EMA “AZ Vaccine, Safe and Effective” Conclusion
Resumption of AZ vaccination in Germany, France, Italy, etc.
Norway and Sweden announce whether to resume next week
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When the European Medicines Agency (EMA) evaluated AstraZeneca (AZ)’s novel coronavirus infection (Corona 19) as a “safe and effective vaccine”, major European countries such as Germany, France, and Italy decided to resume vaccination.
On the 18th (local time), the EMA, which is responsible for the evaluation and approval of pharmaceuticals and vaccines in the European Union (EU), held an extraordinary meeting of the safety committee and announced that the benefits of the AZ vaccine outweigh the risk of side effects. EMA Commissioner Emma Cook said at a press conference, “The committee has come to a clear scientific conclusion,” and “this is a safe and effective vaccine.” “We concluded that this vaccine was not associated with an increased overall risk of blood clots,” he said. However, he recommended that a description of these cases be added to the vaccine information so that patients and healthcare workers can know that the “relationship of this vaccine to certain very rare types of blood clots cannot be clearly excluded.”
Commissioner Cook explained that of the 20 million people who received the vaccine in the UK and the European Economic Area (EEA), there were 25 such rare cases, nine of whom died. Most of these cases were women under the age of 55. In a pre- and post-approval study of the vaccine, EMA found that 469 cases of blood clots were reported among those who received the vaccine in these areas during the vaccination process, which was lower than expected in the general population. He added that there is no evidence that there is a problem with a specific manufacturing unit or a specific manufacturing location of the vaccine. When asked whether countries should resume AstraZeneca vaccination, “we have safe and effective vaccines.” “There is a need to use these vaccines.” He also said, “If I were, I would get the vaccine tomorrow.”
European countries that have temporarily suspended AZ vaccination at the EMA’s announcement have announced that vaccination will be resumed one after another. German Health Minister Jens Sfan said at a press conference on the same day, “As a result of consultations with the federal government and 16 states, the Paul Erlich Institute (PEI), an agency responsible for vaccine approval, we have decided to resume vaccination from tomorrow.” French Prime Minister Jean Castex also said that AZ vaccination will be resumed immediately from the afternoon of the 19th. In addition, Prime Minister Castex plans to inoculate it on the first day of resumption in order to alleviate distrust toward the AZ vaccine, Lefigaro reported daily.
Italy also decided to resume AZ vaccination from the 19th. Prime Minister Mario Draghi said in a statement issued shortly after the EMA’s evaluation results were released, “Welcome to EMA’s announcement of the AZ vaccine,” and said, “As soon as the AZ vaccination is reached, it will resume from tomorrow.” Reuters reported that Spain will resume AZ vaccination on the 24th, health minister Carolina Darias has announced. The Netherlands also said that the AZ vaccine will resume next week, Dutch Minister of Health Hwiho De Yongeo said, and the governments of Lithuania, Latvia and Slovenia decided to use the vaccine again as early as the 19th.
However, Norway and Sweden said they were withholding the AZ vaccine despite the EMA announcement. The Norwegian Institute for Public Health noted the results of the EMA’s review, but said it was too early to draw a final conclusion regarding vaccination. He added that it would release its own guidelines around the next weekend. “We hope to review the EMA investigation and determine the best way to use the vaccine next week,” said Sweden’s chief infectious disease scholar Anders Tennnell.
/ Reporter Kwak Yoon-ah [email protected]
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