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Produced | Sohu Health
Author | Zhou Yichuan
Edit | Wu shinan
Currently, Canada, the United Kingdom and the United States have started vaccinating the new corona 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 discontent in many countries. Germany has increased pressure on the agency. German Health Minister Jens Spahn said we hope to get approval before Christmas so that vaccination can start this year. Germany has established 440 vaccination centers, established a medical staff of 10,000, and prepared a plan for large-scale vaccination activities. The German Hospital Association also stated that Pfizer vaccines should be authorized for emergency use as soon as possible so that medical personnel can enter nursing homes to vaccinate the elderly who are most threatened by the disease.
Italian Health Minister Roberto Speranza expressed the hope that the EMA can approve the Pfizer vaccine earlier than expected and begin vaccination in EU countries as soon as possible, complying with safety procedures.
Why does the EMA take so long to approve vaccines?
Earlier this month, the United Kingdom, Canada and the United States approved Pfizer’s new corona vaccine for use under 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, has 900 employees and is responsible for approving new treatments and vaccines for 27 EU countries. Agency approval of the new coronary pneumonia vaccine is very similar to other types of approval procedures for new vaccines, but it has accelerated progress.
Emer Cooke, CEO of EMA, said EMA began expediting the approval process for the Pfizer and BioNTech vaccines in October this year. Current efficiency has been vastly improved, and approval time has been reduced from approximately 210 days to less than 150 days. On December 15, EMA received additional data from drug manufacturers and moved the vaccine review meeting originally scheduled for December 29 forward 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 invite company representatives to answer questions. A few hours after the meeting, the EMA will issue a statement indicating whether it recommends approval of the vaccine. In a few days, they will announce the results of the comprehensive evaluation.
EMA approval is valid for 27 EU countries. Once approved, countries can start vaccinating. All countries expect to start vaccination the same day.
To ensure the safety of the vaccine, the EMA generally requires vaccine companies to provide safety and side effect reports every six months. During the launch of the new corona vaccine, the company will need to provide monthly data.
The EMA said that considering the vaccine’s performance after large-scale deployment, we need additional monitoring measures to prevent and control any rare or serious side effects. Based on current data, Pfizer said the vaccine is safe, but there have been two cases of serious allergic reactions on the day the vaccination started in the UK.
In addition to the Pfizer vaccine, EMA also plans to hold a meeting on January 12, 2021 to discuss Moderna’s new crown vaccine approval plan, and the follow-up will begin approval of the AstraZeneca and Johnson & Johnson vaccine. .
Reference materials:
1. foxnews
Why is the EU taking so long to approve the vaccine?
https://www.foxnews.com/health/why-is-the-eu-taking-so-long-to-ok-vaccine
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