It was an exciting announcement for Covid-weary people everywhere – but while Scott Morrison has endorsed the importance of sharing vaccines, Australia voted to prevent developing countries from having the chance to build local production.
Covid-weary people everywhere welcomed the early results from the phase 3 trial of a promising vaccine.
The announcement by German firm BioNTech on behalf of itself and US partner Pfizer Pharmaceuticals indicated that initial interim analysis showed that the vaccine, BNT162b2, was ‘more than 90% effective in preventing symptomatic cases’.
It is not clear how effective the vaccine was in different age groups, whether it reduced severity in those who did acquire infection, how long protection lasts, or whether there were any safety signals.
The partners estimate they will be able to produce 50 million doses in late 2020 and about 1.3 billion doses in 2021. Australia has pre-ordered 10 million doses which, at two doses per person, will be enough for 5 million vaccinations before the end of next year.
Pfizer has also sealed advance purchase deals with the UK (30 billion doses), the US (100 million doses with an option of a further 500 million), Canada (20 million), Japan (120 million), EU (200 million with an option for a further 100 million), Qatar (undisclosed), Peru (9.9 million), Chile (10.1 million), Costa Rica (3 million) and NZ (1.5 million). The known commitments total about 500 million doses, which is less than half Pfizers’ projected production capacity for 2021. Clearly Pfizers’ marketing team will be scouring the globe for more paying customers and encouraging existing customers to increase their orders.
Pfizer and BioNTech have expressed interest in, but do not have a contract to supply, the Covax facility (a global platform for subsidised vaccine procurement for low-income countries and supply risk reduction for other countries).
The price has not been disclosed for Australia’s advanced purchase agreement for 10 million doses but we know the US will be paying about $US20 per dose.
It is not clear whether authorities have a policy in place regarding priority populations for vaccination. Certainly, there has been only limited public debate regarding allocation priorities. Globally there are wide differences between different allocation frameworks with different priorities assigned to older people, health care workers and other frontline workers, high-risk settings such as meat works, and vulnerable populations (precarious employment, living in crowded circumstances, etc). As Australia’s ‘aggressive suppression’ strategy seems to be working, one option would be to prioritise vaccination at the borders to reduce the risk of incoming infection.
Australia will face logistical challenges in structuring a community vaccination program. The vaccination protocol adopted by Pfizer and BioNTech involves two jabs, three weeks apart. The vaccine needs to be kept very cold (-70o C) to prevent degradation. One option might be to centralise vaccination services; to bring people to the vaccine rather than the converse.
The Pfizer BioNTech vaccine is an ‘mRNA vaccine’. It comprises a fragment of messenger RNA carried in a tiny protective cage which encourages the recipient’s muscle cells to take up the vaccine into the inside of the cell. The mRNA fragment is specially synthesised to code for the ‘spike protein’ of the corona virus. Once inside the recipient’s cells, the mRNA instructs the cellular protein synthesis mechanisms to synthesise the spike protein which is then released into the body where it stimulates the immune system to make antibodies and killer lymphocytes that will catch and destroy the invading virus.
The Pfizer BioNTech vaccine is named BNT162b2; the b2 variant of the BNT162 vaccine. Scientists associated with BioNTech have been working on this platform for several decades. Pfizer joined in partnership earlier this year as the BioNTech Covid vaccine was starting to show promise. Pfizer’s role until now has been the conduct of the clinical trial, managing regulatory approval and early marketing. Both Pfizer and BioNTech are now also working with contract manufacturers to scale up production.
In fact BioNTech is also working with Fosun Pharma in Shanghai. Fosun began clinical trials in July using the b1 variant of BNT162.
Al-Wassiti and colleagues report that no Australian laboratories have the capacity to make mRNA vaccines such as the Pfizer BioNTech vaccine. They urge Australia to set up such a production capacity.
Reason for releasing this announcement
The purpose of Pfizer and BioNTech in releasing this ‘early interim analysis’ is intriguing. One commentator has referred to it as bad science because the practical implications are uncertain with so many unknowns. Better science might involve holding off with the press release until the peer-reviewed report had been accepted for publication.
However, there are commercial reasons for the announcement at this time; firstly to do with marketing the vaccine to government public health authorities around the world; and secondly, directed to share price appreciation with implications for executive bonuses, shareholder dividends and borrowing capacity.
According to Fortune (10/11/20) some Republicans, including Donald Trump Jr., questioned the timing of Pfizer’s release of its positive data on Monday, almost a week after the presidential election — with the implication that the information could have tipped the scales toward President Donald Trump.
Pfizer has made a virtue out of not participating in President Trump’s Operation Warp Speed through which the US Administration has been supporting a wide range of vaccine and medicine manufacturers. However, it is now facing the task of rapidly upscaling production capacity. Assuming that this involves significant borrowings and capital raising, a 15% lift in share price can only be supportive.
Pfizer plans to outsource production of its current drug portfolio to its current 200 contractors to make way for its COVID-19 vaccine manufacturing operations. It has designated three US sites and one Belgian site for vaccine production. BioNTech is producing the mRNA for the vaccine in house for clinical trials. In addition, BioNTech plans to acquire a GMP-certified manufacturing facility in Marburg, Germany, with a production capacity of up to 750 million doses per year, once fully operational. The company plans to be able to produce up to 250 million doses of BNT162b2 in the first half of 2021.
Pfizer is not without resources. Its CEO for FY2019 was paid $US17.9 million while dividends for FY2019 were $8 billion with a further $8.9 billion spent on buybacks. Spending on federal government lobbying in the first half of 2020 was $6.5 million.
Financial analysts predict sales of up to $258 million in the fourth quarter of 2020. They are projecting sales of $4.6 billion in 2021, declining to $2.8 billion by 2023.
The bruited 90% efficacy of BNT162b2 is likely causing concerns in the head offices of pharmaceutical companies focusing on medicines such as remdesivir and monoclonal antibodies. Their prospective sales are likely to be affected by a successful vaccine, more so if other vaccines have comparable efficacy.
The other side of this bonanza and flurry of marketing is the prospect that developing countries may not see any of this vaccine beyond 2021.
If all the advanced purchase deals materialize and if the US and the EU agree to exercise their options of 500 million and 100 million doses respectively, a full 1.07 billion of the 1.3 billion doses (82%) would be captured by a handful of rich countries, with the US (only 4% of the world’s population) itself cornering 46% of total supply of this vaccine in 2021.
Local production the key to vaccine access
‘Vaccine nationalism’ looks set to capture the vast bulk of effective vaccines in the next several years and the Covax arrangements (for procuring vaccines for low income countries) look set to be underfunded and undersupplied.
Accordingly, local production of a wide range of Covid-related health products (vaccines, medicines, diagnostics, personal protective gear, etc) is seen as being critical in terms of managing and arresting the pandemic.
The need to boost local production has two implications, of which Australia should take note. First, the need for organised technology transfer and second, the need to lift the intellectual property barriers to upscaling such production.
The proposed waiver
At a recent meeting of the WTO’s TRIPS Council India and South Africa circulated a proposal for a waiver of certain TRIPS provisions as an option for countries to choose to allow them to scale up local production of Covid-related health products. The waiver would be voluntary in that it would give countries the right (but not the obligation) to suspend compliance action as needed regarding IP protections to enable the development of local production.
Along with the US, the UK, Europe and Brazil, Australia voted and spoke against the proposal. The proposal was blocked but not defeated and comes back to the Council for further consideration on November 20.
While Prime Minister Morrison has endorsed the importance of sharing vaccines, Australia nonetheless voted to prevent developing countries from having the chance to build local production to compensate for vaccine nationalism and other forms of rich country hoarding.
Pfizer is among the most aggressive defendants of extreme IP. When, in May, the World Health Organisation proposed a scheme for sharing technologies (Covid Technology Access Pool) to ensure rapid development and widespread production, Pfizer was dismissive to the point of contemptuous.
It would not be so surprising if countries that support the waiver find themselves at the end of the line accessing the BNT162b2.