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01 June 2006
Public funders and philanthropic donors begin investment in Cepheid’s diagnostic technologies as a potential game-changing technology for disease diagnosis in Africa and other poor nations.
SOURCEhttps://www.reuters.com/investigates/special-report/health-coronavirus-africa-cepheid/ (cited 7 January 2021). -
01 March 2010
The World Health Organisation recommends the use of Cepheid’s GeneXpert diagnostic systems and test cartridges as the initial test for detecting tuberculosis (TB) in people living with HIV or who have suspected drug resistant TB.
SOURCEhttps://www.who.int/tb/laboratory/whopolicy_framework_mar2011.pdf (cited 7 January 2022) -
24 March 2011
South Africa’s former Health Minister Aaron Motsoaledi announces the rollout of GeneXpert diagnostic systems across South Africa for TB testing, making South Africa the first country to broadly rollout GeneXpert diagnostic systems.
SOURCEhttps://www.spotlightnsp.co.za/2013/09/04/genexpert-an-imperfect-rollout/ (cited 7 January 2022) -
03 October 2012
While Moderna has not sought registration of its COVID-19 vaccine in South Africa, it has sought and received four patents (ZA201303161, ZA201402547, ZA201403666, ZA201403783) related to its vaccine in the country, all of which have been granted without examination of their merits for patentability or consideration of their potential impacts on local access and manufacturing. The granted patents were applied for between 2012 and 2014 and continue through 2031 and 2032.
SOURCE -
01 January 2014
Conducting patent landscapes on diagnostic systems is complex. The lack of transparency regarding patents on health technologies, and the broad range of technology types that may be patented (including diagnostic assays, processes, consumable parts, and machinery) can impede the identification of what patents have been granted on diagnostic systems.
While competitor companies may seek to “design around” intellectual property impediments, the lack of transparency regarding patents granted on diagnostic systems and the lack of clarity about the validity of patents granted in South Africa – given that patents are granted in the country without examination of their merits – can be a significant impediment to competitors companies who may fear patent infringement challenges upon seeking to enter the market. The patent monopolies held by large diagnostic manufacturers are further propped up by the design of diagnostic machinery that only allow for the use of the monopoly holder’s test materials and consumables, and the use of trade-secrets to prevent competitors from manufacturing and supplying equivalent materials.
While conducting an analysis of the landscape of Cepheid’s patents on GeneXpert machinery, consumable parts, processes, and diagnostic assays was beyond the scope of this project, a review of patents sought by Cepheid in South Africa shows that Cepheid applied for 16 patents related to its diagnostic technologies and processes between 2014 and 2021. The five patents applied for before January 2017 have all been granted, while the remainder are pending.
SOURCE(Relevant patent application numbers: 2014/07770, ZA2015/00467, 2015/02463, 2015/06532, 2017/00502, 2017/06683, 2018/01048, 2018/01049, 2018/01050, 2019/03750, 2019/03892, 2020/06485, 2021/01476, 2021/01477, 2021/01478, 2021/02464) (cited 7 January 2022) -
23 June 2017
Emory University has applied for two patents on molnupiravir and its use as an antiviral in South Africa (ZA201704291, ZA202002849). The first patents, which has been granted, was applied for in 2017 and expires in 2035. The second patent, which remains pending, was applied for in 2020 and continues through 2028. Emory University licensed the medicine to Ridgeback Biotherapeutics, who partnered with Merck to further develop and market the drug.
SOURCE -
11 March 2020
The World Health Organisation declares COVID-19 a pandemic.
SOURCEhttps://time.com/5791661/who-coronavirus-pandemic-declaration/ (cited 9 January 2022) -
21 March 2020
Cepheid receives Emergency Use Approval for its COVID-19 test from the U.S. Food and Drug Administration, allowing the company to start marketing its COVID-19 tests in the United States. The approved test is sold in the form of a cartridge into which a sample for testing is inserted and then processed using Cepheid’s GeneXpert diagnostic systems. Cepheid’s diagnostic systems only allow for the use of Cepheid-produced test cartridges, requiring countries with GeneXpert testing systems to buy test cartridges from Cepheid.
SOURCE -
25 March 2020
South Africa’s National Health Laboratory Services (NHLS) highlights the country’s readiness to rapidly scale-up COVID-19 diagnosis, given its investments into both Cepheid’s GeneXpert and Roche’s Cobas rapid, high-throughput diagnostic systems. South Africa has over 300 GeneXpert diagnostic machines distributed across the country that can each process between 4 and 80 tests simultaneously. The NHLS says that 180 of these machines can be used for COVID-19 diagnosis, and that it will be able to conduct 36,000 tests daily.
SOURCEhttps://www.nhls.ac.za/nhls-preparedness-for-testing-to-meet-covid-19-demands/ (cited 7 January 2022) -
25 March 2020
The NHLS announces that Cepheid’s COVID-19 test cartridges will arrive in South Africa during April 202.
SOURCEhttps://www.nhls.ac.za/nhls-preparedness-for-testing-to-meet-covid-19-demands/ (cited 7 January 2022) -
31 March 2020
SAHPRA approves the use of Cepheid’s COVID-19 test cartridges for diagnosis of COVID-19, allowing for procurement of the company’s test cartridges by private and public laboratories in South Africa.
SOURCE -
01 April 2020
As global demand for COVID-19 tests soar, large diagnostic manufactures including Cepheid are unable to keep up with demand – leading to significant supply shortages of COVID-19 diagnostics. Rich countries use their political, trade and financial clout to buy-up available supply – leaving scant supply for developing countries seeking to procure test materials.
SOURCEhttps://www.nytimes.com/2020/04/09/world/coronavirus-equipment-rich-poor.html (cited 7 January 2022) -
20 April 2020
The NHLS is unable to meet its target of conducting 36,000 COVID-19 test daily due to ongoing delays in receiving adequate test supplies from Cepheid. The NHLS tells the media that only 10,000 Cepheid test cartridges have arrived in South Africa to date.
SOURCEhttps://www.groundup.org.za/article/covid-19-testing-are-we-scaling/ (cited 7 January 2022) -
29 April 2020
Pfizer and BioNTech initiate a large study in six countries, including South Africa, to evaluate the safety and efficacy of their COVID-19 vaccine.
SOURCE -
18 May 2020
A group of more than 80 prominent academics, researchers and teachers send a letter to Pres. Cyril Ramaphosa calling on him to urgently reform domestic patent laws in order to increase access to COVID-19 related health products. The letter is accompanied by a FTPL social media campaign requesting 3 steps to fight COVID-19 in South Africa: (1) A temporary moratorium on granting patents for COVID-19 products that are proven to be effective; (2) Automatic compulsory licensing on all COVID-19 health products with existing or pending patents; and (3) Reforming domestic patent laws to ensure full use of TRIPS flexibilities.
SOURCE -
30 May 2020
Turnaround times for COVID-19 PCR tests in South Africa’s public sector exceed nine days due to shortages of test materials and other challenges.
SOURCE -
22 June 2020
Spotlight reports the procurement of new diagnostic workstations and test materials to enable greater use of open, non-proprietary testing platforms in South Africa and to reduce NHLS’ dependency on Cepheid and Roche for supply of COVID-19 diagnostic tests.
SOURCE -
22 June 2020
Médecins Sans Frontières’ Candice Sehoma tells Spotlight that “South Africa should explore options to ‘open up’ closed diagnostic platforms to enable additional companies to produce test materials in short supply, through licensing and technology transfer arrangements. Big companies such as Cepheid should also bear the responsibility to share technologies, data and know-how on a mandatory basis with the right to use and produce to benefit producers in developing countries.”
SOURCE -
15 July 2020
Research on the gendered effects of the hard lockdown demonstrates that women workers counted for two-thirds of the approximately 3 million job losses during this period.
SOURCE -
06 August 2020
Women make up 90% of nurses in South Africa. An online national survey of 7607 health workers conducted by HSRC and UKZN Nelson R. Mandela School of Medicine from 11 April – 20 May 2020 reports that Nurses reported the lowest general health and well-being compared to medical practitioners and other health care professionals, and nurses reported significantly higher levels of distress than other health professionals.
SOURCE -
08 August 2020
Moderna announces that it will not enforce patents for the duration of the pandemic. Medicine access advocates call the announcement as a PR move that will not truly advance expanded manufacturing and access as the announcement fails to provide required technology transfer to enable manufacturing by other companies and provides Moderna with discretion in determining when ‘the pandemic is over’ and resuming enforcement of its patents. The uncertain timeline provides significant legal uncertainty for companies and countries seeking to develop local manufacturing capacity and disincentivizes required investment.
SOURCE -
31 August 2020
An analysis of public investments into the development of GeneXpert diagnostic technologies shows that Cepheid has received more than $250 million in public investment toward the development of its technologies, platforms and assays. Yet the company continues to maintain private and monopolistic control over pricing and supply. The public sector has further invested in the rollout of Cepheid’s diagnostic systems in high-burden TB countries.
SOURCEhttps://doi.org/10.1371/journal.pone.0256883 (cited 9 January 2022) -
01 September 2020
BioNTech secures US$ 450 million grant from the German government to support its vaccine development.
SOURCE -
02 October 2020
India and South Africa submits the TRIPS waiver request at WTO calling for a temporary waiver of all TRIPS rules on COVID-19 therapeutics, diagnostics and vaccines
SOURCE -
05 October 2020
FTPL writes to Minister of Trade and Industry, Ebrahim Patel, requesting an update on the status of the draft legislation implementing the Intellectual Property Policy.
SOURCE -
15 October 2020
FTPL releases a press statement supporting India and South Africa’s request for a temporary TRIPS Waiver on all COVID-19 therapeutics, diagnostics and vaccines tabled at the WTO and together with other civil society organisations globally call on WTO members to endorse the request.
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15 October 2020
FTPL launches an online petition aimed at pressuring the SA government to amend domestic patent laws in order to increase access to patented medications, including those needed to treat and prevent COVID-19.
SOURCE -
19 October 2020
Merck begins a large, phase 2/3 trial to assess the safety and effectiveness of molnupiravir in preventing hospitalisation and death among individuals with mild and moderate COVID-19 in 23 countries, including South Africa.
SOURCEhttps://clinicaltrials.gov/ct2/show/study/NCT04575597 (cited 10 January 2022) -
17 November 2020
The Southern African Labour and Development Research Unit (SALDRU) at the University of Cape Town (UCT) releases a report indicating “occupations dominated by women are reported to leave women 16% more at risk of contracting infectious diseases, such as COVID-19. Roughly 23% of the jobs occupied by women are directly exposed to infectious disease, compared with 7% of the jobs occupied by men. The data demonstrates that aside from making up most of the domestic workers and primary school teachers in the country, women also make up 78% of personal care workers, 92% of home-based care workers, 57% of doctors, 87% of nurses, 76% of medical assistants and 47% of pharmacists”.[1] “The high interpersonal nature of women’s work coupled by the fact that they still carry out a larger share of child care puts them at a higher disadvantage relative to men in terms of income or job loss as a result of COVID-19. Finally, that men often do dangerous work (e.g. mining) is an often-invoked justification for the gender wage gap. However, the frontline response to COVID-19 has further shone a light on how the labour market undervalues the type of risky work often carried out by women given women are over-represented in health professional, retail shop clerk and personal care work occupations.[2]
SOURCE -
01 December 2020
Peer-reviewed article published indicating that maternal mortality increased by 30% from April to September 2020 compared to the same period in 2019. These deaths were attributed to a lack of transport, lack of beds and human resources, delays in referral, lack of expertise, and delay in appropriate action – all factors likely to be indirectly related to the first wave of COVID-19 and the lockdown that preceded it.
SOURCE -
08 December 2020
FTPL participates in a twitter storm aimed at pressuring the EU Commission, France, Brazil, USA, Australia, Japan, and Canada to support the TRIPS waiver and temporarily suspend laws enabling monopolies over COVID-19 health technologies.
SOURCE -
10 December 2020
Efforts by South Africa to engage Cepheid around licensing and technology transfer to enable domestic manufacturing of test cartridges in short supply are unsuccessful.
SOURCE -
10 December 2020
PHM SA in collaboration with partners on its Equitable Access to C-19 Technologies project hosts a webinar on regulatory and IPR “Barriers and Enablers to Equitable Access to COVID-19 Health Technologies in South Africa”.
SOURCE -
11 December 2020
The U.S. Food and Drug Administration grants Emergency Use Approval for Pfizer/BioNTech’s COVID-19 vaccine allowing for the marketing and use of this vaccine in the United States.
SOURCEhttps://www.fda.gov/media/150386/download (cited 31/12/2021) -
18 December 2020
The U.S. Food and Drug Administration grants Emergency Use Authorisation for the emergency use of Moderna’s COVID-19 vaccine to prevent COVID-19 in the United States.
SOURCEhttps://www.fda.gov/media/144636/download (cited 30/12/2021) -
21 December 2020
The European Medicines Agency grants Conditional Marketing Authorisation to Pfizer/BioNTech allowing for the use of the company’s COVID-19 vaccine in the EU.
SOURCE -
31 December 2020
The World Health Organisation grants Emergency Use Listing status to the Pfizer/BioNTech vaccine, allowing countries – including South Africa – to expedite their own regulatory reviews of the vaccine.
SOURCE -
06 January 2021
The European Union’s European Medicines Agency grants conditional marketing authorisation to Moderna, allowing the company to market its COVID-19 vaccine in the EU.
SOURCE -
12 January 2021
Peoples Vaccine Campaign of South Africa is formed. Their call to action urges support for the TRIPS waiver request in order to build vaccine production capacity and technology transfer in the global south.
SOURCE -
31 January 2021
Archbishop Thabo Makgoba, writing on behalf of the Peoples Vaccine Campaign South Africa, sends a letter to Dr Tony Fauci, Dr Rochelle Walensky, Dr David Kessler, Dr Vivek Murthy, and Dr Marcella Nunez-Smith requesting that they act to ensure that the US government shares know-how involving the production of the mRNA vaccines, and issue multiple licenses for production of the vaccine to ensure increased supply, including for the global south.
SOURCE -
01 February 2021
Peer reviewed research published indicating women-headed households experienced higher levels of hunger and income loss compared to male-headed ones.
SOURCE -
05 February 2021
MSF in collaboration with FTPL and the Peoples Vaccine Campaign delivers letters to embassies of countries blocking the TRIPS waiver request together with a twitter storm aimed at amplifying this message.
SOURCE -
06 February 2021
Pfizer and BioNTech initiate a trial in five countries, including South Africa, to evaluate the safety and tolerability of their COVID-19 vaccine in pregnant women.
SOURCE -
14 February 2021
U.S. government agencies, BARDA and the Department of Health and Human Services, increase their advance market commitment for procurement of the Pfizer/BioNTech vaccine for use in the United States to US$6 billion.
SOURCE -
25 February 2021
International Labour, Research and Information Group (ILRIG) hosts a webinar on “Covid-19 Vaccines: The New Apartheid?” featuring analyses of how public funding contributed to the development of multiple effective COVID-19 vaccines which are treated as the private property of private pharmaceutical corporations under the TRIPS regulations, a situation which has contributed to constrained production of vaccines globally.
SOURCE -
01 March 2021
The Africa CDC estimates that 1.6 million COVID-19 tests can be conducted per week using Cepheid GeneXpert diagnostic systems installed across the continent. However, the inability of African countries to secure adequate supply of diagnostic tests from Cepheid as wealthy countries cannibalise supply prevents African countries from realising the full benefits of their investments in Cepheid’s GeneXpert diagnostic systems and scaling COVID-19 testing. Médecins Sans Frontières’ Sharonann Lynch tells Reuters: ““There is no excuse for the fact that those consoles, those machines are now empty. I mean, it’s such a dramatic picture of inequity in terms of where Cepheid is choosing to sell.”
SOURCEhttps://www.reuters.com/investigates/special-report/health-coronavirus-africa-cepheid/ (cited 7 January 2022) -
11 March 2021
PVC SA launches a Day of Action against vaccine apartheid and TRIPS waiver blocking. Actions include a press conference and demonstration outside of Johnson&Johnson’s Cape Town offices.
SOURCE -
16 March 2021
The South African Health Products Regulatory Authority authorises the use of Pfizer/BioNTech’s COVID-19 vaccine in South Africa under Section 21 of the Medicine Act.
SOURCE -
18 March 2021
Fix the Patent Laws campaign marches to the DTIC to demand that Minister Patel urgently release draft legislation aimed at realising the South African Policy on Intellectual Property, Phase 1 for public comment, and then table the bill in parliament. Minister Patel’s Chief of Staff, Mr Moosa Ebrahim, received and signed a memorandum handed over by activists.
SOURCE -
13 April 2021
Moderna’s CEO Stéphane Bancel tells the participants at the African Union Conference on Vaccine Manufacturing in Africa that because mRNA is a new technology there is a shortage of individuals with the required skills needed to transfer technology and know-how to companies in Africa
SOURCE -
19 April 2021
The Mail&Guardian reports that South Africa has signed a contract to buy 30 million doses of the Pfizer/BioNTech COVID-19 vaccine at $10 per dose.
SOURCE -
29 April 2021
FTPL hosts a webinar on “Mobilising Support for Patent Law Reform Locally and Internationally” with Achal Prabhala (accessibsa/Shuttleworth Foundation) (moderator) Dr Tlaleng Mofokeng (Un Special Rapporteur on the right to health) Leena Menghaney (Director of MSF Access campaign in India and South Asia) Umunyana Rugege (SECTION27 Executive Director).
SOURCE -
30 April 2021
The World Health Organisation grants Moderna’s COVID-19 Emergency Use Listing for its COVID-19 vaccine, allowing countries – including South Africa – to expedite their own review and approval of the vaccine for in-country use.
SOURCE -
01 May 2021
Moderna’s Bancel tells analysts on a call that he is not worried about the TRIPS waiver proposal, as “You cannot go hire people who know how to make mRNA: Those people don’t exist.”
SOURCE -
02 May 2021
South Africa receives its first shipment of 325,260 doses of Pfizer/BioNTech COVID-19 vaccines.
SOURCE -
07 May 2021
Pfizer CEO Albert Bourla publishes an open letter to employees opposing the TRIPS Waiver championed by South Africa and India to enable low-and middle-income countries to locally manufacture COVID-19 health technologies, including vaccines, to address global supply shortages.
SOURCE -
28 May 2021
FTPL coalition organises a twitter storm aimed at Pres. Macron during his official visit to South Africa calling on him to support the TRIPS waiver request.
SOURCE -
04 June 2021
Health Justice Initiative releases infrographic on “Frequently Asked Questions: The TRIPS Waiver and the WTO”
SOURCE -
16 June 2021
Pfizer initiates a phase 2/3 trial to assess the effectiveness and safety of ritonavir-boosted nirmatrelvir (Paxlovid) in preventing hospitalisation and death in individuals with COVID-19 who face high risks of developing severe disease in 21 countries, including South Africa.
SOURCEhttps://clinicaltrials.gov/ct2/show/record/NCT04960202?cond=COVID-19&cntry=ZA&draw=2 (cited 11 January 2022) -
21 June 2021
The World Health Organisation announces the establishment of an mRNA Technology Transfer Hub to capacitate African manufacturers to make mRNA vaccines. The Hub is based in South Africa and will bring together a network of partners including Afrigen, Biovac, the South African MRC, the Africa CDC, and the Medicines Patent Pool.
SOURCE -
08 July 2021
Researched published which finds that women suffered disproportionate job losses, decline in average hours worked (for employed women), ,a slower and more “incomplete” job market recovery post-lockdowns, and an increased burden of unpaid work as compared to men. The study showed that “women accounted for the majority of the unemployed (or those not working) throughout the period, as well as the majority of the net job losses recorded between any two time periods, they were under-represented in the COVID-specific government income support provided for unemployed and furloughed workers”. Fewer women than men received the special COVID-19 Relief of Distress Grant (CRDG) because women already receiving any other grant (e.g. child support grant) were automatically disqualified from the CRDG.
SOURCE -
09 July 2021
Health Justice Initiative tables a Submission on the Copyright Amendment Bill [B13B-2017] that calls for the government to recognise “the right to repair” and draws attention to the importance of this right in relation to life-saving medical technologies, and specifically in the context of the COVID-19 pandemic, the right to repair technologies such as medical ventilators. It also called for a broader endorsement of “the right to research” than the one currently proposed, in order to support knowledge production related to COVID-19 and other medical conditions. Finally, the submission encouraged parliament to enact domestic patent and copyright law reform that would enable immediate use of existing TRIPS flexibilities.
SOURCE -
19 July 2021
STATSSA reports that the pandemic has coincided with a decline of “life expectancy at birth for males declined from 62,4 in 2020 to 9,3 in 2021 (3,1 year drop) and from 68,4 in 2020 to 64,6 for females (3,8 year drop).”
SOURCE -
21 July 2021
Pfizer and BioNTech announce a deal with the South African vaccine manufacture Biovac. The deal will enable local fill and finish of the Pfizer/BioNTech vaccine in South Africa for distribution across Africa, but does not include licensing or technology transfer to enable manufacture of the vaccine’s active drug substance in South Africa.
SOURCE -
11 August 2021
Merck begins a phase 3 trial to assess the safety and effectiveness of molnupiravir in preventing COVID-19 infection among household contacts of people with COVID-19 in 17 countries, including South Africa.
SOURCEhttps://clinicaltrials.gov/ct2/show/record/NCT04939428 (cited 10 January 2022) -
19 August 2021
The ICESCR Civil Society Coalition Campaign organises a webinar on “The Right to Health and Equitable Access to COVID-19 Health Technologies” which features analysis from Candice Sehoma (MSF), Prof. Yusuf Vawda (UKZN) and Prof. Rodrigo Upriminy (National University of Columbia and Member of the UN Committee on Economic, Social and Cultural Rights) on how the global IPR regime impedes the right to health in the context of the COVID-19 pandemic.
SOURCE -
23 August 2021
Health Justice Initiative releases an “Explainer on Vaccine Licenses for COVID-19”
SOURCE -
25 August 2021
BioNTech initiates a trial in four countries, including South Africa, to evaluate the safety and efficacy of their vaccine when provided as a third booster shot.
SOURCE -
25 August 2021
Pfizer initiates a phase 3 trial to determine whether ritonavir-boosted nirmatrelvir shortens and/or reduces signs and symptoms of COVID-19 in non-hospitalised patients in 20 countries, including South Africa.
SOURCEhttps://clinicaltrials.gov/ct2/show/record/NCT05011513?cond=COVID-19&cntry=ZA&draw=2 (cited 11 January 2022) -
03 September 2021
FTPL launches a video entitled “Why TRIPS acts as a barrier to the C-19 vaccine and how to change it!” based on the “Train the Trainer Vaccine Literacy and Advocacy Manual” developed by health activist organisations including the PVC SA, SECTION27, Workers World Media, Health Justice Initiative, PHM South Africa, and Medecins sans Frontieres Southern Africa.
SOURCE -
09 September 2021
Pfizer initiates a phase 2/3 trial to evaluate the effectiveness of ritonavir-boosted nirmatrelvir in preventing symptomatic COVID-19 disease among household contacts of people with COVID-19 in 17 countries, including South Africa.
SOURCEhttps://clinicaltrials.gov/ct2/show/record/NCT05047601?cond=COVID-19&cntry=ZA&draw=2 (cited 11 January 2022) -
14 September 2021
Activists protest outside the Union Buildings in Pretoria demanding that Germany stops blocking the TRIPS waiver request as part of an Africa-wide campaign targeting the German government.
SOURCE -
22 September 2021
PHM South Africa hosts a webinar on “Lessons from HIV/AIDS access to medicines campaign for the TRIPS waiver” in which Kajal Bhardwaj (IPR lawyer) and Sibongile Tshabalala (Treatment Action Campaign) speak on IPR and health systems challenges that impeded equitable access to HIV/AIDS medical technologies and health care and which continue to negatively affect COVID-19 care.
SOURCE -
01 October 2021
Merck announces early results from phase 3 trial demonstrating molnupiravir reduces the risk of hospitalisation and death by 50% among individuals with mild and moderate COVID-19 disease.
SOURCE -
07 October 2021
Moderna announces it will build a factory in Africa to manufacture vaccines, yet does not provide a timeframe for doing so, and continues to refuse to transfer technology and license existing vaccine manufacturers in Africa to produce its COVID-19 vaccine.
SOURCE -
12 October 2021
A report by the People’s Vaccine Alliance showed that as of October 2021, only a quarter of the total delivered supply of the Pfizer/BioNTech vaccine has gone to low- and middle-income countries, while only a meagre 0.4% of total supply went to low-income countries.
SOURCE -
12 October 2021
FTPL Coalition organises demonstrations outside embassies of countries blocking the TRIPS Waiver request demanding that they support the waiver.
SOURCE -
13 October 2021
United States Senators Elizabeth Warren, Jeff Merkley, and Pramila Jayapal protest Moderna’s ongoing refusal to share its technology to expand vaccine manufacturing despite receiving nearly US$ 10 billion in public funding from the U.S. government for the vaccine’s development.
SOURCE -
13 October 2021
PHM South Africa and Health Justice Initiative launch a video advocating for the TRIPS waiver request. Entitled “Vaccine Patents Kill! A Message on the TRIPS Waiver From South Africa”, the video includes voices of South African health activists explaining how IPR laws impede vaccine access and how the TRIPS waiver can help facilitate vaccine equity.
SOURCE -
20 October 2021
BioNTech announces an agreement with the Rwandan and Senegalese governments to initiate the construction of an mRNA vaccine manufacturing facility in Africa. The agreement is criticised by civil society for bypassing the efforts of the WHO to establish an mRNA Technology Transfer Hub to transfer existing intellectual property and technology to vaccine manufacturers in Africa to enable the manufacturing of COVID-19 mRNA vaccines on the continent. The agreement indicates BioNTech’s intention to transfer capacity to enable African-based manufacturing of future mRNA vaccines under development for neglected diseases like malaria and TB, but not BioNTech’s approved and urgently needed COVID-19 vaccine.
SOURCE -
21 October 2021
A report by the People’s Vaccine Alliance showed that as of October 2021, only 17.6% of Moderna’s total vaccine supply has been delivered to low-and middle-income countries, while only 0.2% of the total supply has gone to low-income countries.
SOURCE -
26 October 2021
Moderna announces that it will supply 110 million doses of its COVID-19 vaccine to the African Union through 2022. The People’s Vaccine Alliance responds: “After having so far delivered zero of their committed doses to COVAX, this new Moderna Memorandum of Understanding with the African Union to at some point deliver 110 million more vaccines is barely worth the paper it is written on. This is a publicly funded vaccine and should be available to all as a public good. It is beyond time that the US government step in and insist the vaccine technology is shared immediately with the WHO mRNA technology hub.”
SOURCE -
27 October 2021
The Medicines Patent Pool announces a licensing deal with Merck enabling manufacture of generic molnupiravir. The deal allows for generic products produced under the deal to be marketed in South Africa’s public health sector, but not its private sector. The deal allows for pharmaceutical companies in South Africa to apply for licenses to manufacture generic molnupiravir. The deal excludes several middle-income countries with high burdens of COVID-19 from accessing generic medicines produced under the licenses.
SOURCE -
27 October 2021
The Public Health and Social Development Sectoral Bargaining Council rules against a demand tabled by NEHAWU that community health workers (CHWs) be permanently employed and integrated into the public health service instead of receiving stipends and being employed on a rolling basis on short-term contracts. This is despite CHWs repeatedly being described by various government officials as footsoldiers of PHC services, and taking on additional work due to COVID-19 during the pandemic. Most CHWs are working class black women.
SOURCE -
01 November 2021
Global media reports highlight efforts by Afrigen, through the mRNA Technology Transfer Hub, to “reverse engineer” Moderna’s COVID-19 vaccine as a step towards enabling African-based manufacturing to address vaccine inequity between wealthy and poor countries.
SOURCE -
01 November 2021
Moderna projects that it will earn up to US$18 billion from the sale of its COVID-19 vaccine during 2021.
SOURCE -
02 November 2021
Pfizer projects that it will earn US$36 billion during 2021 from the sale of its COVID-19 vaccine.
SOURCE -
09 November 2021
Pfizer applies for a patent on the nirmatrelvir (PF-07321332) drug compound in South Africa. If granted it will give Pfizer monopoly patent protection through 2041, which the company may assert to block the use of ritonavir-boosted nirmatrelvir in South Africa’s private sector through 2041.
SOURCE -
09 November 2021
The Medicines Patent Pool announces a licensing deal with Pfizer to allow for the manufacture of generic ritonavir-boosted nirmatrelvir for use in treating COVID-19 in eligible countries. The licensing deal allows for generic products manufactured under the deal to be used in South Africa’s public health sector, but not in its private sector. The deal allows for pharmaceutical companies in South Africa to apply for licenses to manufacture generic ritonavir-boosted nirmatrelvir. The deal prevents several high-burden middle income countries and small island developing states from accessing generic medicines produced under the licenses.
SOURCE -
09 November 2021
FTPL activists march to the DTI to urge the government to reform our intellectual property laws to enable improved access to lifesaving medicines for Covid-19 and other life threatening diseases such as cancer. Demands include publishing the amendments to the Patents Act drafted by the DTIC for public comment, issuing compulsory licenses for Covid-19 treatments and vaccines, and reviewing the legal status of patent applications on all Covid-19 medical technologies, including granted or pending applications on Moderna’s mRNA vaccine;
SOURCE -
10 November 2021
FTPL highlights that while patents limit access, Moderna has not sought registration of its vaccine in South Africa, or delivered a single dose to the continent,
SOURCE -
11 November 2021
PHM South Africa organises a webinar comparing the historical experiences with local manufacturing of vaccines in South Korea (Sun Kim – PHM Brazil), Brazil (Gustavo Matta – Fiocruz) and South Africa (Patrick Tippoo – Biovac) that reflects on some of the IPR challenges to building this capacity.
SOURCE -
19 November 2021
Research report released on the experiences of sex workers in KwaZulu Natal and the Western Cape during the COVID-19 lockdown. The study identifies 80.4% of participants as “female” and 13.7% as “transgender women”. The findings show that 83.7% of the participants in the study felt they were specifically targeted by law enforcement during lockdown, 60.8% had been arrested at some point during lockdown, and 66% of respondents had received a fine during lockdown.
SOURCE -
25 November 2021
South African health activists Tinashe Njanji (PHM South Africa) and Fatima Hassan (Health Justice Initiative) are panelists on a global press conference aimed at briefing health and trade journalists on why a TRIPS waiver is central to a fair and equitable approach to managing the COVID-19 pandemic.
SOURCE -
26 November 2021
Moderna announces it will develop a vaccine candidate that will specifically target the Omicron variant – drawing on research undertaken and knowledge generated in South Africa where the Omicron variant was first discovered
SOURCE -
26 November 2021
Updated data shows that molnupiravir is only 30% effective at reducing COVID-19 deaths and hospitalisation, down from the initially reported 50% reduction.
SOURCE -
30 November 2021
PHM South Africa in collaboration with PHM Global and Public Services International organise an international twitter storm in support of the TRIPS waiver, and as part of a broader set of activities around WTO MC12 coordinated by Our World is Not For Sale network.
SOURCE -
01 December 2021
The COVID-19 Prevention Network initiates a trial to evaluate the efficacy of Moderna’s COVID-19 vaccine in preventing COVID-19 disease in people living with HIV. The trial will be conducted in eight sub-Saharan African countries, including South Africa.
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06 December 2021
Afrigen’s Managing Director Petro Terblanche tells attendees of the Partnership for African Vaccine Manufacturing (PAVM) public stakeholder meeting that efforts to seek technology transfer from Moderna to enable African-based manufacturing of Moderna’s COVID-19 vaccine have been unsucessful to date, yet notes that despite this “We are in fact developing end-to-end mRNA vaccine manufacturing capabilities and capacity, we are doing it ourselves, not with a technology transfer but with knowledge transfer, partnerships and technical support across the globe”. Terblanche adds that the mRNA hub is establishing facilities able to locally manufacture adequate supply of mRNA vaccines required for clinical trials and that this facility is aiming to receive Good Manufacturing Practices certification from the South African Health Products Regulatory Authority by June 2022.
SOURCEhttps://www.youtube.com/watch?v=YpZaPPbrkls (cited 30/12/2021) -
09 December 2021
Afrigen’s Teblanche tells attendees of the multi-stakeholder forum on the mRNA Technology Transfer Hub, convened by South Africa’s Department of Science and Innovation that “The hub was set up with the vision or plan to have a technology transfer… we did not get a technology transfer from the two leading mRNA vaccine manufacturers, but we are doing it ourselves… we are developing our own processes and our own vaccine based on a specific sequence, it has a clear target product profile and it is relevant to what we need to do to bring a COVID-19 vaccine to clinical trials one year from now”.
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14 December 2021
Pfizer announces results from interim analysis demonstrating that ritonavir-boosted nirmatrelvir reduces the risk of hospitalisation and death by 89% among high-risk individuals with COVID-19.
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20 December 2021
South Africa’s National Essential Medicines Committee (NEMLC)/Ministerial Advisory Committee (MAC) on COVID-19 publishes a rapid review of molnupiravir (MOV) stating that “Although MOV modestly reduces the risk of hospitalisation or death in adults with mild to moderate COVID19 who are at high-risk for progression to severe COVID-19, and is well tolerated, its use requires rapid access to definitive diagnosis and initiation within 5 days of the onset of symptoms. MOV is contraindicated in pregnancy, so women of childbearing potential need to take effective contraception. The efficacy and safety of MOV has not been studied in patients previously vaccinated against COVID-19. MOV products have yet to be registered in South Africa and are not available in South Africa. Generic products will only be available to the public sector, and the prices of both generic and innovator brands in South Africa are unknown”.
The Committee notes that the medicine will be reviewed again once molnupiravir products have been registered in the country, or approved for use via Setion21 authorisation, and prices declared.
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22 December 2021
The U.S. Food and Drug Administration grants Emergency Use Approval for the use of Pfizer’s ritonavir-boosted nirmatrelvir for the treatment of COVID-19.
SOURCEhttps://www.fda.gov/media/155049/download (cited 11 January 2022) -
31 December 2021
Moderna continues to refuse to license intellectual property and transfer technology to enable manufacture of its mRNA vaccine by African companies.
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01 January 2022
Politico reports “The team at the world’s first transfer hub for mRNA coronavirus vaccine technology had reason to celebrate… After failing to get Moderna on board to share its mRNA technology, the Cape Town hub went ahead, anyway. It has produced the drug product formulation in just more than six months since the initiative was announced. While the product is currently more of a “training batch” than the finished product, it’s a starting point for Afrigen — the developer behind the hub — to tinker with”.
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01 January 2022
Molnupiravir remains unavailable (except under trial access) and unregistered in South Africa.
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01 January 2022
No ritonavir-boosted nirmatrelvir products are registered or available in South Africa.
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09 January 2022
Vaccination uptake amongst men reaches 43%, compared to 57% of women. However, while the percentage of women vaccinated in each age group is higher that for men, this is not the case in the oldest group (> 60 years) where more men as a percentage (68%) are vaccinated than women in the same age group (65%). So, in the high risk groups, women are doing worse
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16 December 2022
The European Medicines Agency advises that Pfizer’s ritonavir-boosted nirmatrelvir can be used to treat individuals with COVID-19 at high risk of developing severe disease.
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