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UK formally approves Pfizer/BioNTech vaccine against Covid-19

The UK has become the first western country to licence a vaccine against he virus.

Image: DPA/PA Images

THE UK HAS formally approved a vaccine against Covid-19 developed by Germany’s BioNTech and US giant Pfizer, becoming the first country to do so.

The vaccine has been authorised by the UK’s Medicines and Healthcare Products Regulatory Authority (MHRA) for emergency use.

The Guardian reports that the UK has bought 40 million doses of the vaccine, with a statement form the company saying that the first doses will arrive in the UK in coming days.

“The government has today accepted the recommendation from the independent Medicines and Healthcare products Regulatory Agency to approve Pfizer-BioNTech’s Covid-19 vaccine for use,” the UK’s department of health said in a statement.

“The vaccine will be made available across the UK from next week,” the statement said, with priority groups including care home residents, health and care staff.

After months of “rigorous” clinical trials and thorough analysis of the data, the MHRA “concluded that the vaccine has met its strict standards of safety, quality and effectiveness”.

Pfizer chairman Albert Bourla said it was a “historic moment in the fight against Covid-19″. 

“This authorisation is a goal we have been working toward since we first declared that science will win, and we applaud the MHRA for their ability to conduct a careful assessment and take timely action to help protect the people of the UK,” he said.

Pfizer and BioNTech added that they expected further regulatory decisions from other countries “in the coming days and weeks”.

The announcement came as England exited a month-longlockdown, but most of the country remained under restrictions as a new regional system for cutting infection rates kicked in.

The four-week lockdown, which began in November, was imposed to stop surging rates of infection, ease pressure on health services, and to allow families to gather for Christmas.

Yesterday, the European Medicines Agency (EMA) said it would hold an extraordinary meeting on 29 December “at the latest” to consider emergency approval for the vaccine.

However, UK regulators do not have to wait for the EMA’s approval because of Brexit. 

Large-scale trial data released last month showed that the vaccine was safe and around 95 percent effective against Covid-19, the disease caused by the coronavirus.

European Commission spokesman Stefan de Keersmaecker said that once the EMA gave regulatory permission, formal authorisation from Brussels would follow “very quickly” – probably “in a matter of days”.

The companies previously said that the vaccine could potentially be rolled out “in Europe before the end of 2020″ if it is approved.

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“We have known since the beginning of this journey that patients are waiting, and we stand ready to ship Covid-19 vaccine doses as soon as potential authorisations will allow us,” Pfizer CEO Albert Bourla said.

The vaccine is based on new technology, using mRNA (messenger ribonucleic acid) to deliver genetic material to the body and make human cells create a protein from the virus.

This trains the immune system to be ready to attack if it encounters SARS-CoV-2.

BioNTech/Pfizer have also applied for emergency use authorisation in the United States, where Americans are expected to start getting vaccinated around mid-December.

The companies said they had asked the EMA for “conditional market approval” of their vaccine on Monday, after filing a request for emergency authorisation in the US on 20 November.

Contains reporting from © AFP 2020.

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