A large-scale efficacy trial of a promising tuberculosis (TB) vaccine will soon launch with substantial backing from two major philanthropies. The vaccine, dubbed M72, has so far crawled through clinical trials. A placebo-controlled study completed in 2015 found that in adults who had latent infections with the TB-causing mycobacterium, those who received the vaccine had half as many cases of the life-threatening pulmonary form of the disease. (A TB vaccine developed more than a century ago offers some protection to young children, but does little to prevent pulmonary disease in adolescents and adults.)
www.science.org/content/article/news-glance-muscular-dystrophy-therapy-lab-grown-chicken-and-humans-toll-wildlife?
The new trial will enrol 26,000 people at more than 50 sites in Africa and Asia. In 2020, a research branch of the Bill & Melinda Gates Foundation acquired the license from the vaccine’s initial developer, GSK, to further develop the candidate and then, if it proves its worth in efficacy trials, make it available to poor countries hit hardest by TB. The Gates foundation will foot $400 million of the estimated $550 million needed to complete the multiyear trial, with the Wellcome Trust making up the balance.
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The U.S. Food and Drug Administration has approved the first gene therapy for Duchenne muscular dystrophy (DMD), a genetic disease that cripples boys and usually results in death by age 30. www.science.org/content/article/news-glance-muscular-dystrophy-therapy-lab-grown-chicken-and-humans-toll-wildlife?
The treatment from Sarepta Therapeutics introduces a short version of the gene for dystrophin, a crucial muscle protein, which is mutated in patients with DMD. A one-time intravenous infusion of a virus delivers the functioning “microdystrophin” gene into patients’ muscle cells. The 22 June approval is only for boys 4 to 5 years old, a group that appeared likely to benefit from the drug based on their elevated levels of the microdystrophin protein in a clinical trial. The approval could be revoked if an ongoing trial does not show improved muscle function. A single infusion will cost $3.2 million, Sarepta says.
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U.S. consumers will soon get their first taste of lab-grown meat, after the U.S. Department of Agriculture gave two companies—Upside Foods and Good Meat—permission to sell chicken produced from cells grown in bioreactors.
www.science.org/content/article/news-glance-muscular-dystrophy-therapy-lab-grown-chicken-and-humans-toll-wildlife?
Last week’s approval follows earlier decisions by the Food and Drug Administration stating that the chicken is safe to eat. The companies’ plan to initially sell the meat, which will be labelled “cell cultivated chicken,” only to select restaurants. The United States is the second country to approve a lab-grown meat product, after Singapore gave the green light to Good Meat chicken in 2020. The Good Food Institute, an industry think tank, predicts other governments will soon follow suit.
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There is an ongoing global threat posed by toxic cough syrups, the World Health Organization (WHO) told Reuters, saying it was now working with six more countries than previously revealed to track the potentially deadly children’s medicines.
https://www.medscape.com/s/viewarticle/993310?ecd=mkm_ret_230701_mscpmrk-OUS_IntStories_etid5544958&uac=398271FG&impID=5544958&faf=1
The WHO has already named nine countries where tainted syrups may have been on sale, after the deaths of more than 300 infants on three continents last year were linked to the drugs.
Rutendo Kuwana, the WHO team lead for incidents with substandard and falsified medicines, declined to name the six new countries the agency is working with, while investigations are still underway.
He warned that contaminated medicines could still be found for several years, because adulterated barrels of an essential ingredient may remain in warehouses. Cough syrups and the ingredient, propylene glycol, both have shelf-lives of around two years.
Unscrupulous actors sometimes substitute propylene glycol with toxic alternatives, ethylene glycol and diethylene glycol, because they are cheaper, several pharmaceutical manufacturing experts told Reuters. The alternatives are more commonly used in brake fluid and other products not meant for human consumption.
The WHO’s working theory is that in 2021, when prices of propylene glycol spiked, one or more suppliers mixed the cheaper toxic liquids
with the legitimate chemical, Kuwana said. He did not say where the suppliers were based, and added that obscure supply chains have made proving this difficult.
Pharmaceutical manufacturers, including those alleged to have produced the tainted syrups that have been found so far, typically source ingredients from external suppliers.
Earlier this week, Nigeria’s regulator issued a warning about contaminated paracetamol syrups sold in Liberia, although no deaths have been reported there. The Nigerian regulator was testing the syrups, which were not sold in Nigeria, because Liberia has no testing facilities.
The WHO issued safety alerts last year for Indian-made products found in Gambia and Uzbekistan, and this year in Micronesia and the Marshall Islands
It also issued an alert last year for Indonesian-made syrups that were only sold domestically. Indonesian authorities say more than 200 children were likely poisoned by these.
Three Indonesian-based manufacturers – PT Yarindo Farmatama, PT Universal Pharmaceutical Industries, PT AFI Farma – have had their licences revoked. A fourth, PT Konimex, said it had recalled all of the relevant products and its website says it was cleared by the Indonesian regulator to sell new batches as of December 2022. The Indonesian regulator did not immediately respond to a request for comment.
In January, the WHO named four other countries it was working with – Timor Leste, Cambodia, Senegal and the Philippines – to track whether any of the tainted syrups had reached their markets.
There is no current risk to the population in the countries the WHO has named, Kuwana said, either because contaminated medicines had been pulled from shelves or because they never reached the market in the first place.
Cameroon’s health regulator said in April it was investigating the deaths of six children linked to a cough syrup branded as Naturcold. The manufacturer named on the packet is China’s Fraken Group, which did not immediately respond to requests for comment.
But the Cameroon authorities said in an alert the medicine was bought from unauthorised sources and possibly smuggled in. They did not respond to requests for more information.
Other manufacturers identified in the current spate of incidents are largely Indian-based. Two companies whose products have been linked to deaths have been shuttered by the authorities there: Maiden Pharmaceuticals, which sold syrups to Gambia, and Marion Biotech, whose syrups went to Uzbekistan.
Besides these cases, Indian-made medicines supplied to the Marshall Islands and Micronesia have been recalled after Australian laboratory tests showing contamination prompted a WHO safety alert. The manufacturer, QP Pharmachem, told Reuters earlier this year that its own tests had found no issues.
The contaminated syrups in Liberia were made by India’s Synercare Mumbai, according to the Nigerian regulator. The Liberian health regulator said it plans to incinerate the stock and will recall two other Synercare products as well, as a precaution.
Synercare did not respond to a request for comment.
Since 2001, the WHO has recommended against giving cough syrups to children aged under 5, because it says there is limited evidence of how effective they are, or what side-effects they may have.
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An EU-funded and WHO-implemented project helped health systems become more resilient and better prepared to tackle future epidemics of vaccine-preventable diseases. www.who.int/news/item/26-06-2023-supporting-vaccinations-and-strengthening-health-systems-in-16-african-countries
COVID-19 vaccination coverage is on the rise in Africa’s most fragile humanitarian settings as the two-year project comes to a close.
At the start of 2022, the COVID-19 vaccination rate was less than 5% on average in the participating countries: Burundi, Cameroon, the Central African Republic, Chad, the Democratic Republic of the Congo, Guinea, Liberia, Madagascar, Mali, Mozambique, Niger, Nigeria, Somalia, the South Sudan Republic, Sudan, and Tanzania.
That rate is now closing in on 30% – the continent’s average. 34 million people have received the two-dose vaccinations – more than 1 in 4 people across the population of all countries.
The project’s objective has been to prioritize the most vulnerable people and communities.
Crucially important for achieving this success were national health workers trained by WHO that have been administering vaccines in urban hubs, remote villages, refugee and displacement camps, workplaces, public spaces and elsewhere. The number of WHO-
trained health workers rose from about 130 000 in 2022, to almost 2 million by May 2023.
The countries that have seen remarkable improvements are:
· Chad, Guinea, Niger, Sudan, South Sudan and Nigeria – that reached close to 40% vaccination rates.
· The Central African Republic, Mozambique and Somalia that surpassed the 40% rate.
· And Liberia, showing the most progress, with eight out of ten people now vaccinated.
Vaccination efforts have reached close to 12 million refugees, internally displaced persons and migrants across eleven countries. Four in ten of them received a full primary series (first and second dose), and more than half of them received at least one dose. Close to 13 million people amongst these vulnerable groups were reached with awareness campaigns, delivered in their settings and in their own languages by local health workers.
Close to 26 million older people (38%) of the total in all countries) completed their primary vaccine series, providing crucial protection against COVID-19.
With significant knowledge transfer, training and fieldwork, the national vaccination and immunization programmes have been strengthened in the long run.
Countries are now more resilient against COVID-19 and ready to tackle other vaccine-preventable diseases and health emergencies.
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Lalita Panicker is Consulting Editor, Views and Editor, Insight, Hindustan Times, New Delhi
