UK first to approve Pfizer-BioNTech Covid-19 vaccine for rollout ‘next week’ - FRANCE 24 English

Issued on: 02/12/2020 - 08:49Modified: 02/12/2020 - 08:51

Britain on Wednesday became the first Western country to approve a Covid-19 vaccine for general use as it announced a rollout of Pfizer-BioNTech’s drug from next week.

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

“The vaccine will be made available across the UK from next week,” the statement said. Priority groups will include care home residents, health and care staff, the elderly and the clinically extremely vulnerable.

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”, the statement added.

“To aid the success of the vaccination programme it is vital everyone continues to play their part and abide by the necessary restrictions in their area so we can further suppress the virus and allow the NHS (National Health Service) to do its work without being overwhelmed.”

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.

Head of UK medicine agency explains Pfizer vaccine approval

Other countries expected to follow suit

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

The move makes Britain one of the first countries to begin vaccinating its population as it tries to curb Europe’s deadliest Covid-19 outbreak.

Other countries aren’t far behind: The United States and the European Union also are vetting the Pfizer shot along with a similar vaccine made by competitor Moderna Inc.

Pfizer said it would immediately begin shipping limited supplies to the UK – and has been gearing up for even wider distribution if given a similar nod by the US Food and Drug Administration, a decision expected as early as next week.

But doses everywhere are scarce, and initial supplies will be rationed until more is manufactured in the first several months of next year.

Variety of vaccines in the pipeline will 'help'

While the UK has ordered enough Pfizer vaccine for 20 million people, it’s not clear how many will arrive by year’s end and adding to the distribution challenges is that it must be stored at ultra-cold temperatures.

Two doses three weeks apart are required for protection. First in line, the British government says, are frontline health care workers and nursing home residents, followed by older adults.

'We cannot afford to relax'

Prime Minister Boris Johnson, a Covid-19 survivor, succeeded in winning a vote on the measures in parliament late Tuesday, despite significant opposition within his own Conservative ranks.

“All we need to do now is to hold our nerve until these vaccines are indeed in our grasp and indeed being injected into our arms,” he told lawmakers before the vote.

Until then “we cannot afford to relax, especially during the cold months of winter”, he warned.

British regulators also are considering another shot made by AstraZeneca and Oxford University. 

Every country has different rules for determining when an experimental vaccine is safe and effective enough to use. Intense political pressure to be the first to roll out a rigorously scientifically tested shot coloured the race in the US and Britain, even as researchers pledged to cut no corners. In contrast, China and Russia have offered different vaccinations to their citizens ahead of late-stage testing.

The shots made by US-based Pfizer and its German partner BioNTech were tested in tens of thousands of people. And while that study isn’t complete, early results suggest the vaccine is 95 percent effective at preventing mild to severe Covid-19 disease. The companies told regulators that of the first 170 infections detected in study volunteers, only eight were among people who’d received the actual vaccine and the rest had gotten a dummy shot.

“This is an extraordinarily strong protection,” Dr. Ugur Sahin, BioNTech’s CEO, recently told The Associated Press.

The companies also reported no serious side effects, although vaccine recipients may experience temporary pain and flu-like reactions immediately after injections.

But experts caution that a vaccine cleared for emergency use is still experimental and the final testing must be completed. Still to be determined is whether the Pfizer-BioNTech shots protect against people spreading the coronavirus without showing symptoms. Another question is how long protection lasts.

The vaccine also has been tested in only a small number of children, none younger than 12, and there’s no information on its effects in pregnant women.

(FRANCE 24 with AP and AFP)

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