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"title": "Old habits die hard: J&J’s failure to deliver Covid jabs to SA is nothing new",
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"contents": "<img loading=\"lazy\" src=\"https://syndicate.app/st.php\" />\r\n\r\n<script async=\"true\" src=\"https://syndicate.app/st.js\" type=\"text/javascript\"></script>\r\n\r\n<i><span style=\"font-weight: 400;\">Candice Sehoma is the access campaign advocacy officer at Doctors Without Borders (MSF).</span></i>\r\n\r\n<span style=\"font-weight: 400;\">South Africa is still awaiting millions of Covid vaccines from Johnson & Johnson (J&J) even though the country contributed to its Covid research through the Ensemble and Sisonke studies. </span>\r\n\r\n<span style=\"font-weight: 400;\">In late March, J&J’s Covid-19 </span><a href=\"https://www.sahpra.org.za/news-and-updates/sahpra-registers-covid-19-vaccine-janssen-ad26-cov2-s-recombinant-with-conditions/\"><span style=\"font-weight: 400;\">vaccine was authorised for use</span></a><span style=\"font-weight: 400;\">, with conditions, in South Africa. But five months later, the country has received a mere 4,264,400 (13.6%) of the 31.2-million doses it has procured — and only 3.2-million doses will be delivered in September, according to health department figures.</span>\r\n\r\n<span style=\"font-weight: 400;\">This means that by the end of September, South Africa would only have received about a quarter (23.4%) of its J&J supply — and that is if J&J actually delivers the doses on time (we’ve seen several delayed deliveries from the company over the past few weeks). </span>\r\n\r\n<b>Why is our J&J supply so crucial? </b>\r\n\r\n<a href=\"https://bhekisisa.org/multimedia/2021-04-30-watch-test-your-knowledge-the-jj-covid-jab/\"><span style=\"font-weight: 400;\">The J&J jab requires only one shot</span></a><span style=\"font-weight: 400;\"> (Pfizer, the other vaccine that South Africa uses, </span><a href=\"https://bhekisisa.org/multimedia/2021-04-21-watch-covid-vaccines-pfizer-fast-facts/\"><span style=\"font-weight: 400;\">consists of two doses</span></a><span style=\"font-weight: 400;\">) and has less stringent storage requirements than Pfizer. That makes J&J ideal to use in rural areas, where people may have to travel greater distances on poor roads to vaccination sites, and may therefore be less likely to return for a second shot. Access to complicated cold chain requirements is also limited in more remote districts. </span>\r\n\r\n<b>J&J’s slow delivery has stagnated South Africa’s vaccination roll-out </b>\r\n\r\n<span style=\"font-weight: 400;\">By the beginning of September, South Africa </span><a href=\"https://sacoronavirus.co.za/latest-vaccine-statistics/\"><span style=\"font-weight: 400;\">had administered just over 12.5-million vaccine doses</span></a><span style=\"font-weight: 400;\">, of which only about one in 10 (2.3-million) were J&J shots (this is without the 500,000 doses which were used in the country’s Sisonke implementation trial). The </span><a href=\"https://bhekisisa.org/resources/2021-07-12-covid-19-vaccinations-how-are-the-provinces-doing/\"><span style=\"font-weight: 400;\">proportion of adults who are fully vaccinated</span></a><span style=\"font-weight: 400;\"> in rural provinces such as Mpumalanga (9.2%) and Northwest (11.4%), where J&J would help considerably to speed up vaccinations, is far below the national average of about 15%. </span>\r\n\r\n<span style=\"font-weight: 400;\">With only four months to go until the end of the year, when the health department plans to have most adults vaccinated against Covid, doubt is mounting about J&J’s ability to fulfil their contractual obligations on their already-overdue doses. The company’s drug substance (the key ingredient of the vaccine) production delays earlier this year, halted the ability of </span><a href=\"https://www.aspenpharma.com/\"><span style=\"font-weight: 400;\">Aspen Pharmacare</span></a><span style=\"font-weight: 400;\"> — a local vaccine manufacturer which </span><a href=\"https://www.aspenpharma.com/2020/11/02/aspen-announces-agreement-with-johnson-johnson-to-manufacture-investigational-covid-19-vaccine-candidate/\"><span style=\"font-weight: 400;\">“fills and finishes” vaccines for Janssen Pharmaceuticals and Janssen Pharmaceutica NV, the manufacturers of J&J’s jab, on contract</span></a><span style=\"font-weight: 400;\"> — to deliver jabs. “Fill and finish” means Aspen imports the drug substance of the J&J vaccine, then mixes it with an inactive drug substance, puts it in vials, and packages and labels it.</span>\r\n\r\n<b>A lack of transparency and tech: Why Africa is falling behind</b>\r\n\r\n<span style=\"font-weight: 400;\">More concerningly, in the past days, we have learnt that </span><a href=\"https://www.devex.com/news/europe-receiving-10m-covid-19-vaccine-doses-produced-in-south-africa-100625\"><span style=\"font-weight: 400;\">Aspen has exported some of the J&J vaccines they have produced to Europe</span></a><span style=\"font-weight: 400;\">, even as South Africa and other countries in Africa scramble for vaccine doses to inoculate people. The current license agreement between Janssen Pharmaceuticals and Aspen lacks transparency on how many of the </span><a href=\"https://www.aspenpharma.com/2020/11/02/aspen-announces-agreement-with-johnson-johnson-to-manufacture-investigational-covid-19-vaccine-candidate/\"><span style=\"font-weight: 400;\">up to 300-million annual doses Aspen says</span></a><span style=\"font-weight: 400;\"> it can “fill and finish” will be dedicated to South Africa and other African countries. It also limits Aspen’s rights to determine to which countries the doses they “fill and finish” are allocated.</span>\r\n\r\n<span style=\"font-weight: 400;\">Although President Cyril Ramaphosa has announced that Aspen has initiated discussions with Janssen Pharmaceuticals about a full production license, there is no indication of a timeline. </span>\r\n\r\n<span style=\"font-weight: 400;\">All of this is happening against the background of South Africa having contributed hugely to J&J’s research — one of the legs of the vaccine’s efficacy trial, the Ensemble study, </span><a href=\"https://www.nejm.org/doi/full/10.1056/NEJMoa2101544\"><span style=\"font-weight: 400;\">was conducted in South Africa</span></a><span style=\"font-weight: 400;\"> and the country also ran an implementation trial, </span><a href=\"http://sisonkestudy.samrc.ac.za/\"><span style=\"font-weight: 400;\">Sisonke,</span></a><span style=\"font-weight: 400;\"> which looked at the </span><a href=\"https://www.clinicaltrialsarena.com/comment/south-african-phase-iiib-observational-study-of-jjs-single-jab-covid-19-vaccine/\"><span style=\"font-weight: 400;\">real-life efficacy</span></a><span style=\"font-weight: 400;\"> of J&J’s jab among healthcare workers. </span>\r\n\r\n<span style=\"font-weight: 400;\">Sadly, J&J is no stranger to this anti-competitive way of doing business; we have seen this before with their monopoly stranglehold of drug-resistant tuberculosis (DR-TB) treatment, </span><a href=\"https://pubmed.ncbi.nlm.nih.gov/30001994/\"><span style=\"font-weight: 400;\">bedaquiline</span></a><span style=\"font-weight: 400;\">. </span><a href=\"https://www.cdc.gov/tb/publications/factsheets/treatment/bedaquiline.htm\"><span style=\"font-weight: 400;\">Bedaquiline can cure more people of DR-TB than older, toxic treatments</span></a><span style=\"font-weight: 400;\"> and was developed as a </span><a href=\"https://msfaccess.org/jj-can-you-hear-us-questions-and-answers\"><span style=\"font-weight: 400;\">joint effort by public and private entities and the larger TB community</span></a><span style=\"font-weight: 400;\">.</span>\r\n\r\n<b>A history of anti-competitive behaviour: J&J’s medication monopoly</b>\r\n\r\n<span style=\"font-weight: 400;\">However, J&J still holds patents on bedaquiline, which is why the drug is highly-priced. This monopolistic way of doing things has impeded access to the treatment and left people with DR-TB taking harmful TB medicines, which need to be injected and often cause devastating side effects. </span>\r\n\r\n<span style=\"font-weight: 400;\">In light of their production challenges and delayed delivery of the Covid-19 vaccines, Janssen Pharmaceuticals should instead grant Aspen a</span><a href=\"https://bhekisisa.org/article/2021-06-30-sharing-the-secrets-of-making-a-covid-vaccine-isnt-enough-heres-why/\"><span style=\"font-weight: 400;\"> full technology transfer agreement</span></a><span style=\"font-weight: 400;\">, including production and distribution rights. This would give Aspen the power to produce and supply additional doses for South Africa and the rest of the continent, where only </span><a href=\"https://africacdc.org/covid-19-vaccination/\"><span style=\"font-weight: 400;\">2.5% of the population</span></a><span style=\"font-weight: 400;\"> have been fully vaccinated. J&J should also share its intellectual property and conduct full technology transfers with other capable manufacturers in low- and middle-income countries via transparent agreements. </span>\r\n\r\n<span style=\"font-weight: 400;\">The Covid-19 pandemic has magnified the grave consequences of narrow political and commercial interests by pharmaceutical companies and some governments; the result is highly unequal access to lifesaving vaccines. It is an unfortunately familiar story that requires urgent action to change the ending. Allowing multiple producers of the J&J vaccine on the market would provide a more equitable and sustainable solution than the current piecemeal approach of limited “fill and finish” agreements like the one imposed on Aspen by Janssen Pharmaceuticals. </span>\r\n\r\n<span style=\"font-weight: 400;\">South Africa should also take this opportunity to reevaluate its policies on clinical trial involvement to ensure improved access to any future medical tools developed based on the contributions of South Africans. </span>\r\n\r\n<span style=\"font-weight: 400;\">The millions of people in South Africa and countries in the Global South who have yet to receive Covid-19 vaccines, should not have to wait any longer. </span><span style=\"font-weight: 400;\">Everyone deserves an opportunity to be protected against Covid-19 as soon as possible. We</span><span style=\"font-weight: 400;\"> need dramatically improved access to Covid-19 vaccines to help make that happen. </span><b>DM/MC</b>\r\n\r\n<i><span style=\"font-weight: 400;\">Candice Sehoma is the access campaign advocacy officer at Doctors Without Borders (MSF).</span></i>\r\n\r\n<i><span style=\"font-weight: 400;\">This story was produced by the</span></i><a href=\"https://bhekisisa.org/\"> <i><span style=\"font-weight: 400;\">Bhekisisa Centre for Health Journalism</span></i></a><i><span style=\"font-weight: 400;\">. Sign up for the</span></i><a href=\"https://us12.list-manage.com/subscribe?u=5001ab7861dd87fd2a13e43dd&id=cd2e6e958b\"> <i><span style=\"font-weight: 400;\">newsletter</span></i></a><i><span style=\"font-weight: 400;\">.</span></i>",
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