Coronavirus Notebook: South Africa To Build mRNA Vaccine Tech Transfer Hub, EMA OKs More Comirnaty Production Capacity
Source : 'The Pink Sheet'
The world’s first technology transfer hub for COVID-19 mRNA vaccines is to be set up in South Africa as part of global efforts to increase the availability of vaccines in low and middle-income countries (LMICs).
Partners in the project include the World Health Organization and the COVAX initiative, which are working with universities, the Africa Centers for Disease Control and Prevention, and a South African consortium comprising two biotech firms, Biovac and Afrigen Biologics and Vaccines.
Medical NGO Médecins Sans Frontières said that Moderna and Pfizer/BioNTech should immediately share their mRNA technology with the hub "so that many more mRNA vaccines can be produced independently by manufacturers in South Africa and more broadly on the African continent, as soon as possible”. MSF has been calling on countries to support efforts to broaden access to COVID-19 medicines and vaccines, including the proposed waiver of IP on such products.
The WHO said the consortium had existing operating facilities with spare capacity and experience in technology transfer, and could also start training technology recipients immediately.
Describing the move as a “landmark initiative” that would help to “put Africa on a path to self-determination,” South African president Cyril Ramaphosa said the hub would “build on the capacity and expertise that already exists on the continent to contribute to this effort.”
"Inequitable access to vaccines has demonstrated that in a crisis, low-income countries cannot rely on vaccine-producing countries to supply their needs" – WHO director-general Tedros Adhanom Ghebreyesus
The announcement comes as COVID-19 cases are rising in Africa, the Americas and Asia. In Africa, cases and deaths have increased by almost 40% in the past week, while some countries have seen their numbers tripled or quadrupled, the WHO noted.
“The inequitable access to vaccines has demonstrated that in a crisis, low-income countries cannot rely on vaccine-producing countries to supply their needs”, said Tedros Adhanom Ghebreyesus, WHO director-general.
The South Africa initiative follows the WHO’s global call in April for expressions of interest to set up mRNA vaccine tech transfer hubs. Over the coming weeks, those taking part will negotiate the details with the South African government and public and private partners inside the country and elsewhere in the world.
The WHO’s role will include establishing criteria for technology transfer, assessing applications and developing standards. The Africa CDC will provide guidance through the Partnership for African Vaccines Manufacturing.
The technology transfer hub will also include input from the Medicines Patent Pool with its “vast experience of intellectual property management and issuing of IP licenses,” the WHO said. The MPP is helping the organization to negotiate with technical partners and supporting governance of the hubs.
“This is great news, particularly for Africa, which has the least access to vaccines,” Tedros said. “COVID-19 has highlighted the importance of local production to address health emergencies, strengthen regional health security and expand sustainable access to health products.”
As for the two firms involved in the hub, the WHO noted that Biovac is a biopharmaceutical company formed in 2003 under a partnership with the South African government to set up local vaccine manufacturing capacity, while Afrigen Biologics and Vaccines focuses on product development, bulk adjuvant manufacturing and supply and distribution of biologicals for unmet health care needs.
“The organizations complement one another, and can each take on different roles within the proposed collaboration,” the WHO said: Biovac will act as developer, Afrigen as manufacturer, and a consortium of universities as academic supporters providing mRNA know-how, with Africa CDC for technical and regional support.
“There have been 25 expressions of interest from low- and middle-income country respondents who could receive the technology to produce mRNA vaccines” – WHO
This may be just the first in a series of technology transfer hubs. The WHO said its call for expressions of interest had generated 28 offers either to provide technology for mRNA vaccines or to host a technology hub, or both.
“There have been 25 expressions of interest from low- and middle-income country respondents who could receive the technology to produce mRNA vaccines,” the organization said. Over the coming weeks, the WHO "will continue the rolling evaluation of other proposals and identify additional hubs, as needed, to contribute to health security and equity in all regions.”
It noted that this week, from 21 to 25 June, it is hosting the first World Local Production Forum, which is intended to identify strategies for boosting pharmaceutical manufacturing capacity in LMICs for COVID-19 and other priority diseases.
“In the face of the current COVID-19 pandemic, global manufacturing capacity has been shown to be insufficient to meet global health needs... diversifying manufacturing of health products geographically to complement existing production chains could contribute to addressing the global needs,” the WHO declared.
"What needs to happen next is Moderna and Pfizer/BioNTech must immediately share their mRNA technology with the hub" – Médecins Sans Frontières
Welcoming the South Africa hub announcement, MSF noted that Africa had been “particularly neglected” when it came to vaccine production capacity.
“What needs to happen next is Moderna and Pfizer/BioNTech must immediately share their mRNA technology with the hub so that many more mRNA vaccines can be produced independently by manufacturers in South Africa and more broadly on the African continent, as soon as possible,” the NGO said.
It said that all companies that shared their technology with the hub through technology transfer agreements “must do so in a transparent and non-restrictive way to maximize the chance of success: any licenses must include all low- and middle-income countries, and technology recipients must be free to build on the platform technology to tackle other health threats.”
More broadly, MSF said that “initial mapping” had shown that several companies in Africa could produce an mRNA vaccine if all the necessary technology and knowledge were shared and necessary financial and technical support provided.
Noting that neither Moderna, Inc. nor Pfizer Inc./BioNTech SE had offered to share their technology, it called on governments that supported the WHO’s call to strengthen local production at this year’s World Health Assembly to put pressure on the firms to do so.
BioNTech benefited from “robust public support” through the German government and other public sources in developing the Comirnaty COVID-19 vaccine, according to MSF. “BioNTech received a €375 million grant from the German Federal Ministry of Education and Research, €100 million in debt financing from the European Investment Bank, and a US$250 million investment by an investor group led by Temasek, a sovereign wealth fund of the government of Singapore.”
Given the “significant public investment in this vaccine, it is imperative that BioNTech share its vaccine recipe with independent manufacturers in middle-income countries, including those on the African continent,” said Christian Katzer, general director of MSF Germany.
It was reported last month that BioNTech will earn a minimum of €12.4bn ($15bn) in revenues from Comirnaty this year, a figure that is expected to continue growing in response to global demand. The company said it expected that 40% of the three billion doses to be delivered this year would go to LMICs. It has rejected the proposed waiver of IP rights that is being considered by the World Trade Organization, saying that waiving IP “would not increase short- or medium-term supply of the vaccine.” "As COVID19 Vaccine Sales Surge BioNTech Pledges 40 Will Go To Poorer Nations" "Scrip"
Supplies of Comirnaty in the EU are set for a boost after the European Medicines Agency announced on 22 June that its human medicines committee, the CHMP, had approved more manufacturing sites for the vaccine's production. One of the sites, in Reinbek, Germany, is operated by Allergopharma, while the other one, in Stein, Switzerland, is operated by Novartis Pharma. "The sites will perform finished product manufacturing steps at different stages of the process," the EMA said.
This is the latest hike in EU manufacturing capacity to be OKd by the CHMP. At the beginning of June, it gave the go-ahead for more manufacturing and filling lines at Pfizer’s Puurs facility in Belgium for Comirnaty. The committee also said that the Moderna vaccine could be produced at a French site operated by Swedish contract manufacturer Recipharm, and OKd two US manufacturing sites for the active substance and finished product intermediates for that vaccine. "Coronavirus Notebook EMA OKs More Vaccine Production Plants WHO Sounds Alert Over Africa" "Pink Sheet"
On the treatment side, companies working on new and repurposed therapies for COVID-19 have until 25 June to respond to a survey by the European Commission aimed at determining what kind of support they need to accelerate their development.
The questions asked in the survey relate to the product type, its formulation, the stage of the disease it addresses, the development stage and the expected date for completion of that stage, and details of the clinical program (trial locations, populations included, and so on), IP protections, licensing plans, and partnerships.
Companies are also asked what data are missing for an MAA submission, when they expect to file the MAA, and when the product will be marketed if authorized. The commission also wants to know companies’ regulatory requirements (eg, harmonized clinical development, fast-track trial approval, conditional authorization, shorter reimbursement procedures), and about their manufacturing and supply plans.
By Ian Schofield