The scientist who developed Pfizer’s COVID-19 vaccine has hit out at the Biden administration’s support for waiving intellectual property protections for coronavirus shots.
Suspending patent enforcement for vaccines ‘will not increase the number of doses we will have available within the next 12 months,’ Dr Özlem Türeci, Chief Medical Officer at Pfizer partner BioNTech, told CNN.
‘It will probably act towards increasing chaos in production.’
The Biden administration said on Tuesday that it backs a World Trade Organization (WTO) initiative to temporarily waive patent and trade secret laws preventing some countries like India and South Africa from making their own copycat versions of various companies’ vaccines.
Advocates say that letting poorer nations make their own cheaper generics as soon as possible could be a critical boon to global vaccine supply.
Critics say waiving protections would be a symbolic gesture, and argue that even with the secret formulas used to make vaccines like Pfizer’s, most countries still would not be able to quickly produce meaningful amounts of vaccine and their attempts could strain the already stretched supply chain of materials.
‘It is so wrong,’ Pfizer CEO Albert Bourla said of the push to open his firm’s patent books in a Wall Street Journal interview.
Most experts say that the patent waiver likely won’t do much for supply and the immediate fight against Covid crises like India’s, which killed a record nearly 4,000 people on Wednesday.
However, waiving patents in combination with other efforts could help combat the pandemic, especially down the line – and scientists anticipate coronavirus vaccines will be part of the global annual routine for years to come.
Suspending patent enforcement for vaccines ‘will not increase the number of doses we will have available within the next 12 months,’ Dr Özlem Türeci, Chief Medical Officer at Pfizer partner BioNTech and co-developer of its vaccine, told CNN (pictured; file)
The Biden administration said on Tuesday that it backs a World Trade Organization (WTO) initiative to temporarily waive patent and trade secret laws preventing some countries like India and South Africa from making their own copycat versions of vaccines like those made by Pfizer/BioNTech and Moderna
That’s why Moderna, which said in October it would not enforce its Covid vaccine patents, is unconcerned about the prospective waiver, and believes countries will continue to purchase its shot for years to come.
‘They will have to go run a clinical trial, get the data, get the product approved and scale manufacturing. This does not happen in 6 or 12 or 18 months,’ Moderna Chief Executive Stephane Bancel said on a post-earnings conference call.
Manufacturing an mRNA vaccine is not as simple as following a recipe, even if you have it in hand.
The shots require niche ingredients, which have to be sourced and transported across the world to highly specialized production plants – and various phases typically take place in different facilities.
And to do that at scale is a massive undertaking on top of a massive undertaking.
Even for Moderna, one of the leaders in the development of mRNA vaccine technology, it’s been a challenge.
Moderna has faced its own hurdles scaling up production with some shortfalls in the manufacturing supply chain, which includes Swiss contract manufacturer Lonza Group, leading to delivery delays in Europe.
The Biden administration said Wednesday it supports waiving intellectual property rights for COVID-19 vaccines so that other countries can make their own versions of the shots
Bancel said he has had to tell some countries, ‘we’re very sorry. We have no more supply for you in 2021.’
In theory, that’s a problem that waiving patents could help solve, but in practice freeing up intellectual property alone may not do much.
‘Patents are not the limiting factor for the production of, for example, our vaccine,’ Dr Tureci told CNN.
‘There are a number of important factors in producing vaccines.
‘For example, our manufacturing process involves more than 50,000 steps, all of which have to be executed accurately in order to ensure the efficacy and safety of vaccine.
‘It takes experienced personnel, it takes specialized facilities, it takes access to raw materials.’
And then there’s the matter of money.
Waiving intellectual property protections could cut into profits for vaccine makers like Pfizer, Moderna and Johnson & Johnson, for whom business has boomed amid the pandemic.
On Tuesday, Pfizer said it had made $3.46 billion in first-quarter vaccine sales. The New York Times estimated that would come out to about $900 million in pretax profits from vaccines in the past three months alone.
Johnson & Johnson reported $100 million in vaccine sales – despite the 11-day pause on the shot in the U.S. – and Moderna will report earnings on Thursday.
On Thursday, Shares of COVID-19 vaccine makers fell on Thursday as governments debated plans to waive patent protection for the shots, with analysts saying the move could rattle investor sentiment or weigh on longer-term business prospects.
Among companies with COVID-19 vaccines, shares of Pfizer fell 1.7 percent and were among the biggest weights on the benchmark S&P 500 index, while U.S. shares of its German partner BioNTech SE shed 0.6 percent after falling as much as 15 percent earlier.
Moderna was off 1.3 percent, recovering after being down nearly 12 percent, while Johnson & Johnson and AstraZeneca Plc were little changed, as the broad S&P 500 rose 0.2 percent.
Whether or not a temporary waiver on patents would significantly reduce global demand for the current Covid vaccinemakers product, the pharmaceutical industry is concerned it could lead to the undoing the tightly wound laws that protect intellectual property worth several fortunes.
‘In the midst of a deadly pandemic, the Biden Administration has taken an unprecedented step that will undermine our global response to the pandemic and compromise safety.
This decision will sow confusion between public and private partners, further weaken already strained supply chains and foster the proliferation of counterfeit vaccines,’ Stephen Ubl, head of PhRMA, the industry’s trade group told Stat.
Public health advocates look at the Biden administration’s new position more favorably.
‘My take is: By itself, it will not get us much benefit in increased manufacturing capacity,’ Prashant Yadav a senior fellow specializing in supply chains at the Center for Global development told Stat.
‘But as part of a larger package, it can.’
Either way, patents will only formally be waived if all of the WTO countries agree to it.
As of Thursday afternoon, the UK, Canada and the EU were still blocking a consensus to waive patents.