UK approves BioNTech / Pfizer COVID-19 vaccine for emergency use – Heaven32

The British government has approved BioNTech / Pfizer COVID-19 vaccine for emergency use, as recommended by the national drug regulator.

The UK is the first country to approve the vaccine for widespread use, paving the way for some of the citizens most at risk, such as nursing home residents and frontline health workers, to receive the vaccine earlier the end of the year.

The BBC The UK Medicines and Health Products Regulatory Agency (MHRA) reports that the vaccine can be safely launched from next week. Although it is not yet clear who will receive the first doses.

The emergency clearance request was submitted by BioNTech and Pfizer to the MHRA last month – as well as regulators in Australia, Canada, Europe, Japan and the United States, none of which has yet given the green light.

In a statement, Albert Bourla, chairman and CEO of Pfizer, described the UK’s emergency use authorization as “a historic moment in the fight against COVID-19”.

“This clearance is a goal we have been working towards since we first declared that science would win, and we commend the MHRA for its ability to conduct careful assessment and take timely action to help protect the UK population. “, told me.” As we anticipate more clearances and approvals, we strive to move forward with the same level of urgency to safely deliver a high-quality vaccine around the world. thousands of people infected, every day is important in the collective race to end this devastating pandemic.

UK approval is based on trial data including a global Phase 3 clinical study by BioNTech / Pfizer that demonstrated a 95% vaccine efficacy rate and did not raise serious security concerns.

The vaccine was also shown to be effective in participants who had not previously contracted the SARS-CoV-2 virus and in those who did, as measured by effectiveness seven days after the second dose.

Efficacy has also been reported to be consistent across all ages, genders, races, and ethnic demographics, with efficacy seen in adults 65 and over of over 94%, according to the companies.

British Prime Minister Boris Johnson tweeted the news of the formal authorization this morning, writing that the vaccine “will be available across the UK from next week”. NAIL second tweet anticipated how vaccination in general will “eventually” come back to economic life as usual.

The UK has ordered 40 million doses of the BioNTech / Pfizer vaccine, which is enough vaccine for 20 million people (as it requires two doses), although it will take some time for the country to receive all of the requested doses.

“Delivery of the 40 million doses will be made throughout 2020 and 2021, in stages, to ensure equitable distribution of vaccines across geographic areas with executed contracts,” the companies wrote in a press release.

“Now that the vaccine is licensed in the UK, companies will take immediate action to start administering doses of the vaccine. The first doses are expected to arrive in the UK in the next few days and delivery is expected to be completed in 2021, ”they added.

The UK’s National Health Service is bracing for what NHS Executive Director Sir Simon Stevens has described as “the biggest vaccination campaign in our country’s history”. For him BBCAbout 50 hospitals are on standby and vaccination centers are also being set up in places like conference centers.

In comments To reporters this morning, Health Secretary Matt Hancock said 800,000 doses of the virus would be available next week, with the bulk of the rollout taking place in the New Year. “We are going to implement it at the rate at which it is being manufactured,” he added.

Hancock said priority for the first batch of beatings will be given to “the elderly” and people in nursing homes, including their caregivers. “So basically the age range is reduced. NHS staff also rank high on this priority list, as do people who are clinically extremely vulnerable… those who are particularly vulnerable to the coronavirus, ”he added.

“The emergency use authorization in the UK will mark the first time that untested citizens will have the opportunity to be immunized against COVID-19,” said Ugur Sahin, MD, CEO and co- founder of BioNTech in a statement of support. . “We believe that the implementation of the vaccination program in the UK will reduce the number of people in the high risk population who will be hospitalized.

“Our goal is to bring a safe and effective vaccine after approval to the people who need it. The data submitted to regulatory agencies around the world is the result of a scientifically rigorous and highly ethical research and development program.