Thursday , February 25 2021

The EU and countries around the world are speeding up approval procedures for the covid-19 vaccine



Groups of scientists worked day and night. They reviewed various aspects of safety assessment, often covering several topics at the same time, said MHRA chief Jun Rains.

British Health Minister Matt Henkock and others say the vaccine could also be approved on the island because of Brexit. “We were able to make that decision thanks to the competent British authorities, and we did not have to follow the slowest pace in Europe,” Hancock said.

Raine confirmed that “no shortcuts” were made during the vaccine approval process, which will be available to the British next week.

The current vaccination of several covid-19 vaccines has been carried out for weeks or months by the European Medicines Agency (EMA), which is responsible for testing medicines and vaccines across the EU, including Slovenia.

This type of test is designed to quickly assess potential drugs or vaccines during a health crisis. This procedure allows the Amsterdam Agency to keep the data under review while the clinical trial is still ongoing. Under normal circumstances, pharmaceutical companies first complete testing and collect data before reviewing it with the competent regulator.

The vaccine, developed by Pfizer and BioNTech, Modern, and developed by AstraZeneca and Oxford University, is currently under review. The application for a conditional marketing authorization for Pfizer and BioNTech will be decided by Ema no later than 29 December and for a modern vaccine license no later than 12 January.

In the European Union, the European Commission is giving the vaccine the final green light.

Pfizer / BioNTech and Moderna have already requested emergency vaccine approval from the US Food and Drug Administration (FDA), but the US process is slightly slower than the UK process. This also includes public consultation.

The FDA analyzes the vaccine and then convenes an independent advisory committee. “The FDA process is completely transparent, with independent experts commenting, asking questions and advising the agency,” said Moncef Slaoui, a White House consultant for the development and distribution of covid-19 vaccines across the country.

The Pfizer and BioNTech Advisory Boards are convened on Thursday and Modernina on December 17. The FDA is expected to make a decision after these meetings. If confirmed, vaccination in the United States could begin later this month, AFP reports. Slaoui said this week that 100 million Americans will be able to be vaccinated by February.

In Russia, meanwhile, the Scientific Center for Drug Evaluation of the Russian Ministry of Health only tests the development of drugs that are still under development. As stated on their website, “unlike many other countries, they have a national testing system that uses comparable drugs, double-blind studies, and other control tests, regardless of the developer.” Elsewhere, most pharmaceutical companies test vaccines and medicines themselves.

Russian President Vladimir Putin has ordered the government to simplify procedures for registering certain drugs in the country in order to speed up the approval of the vaccine.

Testing of the Russian Sputnik V vaccine began in mid-February, and the first and second phases of clinical trials were completed on 1 August. The vaccine was approved on August 11, even before the start of the third phase of the test. In the meantime, this phase, which involved 40,000 volunteers, has already been completed, but the results have not been made public.

The vaccine is expected to be available to the general public in Russia early next year. Mass vaccinations have already begun in the masses, with 80,000 soldiers planned to be vaccinated by the end of the year, followed by another 400,000.

The second Russian-produced vaccine, EpiVacCorona, is also registered in Russia.

In China, too, vaccines must undergo three phases of clinical trials before being approved by the competent regulatory agency. Developers need to test the vaccine’s effectiveness in the third phase and “meet our performance standards,” Wang Tao, the agency’s chief executive, said in October.

The third phase contains four Chinese vaccines. The emergency use of some of them has already been approved by the competent agency. Since July, various groups of people, from civil servants to foreign students, have been vaccinated.

Sinopharm announced in November that nearly a million people have been vaccinated with their covid-19 vaccine. Another Chinese company, Sinovac Biotech, has also announced that almost all of the company’s employees and their families have been vaccinated voluntarily.




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