Frankfurt The British drug supervisory authority MHRA was the first authority in the world to issue
Emergency approval for the corona vaccine BNT162b2 , which was developed by the Mainz-based company Biontech and its US partner Pfizer .
This means that the vaccine will be regularly available in the UK a few weeks earlier than in the EU and the USA .
British Health Minister Matt Hancock announced in an interview with Sky News that people would be vaccinated from the beginning of next week. Prime Minister Boris Johnson hopes that this will boost the economy. “Vaccination protection will ultimately allow us to regain our lives and get the economy back on track,” Johnson said on Wednesday.
However, it will take until the spring to vaccinate the most vulnerable part of the population, said England's top health official, Chris Whitty.
The vaccine from Biontech and Pfizer is the first Covid vaccine to be approved in the western world.
Other products, including a similar product from the US company Moderna , should follow in the next few weeks. The Moderna product is also in a rolling approval process in the UK and a number of other countries.
Both vaccines are based on mRNA, a class of substances for which there have not yet been any product approvals. The approval in Great Britain is therefore also an important first for this novel technology, in which messenger nucleic acids are used as active pharmaceutical ingredients. This confirms that this technique could offer significant advantages in terms of both speed and effectiveness over conventional vaccines.
Biontech and Pfizer want to start delivering to the UK immediately.
Pfizer boss Albert Bourla described the approval as a "historic moment" in the fight against Covid-19. Further approval decisions are expected around the world in the next few days.
Biontech share with strong gains
The European Medicines Agency (Ema) wants to submit an assessment for the vaccine from Biontech and Pfizer by December 29th at the latest, on the basis of which the EU Commission could then issue a conditional approval. In the United States, an advisory board to the FDA is expected to deal with the vaccine from December 8-10.
The Biontech share rose by more than seven percent on Wednesday and was quoted at around 102 euros in the morning. Company boss Ugur Sahin was convinced that the start of the vaccination program in Great Britain will help reduce the number of high-risk patients needing hospital treatment for Covid-19.
The approval is based on the extensive phase 3 study with around 44,000 participants. According to the company, it showed that the vaccine offers 95 percent protection against Covid diseases with the coronavirus. The vaccine works equally well across all age groups and other demographic differences and shows practically no serious side effects. The vaccination protection for people who are over 65 years old is over 94 percent.
As at the EU level, a rolling approval process for the vaccine was already in place in Great Britain.
Data and documents are submitted while the clinical studies are still ongoing. This can significantly speed up the entire evaluation process for new drugs or vaccines.
Biontech and Pfizer want to produce around 50 million doses this year and around 1.3 million units of the vaccine in the coming year. You have already agreed supply contracts for a total of 570 million cans with several countries in advance. The EU has ordered 200 million units, the UK 40 million.
The two partners now want to start delivering directly to the United Kingdom. The first vaccine units are expected to arrive in the UK in the next few days. Biontech and Pfizer want to deliver the total amount in equal steps by the end of 2021.
The UK has been particularly hard hit by the pandemic, and many of the chronically underfunded hospitals have already reached their capacity limits. According to the Department of Health, almost 60,000 people in the UK have already died from Covid-19. A high number of unreported cases is expected. Prime Minister Johnson is accused of responding too late and inadequately to the corona crisis.
50 hospitals and vaccination centers are ready to start vaccination. The 40 million vaccine doses can protect 20 million people - the drug has to be administered twice. Great Britain has almost 67 million inhabitants. According to the Ministry of Health, the military is helping with logistics.
With agency material.