EU industry group warns new export rules threaten COVID-19 vaccine production and supply
Responding to the row with AstraZeneca over a projected shortfall in vaccine deliveries, the EU Commission decided to establish export controls in the EU-27. The measure allows member states to restrict exports of coronavirus vaccines that are made in the bloc if they determine that the vaccine maker has not honored existing contracts with the EU.
Accordingly, vaccine makers must notify export authorization officials in the member state where the vaccine is manufactured and get authorization.
“Even if an export authorization is granted, you are still adding around five days onto the process,” Andy Powrie-Smith, executive director of communications and partnerships at the European Federation of Pharmaceutical Industries and Associations (EFPIA), told BioPharma-Reporter.
And, right now, each day counts, he said.
Bearing in mind the global nature of the vaccine supply chain, the industry body is also concerned about potential retaliatory measures from other regions of the world that produce raw materials for COVID-19 shots, such as lipids, which are sourced from a myriad of markets, said Powrie-Smith.
The EU measure took effect on January 30 and runs until March 31, 2021. At this juncture, though, he said it was too early to tell what the impact has been on specific component parts.
But moves like export controls, commented Powrie-Smith, only serve “to create a lot of nervousness and tension between countries, certainly when we are talking about something as important as COVID-19 vaccines and, particularly, when the whole system is designed to work across borders.”
EU based pharma companies have a global responsibility in addition to their responsibility to all European citizens, he said. “Europe is a big manufacturer of vaccines – markets like Canada are relying on exports from the EU and have advance purchases agreements.”
The EU export controls have already drawn sharp criticism from policymakers globally. “The external reaction, not just from industry, but from other governments around the world, has been not positive and we need to try and restore some of that faith,” said Powrie-Smith.
The Pfizer-BioNTech and Moderna vaccines, according to US Food and Drug Administration (FDA) filings, are composed of such components as:
- nucleoside-modified messenger RNA encoding the viral spike glycoprotein (S) of SARS-CoV-2
- (4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis (ALC-3015)
- (2- hexyldecanoate),2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide (ALC-0159)
- 1,2-distearoyl-snglycero-3-phosphocholine (DPSC)
- potassium chloride
- monobasic potassium phosphate
- sodium chloride
- basic sodium phosphate dihydrate
Insights at the policy level
Powrie-Smith noted some positive developments, though, in the EU political sphere late last week.
“One thing I have seen over recent days is the greater understanding [by the EU executive] of the complexities of manufacturing vaccines and biological products.”
Last Friday, EU Commission president, Ursula von der Leyen, told European news organizations that EU officials misjudged how hard it would be for pharmaceutical companies to manufacture coronavirus vaccines on a vast scale and that hurdles are likely to continue. "A start of vaccination does not mean a seamless flow of vaccine doses coming from the industry. This is a bitter learning part, and this we certainly have underestimated,” she said.
“It is not a linear, chemical process and it is being done on an unprecedented scale, with lots of partners involved through technology transfer and licensing arrangements. I think that complexity is being better understood now,” said Powrie-Smith.
Rather than jumping onto tools such as export authorizations that could ultimately have some negative impact on vaccine supply, being able to fully grasp those complexities and work out how collectively those challenges could be addressed will enable the EU achieve safer vaccines as quickly as possible, he argues. “Carrying on the collaborative spirit that has been there since the outset of the pandemic is a more constructive approach.”
Investing in processes
The vaccine manufactures are “pulling out all the stops”, he said. They are creating new partnerships and developing new systems.
Pfizer’s mid-January announcement that there would be a temporary reduction in deliveries so it could upscale its Puurs, Belgium plant received a lot of media attention and was heavily criticized, he remarked.
The vaccine maker was, in fact, adding a new line to boost its manufacturing capacity, to improve its processes and to increase yield to ensure additional doses could be delivered, stressed Powrie-Smith.
And, evidently, with the additional COVID-19 vaccines set to come online, there will be less pressure on a few actors, he added.
“What we will see throughout February and March I expect will be increases in the delivery of doses of those vaccines already approved, plus new vaccines coming on stream. My hope is when all of this amazing progress kicks in, that will reduce the political pressure and there will not be a need for measures such as these export controls.”
Sharing manufacturing capacity
EFPIA believes it is actions such as technology transfer and licensing agreements that will speed and scale manufacturing of COVID-19 vaccines, and not the temporary suspension of intellectual property (IP) rights on COVID-19 vaccine technology.
Indeed, what was seen as quite a bold statement by EU pharma players back in April 2020 about sharing available capacity to ramp up production is actually now coming to fruition, said Powrie-Smith.
He noted recent announcements by Novartis and Bayer on separate agreements to bolster COVID-19 vaccine manufacturing. Novartis will help manufacture Pfizer/BioNTech's vaccine and Bayer will do the same for CureVac's vaccine
“Companies the size of Novartis and Bayer have the manufacturing reach, capability and capacity, and that is how scale is going to happen quickly; they can ensure quality and pace.”
Suspending IP rights would be enormously detrimental, said Powrie-Smith. “I believe there is now wide recognition that it is the IP framework that has brought us to where we are today [in terms of innovation]; tech transfer, sharing production capacity, and licensing deals are the solutions to getting as many COVID-19 vaccine doses to as many people as possible.”