UK becomes first Western country to approve a coronavirus vaccine
- US pharma giant Pfizer and German biotech BioNTech have developed the world's first effective coronavirus vaccine, in record time.
- The independent UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), said the vaccine works against Covid-19, and is safe.
- Pfizer and BioNTech started developing the experimental shot in March. Usually vaccine research takes several years.
- It's now got emergency use authorisation in the UK, meaning the UK government can give Brits the shot.
- Vaccine frontrunners AstraZeneca and Moderna have submitted trial data for their Covid-19 vaccines to regulators, but they haven't been signed off.
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The UK has become the first Western country to officially have a new coronavirus vaccine, marking a potential exit route out of the pandemic. And it's happened in record time.
The vaccine developed by US drugmaker Pfizer and the small German biotech, BioNTech, can be used in the UK, after the independent regulatory body in the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) signed off the vaccine.
The news was confirmed by Matt Hancock, the UK's secretary of state for health.
He said: "The MHRA has formally authorised the Pfizer/BioNTech vaccine for Covid-19. 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 American FDA, the European Medicines Agency, and authorities in Canada, Japan and Australia - still scrutinising the data.
However, this hasn't compromised a thorough evaluation and ensuring the vaccine's safe, said the MHRA.
"Safety is our watch word," said MHRA Chief Executive Dr. June Raine in a statement.
Pfizer's vaccine is the result of new mRNA technology, which 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, which use mRNA technology too: it signals that similar vaccines could work safely and effectively too.
Pfizer and BioNTech 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 UK government said "it's ready" to start by immunising the most vulnerable Brits, having pre-ordered 40 million doses of Pfizer's shot, enough for roughly one third of the population. The supply chains to get the vaccine to those who need it are already in place, and include designated "hubs" that can store the vaccine, which requires ultra-low temperatures for shipping, and then can be stored for up to 5 days in a normal vaccine fridge.
In order to end the pandemic, roughly 80% of the global population vaccine must be immunised.
"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's given as two shots, two week's 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 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?
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