Jean-Claude Muller

BtoBioInnovation, France

jcm9144@gmail.com

Less than nine months after the World Health Organization (WHO) Director-General Tedros Adhanom Ghebreyesus declared the outbreak of the SARS-CoV-2 coronavirus pandemic outbreak, the first Covid-19 vaccines had proven their efficacy in clinical trials and were approved by health agencies at unprecedented speed around the globe.

This 'warp speed' achievement did not come without some adamant new postures dealing with legal and regulatory issues. In this article, we pinpoint three of them: the handling of political pressure, deal-making and why competitors became partners.

The handling of political pressure

In September 2020, when it became clear that the results of early clinical trials of several Covid-19 vaccines were positive, the biopharmaceutical industry was placed into a fierce political debate. At the time, former United States President Donald Trump put tremendous pressure on all stake holders by stating that he believed that a vaccine could be approved before the 3 November presidential election, and that the industry 'was playing politics'.

The answer from the industry came as a 'historic pledge' by nine leading European and American pharmaceutical companies outlining a united commitment to 'uphold the integrity of the scientific process as they work towards potential regulatory filings and approval of the first COVID-19 vaccines'. The pledge indicated clearly that the top priority would be safety, and that the companies would continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of manufacturing processes.

On 6 October 2020, after weeks of an intense and public struggle between the White House and the US Food and Drug Administration (FDA) over the new Covid-19 Emergency Use Application (EUA), the US Health agency took an original route. Instead of publishing the briefing materials through the White House process, the FDA released the material to all the experts on the Vaccine and Related Biological Products Advisory Committee (VRBPAC) appointed to meet on 22 October. The White House, which was eager to take some shortcuts, could clearly not react afterwards, and had to admit the agency’s independence and authority to 'make the assessment around safety, effectiveness and quality manufacturing'.

Deal-making

On Friday 20 November, in an exclusive TIME 100 Talks, Pfizer chief executive officer (CEO) Albert Bourla announced that his company had submitted a file to the US FDA requesting a EUA for BNT162b or COMIRNATY, its Covid-19 vaccine, co-developed with BioNTech, its German partner. While focusing on the vaccine’s 95 per cent efficacy and the commitment of his company to deliver millions of doses 'within hours' after approval, Bourla mentioned the deal-making itself. In the interview with Alice Park, Bourla said: 'Conviction was part of it, so I was always telling our teams that we will make it by October, and if not us then who?' Bourla and his scientists had unbridled enthusiasm and confidence that their collaboration with BioNTech was the right one. Bourla said the partnership was built on a mutual focus on advancing science and that the two companies began work, including sharing confidential information, before signing a formal contract. At times Bourla and Ugur Sahin, BioNTech’s CEO, had weekly direct interactions to monitor progress and make decisions. 'Ugur is a wonderful human being and a great scientist'. The very day the EUA was filed with the US FDA, the final contract had not been completed. 'In fact, we are still finalising the contractual obligations we have that we need to sign with them. Signing those agreements can take months and we had to move forward quickly', Bourla said. The take-home lesson is that moving collaborative projects quickly needs trust and confidence at the highest executive levels from both parties, thus allowing work to start before formal contracts are finalised.

We are aware of a syringe filling collaborative effort, where high-level executives agreed to start work on the sole basis of a confidential disclosure agreement.

On the less shiny side, the agreement between AstraZeneca and the European Commission is not to be strongly emphasised. When the Anglo-Swedish company announced that it was not able to cope with the announced delivery schedules and the promised number of doses, this was soon considered as 'vaccine nationalism' to favour the United Kingdom. It became even more controversial when Pascal Soriot, the CEO of AstraZeneca, told various newspapers that the European Union contract was signed much later than the one with the UK, and was based 'on best efforts' and did not commit to a specific timetable. Soon after, in an unusual request, the EU demanded that the Advanced Purchase Agreement was published with redacted parts pertaining to confidential information, which was done. On 26 April, European Commissioner for Health and Food Safety, Stella Kyriakides confirmed that the European Union has formally launched legal action against AstraZeneca over delays in vaccine delivery.

Why competitors became partners

The biopharmaceutical industry is a highly regulated sector with strong worldwide patent rights, marketing exclusivity, trademarks, and non-disclosed supply, manufacturing and distribution agreements. Despite being highly competitive, this industry is still rather conservative when it comes to sharing common goals. It therefore came as a surprise when Sanofi, whose Covid-19 vaccine was delayed by several months, announced, in an unusual move, that it would help to manufacture more than 125 million doses of the BioNTech/Pfizer COMIRNATY vaccine by lending spare production facilities at its Frankfurt site. These additional doses would be used for EU countries with initial deliveries expected by August. 'Since our main vaccine is a few months late, we asked yourselves how we could be of assistance now', CEO Paul Hudson claimed. After Sanofi’s announcement, Bayer announced a similar deal with Curevac, Merck KGaA indicated it would accelerate its supply of lipids for the BioNTech Covid-19 vaccine and a few days later, Merck and Teva announced they were in discussions with governments and companies to help accelerate Covid-19 vaccine production and manufacturing without disclosing the parties they were in talks with.

This type of temporary deal between companies that are primarily competitors reflects the urgency of quickly producing more vaccine doses for the world community. These striking, unexpected deals also help vaccine power houses, such as Sanofi and Merck, to keep a foot in the door and not be fully excluded from the next round of deals. The glamorous aspect of these partnerships needs to be a bit mitigated by some of their less ethical aspects. Many governments are challenged by their citizens asking for compulsory licenses and not compliance with intellectual property and patent rights related to the new Covid-19 vaccines. Spontaneous agreements between competing companies that aim at accelerating the availability of Covid-19 vaccines and coping with population needs become a strong argument for governments to stay within the usual international legal business boundaries.

In order to achieve the high-speed delivery of complex projects, we are not proposing systematic shortcuts to the well-accepted legal and regulatory framework, but we want to pinpoint that it can be done, and even successfully.

When recently asked why 'warp speed' was attained with Covid-19 vaccine discovery, development and launch, a panel of experts answered the following:

• strong collaboration between academic institutions and the biopharmaceutical sector;
• high level of transparency between all stakeholders;
• strong momentum;
• sense of optimism with the mantra of 'the impossible becomes possible'; and
• big and sustained government support.

We would like to add the unusual acceptance by all partners of entering new ways of operating.