Europe criticized for ‘slow vaccine approval’

Austrian Prime Minister Sebastian Kurz has criticized the European Pharmaceutical Authority (EMA) for being “too slow” to approve the Covid-19 vaccine.

On March 1, Mr. Kurz said that the EU’s general policy of purchasing and licensing the vaccine is in principle. However, to defeat Covid-19 and develop future vaccine products, he said, it should not rely solely on Europe.

Prime Minister Kurz will travel to Israel together with Danish Prime Minister Mette Frederiksen to agree on a plan to cooperate in research and vaccine production. “Experts estimate that in the near future, Austria must vaccinate two-thirds of its population each year, equivalent to more than 6 million people,” said Mr. Kurz. Prior to his trip to Israel, Kurz will discuss Austria’s vaccination strategy with local pharmaceutical companies and researchers.

Ms. Frederiksen, Prime Minister of Denmark, said that the world is looking for more vaccines, but need to ensure enough doses in the next 2-10 years. “One of the partners I trust is Israel, a leader in immunization,” she said. Currently, only 7.8% of the Danish population and 4.8% of the Austrian population received the first dose of vaccine, while that figure of Israel is more than 50%.

Renee Gallo-Daniel, president of the Austrian Vaccine Manufacturers’ Association, defended the EMA’s approach: “EMA’s first priority is to make sure there are no shortcuts in vaccine approval. What matters is safety. The safety, efficacy and quality of all vaccines have been verified and this is simply time consuming. ” Additionally, Ms. Daniel praised Mr. Kurz’s innovative proposal to make more vaccines domestically, but warned that setting up a production chain could take five to 10 years.

The European Commission said on March 2 that it was considering urgent approval of the Covid-19 vaccine instead of maintaining the current strict licensing process. This move marks a major change in the way vaccines are approved.

The announcement comes as the EU executive board and EMA have come under increasing pressure over comments that vaccine approval is too slow, leaving the vaccination campaign in the EU behind compared to the US and UK. .

“We are discussing with member countries on possible directions to accelerate vaccine approval,” said the spokesman for the European Commission. One possible option, he said, is that the vaccine is approved at the EU level and that members share responsibility. In addition, the work could start very quickly if the EU countries support the idea.

A country is authorized to license vaccines under EU law, but will bear full responsibility if a vaccine goes wrong. The European Commission recommends that each country does not self-approve the Covid-19 vaccine, as rapid approval could lead to a lack of data on the safety and efficacy of vaccines. This also increases people’s hesitation before vaccination.

The EMA doesn’t have emergency approval yet, but in exceptional cases the agency recommends taking the drug before the product is allowed to be marketed. In April 2020, an antibiotic was used urgently before licensing.

Mai Dung (Follow AFP, Reuters)


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