UK becomes first country to authorize Pfizer/BioNTech’s Covid-19 vaccine, first shots roll out next week

The United Kingdom has become the first Western nation to authorize a Covid-19 vaccine, a landmark moment in the coronavirus pandemic that paves the way for the first doses to be rolled out across the country next week.

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

A final analysis of the Phase 3 trial of the vaccine shows it was 95% effective in preventing infections, even in older adults, and caused no serious safety concerns, Pfizer said last month.

The announcement means the UK has vaulted past the United States and European Union in the race to approve a vaccine, months into a pandemic that has killed almost 1.5 million people worldwide.

“We believe it is really the start of the end of the pandemic,” BioNTech CEO Ugur Sahin told CNN in an exclusive interview on Wednesday. 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 an initial 800,000 doses would be delivered from Pfizer’s facilities in Belgium to the UK next week, and “many millions” more before the end of the year.

Elderly people in care homes, those who care for them, health workers and other vulnerable people will be top of the priority list.

The vaccine has been rolled out at extraordinary speed, from conception to approval in around 11 months, according to BioNTech. The process usually takes years.

Prime Minister Boris Johnson called the news “fantastic” in a Downing Street press conference on Wednesday, saying that “we are no longer resting on the mere hope that we can return to normal next year in the spring, but rather on the sure and certain knowledge that we will succeed, and together reclaim our lives.”

But, as a month-long lockdown lifted across England, he urged the public not to get “carried away with over optimism or falling into the naive belief that our struggle is over.”

The UK health department said the approval “follows months of rigorous clinical trials and a thorough analysis of the data” by the Medicines and Healthcare products Regulatory Agency (MHRA), which had “concluded that the vaccine has met its strict standards of safety, quality and effectiveness.”

MHRA chief Dr. June Raine insisted that “no corners have been cut” during a news conference Wednesday. Raine said the clinical trials were “overlapping” to make progress on the process faster. “Separate teams have been working in parallel to deliver this review,” she added.

“Good news, we have a vaccine that is safe and effective,” Vaccine and Immunization committee chair Wei Shen Lim added.

How the vaccine will be rolled out

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

Speaking alongside the Prime Minister on Wednesday night, Simon Stevens, the head of the National Health Service in England, said that the rollout of the vaccine would be phased, with vaccinations for at-risk people taking place between January and March or April.

Starting next week, around 50 “hospital hubs” will begin offering the vaccine to people over 80 and care home staff. After that, doctors’ offices will start operating local vaccine centers — around 1,000 across England — to vaccinate vulnerable patients.

And once MHRA approves a way to split up the supplies of the vaccine, which is delivered in packs of 975 and stored at temperatures of minus-70 degree Celsius (minus-94 Fahrenheit), it will be distributed to care homes.

As more vaccine doses become available, it will be provided at large vaccination centers, and local pharmacists should be able to offer it from January, he said.

The rollout will then filter down to the general public by age, with older groups coming first. Individuals with underlying health conditions that make them vulnerable to the virus will be able to receive the shot after the over-65 group is vaccinated.

Stevens also noted that the vaccine has to be given in two doses 21 days apart, so the process will take time. Second doses will also need to be reserved for people who get a first shot in December, he said, emphasizing that people will need to continue practicing social distancing guidance and be careful as the vaccine is deployed to the wider population.

The vaccine should be available at designated sites in England, seven days a week from 8 a.m. to 8 p.m. including holidays, the UK health department has instructed the national public health agency.

FILE - In this July 27, 2020, file photo, nurse Kathe Olmstead prepares a shot that is part of a possible COVID-19 vaccine, developed by the National Institutes of Health and Moderna Inc., in Binghamton, N.Y. Moderna Inc. says it will ask U.S. and European regulators to allow emergency use of its COVID-19 vaccine as new study results confirm the shots offer strong protection. (AP Photo/Hans Pennink, File)

Related article When can I get a coronavirus vaccine?

At a news conference with BioNTech executives in Mainz, Germany, BioNTech CEO Sahin said full immunity against Covid-19 would occur seven days after a patient’s second dose.

Sean Marett, BioNTech’s chief commercial officer, said doses for the UK were currently being packed very quickly at the Pfizer facility in Belgium. Thermoboxes are being packed with between 1,000-5,000 doses, which they will ship by truck or plane. The boxes are temperature controlled with a tracker to provide minute-by-minute updates before delivery to a site for distribution.

Marett said the companies hoped to have 50 million doses ready by the end of December. “The UK, like every country, gets a fair proportion,” he said, adding that 100 million doses are committed to the US, 200 million to the EU and 40 million to the UK.

Speaking to CNN after the news conference, Sahin raised the possibility of herd immunity by next autumn.

“I personally believe with a number of companies now reaching the approval in the next few months, we might be able to deliver a sufficient number of doses until the end of summer 2021 to reach the 60 to 70% of coverage, which could give us the relief to have a normal winter in 2021.”

More vaccines on the way

The UK authorization will be a welcome moment for the government, which has been roundly criticized for a string of failures that have contributed to a death toll of nearly 60,000 – Europe’s highest.

But officials were quick to warn that the threat was far from over.

“If we relax too soon, if we just kind of go ‘ahh the vaccine is here, let’s abandon caution,’ all you’re going to do is create a tidal wave of infections, and this vaccine’s got to work in a headwind to get back ahead of the game and that will make it harder,” Jonathan Van-Tam, deputy chief medical officer for England, said Wednesday at the Downing Street briefing.

And in a pointed rebuke of vaccine skepticism, Van-Tam emphasized that the only way to get back to normalcy was to take the vaccine.

“Nobody wants lockdowns and to see the damage they do. But if you want that dream to come true as quickly as it can come true, then you have to take the vaccine when it’s offered to you. Low uptake will almost certainly make restrictions last longer.”

WASHINGTON, DC - OCTOBER 13: White House Chief of Staff Mark Meadows is seen as Supreme Court nominee Judge Amy Coney Barrett testifies before the Senate Judiciary Committee on the second day of her Supreme Court confirmation hearing on Capitol Hill on October 13, 2020 in Washington, DC. Barrett was nominated by President Donald Trump to fill the vacancy left by Justice Ruth Bader Ginsburg who passed away in September. (Bonnie Cash-Pool/Getty Images)

Related article Meadows to meet with FDA chief as Trump asks about status of vaccine emergency approval

The news of the UK authorization could also cause a bit of a stir in the US. Earlier this week, President Donald Trump privately demanded to know why the US Food and Drug Administration hadn’t granted emergency use for Pfizer’s vaccine yet, two sources told CNN.

BioNTech and Pfizer submitted their vaccine candidate to the FDA in mid-November, and the regulator’s Vaccines and Related Biological Products Advisory Committee is due to meet on December 10 to consider authorization. They have also submitted their candidate to the EU’s European Medicines Agency (EMA), which is set to deliver a verdict later in December.

Another vaccine, from US biotech firm Moderna, is awaiting approval in various countries, including the US and UK. The company expects to have 20 million doses available in the US by the end of the year and 500 million to 1 billion in 2021. The UK has secured 7 million doses of Moderna’s vaccine, which is set to be available in Europe in spring 2021. Moderna has also submitted its vaccine to the EMA in Europe, which will look at it on January 12.

Claudia Otto, Josefine Ohema and Mick Krever contributed to this report.