Brussels resists requesting delivery of Covid vaccine prior to regulatory approval

Brussels has been asked by some EU member states to provide the Oxford / AstraZeneca Covid-19 vaccine before it is approved by Block’s healthcare regulators as authorities question its legal implications. I’m resisting the push.

This week, Austria, the Czech Republic, Denmark and Greece will bring the idea of ​​”pre-approved distribution” to the European Council chairman Charles Michel so that people can start immunizing the moment they get approval. did.

However, the European Commission has questioned such a move, arguing that pharmaceutical companies are unlikely to be legally responsible for releasing doses prior to formal approval of the vaccine.

This disagreement is due to growing anxiety around EU member states about slow vaccine deployment compared to some other rich countries, especially the United States and the United Kingdom, and for some capitals to accelerate the process. It highlights the unorthodox measures proposed to.

Concerns have been amplified this week as EU countries tightened travel rules in response to concerns about the spread of highly contagious coronavirus variants identified in the United Kingdom and elsewhere.

Earlier this month, the EU government criticized Pfizer’s decision to temporarily reduce the supply of BioNTech-developed vaccines to European countries, but the company later supplemented the supply and the move will produce production later this year. Claims to help increase.

The leaders video summit on Thursday night created tensions over the pace of EU vaccination deployment, given the increasing transmission of new virus strains identified by the United Kingdom in EU countries.

Oxford / AstraZeneca Jab’s proposal for early pre-approval delivery states that countries are ready to begin vaccination on the day the European Medicines Agency and Commission announce approval of the new vaccine (January 29). Means

Danish Prime Minister Mette Frederiksen said people had explained by phone that he had filed a lawsuit for early distribution at a meeting Thursday night.

According to the proposal, Member States are solely responsible for safe storage and unintended use of drugs if this happens before they are licensed.

However, this proposal was skeptical elsewhere. Sandra Galina, chief negotiator of the EU’s vaccine procurement scheme, told member states that this week is unlikely given the strict rules surrounding unlicensed vaccines, diplomats said. She also predicted that the company would not agree with such a move, they added.

Commission chair Ursula von der Leyen repeated these questions in the call of the leader, according to those who outlined the discussion.

The Commission said on Friday that preemptive service requests need to be processed “carefully” due to various regulatory restrictions on the delivery of medicines before they are approved by the regulator. ..

“We are very aware of and understand the need for prompt delivery,” said the Commission. “Member States need to see what they can do to facilitate this … Taking into account all legal restrictions.”

AstraZeneca, which manufactures the vaccine developed at Oxford University, did not receive immediate comment. Jab is already in use in countries such as the United Kingdom, which received regulatory approval at the end of last month.

Brussels is working on other possible steps to speed up the process, including arranging the required regulatory protocols prior to the release of batches from the factory that should take place before the jab is approved, officials said. Said. The Commission also suggests that it may save time by avoiding the need to translate the jab instruction manual into all EU languages.

Focusing on the Oxford / AstraZeneca vaccine highlights its importance to the EU. This is because Block signed a contract to purchase the BioNTech / Pfizer vaccine months later than in the US and UK, which could result in proportionally lower early deliveries. The Oxford / AstraZeneca vaccine was first pre-ordered by the European block, and a 400m dose of a two-shot course covers nearly half of the region’s 446m population.

Some EU member states are increasingly upset by the slow approval of the block for the new Covid-19 drug, especially compared to the United Kingdom and the United States. Both of these countries have speeded up the process by issuing an emergency use authorization. This shifts responsibility for the problem from the pharmaceutical company to the authorities. Hungary broke the ranks this week, making it the first EU country to issue an emergency use authorization for the coronavirus vaccine (in this case Russia’s state-owned Sputnik V-Jab).

Pandemic concerns dominated the EU leaders’ call on Thursday. After the call, Michelle said leaders “know how serious the situation is,” and even if member states avoid strict border closures, new restrictions on non-essential travel. Said that it may be necessary to impose.

French President Emmanuel Macron plans to introduce a new coronavirus regulation for travelers from the EU starting Sunday morning, and in Paris, within three days of entry of visitors from inside and outside the block, Covid- Mandatory to perform 19 negative tests. ..

Additional Report by Anna Gross in London

Brussels resists requesting delivery of Covid vaccine prior to regulatory approval

Source link Brussels resists requesting delivery of Covid vaccine prior to regulatory approval

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