Typically, companies wait for data before initiating large-scale manufacture but because of the urgent global need, they are making doses so that they can be ready the moment they are shown to be effective
Kenya has launched its first clinical drug trial which will see Roche’s rheumatoid arthritis drug studied on 11 Covid-19 patients hospitalised with moderate symptoms of the disease
The experimental study, which was launched in Aga Khan University Hospital in Nairobi, will be complete in October and will see the drug known as Actemra studied on its own and not as a combination with other drugs.
“This is a watershed moment for Kenya and us at the Aga Khan University Hospital that we can participate in an international clinical trial that is testing the effectiveness of this novel drug on our patients here,” said Dr Reena Shah, associate professor of medicine in infectious diseases, and principal investigator of the study in Kenya.
Actemra (tocilizumab), which has been developed by Swiss pharmaceutical giant Roche is an injectable drug treatment for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more anti-rheumatic drugs. The pharma, however, declined to reveal the cost of the drug, saying it is yet to be approved, and therefore, “too early to talk about pricing.”
Clinical trials are experiments or observations done in clinical research to determine if a drug or a vaccine is effective in managing a patient’s condition or not.
According to the hospital, the enrolled patients are part of a larger global clinical trial dubbed Empacta (Evaluating Minority Patients with Actemra) study, a Phase III trial which seeks to evaluate the safety and the ability (efficacy) of the drug in Covid-19 patients hospitalised with pneumonia. The first patient was treated on May 14 in New York. It will involve 379 patients enrolled globally.
In international studies, the anti-inflammatory drug has fallen through in a coronavirus trial. In an Italian study, the drug failed to help patients with early-stage Covid-19 pneumonia. The trial, which enrolled 126 patients, about a third of the intended number, was stopped early after an interim analysis raised doubts about the anti-inflammatory medicine’s effectiveness.
“The Italian Investigator-Initiated Studies study is not a Roche study, so we cannot comment on the specifics. There is a growing body of anecdotal evidence and data from clinical studies investigating the potential role of tocilizumab in Covid-19 associated pneumonia. Actemra is not approved by any health authority for use in this setting, making the need for randomised, placebo-controlled studies in this setting even greater,” said the pharmaceutical company.
“The Ministry of Health lends its support to the global trial... being conducted at the Aga Khan University Hospital here in Kenya as one of the study sites. We commend our partners the Aga Khan University Hospital and Roche Kenya in bringing this study to Kenya,” said Dr Rashid Aman, chief administrative secretary at the Health Ministry.
“Disparities and lack of diversity in medical research hold the global community back, and Roche Kenya is proud to help close this gap,” said Dr Beatrice Nyawira, medical director at Roche.
A vaccine is seen as one of the greatest chances that countries have to return to normalcy following widespread disruptions of societies in efforts to contain the novel coronavirus. The African Academy of Sciences says only two per cent of clinical trials globally, for all types of vaccines, take place in African nations.
The AU launched a new consortium aimed at bringing together global vaccine developers, funders, and African organisations that conduct clinical trials. It aims to ensure that more than 10 late-stage trials are conducted in Africa for the development of a Covid-19 vaccine so that there is enough data gathered on the safety and efficacy of vaccine candidates among African populations.
Currently, there is only one clinical trial of a Covid-19 vaccine candidate in sub-Saharan Africa, taking place in South Africa. But the African Union, WHO and other agencies are hoping that the number of clinical trials will increase across the continent to ensure that any successful vaccines that come to market will actually work for African populations and that they will be accessible to people across the continent.
Meanwhile, pharmaceutical giant Pfizer and German biotechnology firm BioNTech will supply the US government with 100 million doses of their coronavirus vaccine known as BNT162 under a $1.95 billion deal, making it the administration’s largest investment yet in a vaccine that has not been proved effective.
The agreement came on top of the US’s vaccine contracts with AstraZeneca for 300 million doses of ChAdOx1, nCoV-19 vaccine developed by Oxford University, and Novavax for at least 100 million doses of its Covid-19 vaccine candidate, NVX-CoV2373.
Through Operation Warp Speed, reports The Washington Post, an effort to fast-track the development of coronavirus countermeasures, the US is investing billions of dollars to reduce the financial risk to companies of scaling up vaccine production before the products are proved to be safe and effective.
Typically, companies wait for data before initiating large-scale manufacturing, but because of the urgent global need, they are making doses to be ready the day they are shown effective.
The Washington Post said Pfizer contract is the fifth large vaccine investment by the US government to help support the research and development or pre-purchase of experimental vaccines, which have also gone to Johnson & Johnson, Moderna, AstraZeneca and Novavax. The government is also working to increase the supply of other essential components, such as glass vials and syringes, and to ramp up vaccine manufacturing capabilities more broadly.
The US agreements were signed after the WHO said political commitment is needed to ensure equitable distribution of a vaccine, once it is ready.
“The most important element here will be to ensure equitable distribution of vaccines through political commitment, especially by our leaders,” said WHO director-general Dr Tedros Adhanom Ghebreyesus.
Experts have warned that the move by US to procure the vaccines runs a risk of excluding people in low-and-middle-income countries.
“This runs a very high risk of excluding the developing world. Certain rich countries are snapping up the candidate vaccines. and may leave people, who by then are at higher risk, with no protection,” said Peter Lurie, president of the Centre for Science in the Public Interest.
During a US congressional hearing on Tuesday, from major pharmaceutical firms would not commit to providing the vaccines at no profit indefinitely, but several companies did say they would price them at a not-for-profit basis during the pandemic. Pfizer did not.