Cyprus Mail

Coronavirus: health ministry says EU vaccine approval could come as early as December 21

Laboratory Assistant Holds A Tube With Russia's "sputnik V" Vaccine Against The Coronavirus Disease (covid 19) At The National Institute Of Pharmacy And Nutrition In Budapest

The health ministry on Wednesday announced that the European Medicines Agency’s (EMA) Human Medicines Committee (CHMP) and its experts have been working intensively over the past few 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 evaluation,” the ministry said in an announcement.

It added that following receipt Tuesday evening of additional data requested by CHMP from the company and pending the outcome of its evaluation, an exceptional meeting of CHMP has now been scheduled for December 21 to conclude if possible. The meeting planned for December 29 would be maintained if needed, the ministry said.

“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,” it added.

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.

The ministry said that the EMA, its European experts and the European Commission were 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,” the ministry said. “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.”

Health Minister Constantinos Ioannou said on Tuesday the first batch of Covid-19 vaccines was expected to arrive in Cyprus in early January, while plans drawn up say it is possible to vaccinate one person every six minutes.

With the joint provision of vaccines, Cyprus will have the first doses at the same time as all other EU member states, he said.

The first batch of Pfizer-BioNTech vaccines is expected in early January, while within the first quarter of 2021, a second batch will be received from the same company. It is estimated that the first quantities of Moderna and AstraZeneca vaccines will also be received in the first quarter of 2021. The vaccine will be administered free of charge to those who want it.

Priority will be given to vulnerable groups, starting with staff and residents of nursing homes and care homes for people with chronic diseases, and healthcare professionals. Vaccination of the wider population is expected to start in the summer.

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