Tuesday

5th Jul 2022

EU gives first green light to Covid-19 vaccine

The European Commission authorised, on Monday (21 December), the use of the Covid-19 vaccine jointly developed by Pfizer and BioNTech, paving the way for member states to start vaccination programmes within the next few days.

The move came hours after the European Medicine Agency (EMA) issued a positive scientific assessment, recommending conditional marketing authorisation for the vaccine known by the brand-name Comirnaty.

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Comirnaty will be given as two injections into the arm, at least 21 days apart.

"This is a significant step forward in the fight against this pandemic that is causing suffering and hardship," said the head of the EU medicines agency Emer Cooke.

The European drug regulator came under pressure to speed up the approval of the vaccine last week, after the jab had been authorised in the UK, Canada, and the United States.

The EU authorisation is based on a "rolling review" of clinical and non-clinical research data on the quality, safety, and efficacy of the vaccine.

Data, therefore, is being examined as it becomes available in order to accelerate the process.

Last month, the vaccine demonstrated a 95 percent efficacy in phase three of a clinical trial, involving 44,000 participants - including those with asthma, chronic lung disease, diabetes, and high blood pressure.

Under the conditional marketing authorisation, foreseen for emergency provisions, the companies are responsible for monitoring the safety of the vaccine, reporting results from the main trial, which is ongoing for two years.

"This trial and additional studies will provide information on how long protection lasts, how well the vaccine prevents severe Covid-19, how well it protects immunocompromised people, children and pregnant women, and whether it prevents asymptomatic cases," the EMA said in a statement.

Meanwhile, Cooke told a press conference on Monday that there was "no evidence" that Comirnaty would not work against the new strain of coronavirus discovered in the UK.

Earlier this year, the EU Commission reached an agreement with Pfizer and BioNTech to supply the 27-country EU bloc with 200 million doses, and up to 100 million additional doses.

The delivery of the first doses is expected to start on Saturday. But the distribution of all the vaccines will not be completed until September 2021.

"Doses of the vaccine approved today will be available for all EU countries, at the same time, on the same conditions," said EU Commission president Ursula von der Leyen.

Some member states, including Germany, France, Austria, Spain and Italy, previously announced that they planned to start vaccination programmes for their most vulnerable groups on Sunday.

The vaccines for the bloc will be produced in BioNTech's manufacturing site in Germany, and Pfizer's factory in Belgium.

The commission, on behalf of member states, has sealed deals with Moderna, AstraZeneca, Sanofi-GSK, Janssen Pharmaceutica NV, BioNTech/Pfizer and CureVac for up to two billion vaccine doses.

EMA is expected to issue a review for the authorisation of Moderna in early January 2021.

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After the UK approved the use of the Covid-19 vaccine developed by Pfizer/BioNtech, the pressure is mounting on the EU. But how are these vaccines approved in the bloc - and what is the legal liability?

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