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Britain was the first in the Western world to approve a vaccine, several weeks before other countries.
Why are so many different time periods needed? And is something lost in the accelerated process?
Britain: faster to exit the EU?
The UK was able to approve a vaccine from pharmaceutical company Pfizer after the independent Medicines and Healthcare Products Regulatory Agency (MHRA) said yes on December 2.
The rapid process was due to the authority using the so-called continuous review. As early as June, the vaccine review process began, a “24-hour operation,” according to director June Raine, who says issues and issues are constantly being examined in parallel, reports AFP.
Health Minister Matt Hancock is pleased to note that the rapid process is partly due to Britain leaving the EU. It is supported by researchers.
– You can ask questions when they arise and get faster answers when it comes to a single authority, says Penny Ward at King’s College London.
First EU approval at the end of December?
The European Medicines Agency (EMA) in Amsterdam is the EU’s general agency that evaluates and monitors medicines in the 27 EU countries.
The EMA (formally European Medicines Agency) has also used an ongoing review of vaccine research, both in terms of safety and efficacy. Research materials are typically submitted only when an approval process begins, but not this time.
The agency’s decision on Pfizer-Biontech’s vaccine is expected no later than December 29, while a decision on Moderna’s version may come on January 12. So it is up to the European Commission in Brussels to give the go-ahead.
United States – more open and slower process
A request for a so-called emergency use of a vaccine has been received from both Pfizer-Biontech and Moderna to the United States Food and Drug Administration (FDA).
The US process is slower than that of the UK and perhaps more cumbersome compared to the EU approval process. The United States also includes a public hearing on drugs.
The FDA conducts its own review of the vaccine and also refers to an independent advisory committee.
– The FDA process is completely open and transparent, with independent experts commenting and asking questions, and then giving advice or recommendations to authorities, says Moncef Slaoui, advisor to the US crown operation Operation Warp Speed, for AFP.
The Advisory Committee is scheduled to meet on December 10 and 17. The FDA’s decision is expected to come quite soon after. Vaccination could begin in late December in the United States.
Russia: started vaccinating volunteers in August
A unit of the Ministry of Health examines the vaccine. President Vladimir Putin ordered the government to simplify the state registration procedure for certain drugs, in order to speed up approval.
According to the official website of the Scientific Center for Drug Development, Russia “unlike many other countries, has a government testing system, the use of comparable drugs, double-blind studies and other control tests that are independent and independent of researchers and developers “. .
Testing of the Sputnik V vaccine began in mid-February, and both the first and second phases of clinical trials had been completed by August.
The authorities allowed the use of Sputnik V on August 11, before Phase 3 began. A study with 40,000 volunteers is already complete and the results of the research are slowly beginning to be published.
Mass vaccinations begin this week, according to President Putin. Recently, Moscow opened a free vaccination center. Before the end of the year, another 80,000 soldiers must have been vaccinated.
China: one million said to have been vaccinated
China also uses staging systems when it comes to testing vaccines, but at a breakneck pace and enormous scope.
“Researchers and developers must verify the effectiveness of a Phase 3 vaccine,” said Wang Tao, director of the state regulatory body.
He emphasized that the vaccine must “meet the efficiency requirements that we establish.” Companies must also demonstrate that vaccine production meets established standards. If these criteria are met, the vaccine can be used.
As of early December, China has four vaccines in the three-trial phase. The country has approved the emergency use of some of these; Among those vaccinated since July are government employees and international students, according to AFP.
About one million have already received a vaccine developed by Sinopharm, the company reported in November. Another company, Sinovac biotech, claims that almost all employees and their families have taken the company vaccine on a voluntary basis.
India: 30 vaccines in development
India has one of the most extensive vaccination programs in the world, the country produces 60 percent of the world’s vaccine and expects to have 500 million doses of corona vaccine by July next year, writes the BBC.
But the challenge remains total. Centrally controlled vaccination is carried out through state clinics, which does not reach the entire population. Also, there are problems like the availability of needles, the largest Indian manufacturer will try to make 1 billion needles next year.
Five of the 30 vaccines being developed in India are undergoing clinical trials. But the goal is to become independent:
– Our top priority is to have our own national vaccine, says Renu Swarup from the Indian Department of Biotechnology.
