Pressure grows on European Medicines Agency to speed up approval of Covid-19 vaccine

THE European Medicines Agency is scheduled to meet next Monday to consider if it will recommend the vaccine, which could see an earlier arrival here and in other EU countries .

he European agency confirmed today it hopes to bring forward the meeting to December 21 but the December 29 meeting will be “maintained if needed.”

Pfizer Ireland said today it can start the first shipment of its vaccine as soon as possible after regulatory approval – “possibly within hours.”

A spokeswoman said: ”Our goal is to start the first shipment as soon as possible, possibly within hours of receiving authorisation or approval from any regulatory agency.

“We can only supply countries once regulatory authorisation or approval has been granted and we will supply each country with vaccine doses through a robust process, consistent with supply agreements we’ve entered into.”

There is growing optimism that the European Medicines Agency could recommend approval on Monday, with the green light given by Wednesday.

Supplies of the vaccine will be transported to Dublin from Belgium.

Germany, which is fighting a surge in infections, was pressuring EU authorities to bring forward approval of a coronavirus, according to reports.

Chancellor ’s wants the planned meeting of the European Medicines Agency to assess the Pfizer-BioNTech vaccine to be brought forward to December 23 from December 29.

It will take up to ten days for vaccines to arrive in Ireland, which would mean it could still mean it will be early January before the first jabs are administered here.

In a statement today the European Medicines Agency said its human medicines committee (CHMP) and its experts have been working intensively over the past weeks to evaluate data submitted by BioNTech and Pfizer in the context of the conditional marketing authorisation (CMA) application for BNT162b2, a COVID‑19 mRNA vaccine.

The rate of progress is reliant on a robust and complete assessment of the quality, safety and efficacy and is determined by availability of additional information from the company to respond to questions raised during the evaluation.

Following receipt yesterday evening of additional data requested by the CHMP from the company and pending the outcome of its evaluation, an exceptional meeting of the CHMP has now been scheduled for 21 December to conclude if possible. The meeting planned for 29 December will be maintained if needed.

The CHMP will conclude its assessment at the earliest possible timepoint and only once the data on the quality, safety and effectiveness of the vaccine are sufficiently robust and complete to determine whether the vaccine’s benefits outweigh its risks.

Once the CHMP recommends a marketing authorisation, the European Commission will then fast track its decision-making process with a view to granting a marketing authorisation valid in all EU and EEA Member States within days.

EMA, its European experts and the European Commission are working towards the first marketing authorisation of a COVID-19 vaccine, with all the safeguards, controls and obligations that a CMA imposes, including:

  • full prescribing information and package leaflet with detailed instructions for safe use;
  • a robust risk-management and safety monitoring plan;
  • manufacturing controls including batch controls for vaccines and conditions for storage;
  • an investigation plan for use in children;
  • legally binding post-approval obligations (i.e. conditions) and a clear legal framework for evaluation of emerging efficacy and safety data.

A marketing authorisation ensures that COVID-19 vaccines meet the same high EU standards as for all vaccines and medicines. It will be valid in all EU Member States at the same time enabling all Member States to benefit from the joint work done at EU level and allowing them to start rolling out their vaccination campaigns at the same time.

The delay in approval was raising questions over “the European Union’s ability to act”, German newspaper Bild quoted a source as saying.

Meanwhile, the UK government should reverse its rash decision to allow household mixing and instead extend the tiers over the five-day Christmas period, argue Fiona Godlee, editor-in-chief at The BMJ, and Alastair McLellan, editor at the Health Service Journal (HSJ) in a joint editorial.

The Republic of Ireland is to relax post-lockdown restrictions further on Friday when it will be allowed to have visitors to your home from up to two other households.

It will also be possible to travel to different counties.

The Republic’s incidence is among the lowest in Europe currently but there are fears more mixing could see a large increase.

Referring to the UK, the BMJ experts said that with current restrictions failing to control the virus, they calculate that hospitals in England will have just short of 19,000 Covid patients on New Year’s Eve – almost level with the 18,974 peak of the first wave on April 12.

They believe the government “is about to blunder into another major error that will cost many lives” and warn that “if our political leaders fail to take swift and decisive action, they can no longer claim to be ‘protecting the NHS’.”

The UK government was too slow in introducing restrictions in the spring and again in the autumn, they argue. The planned relaxation of restrictions over Christmas “will boost the numbers further as the NHS also struggles with the additional demands of winter.”

They urge members of the public to mitigate the impact of the third wave by being as careful as possible over the next few months. But they warn that many will see the lifting of restrictions over Christmas as permission to drop their guard.

Rather than lifting restrictions over Christmas as currently planned, the UK should follow the more cautious examples of Germany, Italy and the Netherlands, they conclude.

Online Editors

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