EMA brings Pfizer/BioNTech decision forward

The European Medicines Agency on Tuesday announced it would bring forward its evaluation of the Pfizer/BioNTech Covid-19 vaccine by eight days to 21 December, slating it before, rather than after Christmas, reported EFE-EPA.

The news comes as governments across Europe prepare tough restrictions in a bid to avoid a third wave of the virus at a time of year when families and friends travel to spend the festive period together.

The EMA, whose experts will advise whether or not the European Union should approve market authorization for the vaccine, said its human medicines committee had been working “intensively over the past weeks to evaluate data submitted by BioNTech and Pfizer.”

“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,” it added in a statement.

The original evaluation had been scheduled to take place on 29 December.

A number of European nations are beefing up Covid-19 restrictions in a bid to pre-emptively stem any new waves of the virus resulting from the movement of people.

Countries like Germany and the Netherlands are tightening the screws on existing restrictions while experts in the United Kingdom — which has already approved the Pfizer/BioNTech vaccine — warned the government that its current plans to relax measures for the festive period could backfire.

Germany’s government, led by Chancellor Angela Merkel, and the leaders of its 16 federal subdivisions, agreed to enforce a strict lockdown plan throughout the holiday period starting from Wednesday and lasting until 10 January.

All non-essential businesses and schools will have to close, joining hospitality and the culture sector, which has been shuttered up since November. And social gatherings will be limited to five people from no more than two households, although those aged 14 and under are exempt.

On 24, 25, 26 December, that limit will be boosted to nine people.

The plan set out by the government in the Netherlands late Monday marks a U-turn in its former policy of relying on individual responsibility.

Prime Minister Mark Rutte’s new plan, announced during an address to the nation, is more closely resembled the draconian measures seen in Spain and Italy during the first Covid-19 wave, something that back then he tried to avoid.

Minutes after beginning his speech late Monday, he was interrupted by whistles from an anti-lockdown protest outside his office.

Rutte said: “The reality is that this is not an innocent flu as some people — like the demonstrators outside — think.”

“But a virus that can hit everybody hard.”

The new rules in the Netherlands mean all non-essential businesses, schools and museums will close their doors until 19 January and limits the number of people allowed to visit other households each day.

Some 8.4 million watched the live broadcast of the address.

With around 10,000 new cases daily, and an increasing rate of hospitalizations, authorities are already talking of a third wave in the Netherlands, although the second was never really brought under control.

Rutte relaxed the measures when the daily number of infections was 5,000 and promised to reopen the hospitality industry at 3,700, but that never happened thanks to Black Friday.

Health experts in the UK warned the government that going ahead with its plan to relax coronavirus restrictions over Christmas would “cost many lives.”

The warning comes after London was placed on the highest health warning alert and after health authorities announced they had discovered a new strain of Covid-19 in England, which could explain the rapid transmission rate in the region.

The Health Service Journal and British Medical Journal said: “With current restrictions failing to control the virus, extrapolation suggests that the actual figure is likely to be more than 40 times higher. The planned relaxation of restrictions over Christmas will boost the numbers further as the NHS also struggles with the additional demands of winter.”

Although the government has urged citizens to keep social contact to a minimum over the festive period, the health experts warned that people would see the slight easing of restrictions around Christmas day as permission to relax.

France’s strict Covid-19 rules, which entails the closure of bars and restaurants, could extend beyond the provisional expiration date of 20 January, depending on how the situation evolves during the Christmas season, prime minister Jean Castex warned Tuesday.

“It breaks my heart to close bars and restaurants,” he told Europe 1 radio. “But it is necessary. Can we guarantee that they will reopen on 20 January? The answer is no. It depends on all of us, how things go this holiday period.”

The government decided to keep the nighttime curfew in place over the Christmas period to avoid social gatherings.