Against the backdrop of the “second wave” of the pandemic in Europe, the UK government has said it is ready to review its laws and allow emergency use of the coronavirus vaccine before it is fully licensed. The Chinese authorities are acting in the same way. It turns out that other countries have begun to follow the example of Russia, which allowed the temporary registration of a newly developed vaccine that has not yet passed mass testing.
The Cabinet of Prime Minister Boris Johnson is taking “enhanced security measures” that will allow the country’s regulatory body to issue a temporary permit for the COVID-19 vaccine, provided that the drug meets safety and quality standards, the Associated Press reported. This will be an emergency permit that will allow you to start immunization in parallel with the licensing process. In fact, this is the same scheme for allowing the drug to be used, for which our country was criticized – from the very moment it was announced that the vaccine of the Gamalei research center was registered and doctors and teachers will be vaccinated in parallel with the third phase of its trials.
“The need for accelerated registration of safe and effective drugs in the context of a pandemic is gradually being understood in the West,” said Kirill Dmitriev, head of the Russian Federal research INSTITUTE. “The intention to make such amendments to the legislation was announced by British Prime Minister Boris Johnson, although a few days ago the British media and experts spoke very negatively about the decision of the Russian Ministry of health to register the world’s first vaccine against the Sputnik V coronavirus.” China is also beginning to protect its military and doctors on the Russian model, allowing the registration of its vaccine for an emergency.
Now more than 10 countries are studying the Russian experience for accelerated registration of drugs and vaccines against coronavirus with proven safety, which means using previously proven technological solutions (platforms),” the head of RDIF said.
Meanwhile, post-registration studies of the gamaleyev vaccine are due to begin this week. As the head of the Gamalei research center Alexander Ginzburg said earlier, the research is expected to start on September 4-5. The recruitment of volunteers has already been announced. On the official website of the Moscow government, anyone can get acquainted with the conditions, fill out a form and submit an application for participation.