Covid-19 vaccines developed by Moderna, Pfizer/BioNTech, and the University of Oxford/AstraZeneca have been approved at record speed across Europe to fight the Covid-19 pandemic. However, the quest to develop and distribute Covid-19 vaccines is far from over.
All of the three vaccine approvals came through in a matter of weeks. First, there was the UK approval of a messenger RNA (mRNA) vaccine from BioNTech and Pfizer in early December, which then received EMA approval right before Christmas. A few days later, the UK approved a vaccine developed by AstraZeneca and the University of Oxford. And just last week, Moderna got the go-ahead from both the UK and the EU for its mRNA vaccine.
The University of Oxford and AstraZeneca vaccine employs a viral vector to activate the immune system against Covid-19 — a more traditional type of vaccine technology than mRNA vaccines. This vaccine can be stored at fridge temperatures unlike the mRNA vaccines, and, with a per-dose price of around €3, costs at least four times less. As a result, this vaccine is ideal to reach remote areas far from the busiest transportation networks, as well as to vaccinate in countries that cannot afford the mRNA vaccines.
The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK issued an emergency approval of the Oxford and AstraZeneca vaccine on December 30th, followed by approvals in Mexico, Argentina, and India. The EMA will make a decision on the same vaccine by the end of January, but it may be several months before it gets emergency approval in the US. Members of the FDA’s advisory committee have expressed concerns about the vaccine’s phase III results in November, where it achieved 70% protection against Covid-19 compared to more than 90% achieved by mRNA vaccines developed by Moderna and Pfizer/BioNTech.
The MHRA was the first regulator to approve the Pfizer/BioNTech vaccine, ahead of the US and EU regulatory authorities, and this trend continues with the Oxford/AstraZeneca vaccine. According to Zoltán Kis, Research Associate in the UK’s Future Vaccine Manufacturing Hub at Imperial College, both the MHRA and the EMA follow a similar process to grant approvals, called a rolling review.
“The MHRA has been closely following and analyzing the results during the clinical trials. This helped to have a better understanding and faster processing of the trial results,” Kis told me. “It seems that the MHRA has done its rolling review and final review of the data faster than the EMA.”
The importance of vaccinations, as highlighted by the pandemic’s quick spread and financial repercussions, has increased the interest of pharma and biotech in entering the vaccine space. “There have certainly been a number of companies joining the vaccine development space as a result of the pandemic,” said Thomas Lingelbach, CEO of the French biotech Valneva. “Almost immediately, the global hyper-focus on Covid-19 raised the profile of vaccine companies. In addition, the public and media have been tracking clinical development progress like never before.”
One of the lessons learned from this pandemic is that we need vaccine production facilities that can more rapidly meet demand during outbreaks. “The disruption of life for people, businesses, and governments was quick and has been massively impactful. This could be the root of lasting changes to the industry as a whole,” Lingelbach said.
“There need to be new technologies not only for this strain of Covid but for future strains and other forms of infectious diseases,” added Alexandre Le Vert, CEO of the Lyon-based biotech Osivax.
In recent weeks, more virulent Covid-19 strains have caused major disruptions globally. BioNTech and Pfizer recently declared their vaccine is able to combat these new strains. However, future strains could evolve beyond the reach of the first-generation vaccines. For this reason, a number of vaccine developers including Osivax and eTheRNA are working on next-generation Covid-19 vaccines that can immunize against all future strains.
Of course, population vaccination will not be effective unless people agree to be vaccinated. Convincing the general public about the vaccines’ safety and effectiveness is the next big bet the healthcare systems need to win. “Spreading awareness of the value of preventative vaccines to the general public at risk and in need of these life-changing treatments is an important step and one that I believe has been made more apparent to the general population due to Covid-19,” Lingelbach noted.
“I hope that as these vaccination programs continue the general public will see that the misinformation that is circulating out there is indeed incorrect and the safety and benefits of the vaccines will become more tangible,” Kis added.
Cover image from Elena Resko