World News – AU – UK Approves Pfizer / BioNTech Covid Vaccine for Launch Next Week

Britain became the first western country to approve a vaccine against Covid, paving the way for mass immunization with the Pfizer / BioNTech vaccine to begin next week for the most at risk.

The vaccine was approved for emergencies by the Medicines and Health Products Regulatory Authority (MHRA) ahead of US and European decisions. The MHRA was empowered to use the vaccine before Jan.. Approved by the government on January 1st under special regulations if it will take full responsibility for drug approval in the UK after Brexit.

The first doses of the vaccine would arrive in the coming days, the company said. The UK has bought 40 million doses of the vaccine, which in its recent studies has been shown to be 95% effective.

A spokesman for the Department of Health and Social Affairs said: « The government today accepted the MHRA recommendation to approve Pfizer / BioNTech’s Covid-19 vaccine for use.

“This follows months of rigorous clinical trials and a thorough analysis of the data by experts at MHRA who have concluded that the vaccine meets its strict safety, quality and efficacy standards.

“The Joint Vaccination and Immunization Committee will also shortly be releasing its latest recommendations for the priority groups to receive the vaccine, including nursing home residents, health and care workers, the elderly and the most clinically vulnerable. The vaccine will be available across the UK from next week. ”

Health Secretary Matt Hancock said the first doses would be given to the most vulnerable. Britain would be 800 next week. Have 000 cans available, he said.

“This is fantastic news. The MHRA, the highly independent regulatory agency, has clinically approved the vaccine for launch. The NHS is ready to make this happen, ”he told Sky News.

« From the beginning of next week we will start the vaccination program against Covid-19 here in this country. The MHRA recognized it as clinically safe and we have a vaccine. So this is very good news. ”

Hancock said the launch of the vaccine across the UK was « challenging » as it needed to be kept at -70 ° C. A network of 50 hospitals is ready to deliver the first shocks and special vaccination centers are being built.

He said the vaccine would also be available from some general practitioners and pharmacists if they had cold stores.

Hancock told BBC News that it would take two pokes for each person and that the « bulk » of the 40 million order is expected to be available in the new year.

The elderly and people in nursing homes, including staff, would line up for vaccination first, « and then it essentially comes in the age bracket, » Hancock said. NHS staff were also high on that list of priorities and were also extremely clinically at risk, he said.

He added: “The goal will be to vaccinate across the UK as soon as possible through the NHS. It will help save lives. Once we’ve protected the weakest, we can all go back to normal and get back to some of the things we love. ”

Hancock told BBC News that the country could return to some normalcy from Easter next year and said no restrictions would be required until summer 2021.

He said, “So many families have suffered, including my own. I’m just so, so pleased . . . 2020 was just terrible and 2021 will be better. help is on the way. With this vaccine, help is on the way – and we can now say that with confidence instead of all the reservations we normally have to deal with. « With today’s news, I am confident that it will get better from spring – from Easter. We’re going to have a summer everyone can enjoy next year. Until then, we have to keep our resolve. ”

The JCVI is expected to determine later Wednesday morning which groups of people will be eligible from next week.

Albert Bourla, Pfizer Chairman and Chief Executive Officer, added, “Today’s UK Emergency Use Authorization marks a historic moment in the fight against Covid-19. This approval is a goal we have been working towards since we first stated that science will win, and we applaud the MHRA for its ability to carry out a careful assessment and take timely action to protect the people of the UK. ”

Although the vaccine must be stored at -70 ° C, according to the companies it can be stored in the refrigerator at 2-8 ° C for up to five days. The first priority groups for vaccination are nursing home residents who may not be able to come to a vaccination center, along with the staff who care for them. At refrigerator temperatures, the vaccine may be able to be brought to them. Next up are the 80+ staff and the NHS.

The study data showed that the vaccine was equally effective in younger volunteers and those over 65 who are most at risk of Covid. Gender, race, and ethnicity also made no difference.

Pfizer and BioNTech say their combined manufacturing network has the potential to deliver up to 50 million vaccine doses in 2020 and up to 1 worldwide. 3 billion. Doses until the end of 2021.

Delivery of the 40 million cans in the UK will begin immediately. The delivery will continue gradually in 2020 and 2021 « to ensure a fair distribution of the vaccines to the regions with executed contracts, » the companies say.

The US, which ordered 100 million doses, and Europe, which bought 200 million, are expected to approve the vaccine within weeks.

The MHRA has cleared the emergency with unprecedented speed after being released on Aug.. November had received the final data from the company. An on-going approval process was in place, reviewing data from early studies as they were received.

« The emergency use approval in the UK marks the first time that citizens outside of the trials have had the opportunity to get vaccinated against Covid-19, » said Uğur Şahin, CEO and co-founder of BioNTech.

“We believe that the introduction of the UK vaccination program will reduce the number of people in the high risk population being hospitalized. Our goal is to provide a safe and effective vaccine to the people who need it once approved. The data communicated to regulators around the world is the result of a scientifically rigorous and highly ethical research and development program. ”

Vaccine, Moderna, Coronavirus, Pfizer, Emergency Approval, Food and Drug Administration