16 August 2021

• The New York Times reports that millions of J & J’s coronavirus vaccines bottled and packaged in South Africa were being exported to the EU. South Africa has only received two million of the 31 million doses it ordered from J & J – the main reason why only seven percent of the country’s residents have been vaccinated.  Dr. Glenda Gray, who co-led the Sisonke trial of J & J’s vaccine in South Africa, described the situation as “…like a country is making food for the world, and sees its food being shipped off to high-resource settings while its citizens starve.” 

The doses were exported instead of being used in South African because J & J forced the country to waive its right to restrict vaccine exports. Popo Maja, a spokesman for South Africa’s Ministry of Health said, “The government was not given any choice. Sign contract, or no vaccine.” In addition, the contract included provisions that shield J & J from lawsuits by a wide range of parties, including the government, and J & J imposed an unusually high burden on potential litigants, so that they must show that any injuries caused by the vaccine were the direct result of company representatives engaging in deliberate misconduct or failing to follow manufacturing best practices. J & J, which has exported over 32 million doses from South Africa, is charging the country $10 per dose – as much as in the US, and more than in the EU, where doses are $8.50 each. 

Dr. Paul Stoffels, J & J’s Chief Scientific Officer, said “We have done our best to prioritize South Africa as much as we can,” adding that that South Africa’s Aspen plant would exclusively supply doses to African countries later this year. Source

• Malaysia’s Prime Minister Muhyiddin Yassin and his entire cabinet resign on Monday amid anger about the government’s mishandling of the pandemic. Source 

• The US FDA has rejected an emergency use application for Rigel’s fostamatinib (approved for treating thrombocytopenia), saying the 59-person phase II trial was too small. A larger phase III trial in people hospitalized with mild-to-severe complications of COVID-19 is underway.  Fostamatinib is also being studied in ACTHIV-4, an NIH- sponsored trial assessing whether people with COVID-19 who receive it are more likely not to need oxygen. Source         

• Seattle’s HDT Bio has announced a collaboration with Korean biotech Quratis; the companies will work together to develop an mRNA-based coronavirus vaccine for Asia. HTD is expected to announce similar deals in China and Brazil, and is already working with India’s Gennova Biopharmaceuticals, where a phase I/II trial was launched in May.  HDT’s technology differs from existing mRNA vaccines because it uses a new type of nanoparticle which is designed to direct the RNA to a specific subset of immune cells. It also uses self-amplifying RNA ( virus-derived strands that multiply once in the body),  which might be given at lower doses and may enhance immune stimulation more than existing mRNA vaccines. Source         

• As Kenya battles a fourth wave of coronavirus, a Kenyan alliance of national and local organizations, including Amnesty International and Transparency International, described police violence and coronavirus as a “twin pandemic.” Since the nationwide curfew began at the end of March 2020, at least 26 deaths have been associated with enforcement of COVID-19 measures. Police have also beaten and teargassed people waiting for a ferry in Mombasa and forced people stuck in traffic – some trying to reach hospitals – to sleep in their cars to avoid violating curfew. Recently, the deaths of two brothers, Benson Njiru Ndwiga, 22, and Emmanuel Marura Ndwiga, 19, who were detained for being outdoors after curfew, from head and rib injuries, have increased calls for accountabilityFred Matiang’i, Kenya’s Interior Minister, said that the government would “stop at nothing to ensure justice is served.” Source 

• Taiwan’s President Tsai Ing-wen announces that she will be getting vaccinated with a locally produced, protein subunit-based coronavirus vaccine from Medigen. The country’s regulators rejected an emergency use application for another locally-produced candidate from UBI Pharma, which is developing a multitope protein/synthetic peptide; in phase II, the vaccine did not trigger immune responses comparable to those elicited by AstraZeneca’s vaccine. UBI is planning phase III trials in India. Source

• Pfizer and BioNTech issue a press release to announce that they have submitted early data to the US FDA supporting an application for formal (rather than emergency use approval) for a third booster dose. The companies plan to submit additional data from a larger trial to the EMA and other regulatory authorities in the coming weeks. Source

• The Biden administration is planning to send 488,370 doses of the Pfizer/BioNTech coronavirus vaccine to Rwanda through COVAX as part of a pledge made at the G7 summit to donate 500 million doses. The US plans to ship 200 million doses by the end of 2021, and the remaining 300 million by June of 2022. Source

• Moderna issues a press release to announce a revised supply agreement with the Canadian Government for up to 105 million doses of its coronavirus vaccine and candidate booster vaccine (if authorized) The agreement covers 20 million doses in 2022 and 2023, with an option for an additional 15 million doses. For 2024, the agreement provides an option for up to 35 million doses. Source

• The ACT Accelerator announces that it is urgently seeking funding to help countries stop the Delta variant, calling for $ 7.7 billion for medicines, testing, oxygen and protective gear for frontline health workers. Source

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