficient for the registration of the vaccine if it proves to be effective," Smolyarchuk told reporters.

According to the researcher, the vaccine was first tested on primates to see if it's safe. Smolyarchuk told reporters that volunteers were divided into two group s� the first one received only one shot of the vaccine, while the second group received a double dose.

"Their response to the vaccine was not different from what usually happens after vaccination with other preparations. It included localized redness and swelling at the injection site, someone had pain; there were general effects � fever, headache, sore throat, someone had a sore joint, someone had stomach ache," Smolyarchuk said, noting that volunteers stopped experiencing most effects in one-two days.

She told reporters that volunteers discharged today have developed sufficient amount of antibodies against the coronavirus.

"They are not wearing masks, you see?" Smolyarchuk said.

The researched noted, however, that further clinical trials and research would show how long the immunity developed after an injection lasts.

"We hope that immunity will be good, but only time will tell," Smolyarchuk said.

Russia's Sechenov University has completed the first phase of clinical trials of a COVID-19 vaccine, developed by the Gamaleya Institute of Epidemiology and Microbiology. Alexander Lukashev, the director of Sechenov's Institute of Medical Parasitology, Tropical and Vector-Borne Diseases, told Sputnik that the trials had established the vaccine's safety on human health. The second phase will last until the end of July before registration documents are filed.