EMA Greenlights BioNTech and Pfizer mRNA Vaccine for Covid-19

BioNTech and Pfizer’s Covid-19 vaccine, made from messenger RNA, has become the first of its kind to be approved by the EMA.

The EMA has granted conditional approval to Comirnaty, a vaccine against Covid-19 developed by BioNTech and Pfizer. The approval comes weeks after the UK became the first country in the world to approve the vaccine, followed by a number of countries including the US and Canada. 

“Our thorough evaluation means that we can confidently assure EU citizens of the safety and efficacy of this vaccine and that it meets necessary quality standards,” stated Emer Cooke, Executive Director of EMA. “However, our work does not stop here. We will continue to collect and analyse data on the safety and effectiveness of this vaccine to protect people taking the vaccine in the EU.”

The authorizations were made based on the results of a phase III clinical trial during which the vaccine was tested in around 44,000 people  According to the results, two doses of the vaccine around three weeks apart reduced confirmed Covid-19 cases by 95% compared to placebo. The partner companies are busy rolling out vaccine doses around the world, though supply issues and rare adverse effects are starting to bite.

It is only 12 months since the first recorded case of Covid-19 and in that time, researchers around the world have worked tirelessly,stated Arne Akbar, President of the British Society for Immunology, who was not involved in the vaccine’s development. “To achieve this within this timescale is remarkable.

Two Covid-19 vaccines got the green light in Russia earlier this year. However, BioNTech and Pfizer’s vaccine is the first to get approval after undergoing phase III testing, and is also the first-ever approved medicine made of messenger RNA (mRNA). 

Messenger RNA therapies consist of providing our cells with the instructions to produce a therapeutic protein. In the case of BioNTech’s Covid-19 vaccine, the mRNA encodes the spike protein on the surface of the SARS-CoV-2 virus, which is essential for infecting human cells. This trains the immune system to recognize the spike protein and fight the infection.

The US and UK have also approved another mRNA vaccine, developed by the US giant Moderna. The EMA expects to have a decision on this candidate by January 2021.

Meanwhile, another Covid-19 vaccine developed by AstraZeneca and the University of Oxford, using a different technology, showed at least 62% protection in phase III last week. However, the big pharma might run a further clinical trial before applying for regulatory approval in order to test a different dosing strategy.    

RNA therapeutics have been in development for decades, but the technology is only recently beginning to gain recognition. The main advantage of RNA technology over traditional vaccines is that manufacturing is much simpler and more flexible.

The last month has seen huge stock gains for companies making vaccines from mRNA. Since the beginning of November, BioNTech’s stock price has shot up by 40% and Moderna’s has soared by 113%. CureVac, another mRNA contender whose Covid-19 vaccine is in phase IIb testing, has seen a 100% stock price rise over the last month.

These approvals are also benefiting smaller mRNA companies, which are seeing an increase in investor interest.

We have been very active lately in talking to investors,” said Mathieu Ghadanfar, Chief Medical Officer at the Belgian mRNA firm Ziphius Vaccines. “Also, we have been approached by various organizations for potential partnership.

A key issue in the mix for the first generation of Covid-19 vaccines is whether the public will trust in the safety of a vaccine that has gone through clinical development at record speed.

It’s important to emphasize that [the vaccine] will still have gone through all the rigorous safety tests, and [that the] validity of the data on effectiveness will have been assessed meticulously,” assured Akbar. “Building public confidence in the vaccine is going to be crucial in ensuring the high uptake needed to stop the spread of SARS-CoV-2 within our communities.

The EMA itself was critical of how fast the UK’s approval was earlier this month. However, the German government recently pressured the EMA to accelerate its decision by a week with the claim that being too slow could also lose the trust of EU citizens.

Going forward, many caution that vaccines are unlikely to be the silver bullet that lets us return to how things used to be before the pandemic.

For the foreseeable future – and maybe forever – we are very unlikely to reach the situation we are in with smallpox (gone), polio (almost gone), or measles (controlled in populations with high enough vaccine coverage),wrote Liam Smeeth, Professor at the London School of Hygiene and Tropical Medicine. “Instead, we are going to need to find ways to fairly happily live alongside this virus.”


This is an updated version of an article published on the 2nd of December, 2020


Cover illustration by Elena Resko

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