BioNTech and Pfizer’s Covid-19 vaccine has become the first approved vaccine made from messenger RNA.

The Medicines and Healthcare products Regulatory Agency (MHRA) has given BioNTech and Pfizer’s vaccine temporary authorization. This isn’t a full licensing — which takes longer to process and often requires more data — but allows an unlicensed vaccine to be used during the Covid-19 pandemic.

The authorization was made based on the results of a phase III clinical trial released in mid-November. According to the results, two doses of the vaccine around three weeks apart reduced Covid-19 cases by 95% compared to placebo. The partners now expect to roll out the first doses in the UK in the coming days.   

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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.

BioNTech and Pfizer have also applied for authorization from the FDA and EMA; their decisions are due within weeks. The US mRNA developer Moderna sent off applications to the FDA and EMA this week based on phase III results showing 94% protection against Covid-19. Moderna’s vaccine could be approved by the FDA as early as this month, and approved by the EMA by January 2021.

Meanwhile, a Covid-19 vaccine developed by AstraZeneca and the University of Oxford — based on a viral vector — 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%. Another mRNA contender, CureVac — whose Covid-19 vaccine is in phase IIb testing — has seen a 100% stock price rise over the last month.

The recent success of mRNA vaccine heavyweights is 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. Even the EMA was critical of how fast this approval was. 

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 by the MHRA,” 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.

According to Penny Ward, Visiting Professor in Pharmaceutical Medicine at King’s College London, one reason for the MHRA’s quick turnover is that while the EMA considers the views of 27 member states, the MHRA has fewer hoops to jump through. 

The MHRA is a very efficient organization and has been reviewing all the same information as the EU will have received, Ward said. “Unlike the EMA, it can ask questions as it goes and obtain responses faster as a single agency.

Going forward, however, 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.”


Image from Elena Resko

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