Trials of Three Ebola Candidate Vaccines Set for Uganda; India’s Covaxin Vaccine Still Suspended by WHO Infectious Diseases 16/11/2022 • Megha Kaveri Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to print (Opens in new window) Three Ebola vaccine candidates will be tested in Uganda soon. Clinical trials on three Ebola vaccine candidates for the Sudan strain of the virus are due to start soon in Uganda, according to the World Health Organization (WHO). “I’m pleased to announce that a WHO committee of external experts has evaluated three candidate vaccines and agreed that all three should be included in the planned trial in Uganda. WHO and Uganda’s Minister of Health have considered and accepted the committee’s recommendation,” WHO Director-General Dr Tedros Adhanom Ghebreyesus told a media briefing on Wednesday. Doses of the vaccine candidates are set to arrive in Uganda next week. Uganda has been reeling from an Ebola outbreak, with 163 confirmed and probable cases and 77 confirmed and probable deaths. Tedros expressed appreciation for the Ugandan government’s efforts in containing the outbreak: “The government’s efforts to respond to the outbreak have slowed transmission in most districts, and two districts have not reported any case for 42 days, indicating the virus is no longer present in those districts.” Too late for trials? However, with the outbreak in decline, it might mean that it will be hard to test the vaccines. The clinical trials will be conducted by a group of organisations including the WHO, Uganda’s Makerere University, the Coalition for Epidemic Preparedness Innovation (CEPI) and Gavi, the global vaccine alliance. In a joint statement earlier this month, the WHO said that while the vaccines were developed by the Lung Institute at Makerere University, WHO, CEPI and GAVI will ensure that sufficient doses are available for the clinical trials. “We can confirm that we have received written confirmation from the developers that a sufficient number of doses will be available for the clinical trial and beyond if necessary,” Dr Ana Maria Henao-Restrepo, the co-lead of R&D blueprint for epidemics at WHO. While Uganda’s outbreak appears to be largely contained and its caseload is declining, Henao-Restrepo said that it is difficult to predict the evolution of an outbreak. She pointed out that when the Ça Suffit (French for Ebola) trial on Ebola was conducted in Guinea, researchers were also unsure about whether enough evidence would be generated and if it was too late to conduct trials. “It’s better for us to work towards generating the evidence and put all our efforts on that rather than trying to second guess the evolution of the outbreak,” said Henao-Restrepo. Dr Mike Ryan, the executive director of WHO’s health emergencies programme, said that there was no time for “if onlys”. “We’re making these investments, and if we don’t get to the required numbers, we’ve built the collaboration, we’ve built the platform to do this,” he stressed, adding that the Ça Suffit trial in Guinea had also helped to build the necessary infrastructure to prevent future outbreaks and increase protection. Apart from the three vaccine candidates, a separate group of experts have also chosen two therapeutics for clinical trials, which are under review. India’s Covaxin still suspended by WHO Controversy over Covaxin is unresolved. The WHO has still not resumed supplies of Covaxin, India’s indigenous vaccine against COVID-19, the global body confirmed. In March, the WHO inspected the manufacturing site of Bharat Biotech, which produces Covaxin and found serious irregularities in the Good Manufacturing Practices (GMP) at the site. This resulted in the global health agency suspending the supply of the vaccine through UN’s procurement agencies in April, stating the company had altered the GMP after it received the Emergency Use Licence (EUL) from WHO. India’s journalists have consistently questioned the discrepancies in the Covaxin clinical trial data since it was released in 2020. However, these questions have always been met with silence from the manufacturer and the Indian Council of Medical Research. There were several irregularities in Covaxin’s clinical trials and that the country’s drug regulator did not clamp down on the discrepancies, according to a recent investigation by Stat News. The report also quoted company executives acknowledging their mistakes. “They also argued they faced “political” pressure to get a vaccine out of the laboratory door as quickly as possible, but denied taking any shortcuts. And they insisted the steps taken to speed the trial were vetted during discussions with regulators,” the report added. Dr Mariangela Simao, WHO assistant director-general for drug access, vaccines and pharmaceuticals, said that the WHO is yet to receive a corrective and prevention action plan (CAPA) from Bharat Biotech. Once they received and reviewed the CAPA, further steps would be taken on the suspension. Image Credits: Photo by Diana Polekhina on Unsplash. 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