The UK approved Pfizer and BioNTech's COVID-19 vaccine, the first Western nation to give it the green light
Dado Ruvic/Reuters
- 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 authorization 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 early Monday by Matt Hancock, the UK's secretary of state for health.
He said: "The MHRA has formally authorized 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 it's 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.
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 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. And, as multiple vaccines are required to immunize a global population, this is really positive news.
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 UK government said "it's ready" to start by immunizing 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 - it requires ultra-low temperatures for shipping, and then can be stored for up to 5 days in a normal vaccine fridge.
An important milestone, 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'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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