UK approves Pfizer-BioNTech’s COVID-19 vaccine

The UK Government has approved the Pfizer and BioNtech COVID-19 vaccine after accepting recommendations from the independent MHRA (Medicines and Healthcare products Regulatory Agency) which is set to be rolled out from next week according to the UK Health secretary.

The UK Health secretary, Matt Hancock, who says hospitals were ready to receive the doses also mentioned that government has set up a committee that is now working on the final advice for which people should receive it first.

The vaccine by Pfizer and BioNtech which is made by a team of German scientists in partnership with the US Pharmaceutical giants came back after testing with initial results from key trials to suggest that the vaccine is significantly effective.

Data showed the vaccine was strongly effective after trial results made public in mid-November showing the vaccine had a 95-percent success rate and caused no serious side effects.

However, the vaccine which is already estimated to cost about $20 is not yet verified if it can stop persons infected with the coronavirus disease in spreading to others.

Following the announcement, some health experts say that the development is one of the most hopeful since the start of the pandemic given that several vaccines were being developed by different pharmaceutical companies and researchers in different places around the world.

The UK, with Europe’s worst outbreak of more than 1.6 million coronavirus cases recorded to date more than 59,000 deaths according to official records, becomes the first industrialized nation to give a green light to this vaccine allowing it to be essentially rolled out as early as next week Monday morning, according to health minister, Matt Hancock.

One concern is that there needs to be some checks on the vaccine before it leaves Belgium where the factory is based and also people will need two doses of the vaccine injected into their arm 21 days apart, adding to the fact that the vaccine must be kept at an incredibly ultra-cold temperature of around minus 70 degrees Celsius (minus 94 degrees Fahrenheit), as well as the challenge of distribution around the world.

Over 800,000 doses will be available in the UK from the manufacturing centre depending on how fast the manufacturers can make the vaccine to determine how many people it can reach.

In determining who would receive the vaccine first, experts have noted that front-line workers and the elderly will be on the top of the list before it trickles down to national hospitals followed by people of younger ages.

Reactions to the Pfizer vaccine approval by the UK

The UK Prime Minister, Boris Johnson, has said that the development is fantastic adding that “It is the protection of vaccines that will ultimately allow us to reclaim our lives and get the economy moving again.”

“we must first navigate a hard winter of restrictions to try to curb the virus until there is enough vaccine to go around,” Johnson warned.

Similarly, Danny Altmann, professor of immunology at Imperial College London, said: 

“Exciting news keeps coming, but this really is momentous. Nobody knew how the battle to find effective vaccines would pan out. Now, less than 11 months from the first characterisation of the virus sequence, we have the first emergency approval for use of a really effective vaccine”.

Pfizer said the UK’s emergency use authorisation marks an historic moment in the fight against COVID-19.

However, the EU has criticised the approval of the vaccine by the UK describing it as ‘hasty’.

In a statement from the European Medicines Agency (EMA), which is tasked with the job of approving COVID-19 vaccines for the EU, the European regulators noted that its longer approval procedure is more appropriate than the emergency procedure which was adopted by the UK.

The agency gave its criticisms shortly after the UK announced its approval for the vaccine’s first use.

According to Hancock, prior to government giving go ahead for the vaccine, he said they were expecting to receive 10 million doses before the end of the year and they believe majority of people will be vaccinated at the early start of next year.

COVID-19 vaccine competitors

Moderna has filed for US and European emergency regulatory approval after presentation of the final efficacy results on its phase 3 trial of its COVID-19 vaccine.

They have analysed a total number of 196 cases of COVID-19 which has resulted in 94.1% efficacy rate, 100% against severe disease. The vaccine also has been said to be well tolerated with no serious safety to date.

Plans are already on the way to file with the FDA for emergency use authorization and for Europe’s conditional approval.

Moderna says ahead of the FDA advisory committee meeting slated for December 17th, it should have 20 million doses of this vaccine in the US, 500 million to 1 billion doses available globally by 2021.

Meanwhile, Russia is expected to present Sputnik, its COVID-19 vaccine to the United Nations.

Russia had earlier announced the second interim analysis of clinical trial data, which showed over 90% efficacy for the vaccine on day 28 after the first dose; and efficacy of over 95% 42 days after the first dose.