Pfizer vaccine: UK becomes first Western country to approve Covid 19 vaccine for general use



[ad_1]

“Help is on the way,” Health Secretary Matt Hancock announced Wednesday morning after UK regulators granted emergency clearance for a vaccine made by US pharmaceutical giant Pfizer and its German partner. BioNTech.

A final analysis of the phase 3 trial of Pfizer’s vaccine shows that it was 95% effective in preventing infections, even in older adults, and did not cause serious safety concerns, the company said last month.

The announcement means the UK has overtaken the United States and the European Union in the race to approve a vaccine, months after a pandemic that has killed nearly 1.5 million people worldwide. Pfizer CEO Albert Bourla hailed the emergency authorization as “a historic moment in the fight against Covid-19.”

The UK has ordered 40 million doses of the vaccine, enough to vaccinate 20 million people. Hancock told the BBC that 800,000 initial doses would be available in the UK next week and that “we will then implement them at the rate at which they are manufactured” by Pfizer at its Belgian facility. Most of the launch will occur next year.

The elderly in nursing homes, along with healthcare workers and other vulnerable people, will be high on the priority list.

In a statement, the health department said the approval “follows months of rigorous clinical trials and extensive analysis of the data by experts in the [Medicines and Healthcare products Regulatory Agency (MHRA)] who have concluded that the vaccine has met its strict standards of safety, quality and effectiveness.

“The Joint Committee on Vaccination and Immunization (JCVI) will shortly release its latest advice for priority groups to receive the vaccine, including nursing home residents, health and care personnel, the elderly and the clinically extremely vulnerable.”

Prime Minister Boris Johnson praised the news as “fantastic” in a tweet, adding that “it is the protection of vaccines that will ultimately allow us to get our lives back and get the economy moving again.”

How the vaccine will be implemented

The Pfizer / BioNTech vaccine uses a new approach to making vaccines that uses a piece of genetic material called messenger RNA to prompt the body to produce synthetic pieces of the coronavirus and stimulate an immune response. But the mRNA is very fragile, so the vaccine must be kept at ultra-cold temperatures, which means that special storage equipment is required.

Speaking to Sky News, Hancock said there would be “a combination of three modes of delivery.” The first will be the hospitals, with 50 prepared to handle the vaccine and waiting to receive the doses. This will be followed by vaccination centers, which he said were being established now, ahead of a “community rollout” that includes doctors ‘and pharmacists’ offices.

But he pointed to the need for the Pfizer vaccine to be stored at temperatures of minus 70 degrees Celsius (minus 94 Fahrenheit), unlike the University of Oxford and AstraZeneca’s vaccine, which has yet to be approved.

“They [doctors and pharmacists] It should also be there if the AstraZeneca vaccine is approved, because it does not have these cold storage requirements and is therefore easier to implement from an operational point of view, but I just want to thank all the scientists at BioNTech and Pfizer , who are manufacturing this, whom we have worked very closely with. “

UK regulators and officials were due to release more details on why they approved the Pfizer vaccine, and who gets it first, later on Wednesday.

“It is in accordance with clinical need,” Hancock told the BBC. “The goal is to save as many lives as possible and stop hospitalizations.”

He said that implementation would start with the majority of older people, people in nursing homes and their caregivers, and that NHS staff would also rank high on the priority list. “And also the clinically extremely vulnerable whom we have supported during this crisis, those who are particularly vulnerable to the coronavirus.”

Then “it essentially comes down to age range,” he added.

Hancock urged the British to listen to doctors, nurses and “expert voices, those who have been involved in this program and to listen to the independent regulator.”

“They’ve run the checks and they know this is safe and it’s ready … safe for the high clinical standards they require,” he said.

‘A historical moment’

It is the first time that citizens outside of clinical trials around the world will have the opportunity to be immunized against Covid-19, according to BioNTech CEO Ugur Sahin.

“To aid the success of the vaccination program, it is vital that everyone continues to play their role and adhere to the necessary restrictions in their area so that we can further suppress the virus and allow the NHS to do its job without feeling overwhelmed,” said a spokesperson de said the UK health department in a statement.

“The vaccine will be available across the UK from next week. The NHS has decades of experience delivering large-scale vaccination programs and will begin to put into action its extensive preparations to provide care and support to all those they are eligible for vaccination, “the statement said. additional.

“This authorization is a goal we have been working towards since we first declared that science will win, and we applaud the MHRA for its ability to conduct a careful assessment and take timely action to help protect the people of the UK. “Bourla, the CEO of Pfizer, said in a statement.

Sahin added that the regulatory data was the result of “a scientifically rigorous and highly ethical research and development program.”

Other countries, including the United States, are considering approval of several coronavirus vaccines before the end of the year.

BioNTech and Pfizer submitted their vaccine candidate to the US Food and Drug Administration (FDA) in mid-November. They have also been submitted to the EU’s European Medicines Agency.

Josefine Ohema contributed to this report.

[ad_2]