The UK approved Pfizer and BioNTech's COVID-19 vaccine, the first Western nation to give it the green light

Vaccines can't be rolled out in a country until its drug regulator has scrutinized and approved it.

Dado Ruvic/Reuters

• The UK regulator on Wednesday approved a COVID-19 vaccine made by the US Pharma giant Pfizer and German biotech BioNTech.
• The approval makes the UK the first western nation to approve one of the several vaccines in the late stages of development.
• The UK government said that the vaccine will be made available next week.
• Pfizer and BioNTech started developing the experimental shot in March. Usually vaccine research takes several years.
• Vaccine frontrunners AstraZeneca and Moderna have submitted trial data for their COVID-19 vaccines to regulators, but they haven't been signed off.
• Visit Business Insider's homepage for more stories.

The UK has become the first Western country to officially have a new coronavirus vaccine, the government announced Wednesday.

The country's regulatory body, the Medicines and Healthcare products Regulatory Agency (MHRA), gave its approval to the vaccine developed by US drugmaker Pfizer and the small German firm BioNTech.

In a press release, the government said that the vaccine would be available within a week.

It said: "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.

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

The UK has ordered around 40 million doses. Officials have said that healthcare workers, the elderly, those in care homes, and people with other medical conditions making them vulnerable to COVID-19 will get priority.

Matt Hancock, the UK minister in charge of the healthcare system, said of the news on Twitter: "The NHS stands ready to start vaccinating early next week. The UK is the first country in the world to have a clinically approved vaccine for supply."

The MHRA said that Pfizer's vaccine protects against COVID-19 — the disease caused by coronavirus — and is safe, after it reviewed all the vaccine's data including from a large, late-stage clinical trial of 43,661 volunteers. 

Pfizer submitted the data to the regulators on 23 November, after it announced preliminary results that its vaccine was 95% effective.

The turn-around from the MHRA has been unusually quick, with regulators in other countries — including the FDA, EMA and authorities in Canada, Japan and Australia — still scrutinizing the data.

Pfizer's vaccine is a new mRNA technology that uses genetic material to stimulate the immune system to protect against coronavirus infection.

The regulatory approval in the UK marks a milestone for Pfizer, but also for other vaccine-makers, like Moderna, that use mRNA technology too. It signals that similar vaccines could work safely and effectively too.

Read more: How the pharma giant Pfizer teamed up with a little-known biotech to develop an effective coronavirus vaccine in record time

Pfizer and BioNTech themselves plan to deliver 50 million doses across the world by the end of 2020, with production ramping up to produce more than 1 billion in 2021. 

The supply chains to get the vaccine to those who need it are already in place in the UK, authorities said. They include designated "hubs" that can store the vaccine. It requires ultra-low temperatures for shipping, and then can be stored for up to 5 days in a normal vaccine fridge.

Read more: Drugmakers behind 3 coronavirus vaccines say they work. Here's everything we know about the race for a vaccine and when you might be able to get a shot.

The milestone approval is significant, but it's just the start. In order to end the pandemic, roughly 80% of the global population vaccine must be immunized.

"Finding a vaccine is not going to end the pandemic overnight, but we are hopeful of being one step closer to defeating this terrible virus," said UK Business Secretary Alok Sharma.

The vaccine is given as two shots, two weeks apart, and experts have already raised concerns about people returning for the second shot, especially if they get side-effects.

Scientists are also in the unusual position of learning about a disease at the same time as they're creating vaccines against it. They're still investigating how long the vaccine's protection lasts for, and whether additional shots will be required. It's also unclear whether it stops people from spreading the virus to others. 

Above all, we don't know how well Pfizer's vaccine will work in real life. However, tracking its use in millions of people is the only way to figure this out. And there's added benefit that this knowledge could be applied to other harmful diseases.

"Pretty soon the question 'Why only COVID?' will come," Albert Bourla, Pfizer's CEO said at a Goldman Sachs healthcare conference. "If we prove that you can make vaccines in less than a year, OK, why can't we do that with other medicines, with cancer medicines?"

Read more: Pfizer's top scientist tells us the pharma giant is already thinking about a new version of its coronavirus vaccine for 2021 that can overcome one of its biggest limitations

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