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AIn view of the first global approval of a Covid-19 vaccine in Great Britain, the European Medicines Agency (EMA) has made it clear that it will make its decision on the approval of such vaccines in the EU completely independently.
“These vaccines will be administered to millions of people across the EU. We are well aware of the immense responsibility associated with this, ”the Amsterdam-based authority said at WELT’s request. “We have to make the right recommendations to protect Europeans.”
The guards stressed that they did not feel any political pressure either. Scientific evaluation for or against approval of vaccines is done independently. The focus is on the needs of patients and public health. The basis of the recommendation is “the safety, quality and efficacy of a vaccine, and nothing else,” said an EMA spokeswoman. “Approval will be granted when there is convincing evidence that the benefits of vaccination outweigh any risks from the vaccine.”
Meanwhile, the EU notes that it is also about citizens’ confidence in the safety of the vaccine. “Citizens must be able to trust the approval process,” says a European Commission official. This is also necessary so that many people are ready to get vaccinated. Last but not least, it is also a question of responsibility, which is limited to everyone in a proper procedure. The EU Commission has already shortened its own market approval procedure, which is post-EMA procedure and, for example, verifies patient information, from 67 days to three days.
The opposition criticizes the process
In Germany, the parties urge the EMA to make a quick decision on the Biontech vaccine. The FDP called for a short-term increase in staff: “The approval of the corona vaccine should be the top priority for the EMA,” said Parliamentary Managing Director Marco Buschmann WELT. “If necessary, additional resources should be made available for this.” At the same time, it must be ensured that vaccination centers in Germany are ready for use. “Otherwise, there is nothing to be gained from prior approval.”
The leader of the left-wing parliamentary group, Dietmar Bartsch, asked for clarification on why the process in the EU should take a month longer than in Britain. “There is a lack of transparency on both sides.” Also, the federal government is not ready to act. Citizens have not yet been informed about how vaccines should work and what the risks are. “Clearly setbacks due to hasty approval would be devastating.”
“The goal should be to quickly inoculate the vaccines once they have been approved in the EU and also to take into account the countries of the world that are suffering from Covid-19 and that have a less privileged starting financial position,” said Kordula Schulz – Asche, Infection Protection Expert for the Greens Parliamentary Group.
The vice-chairman of the parliamentary union group Georg Nüßlein (CSU) warned: “The EMA must now do everything possible to ensure that the approval process is carried out as quickly as possible without neglecting the security aspects.” His SPD colleague, Bärbel Bas, warned of a loss of trust among the population: “We are all waiting for vaccines to be approved. Safety and efficacy take precedence over speed,” says Bas. “A transparent approval process and Insurance is crucial for the vaccine to be accepted. This is guaranteed. ”More important than starting the vaccination a few days before is the confidence that people have in the vaccine.
Three vaccines are being tested
In principle, EU law allows each member state to independently issue an emergency license like the British one. However, to summon national contingents as part of the EU vaccine strategy, EU market approval must first be available, says a spokesperson for the European Commission. An emergency approval would only be useful if the country in question has signed its own contract with the manufacturer of the vaccine.
Britain’s drug supervisory authority MHRA issued the world’s first emergency approval for the corona vaccine from Mainz-based biotech company Biontech on Wednesday. Earlier in the week, Biontech and its US partner Pfizer had also submitted a request for a conditional marketing authorization to the EMA. If the authority gives the green light, the vaccine could also be used in the EU before the end of the year.
Initially, however, a public hearing on the EU approval of the corona vaccines is scheduled for December 11. Currently, the authority is examining three vaccines using the so-called continuous review process. Supervisors receive clinical trial data as soon as it is available and not just after the clinical trial phase is complete.
By January 12, the EMA also wants to decide on the Covid-19 vaccine from the American biotech group Moderna, which has also submitted an application for a conditional marketing authorization in the EU. There are currently around 50 projects in human clinical trials around the world.
Meanwhile, the German pharmaceutical association vfa declined to comment on why approval of the vaccine in the EU and Britain is progressing at such different speeds. “The manufacturers have done their job, now only the authorities must decide. We did not evaluate that, ”said a spokesperson.
