HEALTH
Breakthrough Deals for Affordable ‘Pandemic-Ending’ HIV Vaccine: A Game Changer!
Two drug companies are set to receive funding to produce HIV prevention drug lenacapavir more cheaply, in what one key researcher has called a “huge” step towards getting the jab – seen as a crucial tool for ending the HIV/AIDs pandemic – to lower-income countries.
Lenacapavir will cost $40 (£30) a year for one patient in 120 low- and middle-income countries from 2027 under the deals.
The distribution of the jab had been called into question after deep cuts to global aid spending, especially by Donald Trump in the US, raising fears among HIV researchers that “prevention would be a casualty,” said Prof Linda-Gail Bekker, a leading researcher who helped prove the jabs’ effectiveness.
Lenacapavir is a twice-yearly preventative jab which provides near-total protection from developing the virus. It has been described as the nearest thing we have to an HIV vaccine.
The Gates Foundation has announced plans to provide funding to to Hetero Labs to make a number of initial doses, and a guarantee to the Hyderabad-based drug company of payment for those doses. This will allow it to produce a generic version of lenacapavir more quickly. The US price of the branded drug made by Gilead sells for $28,218.
The foundation said it had invested more than $80 million in total in the long-acting jab. Most of that will go to Hetero Labs.
At the same time, the Clinton Health Access Initiative, World Health Organization initiative Unitaid and leading South African research foundation the Wits Reproductive Health and HIV Institute announced a corresponding deal with drug company Dr Reddy’s Laboratories.
Prof Bekker hailed these partnerships as, “obviously huge,” adding: “Getting it into a more affordable range means that our governments can plan to include it in our response plans in the future”.
“Scientific advances like lenacapavir can help us end the HIV epidemic – if they are made accessible to people who can benefit from them the most,” said Trevor Mundel, president of global health at the Gates Foundation. “We are committed to ensuring that those at highest risk, who can least afford it, aren’t left behind.”
These cheaper doses will be available to more than 100 countries. However, nations across Latin America which have high burdens of HIV and took part in trials of lenacapavir – for example Brazil – will miss out on access to the cheaper doses, according to Beatriz Grinsztejn, president of the International Aids Society (IAS).
Last December, a deal was struck between Gilead and global funders – led by the US President’s Emergency Plan for Aids Relief (Pepfar) and the Global Fund to Fight Aids, Tuberculosis and Malaria – to provide enough doses of lenacapavir to protect at least two million people over three years.
Gilead said it would not make a profit on the doses, but has not made the price public. And countries will still have to find the money in their increasingly stretched budgets to pay for them.
At the same time, six pharmaceutical companies, including Hetero and Dr Reddy’s, were given licences by Gilead to produce generic versions of the jab, designed to bring prices down in the long-term. While that Gilead deal gave generic manufacturers the ability to produce lenacapavir, the new deals with the Gates Foundation and others are designed to offer the funding and incentives to make it financially viable for manufacturers to take the risk of producing a higher volume of doses within a shorter timeframe. The first generic doses under the deal are expected around the end of 2027.
Despite swingeing cuts to overseas spending by the Trump administration, which initially called Pepfar’s role in funding lenacapavir into question, on 4 September the US State Department said it would go ahead with its contribution to the initiative to reach two million people with the jab by 2028.
“This US commitment exemplifies Secretary Rubio’s America First life-saving assistance agenda,” said Jeremy Lewin, Senior Official for Foreign Assistance, Humanitarian Affairs, and Religious Freedom. “It champions American innovation, advances the administration’s goal of ending mother-to-child transmission of HIV during President Trump’s second term, and will serve as an important catalyst for greater global and private sector investment in access to this groundbreaking medication”.
Prof Bekker said she felt newly “hopeful,” that the deals would see, “greater access and therefore greater impact because that’s what we’re going to need. We’re going to need this innovation to be at scale in all the regions where virus is circulating in order to realise its potential”.
However, she added, despite Pepfar’s commitment to funding the manufacture of lenacapavir, the US’s withdrawal from funding a raft of wider prevention services could jeopardise the jab’s rollout.
Groups that could most benefit from lenacapavir include some of those who find it hardest to access healthcare because of laws criminalising same-sex relationships, selling sex and drug use, she explained.
“There is still work to be done around destigmatising services, making services friendly, making services available. And again this is where Pepfar was doing a huge amount of that work.
“They had these drop-ins, they had community-based services, NGO-run services, peer-led services, so those are going to have to be replaced rapidly in order to make sure that now that we have access to the product, we have somebody who can actually…deploy [it]”.
Without staff and infrastructure to deliver lenacapavir, it won’t get to the people who need it even if enough doses are made.
“We welcome lenacapavir generics being made affordable – a vital step to expand access,” said IAS president Ms Grinsztejn. “But availability in 2027 still feels far away. With the HIV response in a funding crisis, countries are already making difficult trade-offs,” she said, and required, “urgent, additional investment to avoid delays or denied access”.
This story is part of The Independent’s Rethinking Global Aid series