BioNTech and Pfizer: Project “Lightspeed”

Almost one year after the beginning of the Covid-19 outbreak in Europe, we finally start seeing some light at the end of the tunnel.

The first COVID-19 case in Europe was registered on the 24th of January and everything points out to the fact that the patient zero was a German citizen. Now, a new year is closer and it’s also a German company which is leading the race in the development of a vaccine that could bring the pandemic to an end. The company is BioNTech, a biotechnology firm based in Mainz.

After the SARS-CoV-2 genetic sequence being made public in the 12th January 2020, BioNTech initiated the project “Lightspeed”. As the name indicates, the goal was to develop an efficient vaccine in the fastest way possible. Furthermore, on the 17th of March the German company announced a collaboration with the American multinational pharmaceutical Pfizer. Ironically, this company, located on the other side of the Atlantic Ocean, based on New York, was also founded by two German cousins, Charles Pfizer and Charles Erhart.

On the 18th of November, the joint venture between BioNTech and Pfizer started collecting results. The phase 3 of the study regarding the vaccine elaborated by both firms was announced to meet all the primary efficacy endpoints and demonstrated a 95% efficacy against Covid-19. In the sequence of this promising developments, it was submitted an emergency application on the 30th of November to the European Medicines Agency (EMA) in order to get the approval so that the vaccine can be used in Europe. EMA reported that, if there was enough data, by 29th of December this assessment would be completed.

However, Pfizer and BioNTech are not alone in this race and they face the competition of the partnership between Oxford and AstraZeneca and of Moderna, which submitted its application to EMA on the 1st of December. Since the starting of the pandemic, the race for the vaccine, and the consequent normality, brought the attention of several politicians eager to claim their role in solving an epidemic. Therefore, one of the most sensitive issues on the development of the vaccine has been who was funding the BioNTech and Pfizer vaccine. The US vice-president Mike Pence attributed the success of this joint venture to the public-private partnership created by the US administration to accelerate drug development. However, influential media, such as Bloomberg, had noticed that the funding came through BioNTech, the German partner, who received 377 million euros from Angela Merkel’s government.

What makes BioNtech’s vaccine so unique?

For decades has the science community argued between the clear worthiness of investment and a supposed utopian illusion of messenger RNA, or mRNA. Alongside with Moderna, this joint venture is now starting to commercialize the first ever mRNA vaccine, something that scientifically had always made sense, but until last November, had never been granted any approval by the Food and Drug Administration (FDA). 

But What Is mRNA? Unlike conventional vaccines, which consist of injecting dead or weakened forms of the virus so that the immune system learns to fight it and usually take years of research and analysis, RNA vaccines are focused on delivering the virus’ genetic code into our immune system, instead of the virus itself, in the hopes of triggering a response based on anti-bodies able to fight this pathogen. This process, besides having a much more optimal logistical basis, it also takes away part of the time constraint the world is facing today, with positive cases showing no sign of slowing down. However, one big variable is still being questioned at this point, which is for how long can this vaccine provide you immunity? Based on the research and estimates available at this point, it is still uncertain of how long will the vaccine provide the desired immunity. Most likely it will wane over time, but it is unknown the amount of immunity retained in order to guarantee protection.

How will the vaccines get to consumers?

Vaccines have started to roll out, but its distribution will take months. Mass vaccination is expected to start only in 2021, because despite being the fastest vaccine to be developed in human history, it still needs to be delivered to billions of people under strict storage requirements for precaution. Countries face a four-by-four challenge: a vaccine arriving at four times the pace and requiring delivery at four times the scale.

At this moment several countries have given emergency approval, with the UK being the first country vaccinating people outside trials on December the 8th for certain groups, including people who work in care homes and health care workers at high risk. Pfizer and BioNTech have also gained approval in the US, where more than a hundred thousand people have been vaccinated, including the Vice-President Mike Pence as well as other senior officials. In the EU, the joint venture was approved by the European Commission on December 21st.

BioNTech has started mass producing the vaccine in its facilities in Mainz, Germany, with a target of 100 million vaccines in 2020, however recent information suggests the company cut back the target to 50 million doses. Using Pfizer and BioNTech’s facilities across the US and Europe, including the manufacturing site in Marburg which BioNTech acquired a from Novartis this September, the joint venture believes it can produce 1.35bn doses by the end of next year, although Pfizer will be in charge of most of manufacturing and shipping.

The vaccine will be distributed from Pfizer’s centres in the US, Germany, and Belgium, from where the 300 million doses ordered by the EU will be shipped.  It will then be transported in purposely built boxes, packed with dry ice and equipped with GPS tracking, capable of maintaining the vaccines at -75 degrees Celsius. The suitcase sized transport boxes are reusable and can keep up to 5,000 doses of the vaccine at the right temperature for 10 days.  Once it arrives at vaccination centres, the vaccine can survive up to five days at temperatures between 2 and 8 degrees Celsius.

The nanoparticles present in the vaccine, which provide an increase in its effectiveness, are the cause of the strict temperature requirements. Other vaccines, as the one developed by the Oxford university and AstraZeneca, which resort to adenovirus rather than mRNA, do not require freezing, but approval is only projected for next year. The ease of transport and the consequent lower costs means this alternative could be used for mass vaccination in many developing countries, whereas Pfizer/BioNTech and Moderna’s vaccines will most likely be used for groups of risk who require a faster solution.

So, what does the future holds on for us? As the first vaccination phase takes its initial steps in the West, questions about a countdown to normal life has finally started. Supposing everything goes in accordance with expectations, US specialists predict May to be the month of “new normality” where the herd’s immunity threshold is reached but, of course, in a far-fetched scenario where all the Supply Chain’s structure is not mismanaged in that course of time. Until then, it is still fair to say that the use of masks and constant disinfection is going to be our greatest shield against the Covid-19 pandemic.

Sources: Financial Times, Bloomberg, MarketLine, McKinsey, Pfizer, New York Times, UK Government, Federal Drugs Administration, SIC Notícias, BBC, Sábado