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- The UK regulator on Wednesday approved a COVID-19 vaccine made by US pharmaceutical giant Pfizer and German biotech BioNTech.
- The approval makes the UK the first Western nation to approve one of several vaccines in the late stages of development.
- The UK government said the vaccine will be available next week.
- Pfizer and BioNTech began developing the experimental intake in March. Vaccine research typically takes several years.
- Vaccine pioneers AstraZeneca and Moderna have submitted test data for their COVID-19 vaccines to regulators, but they have not been approved.
- Visit the Business Insider home page 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 Health Products Regulatory Agency (MHRA), gave its approval to the vaccine developed by the US pharmaceutical company Pfizer and the small German company BioNTech.
In a press release, the government said the vaccine would be available within a week.
He said: “The Government today accepted the recommendation of the Medicines and Healthcare Products Regulatory Agency (MHRA) to approve the Pfizer-BioNTech COVID-19 vaccine for use.
“This follows months of rigorous clinical trials and careful analysis of the data by MHRA experts who have concluded that the vaccine has met their strict standards for safety, quality and efficacy.”
The UK has ordered around 40 million doses. Officials have said healthcare workers will have priority to start.
Matt Hancock, UK Minister in Charge of Healthcare, said of the news on Twitter: “The NHS is set 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 the coronavirus, and is safe, after reviewing all the vaccine data, including from a large, late-stage clinical trial with 43,661 volunteers.
Pfizer presented the data to regulators on Nov. 23, after it announced preliminary results that its vaccine was 95% effective.
The change in the MHRA has been unusually rapid, and regulators in other countries, including the FDA, EMA, and authorities in Canada, Japan, and Australia, continue to examine the data.
Pfizer’s vaccine is a new mRNA technology that uses genetic material to boost the immune system and protect it against coronavirus infection.
Regulatory approval in the UK marks a milestone for Pfizer, but also for other vaccine manufacturers, such as Moderna, who also use mRNA technology. It indicates that similar vaccines could also work safely and effectively.
Read more: How pharmaceutical giant Pfizer partnered with little-known biotechnology to develop an effective coronavirus vaccine in record time
Pfizer and BioNTech plan to deliver 50 million doses worldwide by the end of 2020, and production will increase to produce more than 1 billion in 2021.
The supply chains to get the vaccine to those who need it are already in the UK, authorities said. They include designated “centers” that can store the vaccine. It requires ultra-low temperatures for shipping and can then be stored for up to 5 days in a normal vaccine refrigerator.
Read more: The drug makers behind 3 coronavirus vaccines say they work. Here’s everything we know about the race for a vaccine and when you might get it.
The milestone approval is significant, but it is only the beginning. To end the pandemic, approximately 80% of the world’s population vaccine must be immunized.
“Finding a vaccine is not going to end the pandemic overnight, but we are hopeful that we are one step closer to defeating this terrible virus,” said UK Commerce Secretary Alok Sharma.
The vaccine is given in two injections, two weeks apart, and experts have already raised concerns about people returning for the second injection, especially if they have side effects.
Scientists are also in the unusual position of learning about a disease while creating vaccines against it. They are still investigating how long the protection of the vaccine lasts and whether additional injections will be required. It is also unclear whether it prevents people from transmitting the virus to others.
Above all, we don’t know how well the Pfizer vaccine will work in real life. However, tracking its use in millions of people is the only way to find out. And there is an added benefit that this knowledge could be applied to other harmful diseases.
“Very soon the question ‘Why only COVID?’ it will come, “Albert Bourla, Pfizer CEO, told a Goldman Sachs health conference. “If we prove that vaccines can be done in less than a year, that’s fine, why can’t we do that with other drugs, with anticancer drugs?”
Read more: Pfizer’s chief scientist tells us that the pharmaceutical giant is already thinking of a new version of its coronavirus vaccine for 2021 that can overcome one of its biggest limitations.
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