On February 24, Italian authorities received a request for export authorization from AstraZeneca. The British-Swedish company intended to fly over 250,000 doses of its COVID-19 vaccine to Australia. Eight days later, on March 4, the request was denied. Italy’s Ministry of Foreign Affairs released a statement explaining that the denial had been subsequently approved by the European Commission.

Italy cited Australia being a “non-vulnerable” country, the ongoing shortage of vaccines in the EU and Italy and “the delays in the supply of vaccines by AstraZeneca to the EU and Italy.”

The move was in accordance with recent European regulations “making the exportation of certain products subject to the production of an export authorization”, and the Australian government reacted calmly, asking the European Commission to review the decision while its Prime Minister, Scott Morrison, said that the shipment “was not one we’d counted on for the rollout, and so we will continue unabated.”

But even though the situation did not escalate in a geopolitical conflict, it did put a spotlight on the fierce race for COVID-19 vaccines all over the world, the shortages in supply and the uncomfortable position of big pharma.

 

The Fight over Uneven Access to COVID-19 Vaccines

In February, Mustaqeem De Gama, South Africa’s delegate at the World Trade Organization (WTO) on intellectual property rights, excoriated major pharmaceutical companies, asking the international community to confront them in order to provide fairer access to COVID-19 vaccines. “While Rome is burning, we are fiddling around [waiting],” he said.

Seconding that opinion, the director general of the World Health Organization (WHO), Tedros Adhanom Ghebreyesus, recently argued that of the 225 million+ vaccine doses administered so far, the vast majority have been in a “handful of rich and vaccine-producing countries, while most low- and middle-income countries watch and wait.”

While Rome is burning, we are fiddling around [waiting]

Mustaqeem De Gama, South African delegate, WTO

Ghebreyesus’ argument is simple: as long as the virus is spreading anywhere, it has more opportunities to mutate and potentially undermine the efficacy of vaccines everywhere. “A me-first approach might serve short-term political interests, but it is self-defeating and will lead to a protracted recovery, with trade and travel continuing to suffer,” he said in an op-ed for The Guardian.

The Italy-Australia hassle illustrates both De Gama and Ghebreyesus’ point, a handful of countries and companies have a grip on vaccine shipments and their destination. Solutions being raised range from dose sharing to waiving intellectual property rights, as South Africa and India have suggested.

A waiver proposal currently being discussed by the World Trade Organization (WTO) is looking to suspend member states’ obligations to protect intellectual property rights related to prevention, containment or treatment of COVID-19. “There is an urgent call for global solidarity… The waiver should continue until widespread vaccination is in place globally, and the majority of the world’s population has developed immunity,” read the proposal by India and South Africa.

Three days before Italy’s export request denial, AstraZeneca announced that the first of many millions of vaccine doses had begun arriving in low and middle-income countries through the multilateral COVAX initiative. “Further shipments will arrive in the coming weeks with the aim of supplying a total of 142 countries with hundreds of millions of doses of the vaccine in the coming months. The majority of these doses… will go to low and middle-income countries,” read a statement.

Even with AstraZeneca’s promise and the COVAX initiative, most poor countries will not achieve mass Covid-19 immunization until at least 2024 and some may never get there, according to a new forecast by the Economist Intelligence Unit.

European countries, the United States and Israel will probably achieve widespread vaccination coverage this year, followed by other developed countries by the middle of 2022 and middle-income countries by the end of 2022, according to the forecast. But, as Ghebreyesus argues, the poorest countries will be left behind: “The world is on the brink of a catastrophic moral failure – and the price of this failure will be paid with lives and livelihoods in the world’s poorest countries.”.

 

Big Pharma’s Argument

Both sides of the argument agree that sustainable COVID-19 vaccine manufacturing and production is necessary to achieve the ultimate goal, defeating the virus.

According to Thomas Cueni, director general of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), biopharmaceutical companies have walked the talk from the outset of the pandemic.

Arguing against the proposed IP waiver, IFPMA contends that diluting national and international IP frameworks during this pandemic is counterproductive. “It will not lead to faster research and development or access, but it will undermine confidence in what has proven to be a well-functioning IP system, allowing industry to partner with confidence with academia, research institutes, foundations and other private companies, significantly expediting the research and development of medicines to address the worlds’ many unmet medical needs.”

Based in Geneva, the IFPMA represents research-based pharmaceutical companies and associations across the globe.

[An IP waiver] will not lead to faster research and development or access, but it will undermine confidence in what has proven to be a well-functioning IP system

Thomas Cueni, IFPMA

The association also pointed out that pharma companies have begun making partnerships, leaving their usual competition aside. French Sanofi said in January that it had struck a deal with BioNTech to supply the European Union with their vaccine developed in partnership with Pfizer. Weeks later, US President Joe Biden announced that his administration had brokered a deal between MSD and Johnson & Johnson to boost the manufacturing of J&J’s vaccine.

More examples of collaboration abound, including the partnership between Takeda, Novavax and the Japanese Ministry of Health, Labor and Welfare to increase manufacturing capacity of Novavax’s COVID-19 vaccine candidate.

Making the counterargument, the WHO’s director general said that “waiving patents temporarily won’t mean innovators miss out. Like during the HIV crisis or in a war, companies will be paid royalties for the products they manufacture.”