Monday, August 8, 2022

Brussels resists demand for Covid vaccine deliveries ahead of regulatory approval

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Brussels is resisting push from some EU member states to have the Oxford / AstraZeneca Covid-19 vaccine delivered before it receives clearance from the bloc’s medical regulator, as officials raise questions about the implications legal.

Four countries – Austria, the Czech Republic, Denmark and Greece – wrote this week to the President of the European Council, Charles Michel, to launch the idea of ​​a ‘pre-authorization distribution’, allowing them to start to vaccinate people as soon as approval is received.

However, the European Commission has cast doubts on such a move, arguing that pharmaceutical companies are unlikely to be willing to take legal responsibility for releasing doses before the vaccine is formally authorized.

The disagreement highlights growing concern among EU member states about the slow rollout of vaccines compared to some other wealthy countries, notably the US and UK, and the unorthodox measures some capitals propose to speed up the process.

Concerns were amplified this week as EU countries tighten travel rules in response to fears over the spread of highly transmissible coronavirus variants identified in the UK and elsewhere.

Earlier this month, EU governments criticized Pfizer’s decision to temporarily cut off the supply of the vaccine developed with BioNTech to European countries, although the company insists the supply will be replenished later and that the move will help it increase production later in the year.

Tensions over the pace of the vaccination rollout in the EU boiled over at the leaders’ video summit on Thursday evening, given the increasing transmission of the new strain of the virus identified in the UK to EU countries.

The Oxford / AstraZeneca vaccine pre-authorization early delivery proposal would mean countries would be ready to start vaccination the day the European Medicines Agency and the Commission announce the approval of the new vaccine, which could take place on the 29th. January.

Danish Prime Minister Mette Frederiksen pleaded for a swift distribution during talks on Thursday evening, people briefed on the call said.

Member states would take full responsibility for safe storage and any unintentional use of the medicine if this happens before its authorization, according to the proposal.

But this suggestion has been met with skepticism elsewhere. Sandra Gallina, chief negotiator for the EU’s vaccine purchasing program, told member states this week that it was unlikely to be possible given the strict rules on vaccines that have yet to be released. authorized, diplomats said. She also predicted that companies would not agree to such a move, they added.

Ursula von der Leyen, chairman of the committee, echoed these doubts over the leaders’ call, according to people briefed on the discussion.

The commission said Friday that requests for preventive delivery should be treated “with caution” because of various regulatory restrictions on the delivery of drugs before they have received regulatory clearance.

“We are very much aware of and understand the need for rapid delivery,” the commission said. “Member States also need to see what they can do to facilitate this. . . taking into account all legal constraints. ”

AstraZeneca, which produces the vaccine developed with the University of Oxford, did not immediately comment. The jab is already in use in countries including the UK, where it gained regulatory approval late last month.

Brussels is working on other possible measures to speed up the process, such as putting in place the necessary regulatory protocols before batch release from the factories before the coup is cleared, officials said. The committee also suggested that it might be possible to save time by not having to translate the instruction booklet with the jabs into all EU languages.

The focus on the Oxford / AstraZeneca vaccine underlines its importance to the EU, given that the bloc reached its deal to buy the BioNTech / Pfizer vaccine months later than the US and UK and that ‘it is therefore likely to receive proportionately fewer early deliveries. The Oxford / AstraZeneca vaccine was the first pre-ordered by the European bloc, and the 400 million doses of the two-dose course would cover nearly half of the region’s 446 million people.

Some EU member states are also increasingly agitated by the bloc’s slower approvals for new Covid-19 drugs, particularly compared to the UK and the US. These two countries have speeded up the process by issuing emergency use authorizations, which shift responsibility for any problems from the drug manufacturers to the authorities. Hungary broke ranks this week and became the first EU country to issue a national emergency use authorization for a vaccine against the coronavirus, in this case, Sputnik V developed by the Russian state.

Concerns over the pandemic dominated the appeal of European leaders on Thursday. Mr Michel said after the call that leaders were “aware of the gravity of the situation,” and member states may have to impose further restrictions on non-essential travel while avoiding strict border closures.

French President Emmanuel Macron plans to introduce new coronavirus rules for EU travelers from Sunday morning, with Paris set to require visitors from inside and outside the bloc to qu ‘they undergo a negative Covid-19 test less than three days before entering the country. .

Additional reporting by Anna Gross in London


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