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Why has EU not approved COVID-19 vaccine?
Why has EU not approved COVID-19 vaccine? The United Kingdom and the United States have launched Pfizer’s COVID-19 vaccine, why has the EU not approved it?
At present, Canada, the United Kingdom, and the United States have begun to vaccinate the COVID-19 pneumonia vaccine developed by Pfizer and BioNTech, but EU countries have been slow to act.
The efficiency of the European Medicines Agency (EMA) has caused dissatisfaction in many countries. Germany has increased pressure on the agency. German Health Minister Jens Spahn said that we hope to get approval before Christmas so that vaccination can be started this year.
Germany has established 440 vaccination centers, has set 10,000 medical staff, and has prepared a plan for large-scale vaccination activities. The German Hospital Association also stated that Pfizer’s vaccines should be authorized for emergency use as soon as possible so that medical staff can enter nursing homes to vaccinate the elderly who are most threatened by the disease.
Italian Minister of Health Roberto Speranza expressed the hope that EMA can approve Pfizer vaccine earlier than expected and start vaccination in EU countries as soon as possible while complying with safety procedures.
Why does EMA take so long to approve vaccines?
Earlier this month, the United Kingdom, Canada and the United States approved Pfizer’s COVID-19 vaccine for use in emergency conditions. This vaccine is equivalent to an unlicensed product, but because the current epidemic situation is very tense, it has caused 1.6 million deaths worldwide and is a temporary emergency means.
The European Medicines Agency is headquartered in Amsterdam, the Netherlands. It has 900 employees and is responsible for approving new treatments and vaccines for 27 EU countries. The agency’s approval of the new coronavirus pneumonia vaccine is largely similar to other types of new vaccine approval procedures, but it has accelerated the progress.
Emer Cooke, executive director of EMA, said that EMA began to accelerate the approval process of Pfizer and BioNTech vaccines in October this year. The current efficiency has been greatly improved, and the approval time has been shortened from about 210 days to less than 150 days. On December 15th, EMA received additional data from pharmaceutical manufacturers and advanced the vaccine evaluation meeting originally scheduled for December 29th to next Monday.
At the EMA meeting, experts from various countries will discuss the data behind the vaccine. Two officials responsible for evaluating vaccines will make presentations and will invite company representatives to answer questions. Within a few hours after the meeting, the EMA will issue a statement stating whether it recommends approval of the vaccine. In a few days, they will release the comprehensive evaluation results.
EMA’s approval is valid for 27 EU countries. Once approved, countries can start vaccinating. All countries hope to start vaccination on the same day.
In order to ensure vaccine safety, EMA usually requires vaccine companies to provide safety and side effects reports every six months. During the launch of the COVID-19 vaccine, the company will be required to provide monthly data.
EMA said that considering the performance of the vaccine after large-scale deployment, we need additional monitoring measures to prevent and control any rare or serious side effects. According to current data, Pfizer said the vaccine is safe, but there have been two cases of severe allergic reactions on the day of the start of vaccination in the UK.
In addition to Pfizer’s vaccine, EMA also plans to hold a meeting on January 12, 2021 to discuss Moderna’s COVID-19 vaccine approval plan, and follow-up will start the vaccine approval of AstraZeneca and Johnson & Johnson.