EMA Green Light Sends Oxford Covid-19 Vaccine Into Turbulent Market

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As AstraZeneca and the University of Oxford’s Covid-19 vaccine debuts in the EU market this month, supply bottlenecks, viral variants, and political squabbles demonstrate that the quest to develop and distribute Covid-19 vaccines is far from over.

The list of approved Covid-19 vaccines in Europe is growing ever longer with the EMA approval of the viral vector vaccine developed by the big pharma AstraZeneca and the University of Oxford, following UK approval in December. The so-called Oxford vaccine joins two other Covid-19 vaccines in the bloc’s arsenal: a messenger RNA (mRNA) vaccine from BioNTech/Pfizer and another developed by Moderna.

The Oxford vaccine employs a viral vector to activate the immune system against Covid-19, a more established 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 Covid-19 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.

Many individual EU member states, such as Germany, Austria, and Portugal, have recommended the Oxford vaccine only for people between 18 and 65 years of age. They based this decision on the vaccine’s phase III results last year, which featured mostly efficacy data from people younger than 55. In contrast, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) included adults over 65 in its approval of the same vaccine. 

There is relatively little data currently available in the elderly from the phase III trials. Therefore, the UK made a pragmatic decision to recommend this vaccine in older populations,” stated Michael Head, Senior Research Fellow in Global Health, University of Southampton, UK. “These decisions are all in the context of a very high burden of Covid-19, and thus leaving vulnerable populations unprotected is in itself a risky decision at this point in time.”

It may be several months before the Oxford vaccine gets emergency approval in the US since AstraZeneca hasn’t yet applied for authorization from the FDA. Additionally, members of the FDA’s advisory committee have expressed concerns about the vaccine’s phase III results in November. While it achieved 70% protection against Covid-19, there were deviations in the dosing, with a small group of participants mistakenly given half doses.

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 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 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 speed of the MHRA’s vaccine approvals gave the UK a lead over the EU’s sluggish vaccine distribution program. Furthermore, the EU has clashed with AstraZeneca regarding supply hiccups over the last few weeks, causing big political fallout. While the dust is starting to settle on the row, the EU’s vaccination rates still trail those of many other countries. Hungary, meanwhile, has tried to boost its Covid-19 vaccination efforts by approving vaccines from the Russian Gamaleya Center and Chinese company Sinopharm.

The huge economic and human threat of the Covid-19 pandemic has highlighted the importance of vaccinations, and increased the interest of pharma and biotech in entering the vaccine space. Prominent examples of Covid-19 vaccine developers include the big pharma Johnson & Johnson, the Gamaleya Center, and the US firm Novavax, which all had promising phase III results within the last two weeks. The German biotech CureVac also recently amassed support from Bayer and GlaxoSmithKline for its phase III-stage mRNA candidate.

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, which is developing its own Covid-19 vaccine. “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 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. 

In recent weeks, more virulent Covid-19 strains have caused major disruptions globally as vaccine developers race to catch up. South Africa recently halted the rollout of the Oxford vaccine as a clinical trial suggested it might prove less effective than normal against a variant circulating in the region. A number of vaccine developers including Osivax and eTheRNA are aiming to meet this demand by developing next-generation Covid-19 vaccines that could immunize against all future strains.

There need to be new technologies not only for [the current] strain of Covid but for future strains and other forms of infectious diseases,” added Alexandre Le Vert, CEO of Osivax. 

Of course, these vaccines will not protect the population 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.

This is an update of an article first published on the 12th of January, 2021

Cover image from Elena Resko

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